Summary
Sarilumab has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Rheumatoid Arthritis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Rheumatoid Arthritis. ClinicalTrials.gov lists 8 registered trials linking Sarilumab to Rheumatoid Arthritis: 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04251741). The largest enrolment is 2023 participants (NCT01146652). Registration activity spans 2008 to 2022. The literature layer holds 16 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 3 systematic reviews and 5 clinical trial publications. Publication years run from 2019 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Rheumatoid Arthritis ranks 544 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: 11% achieve drug-free remission (DFR) at median 74 months; most cohorts show 10-15% DFR ceiling.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 72.5 (trials 22.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 5 completed, 3 other |
| Linked publications | 16 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 3 systematic reviews) |
| Agent type | Biologic |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT04251741 | Using Adalimumab Serum Concentration to Choose a Subsequent Biological DMARD in Rheumatoid Arthritis Patients Failing Adalimumab Treatment 2020 | status unknown | Phase 4 | 86 |
| NCT01146652 | Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND) 2010 | completed | Phase 3 | 2,023 |
| NCT02293902 | A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI) 2014 | completed | Phase 3 | 243 |
| NCT01026519 | A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis 2008 | completed | Phase 1 | 32 |
| NCT01328522 | Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients 2011 | completed | Phase 1 | 32 |
| NCT03378219 | An Observational Study on Sarilumab-exposed Pregnancies 2018 | completed | Not applicable | 113 |
| NCT04505982 | Anti IL6R Reduce Complement Serum Level in Rheumatoid Arthritis Patients: Facts and Implications 2020 | status unknown | Not applicable | 35 |
| NCT05119452 | Screening for Flare After b/tsDMARD Discontinuation in Rheumatoid Arthritis 2022 | status unknown | Not applicable | 85 |
Published literature
- Systematic review From Methotrexate Resistance to Biologic and Targeted Pharmacotherapy: A Decade of Phase 4 Clinical Trials Evidence in Rheumatoid ArthritisAlsharif ST · Drug design, development and therapy · 2026 · PMID 41836530
- Clinical trial publication Deciphering differential biomarkers for anti-interleukin-6 receptor and anti-tumour necrosis factor-α treatment response in rheumatoid arthritis by multiomics analysisAgueusop I, Margerie D, Remaury A et al. · RMD open · 2025 · PMID 40759562
- Clinical trial publication Long-term safety and efficacy of anti-GM-CSF otilimab in patients with rheumatoid arthritis: long-term extension of three phase 3 randomised trials (contRAst X)Weinblatt ME, Taylor PC, McInnes IB et al. · BMJ open · 2025 · PMID 40044198
- Clinical trial publication The effects of sarilumab as monotherapy and in combination with non-methotrexate disease-modifying anti-rheumatic drugs on unacceptable pain in patients with rheumatoid arthritis: A post-hoc analysis of the HARUKA phase 3 studyTanaka Y, Takahashi T, van Hoogstraten H et al. · Modern rheumatology · 2024 · PMID 39073577
- Clinical trial publication Efficacy and safety of sarilumab in patients with rheumatoid arthritis stratified by age (<65 and ≥65 years): A post hoc analysis of Japanese Phase 3 clinical trialsTanaka Y, Takahashi T, van Hoogstraten H et al. · Modern rheumatology · 2024 · PMID 39073574
- Meta-analysis Comparison of the efficacy and safety of tocilizumab, sarilumab, and olokizumab in patients with active rheumatoid arthritis: a network meta-analysis of randomized controlled trialsHo Lee Y, Gyu Song G · Zeitschrift fur Rheumatologie · 2024 · PMID 36607422
- Clinical trial publication Anti-GM-CSF otilimab versus sarilumab or placebo in patients with rheumatoid arthritis and inadequate response to targeted therapies: a phase III randomised trial (contRAst 3)Taylor PC, Weinblatt ME, McInnes IB et al. · Annals of the rheumatic diseases · 2023 · PMID 37696589
- Cochrane review Efficacy of pharmacological interventions: a systematic review informing the 2023 EULAR recommendations for the management of fatigue in people with inflammatory rheumatic and musculoskeletal diseasesFarisogullari B, Santos EJF, Dures E et al. · RMD open · 2023 · PMID 38056919
- Cochrane review Efficacy of synthetic and biological DMARDs: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritisKerschbaumer A, Sepriano A, Bergstra SA et al. · Annals of the rheumatic diseases · 2023 · PMID 36368906
- Meta-analysis Comparative efficacy and safety of biologic agents in patients with active rheumatoid arthritis and inadequate response to tumor necrosis factor inhibitors: A Bayesian network meta-analysis of randomized controlled trialsSung YK, Lee YH · International journal of clinical pharmacology and therapeutics · 2022 · PMID 34622767
- Cochrane review Comparison of the efficacy and safety indicators of DMARDs for rheumatoid arthritis: A network meta-analysisWang Z, Huang M, Yu B et al. · Medicine · 2021 · PMID 34398007
- Meta-analysis Comparison of the efficacy and safety of tocilizumab, sarilumab, and sirukumab in comparison with adalimumab as monotherapy in patients with active rheumatoid arthritis: A Bayesian network meta-analysis of randomized controlled trialsSung YK, Lee YH · International journal of clinical pharmacology and therapeutics · 2021 · PMID 34281633
- Systematic review Response to interleukin-6 receptor antagonists in patients with rheumatoid arthritis is independent of the number of prior used TNF inhibitors: A systematic review and metaanalysisNarváez J, Oton T, LLuch J et al. · Joint bone spine · 2021 · PMID 33276135
- Cochrane review Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritisKerschbaumer A, Sepriano A, Smolen JS et al. · Annals of the rheumatic diseases · 2020 · PMID 32033937
- Systematic review Safety of synthetic and biological DMARDs: a systematic literature review informing the 2019 update of the EULAR recommendations for the management of rheumatoid arthritisSepriano A, Kerschbaumer A, Smolen JS et al. · Annals of the rheumatic diseases · 2020 · PMID 32033941
- Cochrane review Effect of biologics and targeted synthetic disease-modifying anti-rheumatic drugs on fatigue in rheumatoid arthritisChoy EH · Rheumatology (Oxford, England) · 2019 · PMID 31682274
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Sarilumab approved for Rheumatoid Arthritis?
Sarilumab has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Rheumatoid Arthritis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Rheumatoid Arthritis. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Sarilumab in clinical trials for Rheumatoid Arthritis?
ClinicalTrials.gov lists 8 registered trials linking Sarilumab to Rheumatoid Arthritis: 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04251741). The largest enrolment is 2023 participants (NCT01146652). Registration activity spans 2008 to 2022.
What does the evidence show for Sarilumab in Rheumatoid Arthritis?
Sarilumab has both completed registered trials and synthesis-level publications linked to Rheumatoid Arthritis. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.