This page shows what was measured, who it was measured in, and what that does not settle.
What Siltuximab does in the body
From the FDA-approved label: Siltuximab binds human IL-6 and prevents the binding of IL-6 to both soluble and membrane-bound IL-6 receptors.
IL-6 has been shown to be involved in diverse normal physiologic processes such as induction of immunoglobulin secretion. Overproduction of IL-6 has been linked to systemic manifestations in patients with MCD.
Why people take it. SYLVANT is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
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 · T4H8FMA7IM · read 2026-08-29
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 88 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.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
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.
What happened in people◇Read 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 24 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.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Healthy ageing
…Waiting for a reviewer1 registered study measure of this kind. No reviewed result yet.
∅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.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅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
Healthy ageing
28 day all cause mortality
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
… Waiting for a reviewer
1 registered study measure of this kind. No reviewed result yet.
∅ Nothing in the sources checked
No registered study lists a performance measure for this goal.
— Not recorded
Harms were not a registered measure for this goal.
What happened in people◇Read 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.
28-day all-cause mortality
✗ The study did not show it
Who was studied
NCT04616586
How many people
555
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Time to Clinical Improvement
✗ The study did not show it
Who was studied
NCT04330638
How many people
342
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Percentage of Participants with Complete Remission (CR) in Study Part 1 and Part 2
✗ The study did not show it
Who was studied
NCT07570173
How many people
340
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Progression-free Survival
✗ The study did not show it
Who was studied
NCT00401843
How many people
307
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
rate of stringent complete response (sCR)
✗ The study did not show it
Who was studied
NCT06679829
How many people
215
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Proportion of patients requiring ICU admission at any time within the study period.
✗ The study did not show it
Who was studied
NCT04329650
How many people
163
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 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 people◇Read 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.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.6 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.1 registered measure of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□A guess from softwareNo 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 would be like to take◇Read 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
Meaningful
Things that change how a life goes, not only a number.
part 2 progression free survival
progression free survival
one year progression free survival rate
28 day all cause mortality
complete remission in study part 1 and part 2
overall survival in study part 2
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 (17)
tumor response
adverse events
part 1 number of adverse events and serious adverse events
adverse events as a measure of safety and tolerability
adverse events or serious adverse events
overall response
clinical benefit response
qtc interval
cognition
incidence of adverse events
time to clinical improvement
ventilator free days
overall response rate
incidence of all grade cytokine release syndrome
who experience an adverse event in study part 1
cohort a part 1 number of who experience an ae
cohort a parts 1 and 2 objective response rate
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What is missing or unclear◇Read 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.
SYLVANT is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. SYLVANT is an interleukin-6 (IL-6) antagonist indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.
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: “The safety and efficacy of SYLVANT have not been established in pediatric patients.”
US prescribing information · 8d663642-f52e-49c0-a023-2da083fdfc0b · read 2026-08-30
On older people, the label states: “Clinical studies did not include sufficient numbers of patients aged 65 years and older to determine the effect of age on efficacy in MCD population.”
US prescribing information · 8d663642-f52e-49c0-a023-2da083fdfc0b · read 2026-08-30
On people who are pregnant, the label states: “Fetuses were evaluated on GD 140, approximately 25 days prior to the natural birth.”
US prescribing information · 8d663642-f52e-49c0-a023-2da083fdfc0b · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of siltuximab in human milk, the effects on the breastfed child, or the effects on milk production.”
US prescribing information · 8d663642-f52e-49c0-a023-2da083fdfc0b · read 2026-08-30
Where the result stopped carrying
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 take◇Read 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 take◇Read 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
Injection
✎ 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.
No source is stored against this line.
What is in the pack
Sold as injectable, injection, powder, for solution, given by the injection, intravenous route.
✎ 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.
What it would be like to take∅Nothing found in the sources checked
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.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
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.
Siltuximab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 60 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
hypercholesterolaemia — 10 reaction mentions
hypertriglyceridaemia — 9 reaction mentions
weight increased — 9 reaction mentions
thrombocytopenia — 7 reaction mentions
disease progression — 6 reaction mentions
pulmonary embolism — 6 reaction mentions
cytokine release syndrome — 5 reaction mentions
drug effective for unapproved indication — 4 reaction mentions
astigmatism — 2 reaction mentions
bcg related cystitis — 2 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 unclear◇Read 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
Injection
✎ 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
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
3 products list this as an active ingredient in the United States drug directory. 3 of them contain it and nothing else.
FDA National Drug Code directory · 65267-903 · read 2026-08-29
They are sold as injection, powder, for solution and solution, taken intravenous.
FDA National Drug Code directory · 65267-903 · read 2026-08-29
The regulator's established pharmacologic class for it is interleukin-6 antagonist [epc] and interleukin-6 antagonists [moa].
FDA National Drug Code directory · 65267-903 · 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 · 8d663642-f52e-49c0-a023-2da083fdfc0b · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 8d663642-f52e-49c0-a023-2da083fdfc0b · read 2026-08-29
Sylvant is intravenous at 3 DOSAGE FORMS AND STRENGTHS SYLVANT (siltuximab) for injection is available as: 100 mg of lyophilized powder in a single-dose vial for intravenous infusion. 400 mg of lyophilized powder in a single-dose vial for intrav…, recorded as fda label in effect 2024-08-27 in the United States.
US prescribing information · 8d663642-f52e-49c0-a023-2da083fdfc0b · read 2026-08-30
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 take◇Read 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 Siltuximab 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 unclear◇Read 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 Siltuximab 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 people◇Read 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.
Where else this substance is registered
FDA substance identifier (UNII)
T4H8FMA7IM
RxNorm concept
1658132
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
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
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S1.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read 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 BLA125496, approved 20140423 to RECORDATI RARE DISEASES, INC..
This order is fixed in code and does not count clicks or time on the page.
What is not here
6 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.
The path through the body — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — 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.
Recorded evidence blocks (10)
Q2
What did Siltuximab's largest trial (860 people) and its longest (13 years) measure?
860 people in Siltuximab's largest registered study, 13 years in its longest registered window, measuring 28-day all-cause mortality. ClinicalTrials.gov · 2026-09-01
26 phase2, 14 phase1, 3 early phase1, 3 phase3, 1 na or unstated; NCT00401843; 2019-09-24; no ageing endpoint recorded. Last human test completed 2026, NCT04975555.
Interpretation These counts include studies where Siltuximab 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
phase2
26
phase1
14
early phase1
3
phase3
3
na or unstated
1
Last recorded human testNCT04975555
2026-01-20
recorded 2026-09-01 · last checked 2026-09-04
Q3
Siltuximab was tested only in human — what did it show?
28-day all-cause mortality — the recorded outcome words.
Show the evidence
humanNCT04616586
lifespan; 28-day all-cause mortality; 41
recorded 2026-09-01 · last checked 2026-09-04
Q4
9 of Siltuximab's trials stopped: safety, futility/efficacy, funding/business, other?
safety (2), futility/efficacy (2), funding/business (4) and other (1): Siltuximab's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"withdrawal of support for drug supply"; 9 of 41 registered studies
Show the evidence
Trial
NCT00311545
withdrawn; "withdrawal of support for drug supply"
NCT00385827
terminated; "Prematurely stopped after Independent Data Monitoring Committee (IDMC) evaluation for lack of efficacy."
NCT01309412
terminated; "Protocol was stopped due to the safety issue in Global"
NCT01513317
terminated; "The study was stopped after the interim analysis based on lack of sufficient efficacy. There were no safety concerns."
NCT02805868
withdrawn; "Funding"
NCT04616586
terminated; "The REMAP-CAP and RECOVERY substudy results appear to support the survival benefit of tocilizumab in corticosteroid-treated or untreated patients with critically ill COVID-19-associated ARDS."
3 further recorded trials
NCT04838860
terminated; "Internal Company Decision"
NCT05316116
terminated; "lack of efficacy/futility"
NCT06352866
withdrawn; "Funding unavailable"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Siltuximab used Siltuximab 8.3 mg/kg or 11 mg/kg — over how long?
1 recorded entry; human; also "Siltuximab 8.3 mg/kg or 11 mg/kg"
Show the evidence
humanNCT00911859
Siltuximab 8.3 mg/kg or 11 mg/kg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which of 28 day all cause mortality, adverse events and adverse events as a measure of safety and tolerability did Siltuximab's trials measure?
28 day all cause mortality, adverse events and adverse events as a measure of safety and tolerability lead 24 outcome terms across Siltuximab's trials. ClinicalTrials.gov · 2026-09-01
part 1 number of adverse events and serious adverse events, part 2 progression free survival, adverse events as a measure of safety and tolerability, progression free survival, adverse events or serious adverse events and overall response follow.
Show the evidence
tumor response
1
adverse events
1
c reactive protein
1
part 1 number of adverse events and serious adverse events
1
part 2 progression free survival
1
adverse events as a measure of safety and tolerability
1
14 more recorded rows
progression free survival
1
adverse events or serious adverse events
1
overall response
1
clinical benefit response
1
qtc interval
1
one year progression free survival rate
1
cognition
1
incidence of adverse events
1
time to clinical improvement
1
ventilator free days
1
28 day all cause mortality
1
overall response rate
1
incidence of all grade cytokine release syndrome
1
complete remission in study part 1 and part 2
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Siltuximab's 9 ongoing trials reports first?
number of patients with improved symptoms; Change in worst pain intensity for each drug sub-study; latest 2033-11-16
Show the evidence
Trial
NCT03315026
"Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis"; n 30; "number of patients with improved symptoms"; 2026-10
NCT05684692
"Screening Trial for Pain Relief in Schwannomatosis (STARFISH)"; n 40; "Change in worst pain intensity for each drug sub-study"; 2028-11-30
NCT06447376
"Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab"; n 20; "Incidence of all-grade cytokine release syndrome"; 2028-09-01
NCT06470971
"Siltuximab for the Prevention of Severe Immune-Related Adverse Events During Immune Checkpoint Inhibitor Rechallenge in Patients With Advanced Cancer, CIRES Trial"; n 40; "Incidence of severe immune-related adverse event (irAE)"; 2030-12-31
NCT06679829
"A Study of Melphalan With or Without Siltuximab in People With Multiple Myeloma Having an Autologous Stem Cell Transplant"; n 215; "rate of stringent complete response (sCR)"; 2027-11
NCT06990711
"A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation"; n 30; "Incidence of CTCAE ≥ grade 3"; 2028-08-31
3 further recorded trials
NCT07106671
"A Phase II Study of Siltuximab for CRS/ICANs After CAR-T in Multiple Myeloma"; n 20; "Complete CRS resolution rate"; 2027-08-01
NCT07570173
"A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)"; n 340; "Percentage of Participants with Complete Remission (CR) in Study Part 1 and Part 2"; 2033-10-18
NCT07709000
"A Clinical Trial of MK-1045 in People With B-cell Cancer (MK-1045-006)"; n 60; "Cohort A Part 1: Number of Participants Who Experience Dose-Limiting Toxicity (DLT)"; 2033-11-16
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which 8 trials of Siltuximab posted no result?
Posted no result
8 of 8 completed trials
Registrations
NCT00265135, NCT02074800, NCT00402181, NCT00401765, NCT00412321 and NCT00841191, and 2 more
Completion dates
oldest 2006-02; newest 2021-02-26
Show the evidence
Trial
NCT00265135
2006-02
NCT02074800
2009-06
NCT00402181
2009-07
NCT00401765
2009-11
NCT00412321
2011-04
NCT00841191
2011-04
2 further recorded trials
NCT01219010
2014-03
NCT04329650
2021-02-26
Q9
At the median, Siltuximab's trials enrolled 40 people — anything larger?
Median enrolment
40
Largest enrolment
860
Registered trials counted
41
Q10
What do 60 spontaneous reports say about Siltuximab — 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.
Siltuximab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 60 reaction mentions were counted: hypercholesterolaemia 10; hypertriglyceridaemia 9; weight increased 9; thrombocytopenia 7. open-targets-adr · CHEMBL1743070 · 2026-06-24
Show the evidence
hypercholesterolaemia
10
hypertriglyceridaemia
9
weight increased
9
thrombocytopenia
7
disease progression
6
pulmonary embolism
6
4 more recorded rows
cytokine release syndrome
5
drug effective for unapproved indication
4
astigmatism
2
bcg related cystitis
2
recorded 2026-06-24 · last checked 2026-09-04
Q11
Siltuximab and CYP450, CYP3A4 and Cytochrome P450: shared by which compounds?
CYP450, CYP3A4 and Cytochrome P450 appear in Siltuximab's recorded interaction sentences, 5 in all. openfda-label+europepmc · 2024-08-27
Interpretation drug_interactions
Show the evidence
Cytochrome P450drug_interactions
7 DRUG INTERACTIONS 7.1 Cytochrome P450 Substrates Cytochrome P450s in the liver are down regulated by infection and inflammation stimuli including cytokines such as IL-6.
CYP450
drug_interactions
Inhibition of IL-6 signaling in patients treated with SYLVANT may restore CYP450 activities to higher levels leading to increased metabolism of drugs that are CYP450 substrates compared to metabolism prior to treatment with SYLVANT.
drug_interactions
Upon initiation or discontinuation of SYLVANT, in patients being treated with CYP450 substrates with a narrow therapeutic index, perform therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) as needed and adjust dose.
drug_interactions
The effect of SYLVANT on CYP450 enzyme activity can persist for several weeks after stopping therapy.
CYP3A4drug_interactions
Exercise caution when SYLVANT is co-administered with CYP3A4 substrate drugs where a decrease in effectiveness would be undesirable (e.g., oral contraceptives, lovastatin, atorvastatin).
recorded 2024-08-27 · last checked 2026-09-04
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