Celecoxib
| Evidence Level: L1 | Predicted Indications: 10 |
Table of Contents
Celecoxib: From Arthritis Pain to Inflammatory Spondylopathy (Axial Spondyloarthritis)
One-Sentence Summary
Celecoxib is a COX-2-selective NSAID. Published reviews describe its use for osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and acute pain. The TxGNN model predicts it may be effective for Inflammatory Spondylopathy (axial spondyloarthritis and ankylosing spondylitis). This is the best-supported of the top 10 predictions, with 17 registered trials (2 completed Phase 3 randomised trials) and 20 publications.
Note: TxGNN’s rank-1 prediction (acromesomelic dysplasia, Hunter-Thompson type) has no trials or literature and no plausible mechanism. This report therefore centres on the best-evidenced prediction, rank 9.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Symptomatic relief in osteoarthritis and rheumatoid arthritis, and acute pain (from published reviews; the supplied SAHPRA record has no indication text) |
| Predicted New Indication | Inflammatory spondylopathy (axial spondyloarthritis / ankylosing spondylitis) |
| TxGNN Prediction Score | 99.80% |
| Evidence Level | L1 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 1 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available in the supplied record. Celecoxib is a selective COX-2 inhibitor. COX-2 inhibition reduces prostaglandin E2-driven inflammation and pain. This is the same mechanism through which celecoxib relieves arthritis symptoms.
Axial spondyloarthritis and ankylosing spondylitis are inflammatory rheumatic diseases with inflammatory back pain and stiffness. NSAIDs are a recognised first-line symptomatic therapy for them. The mechanism therefore fits.
There is also an emerging signal that celecoxib may slow radiographic bone progression (PMID 39757202). This is not yet established. Published reviews already list ankylosing spondylitis among celecoxib’s approved uses in one or more countries. This may therefore not be true repurposing, so please verify the label status for South Africa.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00648141 | Phase 3 | Completed | 458 | 12-week comparison of celecoxib 200 mg QD, 200 mg BID and diclofenac SR in ankylosing spondylitis (safety and efficacy) |
| NCT00762463 | Phase 3 | Completed | 240 | Randomised, double-blind study of celecoxib 200 mg QD vs diclofenac SR in Chinese ankylosing spondylitis patients; 6-week extension |
| NCT02528201 | Phase 4 | Completed | 330 | 12-week, randomised, double-blind study of celecoxib 200 mg and 400 mg daily vs diclofenac in ankylosing spondylitis |
| NCT01934933 | Phase 4 | Completed | 150 | Open-label randomised trial of etanercept and celecoxib alone or combined in active ankylosing spondylitis; MRI primary endpoint |
| NCT02758782 | Phase 4 | Completed | 156 | Celecoxib added to golimumab vs golimumab alone: spinal structural damage progression over 2 years (CONSUL) |
| NCT04115098 | Phase 2 | Terminated | 42 | N-of-1 trials comparing selective COX-2 and non-selective COX inhibitors in axial spondyloarthritis |
| NCT03190603 | Phase 4 | Completed | 12 | Effect of NSAIDs on MRI inflammatory lesions in axial spondyloarthritis; small, class-level |
| NCT03473665 | Phase 4 | Terminated | 9 | 6-week double-blind pilot of 4 NSAIDs on pain score in axial spondyloarthritis |
No SANCTR or PACTR registrations were found in the supplied data.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 38228361 | 2024 | RCT analysis | Ann Rheum Dis | CONSUL trial: celecoxib added to golimumab vs golimumab alone on 2-year spinal radiographic progression in r-axSpA |
| 38832489 | 2024 | RCT | Scand J Rheumatol | Iguratimod combined with celecoxib in active axSpA (randomised, double-blind, placebo-controlled) |
| 28626213 | 2017 | Randomised clinical study | Med Sci Monit | Imrecoxib vs celecoxib 200 mg twice daily in 60 axSpA patients; efficacy, side effects and DKK-1 levels |
| 16960941 | 2006 | Clinical study | J Rheumatol | Celecoxib reported as efficacious and well tolerated for signs and symptoms of ankylosing spondylitis |
| 39757202 | 2025 | Comparative study | BMB Rep | Celecoxib was the only NSAID reported to inhibit bone progression in spondyloarthritis |
| 36800138 | 2023 | Clinical study | Clin Rheumatol | Imrecoxib and celecoxib effects on bone metabolism markers and sacroiliac joint inflammation in axSpA |
| 40028763 | 2025 | Cohort | Scand J Rheumatol | Cardiovascular and GI bleeding risk comparable between celecoxib and non-selective NSAIDs in ankylosing spondylitis |
| 25623277 | 2015 | Cohort | Arthritis Care Res | Swedish population cohort comparing safety of etoricoxib, celecoxib and non-selective NSAIDs in spondyloarthritis |
| 40911151 | 2025 | Umbrella review | Drugs | Synthesis of celecoxib safety evidence in chronic musculoskeletal conditions |
| 22141388 | 2011 | Review | Drugs | Celecoxib for symptomatic relief in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis |
South Africa Market Information
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Reg. No. 33/3.1/0333 | Celebrex | Capsule (oral) | Not stated in the supplied record |
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
The supplied data has no warnings, contraindications or drug-interaction entries. The literature above points to cardiovascular risk, GI bleeding, and renal and hepatic function as the main areas to monitor with long-term use (PMIDs 40028763, 39315555).
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Two completed Phase 3 randomised trials (NCT00648141, NCT00762463) and several Phase 4 trials test celecoxib directly in ankylosing spondylitis. The mechanism is plausible. Celecoxib may already carry this indication in other jurisdictions, so the case for true repurposing is unclear.
The other top-10 predictions are weaker:
- Rank 8, rheumatoid factor-positive polyarticular JIA, is a research question only. Its single publication is a safety registry.
- Rank 3, rheumatoid vasculitis, has only a case report and no mechanistic support.
- The rest are model predictions with no supporting evidence or plausible mechanism. Keep them on Hold.
To proceed, the following is needed:
- The SAHPRA package insert (warnings, contraindications, approved indications), to confirm whether ankylosing spondylitis is already labelled in South Africa
- Verification of the completed Phase 3 trials, given truncated titles and summaries
- Mechanism-of-action data from DrugBank
- A safety monitoring plan for long-term use (cardiovascular, GI, renal and hepatic)
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.