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Etanercept

  • Biologic
  • Given by a clinician
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Etanercept does in the body

Rheumatoid arthritis, psoriasis and related long-term inflammatory diseases

Your cells listen for TNF using a receptor on their surface. Etanercept is that receptor, cut off the cell and glued to the tail end of an antibody so it stays in the blood instead of being cleared in minutes. It floats around as a decoy: TNF binds it and is taken out of circulation before it reaches a real cell. Nothing is being blocked or destroyed. The signal is simply being intercepted.

What happened in people

ACR20 at six months: 59% on etanercept 25 mg versus 11% on placebo

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.

The limit that matters most

That neutralising a cytokine that is elevated in a disease will treat that disease — sepsis and heart failure both falsified this

Where it acts
Extracellular fluid, inflamed synovium and skin
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as protein.

    FDA substance registry · OP401G7OJC · read 2026-08-29

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

A limit recorded against this substance. Not signed off as a reviewed claim.

The four opening statements run to 96 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

Confidence interval

A confidence interval is the range the true answer is likely to sit in.

A picture of it, and where the picture fails

It is like a weather forecast giving a range rather than one number.

Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.

What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.

An interval estimate that would contain the true parameter in a stated proportion of repeated studies.

Receptor

A receptor is a part of a cell that a signal fits into.

A picture of it, and where the picture fails

A receptor is like a lock waiting for one key.

Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.

What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.

A protein that binds a specific ligand and converts that binding into a cellular response.

Pathway

A pathway is a chain of steps inside a cell, each one setting off the next.

A picture of it, and where the picture fails

A pathway is like a row of dominoes.

Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.

What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.

An ordered series of molecular interactions producing a defined cellular change.

What happened in peopleRead from sources, not yet reviewed

What was measured, goal by goal

One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.

Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.

There is no single score. A strong test result and a weak life result are different facts.

Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
Blood sugarNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved2 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Blood sugar
hba1c less than 7 0 and free of severe hypoglycemic events; insulin independent

Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.

What each mark on this table means
Nothing in the sources checked
No registered study lists a life outcome for this goal.
Only a number moved
2 registered test measure.
Not recorded
Harms were not a registered measure for this goal.
Waiting for a reviewer
Who was studied is listed further down the page.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

ACR20 and ACR50 response at three and six months

The study showed what it set out to show

Who was studied
Moreland 1999 registration trial (predates ClinicalTrials.gov registration)
How many people
234
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
p < 0.001 (ACR20 59% versus 11% at six months)
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous injection: prefilled syringe, autoinjector, single-dose vial, or cartridge with a reusable autoinjector

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

ACR-N area under the curve over 24 weeks and modified Sharp score change at 52 weeks

The study showed what it set out to show

Who was studied
TEMPO (Klareskog 2004)
How many people
686
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
p < 0.0001 for combination versus each monotherapy
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous injection: prefilled syringe, autoinjector, single-dose vial, or cartridge with a reusable autoinjector

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

All-cause mortality at 28 days in septic shock

The study did not show it

Who was studied
Soluble TNF Receptor Sepsis Study (Fisher 1996)
How many people
141
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
p = 0.02 for a dose-response relation in the direction of harm
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. Mortality rose monotonically with dose: 30%, 30%, 48%, 53%. This trial is rarely cited in materials about the marketed product.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous injection: prefilled syringe, autoinjector, single-dose vial, or cartridge with a reusable autoinjector

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

Death or hospitalisation for chronic heart failure

The study did not show it

Who was studied
RENEWAL, pooling RECOVER and RENAISSANCE (Mann 2004)
How many people
2048
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
p = 0.33 (relative risk 1.1, 95% CI 0.91-1.33); both trials stopped early for futility
Repeated elsewhere
Replicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous injection: prefilled syringe, autoinjector, single-dose vial, or cartridge with a reusable autoinjector

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

Clinical response at week 4 by Crohn Disease Activity Index

The study did not show it

Who was studied
Sandborn 2001 Crohn disease trial
How many people
43
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
p = 0.763 (39% etanercept versus 45% placebo)
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous injection: prefilled syringe, autoinjector, single-dose vial, or cartridge with a reusable autoinjector

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 5 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.3 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.3 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it changes in the bodyRead from sources, not yet reviewed

The path through the body

From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.

Where a source records it acting

  • Immune and lymphatic system: A dimeric soluble form of the p75 TNF receptor that binds TNF, a cytokine the label records as involved in normal inflammatory and immune responses, rendering it biologically inactive

    US prescribing information · a002b40c-097d-47a5-957f-7a7b1807af7f · read 2026-08-28

  • Joints: Blocks TNF, which the label records as playing an important role in the inflammatory processes of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis and the resulting joint pathology

    US prescribing information · a002b40c-097d-47a5-957f-7a7b1807af7f · read 2026-08-28

  1. Start

    Etanercept

    What a person takes: Subcutaneous injection: prefilled syringe, autoinjector, single-dose vial, or cartridge with a reusable autoinjector.

    The measurement behind this step

    Clear, colourless, preservative-free solution formulated at pH 6.3 with L-arginine, sodium chloride and sucrose. A lyophilised multiple-dose vial presentation exists and is reconstituted with bacteriostatic water containing benzyl alcohol, which is why that presentation is not for neonates.

  2. Getting in

    Injected under the skin, once or twice a week

    A subcutaneous injection from a prefilled syringe, autoinjector or reusable device, typically 50 mg once a week.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Subcutaneous bioavailability is roughly 60% with a terminal half-life of about 70 to 100 hours, considerably shorter than an IgG monoclonal antibody because the fusion protein engages FcRn recycling less efficiently.

  3. Getting in

    The Fc tail keeps it in circulation

    The antibody tail is not there to attack anything. It is there so the molecule lasts days instead of minutes.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    The IgG1 CH2 and CH3 domains plus hinge, without CH1, provide FcRn-mediated recycling from the endosome and force dimerisation. Omitting CH1 removes the light chain requirement and the assembly problem that would come with it.

  4. What it acts on

    Two receptor arms capture TNF trimers

    Each molecule carries two copies of the natural TNF receptor, so it grips the signal much more tightly than a single loose receptor could.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    TNF-alpha is a homotrimer with three receptor-binding grooves. The dimeric decoy engages more than one groove, giving an avidity gain of orders of magnitude over the monomeric soluble p75 receptor. Etanercept also binds lymphotoxin alpha, which the anti-TNF antibodies do not.

  5. The change it makes

    Bound TNF never reaches a cell

    Captured TNF cannot dock onto a real receptor on a real cell, so the alarm signal is never received.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Competitive sequestration of soluble TNF prevents engagement of TNFR1 and TNFR2 on synoviocytes, endothelium and leucocytes. Etanercept binds transmembrane TNF less stably than an anti-TNF antibody and does not induce reverse signalling or apoptosis in mucosal T cells, which is the leading explanation for its failure in Crohn disease.

  6. The change it makes

    The inflammatory cascade downstream shuts down

    Without the TNF signal, the cells stop calling in reinforcements and stop producing the enzymes that dissolve cartilage.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    NF-kB activation falls in synovial fibroblasts and macrophages, reducing IL-1, IL-6, GM-CSF, matrix metalloproteinase and adhesion molecule expression, and lowering RANKL-driven osteoclast activation at the bone-pannus interface.

  7. What that does for a person

    Symptoms fall, and erosion stops on the X-ray

    Joints hurt and swell less within weeks. On serial X-rays over a year, the structural damage stops advancing and on combination therapy it went slightly backwards.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    ACR20 response 59% versus 11% at six months against placebo. Modified Sharp score change at 52 weeks was -0.54 for etanercept plus methotrexate against +2.80 for methotrexate alone, meaning the combination arm ended the year with slightly less measured damage than it started with.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

What it would be like to takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

No registered study measured anything of this kind.

Measured

Things only a test, a scale or a device shows.

  • c reactive protein
  • hba1c less than 7 0 and free of severe hypoglycemic events
  • insulin independent

Meaningful

Things that change how a life goes, not only a number.

  • total exposure adjusted rate of deaths
  • death
  • who experienced relapse by 6 months

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (34)
  • changes from baseline in laboratory values
  • occurrence of at least one adverse event
  • tolerability
  • average change in oral temperature from baseline to week 52
  • average change in respiration rate from baseline to week 52
  • average change in pulse comparing baseline to week 52
  • adverse events
  • adverse events and serious adverse events
  • year 1 having an annualized modified total sharp 0 5
  • response rate
  • clinical efficacy
  • complete response at day 28 of therapy
  • disease activity erythrocyte sedimentation rate
  • methacholine pc20
  • albumin
  • treatment emergent adverse events or serious adverse events
  • at least one serious infection through week 24
  • any infections or any grade 3/4 infections through week 24
  • maximum duration of infections through week 24
  • adverse events and serious adverse events through week 24

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What it would be like to takeRead from sources, not yet reviewed

How long anything takes

Nine different lengths of time that get confused with each other. None of them is worked out from another.

  1. Before anything is noticed. RNAWiki does not store this separately, and never works it out from another figure on this page.

  2. Before a test result moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  3. Before performance moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  4. How long the result was watched. No finished study window is recorded for a study that tested this substance.

  5. How long people took it. How long people actually took it is not stored. The study window is not the same thing.

  6. How long people were followed. Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.

  7. How fast the body clears it. 102 ± 30 hours hours

    Read from the label, which states: “After administration of 25 mg of Enbrel by a single SC injection to 25 patients with RA, a mean ± standard deviation half-life of 102 ± 30 hours was observed with a clearance of 160 ± 80 mL/hr.”

  8. How long effects linger. RNAWiki does not store this separately, and never works it out from another figure on this page.

  9. Beyond the studies. Nothing is recorded about the long term.

    The longest finished study sets the edge of what anyone measured.

A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Adults and children with moderate to severe inflammatory arthritis or psoriasis that methotrexate or another conventional agent has not controlled.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “Enbrel has been studied in 69 children with moderately to severely active polyarticular JIA 2 to 17 years of age.”

    US prescribing information · a002b40c-097d-47a5-957f-7a7b1807af7f · read 2026-08-30

  • On older people, the label states: “A total of 480 RA patients ages 65 years or older have been studied in clinical trials.”

    US prescribing information · a002b40c-097d-47a5-957f-7a7b1807af7f · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Available studies with use of etanercept during pregnancy do not reliably support an association between etanercept and major birth defects.”

    US prescribing information · a002b40c-097d-47a5-957f-7a7b1807af7f · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Data from published literature show that etanercept is present in low levels in human milk but is not detected in the plasma of breastfed infants (see Data ) .”

    US prescribing information · a002b40c-097d-47a5-957f-7a7b1807af7f · read 2026-08-30

Where the result stopped carrying

  • Septic shock, where higher doses were associated with higher mortality
  • Chronic heart failure, where RECOVER and RENAISSANCE were both stopped early for futility
  • Crohn disease, where a randomised trial found it no better than placebo
  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Given by a clinician

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Subcutaneous injection: prefilled syringe, autoinjector, single-dose vial, or cartridge with a reusable autoinjector

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S1, S6.

No source is stored against this line.

What is in the pack

3 with L-arginine, sodium chloride and sucrose. A lyophilised multiple-dose vial presentation exists and is reconstituted with bacteriostatic water containing benzyl alcohol, which is why that presentation is not for neonates.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

The recorded stepping schedule

  • What follows is the schedule printed on the label, recorded as it is written there. It is a record of what was done, not a recommendation.

    US prescribing information · a002b40c-097d-47a5-957f-7a7b1807af7f · read 2026-08-28

  • Starting dose (adult plaque psoriasis): 50 mg twice weekly for 3 months

    US prescribing information · a002b40c-097d-47a5-957f-7a7b1807af7f · read 2026-08-28

  • Maintenance dose (adult plaque psoriasis): 50 mg once weekly

    US prescribing information · a002b40c-097d-47a5-957f-7a7b1807af7f · read 2026-08-28

What it would be like to takeRead from sources, not yet reviewed

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Worth asking a clinician aboutWritten into the record from the studies named on this page

Boxed warning for serious infections, including tuberculosis, bacterial sepsis and invasive fungal infection, and for lymphoma and other malignancies in children and adolescents. Latent tuberculosis testing is required before starting. Demyelinating disease, new or worsening heart failure, cytopenias and lupus-like syndromes are labelled risks.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

Reports sent to a regulator

  • These are reports people sent to a regulator. They do not show the medicine caused the reaction.
  • Nobody counted how many people took the medicine and reported nothing.
  • The same event can be reported more than once, and many reports are incomplete.
  • News coverage, lawsuits and new warnings change how often people report.
  • A count is not a rate and not a risk.

Etanercept appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 229143 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • injection site pain — 36582 reaction mentions
  • arthralgia — 32254 reaction mentions
  • pain — 28949 reaction mentions
  • injection site erythema — 28046 reaction mentions
  • rheumatoid arthritis — 26299 reaction mentions
  • psoriasis — 17688 reaction mentions
  • injection site pruritus — 15404 reaction mentions
  • injection site swelling — 15132 reaction mentions
  • injection site reaction — 14682 reaction mentions
  • joint swelling — 14107 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Subcutaneous injection: prefilled syringe, autoinjector, single-dose vial, or cartridge with a reusable autoinjector

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

3 with L-arginine, sodium chloride and sucrose. A lyophilised multiple-dose vial presentation exists and is reconstituted with bacteriostatic water containing benzyl alcohol, which is why that presentation is not for neonates.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on which forms are sold and how they compare.

No source is stored against this line.

What is recorded as being sold

  • 6 products list this as an active ingredient in the United States drug directory. 6 of them contain it and nothing else.

    FDA National Drug Code directory · 58406-021 · read 2026-08-29

  • They are sold as injection, powder, lyophilized, for solution and solution, taken subcutaneous.

    FDA National Drug Code directory · 58406-021 · read 2026-08-29

  • The regulator's established pharmacologic class for it is tumor necrosis factor blocker [epc] and tumor necrosis factor receptor blocking activity [moa].

    FDA National Drug Code directory · 58406-021 · read 2026-08-29

  • 1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · a002b40c-097d-47a5-957f-7a7b1807af7f · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · a002b40c-097d-47a5-957f-7a7b1807af7f · read 2026-08-29

  • Enbrel is injection: solution in a single-dose prefilled syringe, a single-dose prefilled sureclick autoinjector, a single-dose vial or an enbrel mini single-dose prefilled cartridge; also a lyophilized powder in a multiple-dose vial for reconstitution at 25 mg/0.5 mL and 50 mg/mL solution; 25 mg lyophilized powder for reconstitution, recorded as prescription product; fda label in effect 2026-05-11 in the United States.

    US prescribing information · a002b40c-097d-47a5-957f-7a7b1807af7f · read 2026-08-28

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Etanercept studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

Claims that go past the evidence

Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.

Goes past the evidence

That neutralising a cytokine that is elevated in a disease will treat that disease — sepsis and heart failure both falsified this

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That TNF blockers are interchangeable; etanercept fails in inflammatory bowel disease where the antibodies work

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That an approved biosimilar means an available biosimilar; two have been approved in the US and neither is sold there

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Etanercept are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Every line above can be traced to the study named beside it. Follow the link and read it.

Registration trial: 59% ACR20 at six months against 11% on placebo
In plain words
In 234 people whose rheumatoid arthritis had not responded to conventional drugs, roughly six in ten improved by at least 20% on the standard composite measure, against about one in ten on placebo.
What was measured
ACR20 at six months 59% versus 11% (p < 0.001); ACR50 40% versus 5%
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Randomised, double-blind, placebo-controlled trial with blinded joint assessors across 13 North American centres. Twice-weekly subcutaneous etanercept 10 mg or 25 mg or placebo for six months. At three months 62% of the 25 mg group versus 23% of placebo achieved ACR20 (p < 0.001). At six months 59% versus 11% achieved ACR20 (p < 0.001) and 40% versus 5% achieved ACR50 (p < 0.01). Mean reduction in tender and swollen joint counts at six months was 56% and 47% on 25 mg versus 6% and -7% on placebo.
Source
Moreland LW et al. Ann Intern Med 1999;130:478-486
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
TEMPO: joint damage stopped and partially reversed on combination therapy
In plain words
In 682 patients followed for a year with serial X-rays, the combination of etanercept and methotrexate did not merely slow joint destruction. The average damage score went slightly backwards.
What was measured
Modified Sharp score change at 52 weeks: -0.54 combination versus +2.80 methotrexate alone
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Double-blind randomised trial of etanercept 25 mg twice weekly, oral methotrexate up to 20 mg weekly, or the combination. Primary efficacy endpoint ACR-N area under the curve over 24 weeks: 18.3%-years for combination versus 14.7% for etanercept alone (p < 0.0001) and 12.2% for methotrexate alone (p < 0.0001). Primary radiographic endpoint, change in modified Sharp score to week 52: -0.54 (95% CI -1.00 to -0.07) for combination, 0.52 for etanercept alone and 2.80 for methotrexate alone. Infection and adverse event rates were similar across groups.
Source
Klareskog L et al. Lancet 2004;363:675-681
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
In septic shock the same molecule killed people, dose-dependently
In plain words
TNF blockade was tried first in sepsis, where TNF is the central mediator. Mortality rose with dose: 30% on placebo, 48% on the middle dose, 53% on the high dose.
What was measured
That because TNF drives the pathology of septic shock, neutralising TNF will improve survival in septic shock
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Randomised, double-blind, placebo-controlled multicentre trial of a single intravenous infusion of TNFR:Fc at 0.15, 0.45 or 1.5 mg/kg in 141 patients with septic shock. Primary endpoint all-cause 28-day mortality. Deaths: 10 of 33 on placebo (30%), 9 of 30 on low dose (30%), 14 of 29 on middle dose (48%) and 26 of 49 on high dose (53%); p = 0.02 for the dose-response relation. Baseline severity differences did not account for the excess. The paper concluded that higher doses appear to be associated with increased mortality.
Source
Fisher CJ Jr et al. N Engl J Med 1996;334:1697-1702
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Two heart failure trials were stopped early for futility
In plain words
TNF is elevated in heart failure, so blocking it looked promising. Two trials totalling over 2,000 patients were stopped early because there was no benefit.
What was measured
That elevated TNF in heart failure is causal and therefore a treatable target
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
RECOVER randomised 1,123 patients with NYHA class II to IV heart failure and ejection fraction 0.30 or below to placebo or etanercept 25 mg weekly or twice weekly. RENAISSANCE randomised 925 patients to placebo or etanercept 25 mg twice or three times weekly. Both were terminated prematurely on prespecified stopping rules for lack of benefit. Etanercept had no effect on clinical status in RENAISSANCE (p = 0.17) or RECOVER (p = 0.34). The prespecified pooled analysis, RENEWAL, gave a relative risk of 1.1 (95% CI 0.91-1.33, p = 0.33) for death or heart failure hospitalisation.
Source
Mann DL et al. Circulation 2004;109:1594-1602
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
It does not work in Crohn disease, and the antibodies do
In plain words
A trial in 43 people with active Crohn disease found 39% responded to etanercept and 45% to placebo. Anti-TNF antibodies work well in the same disease. Blocking TNF is not one thing.
What was measured
That drugs described as TNF blockers are interchangeable because they share a target
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Eight-week randomised, double-blind, placebo-controlled trial of subcutaneous etanercept 25 mg twice weekly in 43 patients with moderate to severe Crohn disease. Clinical response at week 4, defined as a fall of at least 70 points in the Crohn Disease Activity Index or an index below 150, occurred in 39% of etanercept patients versus 45% of placebo patients (p = 0.763). Adverse event rates were similar. Infliximab and adalimumab, which are anti-TNF monoclonal antibodies, are effective in the same disease. The mechanistic candidates for the difference include binding to transmembrane TNF and induction of apoptosis in lamina propria T cells, neither of which etanercept does the way an antibody does.
Source
Sandborn WJ et al. Gastroenterology 2001;121:1088-1094
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Approved biosimilars that no US patient can buy
In plain words
Two etanercept biosimilars have been approved by the FDA, one in 2016 and one in 2019. Neither has launched in the United States, because of patents on a drug first approved in 1998.
What was measured
Two US biosimilar approvals, 2016 and 2019; zero US launches
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Erelzi (etanercept-szzs, BLA 761042) was approved 30 August 2016 and Eticovo (etanercept-ykro, BLA 761066) on 25 April 2019. Neither is marketed in the United States. Etanercept biosimilars have been available in Europe since 2016. The gap between regulatory approval and patient access here is a legal artefact and not a scientific one, and it is the clearest illustration in this modality group that biosimilar approval and biosimilar availability are different events.
Source
Drugs@FDA, BLA 761042 (Erelzi) and BLA 761066 (Eticovo)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim

Where else this substance is registered

RxNorm concept
214555

Checks this page had to pass

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  • Passed

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    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

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    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S1, S6.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 1 approved application covers products containing this substance. The earliest was BLA103795, approved 19981102 to IMMUNEX.

    Drugs@FDA application register · BLA103795 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · BLA103795 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20030102.

    FDA National Drug Code directory · 58406-021 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

3 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

The older medicine-wide conclusion held in this record

Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.

A dimeric decoy receptor built from the p75 TNF receptor fused to an antibody Fc tail, which soaks up TNF before cells see it; 59% of patients reached an ACR20 response at six months against 11% on placebo, and the same molecule increased mortality when it was tried in septic shock.

Recorded evidence blocks (12)

What did Etanercept's largest trial (105711 people) and its longest (32 years) measure?


105711 people in Etanercept's largest registered study, 32 years in its longest registered window, measuring Crude Incidence Rate of All-Cause Mortality. ClinicalTrials.gov · 2026-09-01

99 phase4, 90 phase3, 71 phase2, 68 na or unstated, 38 phase1, 19 na, 3 early phase1; NCT04725422; 2050-08; no ageing endpoint recorded. Last human test completed 2025, NCT04254627.

Interpretation These counts include studies where Etanercept was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase4
    99
  • phase3
    90
  • phase2
    71
  • na or unstated
    68
  • phase1
    38
  • na
    19
2 more recorded rows
  • early phase1
    3
  • Last recorded human test NCT04254627
    2025-09-30

recorded 2026-09-01 · last checked 2026-09-04

From mouse to human: where has Etanercept shown lifespan?


mouse: lifespan, rat: mechanism-only and human: lifespan (364): the rungs where Etanercept has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Crude Incidence Rate of All-Cause Mortality — the recorded outcome words.

Yeast C. elegans Drosophila Mouse lifespanRat mechanism-onlyDog Non-human primate Human lifespan
Show the evidence
  • mouse
    lifespan
  • rat
    mechanism-only
  • human NCT01646385
    lifespan; Crude Incidence Rate of All-Cause Mortality; 364

recorded 2026-09-01 · last checked 2026-09-04

32 of Etanercept's trials stopped: safety, accrual/recruitment, sponsor decision unspecified, other?


safety (3), accrual/recruitment (17), sponsor decision unspecified (2) and other (10): Etanercept's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"It was not feasible to recruit required sample size from two clinical sites."; 32 of 364 registered studies

Show the evidence

Trial

  • NCT00031551
    terminated; "It was not feasible to recruit required sample size from two clinical sites."
  • NCT00035958
    terminated; "Incorporating the recommendations of the NIH-formed DSMB in the study procedures would make the project budget over the limit for this funding mechanism."
  • NCT00078806
    terminated; "the study was terminated because of slow enrollment"
  • NCT00127387
    terminated; "PI moved to Oregon"
  • NCT00285779
    terminated; "Slow recruitment"
  • NCT00293202
    terminated; "We were unable to recruit sufficient patients within the confines of our budget considering the restrains on our recruitment criteria"
14 further recorded trials
  • NCT00298272
    terminated; "Sponsor decided to end long term extension phase for business reasons unrelated to safety."
  • NCT00447265
    terminated; "The perceived risk-benefit ratio for individuals with early active RA"
  • NCT00477191
    terminated; "Difficulty in recruitment."
  • NCT00509600
    terminated; "Slow enrollment; study terminated."
  • NCT00784966
    withdrawn; "University decision."
  • NCT00796705
    terminated; "Lack of Enrollment"
  • NCT00832364
    withdrawn; "Business decision. No patients were enrolled"
  • NCT01009879
    withdrawn; "No subjects were enrolled"
  • NCT01030120
    withdrawn; "Unable to complete agreement with sponsor"
  • NCT01294397
    terminated; "Lack of enrollment."
  • NCT01394913
    withdrawn; "Sponsor decision"
  • NCT01411215
    terminated; "See termination reason in detailed description."
  • NCT01543204
    terminated; "Business decision due to slow enrollment"
  • NCT01602302
    terminated; "low recruitment"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Etanercept used 50 mg Etanercept — over how long?


studies of Etanercept used the recorded amount. ClinicalTrials.gov · 2026-09-01

15 recorded entries; human; also "50 mg Etanercept", "Etanercept 50 mg", "Etanercept 25mg"

Show the evidence

human

  • NCT00249041
    50 mg Etanercept
  • NCT00454584
    Etanercept 50 mg
  • NCT00844142
    Etanercept 25mg
  • NCT00936065
    Etanercept 50mg followed by 25mg
  • NCT00967538
    etanercept 50 mg
  • NCT01597245
    50 mg etanercept
9 more recorded rows
  • human NCT01725620
    LBEC0101 (Etanercept 25mg)
  • human NCT01725620
    Enbrel (Etanercept 25mg)
  • human NCT02364479
    25mg etanercept
  • human NCT02960035
    50mg etanercept
  • human NCT03033095
    Etanercept ® 50 mg
  • human NCT04077957
    Etanercept (50mg per week, for 4 weeks)
  • human NCT04077957
    Etanercept (50mg per week, for 2 weeks)
  • human NCT04077957
    Etanercept (50mg per week)
  • human NCT07386587
    Injection, Etanercept, 25 Mg (Code May Be Used for Medicare When Drug Administered Under the Direct Supervision of A Physician, Not for Use When Drug is Self Administered)

recorded 2026-09-01 · last checked 2026-09-04

Etanercept's half-life is 102 ± 30 hours — which schedules were studied?


102 ± 30 hours, the half-life Etanercept's label states. openfda-label · a002b40c-097d-47a5-957f-7a7b1807af7f · 2026-08-28

Show the evidence
  • half life
    102 ± 30 hours hours; After administration of 25 mg of Enbrel by a single SC injection to 25 patients with RA, a mean ± standard deviation half-life of 102 ± 30 hours was observed with a clearance of 160 ± 80 mL/hr.

recorded 2026-08-28 · last checked 2026-09-04

Which of 48 week change in das28, adiponectin and adverse events did Etanercept's trials measure?


48 week change in das28, adiponectin and adverse events lead 40 outcome terms across Etanercept's trials. ClinicalTrials.gov · 2026-09-01

tolerability, average change in oral temperature from baseline to week 52, average change in respiration rate from baseline to week 52, average change in pulse comparing baseline to week 52, adverse events and adverse events and serious adverse events follow.

Show the evidence
  • changes from baseline in laboratory values
    1
  • c reactive protein
    1
  • occurrence of at least one adverse event
    1
  • tolerability
    1
  • average change in oral temperature from baseline to week 52
    1
  • average change in respiration rate from baseline to week 52
    1
14 more recorded rows
  • average change in pulse comparing baseline to week 52
    1
  • adverse events
    1
  • adverse events and serious adverse events
    1
  • year 1 having an annualized modified total sharp 0 5
    1
  • response rate
    1
  • clinical efficacy
    1
  • complete response at day 28 of therapy
    1
  • disease activity erythrocyte sedimentation rate
    1
  • methacholine pc20
    1
  • albumin
    1
  • treatment emergent adverse events or serious adverse events
    1
  • at least one serious infection through week 24
    1
  • any infections or any grade 3/4 infections through week 24
    1
  • maximum duration of infections through week 24
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Etanercept's 18 ongoing trials reports first?


18 registered trials of Etanercept are open; earliest completion 2025-02-28. ClinicalTrials.gov · 2026-09-01

Treatment Emergent Adverse Events; Psoriasis Area Severity Index (PASI); latest 2050-08

Show the evidence

Trial

  • NCT00679042
    "Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol"; n 21; "Treatment Emergent Adverse Events"; 2026-06-14
  • NCT01706692
    "Swiss Dermatology Network of Targeted Therapies (SDNTT)"; n 1121; "Psoriasis Area Severity Index (PASI)"; 2032-03-15
  • NCT03414502
    "Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response"; n 400; "Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis"; 2029-03
  • NCT03451851
    "A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants"; n 120; "Part 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16"; 2026-12-18
  • NCT03728478
    "STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS"; n 260; "Clinical remission on or off medication at 12 months"; 2025-02-28
  • NCT03976245
    "Advanced Therapeutics in Rheumatoid Arthritis (RA)"; n 144; "Retention Rates"; 2025-03
12 further recorded trials
  • NCT03997786
    "A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis"; n 135; "Part A - Dose determination for pediatrics population 12 to <18-year-old age group"; 2031-08-05
  • NCT04066348
    "TNF-α Treatment of Blast-Induced Tinnitus"; n 88; "Tinnitus Functional Index (TFI)"; 2026-09
  • NCT04725422
    "CHronic Nonbacterial Osteomyelitis International Registry"; n 2000; "The change of CNO disease activity score"; 2050-08
  • NCT05305066
    "Stand UP to Rheumatoid Arthritis (SUPRA)"; n 75; "Rate of recruitment at two RA referral centers over 12 months"; 2030-12
  • NCT06011889
    "Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome"; n 60; "Change in the scope of disease activity as assessed by the patient- a decrease in the overall disease activity on the Visual Analogue Scale by min. 50 percent and a decrease in pain assessed by the patient on the Visual Analogue Scale by…"; 2028-10-18
  • NCT06016517
    "Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis"; n 18; "Change in Disease Activity Score (DAS) 28"; 2028-12-15
  • NCT06596772
    "A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis"; n 458; "American College of Rheumatology 20% Response Criteria (ACR20)"; 2026-01
  • NCT06707194
    "Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis"; n 340; "Patient ASAS40 remission rate after 12 weeks of patient medication"; 2027-07-31
  • NCT07138898
    "Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty"; n 80; "Incidence of wound complications"; 2028-01
  • NCT07184853
    "Ruxolitinib Plus Etanercept vs Ruxolitinib for Steroid-Refractory Severe Acute GVHD"; n 122; "Overall Response Rate (ORR) at Day 28"; 2028-09-25
  • NCT07352566
    "Utilization of a Microdevice for Psoriasis and Atopic Dermatitis"; n 10; "Number of participants with adverse events"; 2030-06-01
  • NCT07386587
    "Methotrexate Alone vs Methotrexate + Etanercept for Minimal/Low Disease Activity in Juvenile Idiopathic Arthritis"; n 60; "Achievement of Minimal/Low Disease Activity Level in Polyarticular JIA"; 2026-07-27

recorded 2026-09-01 · last checked 2026-09-04

Which 118 trials of Etanercept posted no result?


Posted no result
118 of 118 completed trials
Registrations
NCT00393471, NCT00317499, NCT00421915, NCT00001862, NCT00005007 and NCT00029328, and 112 more
Completion dates
oldest 2001-10; newest 2024-07-15
Show the evidence

Trial

  • NCT00393471
    2001-10
  • NCT00317499
    2002-07
  • NCT00421915
    2002-08
  • NCT00001862
    2003-03
  • NCT00005007
    2003-03
  • NCT00029328
    2003-09
14 further recorded trials
  • NCT00001954
    2003-11
  • NCT02799498
    2004-01
  • NCT00001955
    2004-02
  • NCT00132418
    2004-02
  • NCT00048373
    2004-04
  • NCT00006070
    2004-05
  • NCT00205231
    2004-05-01
  • NCT00421980
    2004-07
  • NCT00276029
    2004-09
  • NCT00091741
    2004-10
  • NCT00418548
    2005-02
  • NCT00546533
    2005-02
  • NCT00001901
    2005-03
  • NCT00063869
    2005-03

At the median, Etanercept's trials enrolled 92 people — anything larger?


Median enrolment
92
Largest enrolment
105711
Registered trials counted
357

What do 229143 spontaneous reports say about Etanercept — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Etanercept appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 229143 reaction mentions were counted: injection site pain 36582; arthralgia 32254; pain 28949; injection site erythema 28046. open-targets-adr · CHEMBL1201572 · 2026-06-24

Show the evidence
  • injection site pain
    36582
  • arthralgia
    32254
  • pain
    28949
  • injection site erythema
    28046
  • rheumatoid arthritis
    26299
  • psoriasis
    17688
4 more recorded rows
  • injection site pruritus
    15404
  • injection site swelling
    15132
  • injection site reaction
    14682
  • joint swelling
    14107

recorded 2026-06-24 · last checked 2026-09-04

Was Etanercept studied with fasting and exercise?


fasting and exercise are named in Etanercept's label sentences: "Etanercept significantly improved fasting glucose (treatment effect vs. placebo over 6 months, -10.8 ± 4.4%, P = 0.02)." openfda-label+europepmc · 2010-11-03

2 recorded statements; fasting, exercise

Show the evidence
  • fasting
    Etanercept significantly improved fasting glucose (treatment effect vs. placebo over 6 months, -10.8 ± 4.4%, P = 0.02).
  • exercise
    On two separate occasions at least 6 weeks apart, etanercept 25 mg or vehicle was given subcutaneously 1 hour before unaccustomed exercise to 12 healthy men in a randomised double-blind cross-over format.

recorded 2010-11-03 · last checked 2026-09-04

What is recorded about Etanercept and mTOR?


"Using D-galactose (D-gal)-treated NRK-52E cells and aged rats, we assessed rhein's effects with/without mTOR regulators (rapamycin/MHY1485) or etanercept (TNF-α inhibitor)." — where Etanercept and mTOR appear together. Europe PMC · pathway abstract search · 2026-06-17

mTOR, autophagy, NAD+, AMPK, sirtuin; PMID 41669682, 42309492, 40612947, 34927459

Show the evidence

mTOR

  • PMID 41669682
    "Using D-galactose (D-gal)-treated NRK-52E cells and aged rats, we assessed rhein's effects with/without mTOR regulators (rapamycin/MHY1485) or etanercept (TNF-α inhibitor)."
  • PMID 42309492
    "Etanercept inhibited MH7A cell viability, promoted apoptosis and ferroptosis, and exerted anti-inflammatory effects, which were abolished by miR-125a-3p inhibitor, partially via the PI3K/AKT/mTOR pathway. miR-125a-3p was downregulated in MH7A cells and RA patients but upregulated following etanercept treatment."
  • autophagy PMID 40612947
    "Clinical studies demonstrate that TNF-α inhibitors (etanercept, infliximab), IL-6 blockade (tocilizumab), and autophagy modulators effectively reduce flares and inflammation in treatment-resistant GA."
  • mTOR PMID 34927459
    "Induction with T-cell depleting agents and the TNF-α inhibitor etanercept and maintenance systemic immunosuppression with mTOR inhibitors in combination with calcineurin inhibitors also appear advantageous, but concerns remain over immunosuppressive toxicity."
  • NAD+ PMID 18493620
    "Importantly, a specific competitive inhibitor of NAMPT effectively reduced arthritis severity with comparable activity to etanercept, and decreased pro-inflammatory cytokine secretion in affected joints."
  • AMPK PMID 25345753
    "These strategies include: approaches targeting IKK-b-NF-kB (salicylates, salsalate), TNF-α (etanercept, infliximab, adalimumab), IL-1β (anakinra, canakinumab) and IL-6 (tocilizumab), AMP-activated protein kinase activators, sirtuin-1 activators, mammalian target of rapamycin inhibitors and C-C motif chemokine receptor 2 antagonists."
  • sirtuin PMID 25345753
    "These strategies include: approaches targeting IKK-b-NF-kB (salicylates, salsalate), TNF-α (etanercept, infliximab, adalimumab), IL-1β (anakinra, canakinumab) and IL-6 (tocilizumab), AMP-activated protein kinase activators, sirtuin-1 activators, mammalian target of rapamycin inhibitors and C-C motif chemokine receptor 2 antagonists."

recorded 2026-06-17 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201572
CAS number
185243-69-0
RxCUI
214555
Trade name
Benepali, Enbrel, Lifmior, Nepexto, ENBREL [PURPLE BOOK CDER], Fubelv
Also called
Chs-0214, Davictrel, Dwp-422, Enia-11, Erelzi, Etanercept biosimilar (gp-2015), Etanercept szzs, Etanercept ykro, Eticovo, Hd-203, L04ab01, Lbec-0101
Development code
GP-2015, GP2015, GP2015C, HD203, LBEC0101, RHU TNFR:FC, SB-4, SB4, TNFR-IMMUNOADHESIN, YLB-113, YLB113
Sources (11)

Sources

  • ClinicalTrials.gov clinicaltrials.gov ·
  • ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
  • this record's own fields 2,3,5 ·
  • Europe PMC dose-response search ·
  • Europe PMC pathway abstract search ·
  • Europe PMC search ·
5 more sources

ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 11 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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