Adalimumab

Evidence Level: L5

Predicted Indications: 3

Adalimumab

Pharmacist Assessment Report

Adalimumab: TNF-alpha–blocking monoclonal antibody → hypermobility of coccyx

One-Sentence Summary

Adalimumab is an anti-TNF-alpha monoclonal antibody used for several inflammatory and autoimmune conditions. The TxGNN model predicts it may be effective for hypermobility of coccyx, but there are no clinical trials and no publications directly studying this condition, so the prediction rests on the model score alone.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	hypermobility of coccyx
TxGNN Prediction Score	0.9977
Evidence Level	L5
India Market Status	Listed in a compiled Indian medicine price dataset (15 of 15) – CDSCO approval status is not included in this data
Number of Listed Products	15 (valid: 15)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Detailed mechanism of action data is not available in the data compiled for this report. Adalimumab is known as a TNF-alpha inhibitor, and its action in inflammatory conditions is driven by blocking this cytokine.

Coccygeal hypermobility is generally a mechanical or traumatic condition, not a TNF-driven inflammatory one. The mechanistic rationale is therefore weak. The high score may reflect the condition’s proximity to spondyloarthropathy-related disease nodes in the model’s training data rather than a true pharmacological link. Without direct studies, this prediction should be treated as a hypothesis only.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available for hypermobility of coccyx.

India Market Information

Adalimumab is marketed in India under 15 valid single-ingredient licences, all injectable (vials and prefilled syringes). The licence records carry no indication text. The main authorisations are listed below.

Authorization Number	Product Name	Dosage Form	Approved Indication
2395	Adalirel 40mg Injection (Reliance Life Sciences)	Vial of 1 injection	Not recorded
8950	Adalirel 20mg Injection (Reliance Life Sciences)	Vial of 0.4 ml injection	Not recorded
10487	Amab Injection (Dr Reddy’s Laboratories Ltd)	Prefilled syringe of 0.8 ml injection	Not recorded
36414	Cipleumab 40mg Injection (Cipla Ltd)	Prefilled syringe of 0.8 ml injection	Not recorded
72488	Exemptia 40mg/0.8ml Injection (Zydus Cadila)	Prefilled syringe of 1 injection	Not recorded

Safety Considerations

Drug Interactions: 353 interactions were identified in the interaction screening. The main ones are:
- Major: corticosteroids (betamethasone, budesonide, dexamethasone, hydrocortisone, prednisolone, prednisone, triamcinolone), deferiprone, and radiopharmaceutical or radioimmunotherapy agents (ibritumomab tiuxetan, iobenguane I-131, tositumomab and tositumomab I-131).
- Moderate: metronidazole, tinidazole, rosuvastatin, simvastatin.
- Minor: zinc salts (acetate, gluconate, sulfate).

Please refer to the package insert for warnings and contraindications, as these were not available in the data compiled for this report.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction has a high model score (0.9977) but no clinical trials or publications, and the condition is mechanical rather than TNF-driven. The evidence level is L5, so there is no basis to proceed.

To proceed, the following is needed:

Any direct clinical or preclinical evidence linking TNF blockade to coccygeal hypermobility
Mechanism of action data for adalimumab
Package insert warnings and contraindications from the India licence holders
A clearer biological rationale, for example whether an inflammatory component exists in the target population
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.