Golimumab
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
Golimumab: Hypermobility of coccyx
One-Sentence Summary
Golimumab is a TNF-alpha–blocking antibody originally used for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.
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 |
| India Market Status | Listed in a compiled Indian medicine price dataset (1 of 1) – CDSCO approval status is not included in this data |
| Number of Listed Products | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Golimumab is a fully human anti-TNF-alpha monoclonal antibody (IgG1κ) given by injection. Detailed mechanism-of-action data were not available in the compiled data. The description above comes from the published reviews. By neutralizing TNF-alpha, a central driver of joint and systemic inflammation, golimumab reduces the inflammatory signalling behind rheumatoid arthritis and related diseases.
Rheumatoid vasculitis is an extra-articular complication of rheumatoid arthritis, seen mainly in seropositive patients. Its biology overlaps with the original indication. The literature notes that its incidence has fallen since biologic anti-TNF drugs were introduced. This gives a plausible mechanistic link between the original and the predicted indication.
The link is still indirect. No study in the compiled data evaluates golimumab in rheumatoid vasculitis. Two case reports describe Takayasu’s arteritis appearing during anti-TNF therapy, which is a safety signal. A case report of Behçet-associated uveitis treated successfully with golimumab hints at possible benefit in other inflammatory vascular conditions. The prediction is therefore mechanistically reasonable but unproven.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT07138898 | Phase 2 | Recruiting | 80 | Compares shorter versus longer preoperative holds of immunosuppressants in rheumatology patients having shoulder replacement. It does not test golimumab in vasculitis and is only indirectly related. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 31491879 | 2019 | Network meta-analysis of 36 RCTs | Int J Mol Sci | Original and biosimilar TNF inhibitors, including golimumab, similarly reduce joint destruction in rheumatoid arthritis. Not specific to vasculitis. |
| 23557513 | 2013 | Review | BMC Med | Update on biologic therapy for autoimmune diseases, covering benefits and drawbacks such as cost and adverse events. |
| 27591827 | 2017 | Review | Semin Arthritis Rheum | Frequency and causes of end-stage renal disease in rheumatoid arthritis, and RA treatment in that setting. |
| 29075910 | 2018 | Case report | Rheumatol Int | Pyoderma gangrenosum and pyogenic arthritis presenting as severe sepsis in an RA patient on golimumab. Notes that rheumatoid vasculitis has become less frequent in the anti-TNF era. |
| 23252659 | 2013 | Case report | Ocul Immunol Inflamm | Behçet disease–associated uveitis successfully treated with golimumab. |
| 22999907 | 2013 | Case report | Joint Bone Spine | Two cases of Takayasu’s arteritis arising during anti-TNF therapy, a safety signal. |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Registration No. 214765 | Simponi 50mg Injection (Johnson & Johnson Ltd) | Prefilled syringe of 0.5 ml, injection | Not stated in the registration record |
Safety Considerations
- Drug Interactions: 352 interactions were identified.
- Major: systemic corticosteroids (hydrocortisone, prednisone, prednisolone, dexamethasone, betamethasone, triamcinolone including ophthalmic, budesonide), deferiprone, and radiopharmaceuticals or radioimmunotherapies (iobenguane I-131, ibritumomab tiuxetan, tositumomab with and without I-131).
- Moderate: metronidazole, tinidazole, rosuvastatin, simvastatin.
- Minor: zinc salts (sulfate, acetate, gluconate).
- Literature safety signals: Vasculitis (Takayasu’s arteritis) has been reported during anti-TNF therapy. Severe infection (sepsis with pyogenic arthritis) has been reported in an RA patient on golimumab.
Please refer to the package insert for warnings and contraindications. These were not available in the compiled data.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is high and the TNF-alpha mechanism is plausible. However, no trial or study directly evaluates golimumab in rheumatoid vasculitis, the only matched trial is indirectly related, and the literature includes reports of vasculitis occurring during anti-TNF therapy.
To proceed, the following is needed:
- Direct clinical evidence of golimumab or other anti-TNF agents in rheumatoid vasculitis, such as case series, registry data or a pilot trial
- Package insert warnings and contraindications for the India-registered product, along with its approved indication text
- Detailed mechanism-of-action data
- A safety-monitoring plan covering infection and TB screening, vaccination, malignancy risk, and paradoxical vasculitis
- A decision on whether to prioritize other predicted indications with stronger evidence. Inflammatory spondylopathy and polyarticular juvenile rheumatoid arthritis each have multiple Phase 3 trials, but the first overlaps with golimumab’s existing approved uses.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.