Tildrakizumab

Evidence Level: L5

Predicted Indications: 4

Tildrakizumab

Pharmacist Assessment Report

Tildrakizumab: From Plaque Psoriasis to Severe Nonproliferative Diabetic Retinopathy

One-Sentence Summary

Tildrakizumab is an anti-IL-23 p19 monoclonal antibody marketed in Australia as Ilumya; the approved indication text was not available in the data compiled for this report. The TxGNN model predicts it may be effective for severe nonproliferative diabetic retinopathy, but there are currently 0 clinical trials and 0 publications supporting this direction. This is a model prediction only.

Quick Overview

Item	Content
Original Indication	Not available in the compiled data
Predicted New Indication	Severe nonproliferative diabetic retinopathy
TxGNN Prediction Score	0.9963
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?

Currently, detailed mechanism of action data is not available in the compiled data. Based on its known drug class, tildrakizumab is an anti-IL-23 p19 monoclonal antibody. It blocks IL-23, a cytokine that drives the IL-23/Th17 inflammatory axis.

Chronic low-grade inflammation, including IL-17/IL-23 signalling, has been proposed as a contributor to diabetic retinopathy. On this basis, a mechanistic link is conceivable, but it is speculative. The high TxGNN score (0.9963) reflects a TxGNN model (deep learning) prediction only, with no supporting clinical or preclinical data. The established therapies for diabetic retinopathy (anti-VEGF agents, laser and corticosteroids) act through different mechanisms. Delivery to the eye and ocular safety of a systemic IL-23 inhibitor have not been evaluated.

Other top predictions for this drug are also at L5 with no supporting evidence:

Rank	Predicted Indication	TxGNN Score	Comment
2	Diabetic retinopathy	0.9953	Possible indirect link via inflammatory pathways; no evidence
3	Diabetic cataract	0.9921	No clear mechanistic rationale
4	Drug-induced osteoporosis	0.9920	IL-23/IL-17 axis implicated in bone remodelling; unestablished

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available.

Australia Market Information

ARTG Number	Product Name	Dosage Form	Approved Indication
ARTG 11613F	Ilumya	Injection 100 mg in 1 mL single dose pre-filled syringe	Not available in the compiled data

Safety Considerations

Drug Interactions: 78 interactions were identified. Examples of the main ones:
- Major: adalimumab, baricitinib, certolizumab pegol, cladribine (combined immunosuppression)
- Moderate: tacrolimus, cyclosporine, azathioprine, roflumilast, anakinra, alefacept, alemtuzumab, canakinumab, denosumab, and several vaccines (tetanus toxoid, anthrax, live cholera)
- Minor: zinc salts (sulfate, acetate, gluconate, chloride)

Please refer to the TGA-approved Product Information (PI) for warnings and contraindications.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction is supported only by a TxGNN model (deep learning) score. There are no clinical trials, no literature and no confirmed mechanism, so the evidence level is L5. The ocular safety and delivery of a systemic IL-23 inhibitor are also unevaluated.

To proceed, the following is needed:

The TGA-approved Product Information, including the approved indication, warnings and contraindications
Detailed mechanism of action data
Preclinical evidence of IL-23/IL-17 involvement in diabetic retinopathy
Literature and trial registry searches (including ANZCTR) for IL-23 inhibition in retinal disease
An assessment of route and ocular safety, since systemic administration may not reach the retina adequately
Disclaimer

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