Golimumab
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
Golimumab: Hypermobility of coccyx
One-Sentence Summary
Golimumab is an anti-TNF-alpha monoclonal antibody originally used for inflammatory arthritis and bowel disease, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis. The TxGNN model’s top prediction is hypermobility of coccyx (0.9967), but direct evidence is thin: 1 loosely related clinical trial and 6 publications, none testing golimumab in this disease.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Hypermobility of coccyx |
| TxGNN Prediction Score | 0.9967 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs: 5 of 5) |
| Number of DINs | 5 (marketed: 5) |
| Recommended Decision | Hold |
Other Predicted Indications
| Rank | Predicted Indication | Score | Evidence Level | Decision |
|---|---|---|---|---|
| 2 | Hypermobility of coccyx | 0.9967 | L5 | Hold |
| 4 | Kummell disease | 0.9961 | L5 | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. From the published literature, golimumab is a fully human monoclonal antibody that neutralises TNF-alpha, both soluble and transmembrane forms. Its efficacy in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is established.
Among the other predictions:
- Inflammatory spondylopathy and polyarticular juvenile rheumatoid arthritis are mechanistically well supported, since TNF-alpha drives both axial and synovial inflammation. They are largely on-label or closely adjacent to approved uses, so they are better viewed as confirmation of existing use than as true repurposing.
- Hypermobility of coccyx and Kummell disease are mechanical or ischaemic bone conditions with no clear TNF-driven mechanism. Their scores come from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT07138898 | Phase 2 | Recruiting | 80 | Perioperative immunosuppressant management in rheumatology patients having shoulder arthroplasty. Does not evaluate golimumab for vasculitis. |
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT02186873 | Phase 3 | Completed | 208 | Randomised, double-blind, placebo-controlled trial of IV golimumab in active ankylosing spondylitis |
| NCT01453725 | Phase 3 | Completed | 198 | Subcutaneous golimumab versus placebo in active axial spondyloarthritis |
| NCT00265083 | Phase 3 | Completed | 356 | Subcutaneous golimumab versus placebo in active ankylosing spondylitis |
| NCT01248793 | Phase 3 | Completed | 213 | Golimumab versus placebo in Chinese patients with ankylosing spondylitis |
| NCT03253796 | Phase 4 | Completed | 323 | Treatment withdrawal versus continued golimumab in non-radiographic axial spondyloarthritis |
| NCT03270501 | Phase 3 | Completed | 64 | Golimumab in early axial spondyloarthritis in relation to gut inflammation |
| NCT02181673 | Phase 3 | Completed | 480 | IV golimumab versus placebo in active psoriatic arthritis |
| NCT00265096 | Phase 3 | Completed | 407 | Subcutaneous golimumab versus placebo in active psoriatic arthritis |
| NCT02758782 | Phase 4 | Completed | 156 | Celecoxib added to golimumab versus golimumab alone on spinal structural damage in ankylosing spondylitis |
| NCT01313858 | N/A | Completed | 1,613 | Non-interventional real-world safety study of golimumab |
Only the 10 most relevant trials are shown; further golimumab and anti-TNF studies in spondyloarthritis are registered.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01230827 | Phase 3 | Terminated | 173 | Double-blind randomised-withdrawal trial of subcutaneous golimumab in active polyarticular JIA |
| NCT02277444 | Phase 3 | Completed | 130 | Open-label IV golimumab in paediatric polyarticular JIA despite methotrexate |
Hypermobility of coccyx and Kummell disease: currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 29075910 | 2018 | Case report | Rheumatol Int | Pyoderma gangrenosum and pyogenic arthritis with sepsis in a rheumatoid arthritis patient on golimumab |
| 31491879 | 2019 | Network meta-analysis | Int J Mol Sci | Original and biosimilar TNF inhibitors similarly reduce joint destruction in RA |
| 23557513 | 2013 | Review | BMC Med | Update on biologic therapy for autoimmune diseases |
| 27591827 | 2017 | Review | Semin Arthritis Rheum | End-stage renal disease in RA |
| 23252659 | 2013 | Case report | Ocul Immunol Inflamm | Behçet-associated uveitis treated successfully with golimumab |
| 22999907 | 2013 | Case report | Joint Bone Spine | Two cases of Takayasu’s arteritis arising under anti-TNF therapy |
None of these studies tests golimumab in rheumatoid vasculitis. They are indirect or cautionary.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 36270657 | 2023 | Systematic review | Ann Rheum Dis | Efficacy and safety of biological DMARDs in axial spondyloarthritis (2022 ASAS-EULAR update) |
| 38503473 | 2024 | Systematic review | Ann Rheum Dis | Pharmacological treatment of psoriatic arthritis (2023 EULAR update) |
| 40621455 | 2025 | Network meta-analysis | Front Immunol | Uveitis risk with different biologics in ankylosing spondylitis |
| 27924643 | 2016 | Meta-analysis | Expert Opin Drug Saf | Infection risk with anti-TNF agents in RA, PsA and AS |
| 26798943 | 2016 | Review | Immunotherapy | Golimumab for axial spondyloarthritis |
| 28530020 | 2017 | Review | BioDrugs | Golimumab in inflammatory arthritis |
| 18155297 | 2008 | Review | Pharmacol Ther | Mechanisms of action of TNF antagonists |
| 20065639 | 2009 | Review | mAbs | Golimumab drug profile; approved in the US and Canada in 2009 |
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 28507219 | 2018 | RCT (Phase 3) | Ann Rheum Dis | Subcutaneous golimumab in polyarticular JIA: randomised-withdrawal trial |
| 33493312 | 2021 | Open-label Phase 3 | Rheumatology (Oxford) | IV golimumab in polyarticular JIA |
| 39089836 | 2024 | Long-term follow-up | J Rheumatol | Long-term extension of IV golimumab (GO-VIVA) through week 252 |
| 40763950 | 2025 | Long-term follow-up | J Rheumatol | Long-term extension report of the same open-label Phase 3 study |
| 36171515 | 2022 | Phase 3 analysis | Paediatr Drugs | Extrapolation of adult and adjacent paediatric data to support IV golimumab |
| 33626206 | 2021 | Pharmacologic analysis | Clin Pharmacol Ther | Response similarity between polyarticular JIA and adult RA for biologics |
Hypermobility of coccyx and Kummell disease: currently no related literature available.
Canada Market Information
| DIN | Product Name |
|---|---|
| 02324784 | SIMPONI |
| 02417472 | SIMPONI I.V. |
| 02413183 | SIMPONI |
| 02324776 | SIMPONI |
| 02413175 | SIMPONI |
Dosage form and approved indication text were not available for these authorisations.
Safety Considerations
- Drug Interactions: 100 interactions were identified, and the main ones are listed here.
- Major: corticosteroids (hydrocortisone, prednisone, prednisolone, dexamethasone, betamethasone, budesonide, triamcinolone including the ophthalmic form), deferiprone, and radiopharmaceutical or radioimmunotherapy agents (iobenguane I-131, ibritumomab tiuxetan, tositumomab and tositumomab I-131).
- Moderate: metronidazole, tinidazole, rosuvastatin, simvastatin.
- Minor: zinc salts (sulfate, acetate, gluconate).
- Context from the literature: anti-TNF agents are associated with an increased risk of infection (PMID 27924643). Vasculitis has been reported under anti-TNF therapy.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold (for the top-ranked prediction, hypermobility of coccyx)
Rationale:
- Rheumatoid vasculitis has only a plausible mechanistic link. No study tests golimumab in this disease, and anti-TNF-induced vasculitis makes the direction of effect uncertain.
- Hypermobility of coccyx and Kummell disease (L5) also stay on Hold, as their scores come from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence.
- Proceed with Guardrails applies to inflammatory spondylopathy (L1, several completed Phase 3 placebo-controlled trials) and polyarticular juvenile rheumatoid arthritis (L1, Phase 3 trials with long-term follow-up). Both are largely on-label or adjacent to approved uses, so they confirm existing use more than they represent new repurposing.
To proceed, the following is needed:
- Package insert warnings and contraindications from Health Canada, which are currently missing and block safety screening.
- Mechanism of action data from DrugBank.
- Canadian licence details (dosage forms and approved indications) to confirm which predicted indications are already on-label.
- For rheumatoid vasculitis, case series or a pilot study that addresses the risk of anti-TNF-induced vasculitis.
- For the two “Proceed with Guardrails” indications, a safety monitoring plan, with particular attention to infection risk, corticosteroid co-medication and paediatric use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.