Summary
Etanercept has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Ankylosing Spondylitis / Axial Spondyloarthropathy would be drug repurposing rather than first-in-human development. This does not mean it is approved for Ankylosing Spondylitis / Axial Spondyloarthropathy. ClinicalTrials.gov lists 8 registered trials linking Etanercept to Ankylosing Spondylitis / Axial Spondyloarthropathy: 3 have completed; 5 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04077957). The largest enrolment is 5000 participants (NCT03470688). Registration activity spans 2004 to 2019. The literature layer holds 14 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 1 systematic review and 5 clinical trial publications. Publication years run from 2017 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 Ankylosing Spondylitis ranks 151 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: Progressive structural damage (sacroiliac fusion, syndesmophytes) in majority without treatment; spontaneous radiographic remission essentially zero; ~10% achieve clinical remission without anti-inflammatory therapy.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 69.0 (trials 19.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 3 completed, 5 other |
| Linked publications | 14 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 1 systematic review) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00458185 | Study Evaluating Etanercept in Patients With Ankylosing Spondylitis 2006 | completed | Phase 4 | 40 |
| NCT00133315 | TNFalfa Blocking Treatment of Spondylarthropathies 2004 | completed | Phase 4 | 50 |
| NCT04077957 | Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs 2019 | status unknown | Phase 4 | 100 |
| NCT00844142 | Enbrel-Sulfasalazin-Early-Axial Spondyloarthritis (AS) 2005 | status unknown | Phase 2 | 80 |
| NCT01421303 | Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel. 2009 | completed | Not applicable | 80 |
| NCT01411215 | A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department 2011 | terminated | Not applicable | 160 |
| NCT03729674 | Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs 2018 | status unknown | Not applicable | 800 |
| NCT03470688 | Investigating the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents 2018 | status unknown | Not applicable | 5,000 |
Published literature
- Cochrane review Impact of Biologics on Cardiovascular Events in Ankylosing Spondylitis: A Meta-AnalysisYin H, Wang Y, Chen Z et al. · International journal of rheumatic diseases · 2026 · PMID 41672949
- Cochrane review Comparative efficacy, safety and immunogenicity of biosimilars and their reference biologic drugs in ankylosing spondylitis: a systematic review and meta-analysis of randomized controlled trialsYiu CH, Or CH, Almutairi K et al. · Expert opinion on biological therapy · 2025 · PMID 40418343
- Meta-analysis Risk of new-onset and recurrent uveitis with different biologics for ankylosing spondylitis: a network meta-analysisZhao X, Xie Q, He X et al. · Frontiers in immunology · 2025 · PMID 40621455
- Meta-analysis Targeted therapies and conventional care for the treatment of ankylosing spondylitis in China: a cost-effectiveness analysis based on the network-meta analysisShi J, Zhou W, Lin T et al. · Journal of orthopaedic surgery and research · 2024 · PMID 39155381
- Clinical trial publication Does a short course of etanercept influence disease progression and radiographic changes in patients suspected of non-radiographic axial spondyloarthritis? Three -years follow- up of a placebo-controlled trialRusman T, van der Weijden M, Nurmohamed MT et al. · Scandinavian journal of rheumatology · 2023 · PMID 35543102
- Clinical trial publication Interval prolongation of etanercept in rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis: a randomized controlled trialRuwaard J, L' Ami MJ, Kneepkens EL et al. · Scandinavian journal of rheumatology · 2023 · PMID 35234569
- Meta-analysis Work productivity in patients with axial spondyloarthritis initiating biological or targeted synthetic disease-modifying antirheumatic drugs: a systematic literature review and meta-analysisRudwaleit M, Mørup MF, Humphries B et al. · RMD open · 2023 · PMID 38035757
- Systematic review Efficacy and safety of biological DMARDs: a systematic literature review informing the 2022 update of the ASAS-EULAR recommendations for the management of axial spondyloarthritisWebers C, Ortolan A, Sepriano A et al. · Annals of the rheumatic diseases · 2023 · PMID 36270657
- Clinical trial publication Etanercept/celecoxib on improving MRI inflammation of active ankylosing spondylitis: A multicenter, open-label, randomized clinical trialTu L, Zhao M, Wang X et al. · Frontiers in immunology · 2022 · PMID 36091030
- Clinical trial publication Simplified Ankylosing Spondylitis Disease Activity Score (SASDAS) Versus ASDAS: A Post Hoc Analysis of a Randomized Controlled TrialSchneeberger EE, Citera G, de Leon DP et al. · The Journal of rheumatology · 2022 · PMID 35840157
- Clinical trial publication Efficacy of needle-knife combined with etanercept treatment regarding disease activity and hip joint function in ankylosing spondylitis patients with hip joint involvement: A randomized controlled studyYou Y, Cai M, Lin J et al. · Medicine · 2020 · PMID 32384461
- Cochrane review Drug Survival of Biologics in Treating Ankylosing Spondylitis: A Systematic Review and Meta-analysis of Real-World EvidenceYu CL, Yang CH, Chi CC · BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020 · PMID 32946076
- Cochrane review Risk of serious infections in biological treatment of patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis: a meta-analysisWang S, He Q, Shuai Z · Clinical rheumatology · 2018 · PMID 29290076
- Cochrane review DOSAGE AND DURATION OF ETANERCEPT THERAPY FOR ANKYLOSING SPONDYLITIS: A META-ANALYSISLee H, Jung Y, Song S et al. · International journal of technology assessment in health care · 2017 · PMID 28434410
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 Etanercept approved for Ankylosing Spondylitis / Axial Spondyloarthropathy?
Etanercept has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Ankylosing Spondylitis / Axial Spondyloarthropathy would be drug repurposing rather than first-in-human development. This does not mean it is approved for Ankylosing Spondylitis / Axial Spondyloarthropathy. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Etanercept in clinical trials for Ankylosing Spondylitis / Axial Spondyloarthropathy?
ClinicalTrials.gov lists 8 registered trials linking Etanercept to Ankylosing Spondylitis / Axial Spondyloarthropathy: 3 have completed; 5 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04077957). The largest enrolment is 5000 participants (NCT03470688). Registration activity spans 2004 to 2019.
What does the evidence show for Etanercept in Ankylosing Spondylitis / Axial Spondyloarthropathy?
Etanercept has both completed registered trials and synthesis-level publications linked to Ankylosing Spondylitis / Axial Spondyloarthropathy. 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.