Summary
Anakinra 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lists 8 registered trials linking Anakinra to Rheumatoid Arthritis: 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02236481). The largest enrolment is 85 participants (NCT05119452). Registration activity spans 2001 to 2022. The literature layer holds 14 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2014 to 2025. 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 | 71.5 (trials 21.5, 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 | 14 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 2 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00111410 | Evaluating the Effect of Anakinra (r-metHuIL-1ra) on Vaccine AntibodyResponse in Subjects With Rheumatoid Arthritis (RA) | completed | Phase 4 | — |
| NCT02236481 | Clinical Study to Evaluate the Efficacy of Anakinra in Patients With Rheumatoid Arthritis and Diabetes 2013 | terminated | Phase 4 | 41 |
| NCT01033656 | Treatment of Refractory Adult-onset Still's Disease With Anakinra: a Randomized Study 2005 | completed | Phase 2 | 23 |
| NCT00037700 | Evaluation of the Efficacy of Combination Treatment With Anakinra and Pegsunercept in Improving Rheumatoid Arthritis 2001 | completed | Phase 2 | — |
| NCT02175056 | A Dose-Block Randomized, Placebo Controlled (Double-blind), Active Controlled(Open-label), Dose-escalation Study 2014 | completed | Phase 1 | 58 |
| NCT00121056 | REKinDLE: Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations 2002 | completed | Not applicable | — |
| NCT03288584 | Effects of Interleukin-6 Inhibition on Vascular, Endothelial and Left Ventricular Function in Rheumatoid Arthritis 2017 | status unknown | Not applicable | 60 |
| NCT05119452 | Screening for Flare After b/tsDMARD Discontinuation in Rheumatoid Arthritis 2022 | status unknown | Not applicable | 85 |
Published literature
- Meta-analysis Efficacy and safety of biologic drugs in Still's disease: a systematic review and network meta-analysis of randomized controlled trialsKilic B, Ozturk A, Karup S et al. · Rheumatology (Oxford, England) · 2025 · PMID 38775654
- Cochrane review Efficacy and safety of therapies for Still's disease and macrophage activation syndrome (MAS): a systematic review informing the EULAR/PReS guidelines for the management of Still's diseaseBindoli S, De Matteis A, Mitrovic S et al. · Annals of the rheumatic diseases · 2024 · PMID 39317415
- Cochrane review Systematic Review and Metaanalysis of Pharmacological Interventions in Adult-Onset Still Disease and the Role of Biologic Disease-Modifying Antirheumatic DrugsRuscitti P, McGonagle D, Garcia VC et al. · The Journal of rheumatology · 2024 · PMID 38302170
- Systematic review Vascular effects of biologic and targeted synthetic antirheumatic drugs approved for rheumatoid arthritis: a systematic reviewGerganov G, Georgiev T, Dimova M et al. · Clinical rheumatology · 2023 · PMID 36991244
- Systematic review Systematic Review of Safety and Efficacy of IL-1-Targeted Biologics in Treating Immune-Mediated DisordersArnold DD, Yalamanoglu A, Boyman O · Frontiers in immunology · 2022 · PMID 35874710
- Clinical trial publication Benefits of anakinra versus TNF inhibitors in rheumatoid arthritis and type 2 diabetes: long-term findings from participants furtherly followed-up in the TRACK study, a multicentre, open-label, randomised, controlled trialRuscitti P, Berardicurti O, Cipriani P et al. · Clinical and experimental rheumatology · 2021 · PMID 33666156
- Cochrane review Effectiveness and adverse effects of anakinra in treatment of rheumatoid arthritis: a systematic reviewBedaiwi MK, Almaghlouth I, Omair MA · European review for medical and pharmacological sciences · 2021 · PMID 34982445
- Cochrane review Fusion proteins of biologic agents in the treatment of rheumatoid arthritis (RA): A network meta-analysisWu M, Tao M, Wang Q et al. · Medicine · 2021 · PMID 34128886
- Meta-analysis Comparative effectiveness of biological medicines in rheumatoid arthritis: systematic review and network meta-analysis including aggregate results from reanalysed individual patient dataJanke K, Biester K, Krause D et al. · BMJ (Clinical research ed.) · 2020 · PMID 32636183
- Clinical trial publication Anti-interleukin-1 treatment in patients with rheumatoid arthritis and type 2 diabetes (TRACK): A multicentre, open-label, randomised controlled trialRuscitti P, Masedu F, Alvaro S et al. · PLoS medicine · 2019 · PMID 31513665
- Clinical trial publication Differential effects of inhibition of interleukin 1 and 6 on myocardial, coronary and vascular functionIkonomidis I, Pavlidis G, Katsimbri P et al. · Clinical research in cardiology : official journal of the German Cardiac Society · 2019 · PMID 30859382
- Cochrane review Efficacy and safety of topical and systemic medications: a systematic literature review informing the EULAR recommendations for the management of Sjögren's syndromeBrito-Zerón P, Retamozo S, Kostov B et al. · RMD open · 2019 · PMID 31749986
- Clinical trial publication A randomised trial evaluating anakinra in early active rheumatoid arthritisScott IC, Ibrahim F, Simpson G et al. · Clinical and experimental rheumatology · 2016 · PMID 26842950
- Clinical trial publication Increased benefit of interleukin-1 inhibition on vascular function, myocardial deformation, and twisting in patients with coronary artery disease and coexisting rheumatoid arthritisIkonomidis I, Tzortzis S, Andreadou I et al. · Circulation. Cardiovascular imaging · 2014 · PMID 24782115
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 Anakinra approved for Rheumatoid Arthritis?
Anakinra 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 Anakinra in clinical trials for Rheumatoid Arthritis?
ClinicalTrials.gov lists 8 registered trials linking Anakinra to Rheumatoid Arthritis: 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02236481). The largest enrolment is 85 participants (NCT05119452). Registration activity spans 2001 to 2022.
What does the evidence show for Anakinra in Rheumatoid Arthritis?
Anakinra 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.