Golimumab
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
Golimumab: Hypermobility of coccyx
One-Sentence Summary
Golimumab is a TNF-alpha blocking antibody already used for inflammatory arthritis, including rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, and for ulcerative colitis. The TxGNN model predicts it may be useful for hypermobility of coccyx. Support is weak: 1 tangentially related clinical trial and 6 publications, mostly case reports and general reviews, none directly testing golimumab in this condition.
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 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Golimumab is a fully human monoclonal antibody that blocks TNF-alpha, as described in the published literature. TNF-alpha is a central driver of inflammation in rheumatoid arthritis and related diseases.
There are important caveats:
- None of the retrieved studies tests golimumab in rheumatoid vasculitis.
- The supporting literature is limited to case reports, such as golimumab for Behçet-associated uveitis, and to general reviews.
- Anti-TNF agents have themselves been linked to paradoxical vasculitis. One retrieved report describes Takayasu’s arteritis arising during anti-TNF therapy. This weakens the mechanistic case and raises a safety question.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrolment | Key Findings |
|---|---|---|---|---|
| NCT07138898 | Phase 2 | Recruiting | 80 | Compares shorter versus longer preoperative holding of immunosuppressants in rheumatology patients having shoulder replacement. It does not test golimumab for vasculitis and is only tangentially related. |
No ANZCTR trials were identified in the data compiled for this report.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 29075910 | 2018 | Case report | Rheumatology International | Pyoderma gangrenosum and pyogenic arthritis presenting as severe sepsis in a rheumatoid arthritis patient on golimumab. Describes a safety event and notes rheumatoid vasculitis only as background. |
| 31491879 | 2019 | Network meta-analysis of 36 RCTs | International Journal of Molecular Sciences | TNF inhibitors, including golimumab, similarly reduce joint destruction in rheumatoid arthritis. Does not address vasculitis. |
| 23557513 | 2013 | Review | BMC Medicine | Overview of biologic therapies in autoimmune diseases, including benefits and adverse events. |
| 27591827 | 2017 | Review | Seminars in Arthritis and Rheumatism | Frequency, causes and management of end-stage renal disease in rheumatoid arthritis. |
| 23252659 | 2013 | Case report | Ocular Immunology and Inflammation | Behçet disease-associated uveitis treated successfully with golimumab. Shows activity in another inflammatory condition, not vasculitis in RA. |
| 22999907 | 2013 | Case report | Joint Bone Spine | Two cases of Takayasu’s arteritis occurring during anti-TNF therapy, suggesting a possible paradoxical effect. |
Australia Market Information
| ARTG Number | Product Name | Dosage Form |
|---|---|---|
| 11361Y | Simponi | Injection 50 mg in 0.5 mL single use pre-filled pen |
Safety Considerations
- Drug Interactions: 100 interactions are recorded. The main ones are:
- Major: corticosteroids (hydrocortisone, prednisone, prednisolone, dexamethasone, betamethasone, triamcinolone, budesonide), deferiprone, and radiopharmaceuticals (iobenguane I-131, ibritumomab tiuxetan, tositumomab).
- Moderate: metronidazole, tinidazole, rosuvastatin and simvastatin.
- Minor: zinc salts.
- Condition-specific concern: anti-TNF therapy has been associated with paradoxical vasculitis, so its use in an existing vasculitis needs careful consideration.
For warnings and contraindications, please refer to the TGA-approved Product Information (PI).
Conclusion and Next Steps
Decision: Hold
Rationale: The high model score is not backed by direct evidence. The only registered trial is unrelated to efficacy, and the literature consists of case reports and reviews. Anti-TNF therapy has also been linked to paradoxical vasculitis, which weakens the mechanistic case.
To proceed, the following is needed:
- Clinical studies, even small case series or cohorts, of golimumab or other TNF inhibitors in rheumatoid vasculitis
- Review of the safety signal for anti-TNF-associated vasculitis
- Detailed mechanism of action data
- Product Information warnings and contraindications for Australia
- Confirmation of the approved indication text for the ARTG entry
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.