Risankizumab
| Evidence Level: L2 | Predicted Indications: 10 |
Table of Contents
Risankizumab: Dermatitis
One-Sentence Summary
Risankizumab is an IL-23 p19 monoclonal antibody, originally used to treat psoriasis (and related conditions such as parapsoriasis). The TxGNN model predicts it may be effective for dermatitis (in practice, mainly atopic dermatitis), with 2 clinical trials and 20 publications currently associated with this prediction. Direct evidence is limited to one completed Phase 2 RCT. Much of the literature concerns psoriasis, or eczematous reactions occurring during risankizumab treatment.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Dermatitis |
| TxGNN Prediction Score | 0.9998 |
| Evidence Level | L2 |
| 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 (research question only) |
Why is This Prediction Reasonable?
Risankizumab is a humanised IgG monoclonal antibody that selectively blocks the p19 subunit of IL-23, a cytokine that drives Th17-mediated skin inflammation in psoriasis. Detailed mechanism of action data was not available in the data compiled for this report, so this description draws on published literature.
Atopic dermatitis is mainly Th2-driven, so the mechanistic overlap with psoriasis is only partial. IL-23 and IL-22 pathways (Th22, possibly Th17) may contribute in some phenotypes, such as chronic or mixed psoriasis-eczema presentations. Case reports of combined dupilumab and risankizumab use in patients with both atopic dermatitis and psoriasis suggest a niche role rather than broad efficacy.
The very high TxGNN score comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence. It should not be read as evidence of clinical efficacy. Several reports also describe eczematous eruptions or paradoxical eczema arising during IL-23 inhibitor treatment, which cautions against assuming benefit.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrolment | Key Findings |
|---|---|---|---|---|
| NCT03706040 | Phase 2 | Completed | 172 | Randomised, double-blind, placebo-controlled study of risankizumab in adults and adolescents with moderate to severe atopic dermatitis. Safety and efficacy were the objectives (results published as PMID 36588137). |
| NCT07352566 | Phase 4 | Not yet recruiting | 10 | Microdevice that delivers small amounts of approved drugs into skin to test responses in atopic dermatitis and psoriasis. Methodological study with limited relevance to efficacy. |
No ANZCTR entries were identified in the data compiled for this report.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 36588137 | 2023 | RCT | Dermatol Ther | Phase 2 placebo-controlled study of risankizumab in moderate-to-severe atopic dermatitis, based on the rationale of IL-23/IL-22 blockade (the abstract available here does not report outcomes) |
| 40856907 | 2025 | Systematic Review | Am J Clin Dermatol | Systemic therapies for erythrodermic psoriasis |
| 40794374 | 2025 | Systematic Review | Inflammopharmacology | Therapeutic and paradoxical effects of interleukin inhibitors in lichen planus |
| 41822639 | 2026 | Systematic Review | Cureus | Cardiovascular outcomes with biologic therapy in inflammatory skin diseases |
| 39668419 | 2025 | Cohort | Int J Dermatol | Combined dupilumab and risankizumab in concomitant atopic dermatitis and psoriasis |
| 31098898 | 2019 | Review | Drugs | First global approval of risankizumab (Japan, March 2019) for psoriasis vulgaris, psoriatic arthritis, generalised and erythrodermic psoriasis |
| 39201826 | 2024 | Review | Children (Basel) | Biologics and small molecules for paediatric alopecia areata, psoriasis, atopic dermatitis and hidradenitis suppurativa |
| 41645692 | 2026 | Case Report | Dermatol Rep | Upadacitinib used for paradoxical eczema induced by IL-23 inhibitors |
| 33185530 | 2020 | Case series | Eur J Dermatol | Eczematous eruption in patients with psoriasis during risankizumab treatment |
| 37014149 | 2023 | Case series | J Cutan Med Surg | Brodalumab-induced eczematous reactions managed by switching to risankizumab |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 14111Q | Skyrizi | Injection 150 mg in 1 mL pre-filled pen | Not available in the data compiled for this report |
Safety Considerations
- Drug Interactions: 78 interactions were identified. Major-level interactions include adalimumab, baricitinib, certolizumab pegol and cladribine. Moderate-level interactions include tacrolimus, cyclosporine, azathioprine, roflumilast, anakinra, alemtuzumab, denosumab and several vaccines (such as tetanus toxoid, anthrax and live cholera vaccines). Zinc salts are classed as minor. Most major and moderate interactions relate to additive immunosuppression.
- Other safety considerations from the literature: Eczematous eruptions or paradoxical eczema have been reported during IL-23 inhibitor treatment (estimated at 1-3% of psoriasis patients on biologics).
Please refer to the TGA-approved Product Information (PI) for warnings and contraindications, as these were not available in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold (research question only)
Rationale: A completed Phase 2 RCT exists in atopic dermatitis, but the mechanism (Th2-dominant disease) offers only partial support, and the published literature includes reports of eczematous reactions on risankizumab. The high TxGNN score comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence or clinical efficacy. Other predicted indications (for example dermatomyositis subtypes, acrodermatitis chronica atrophicans, diabetic retinopathy) have no clinical evidence, and some carry plausible harm. Pityriasis lichenoides and acute lichenoid pityriasis are mechanistically plausible but remain prediction-only.
To proceed, the following is needed:
- Full efficacy and safety results of NCT03706040 (PMID 36588137), including primary endpoints versus placebo
- Identification of any subgroup (for example mixed psoriasis-eczema phenotypes) that might benefit
- TGA-approved PI warnings, contraindications and approved indication text for ARTG 14111Q
- Mechanism of action data to support mechanistic-link analysis
- Case series or exploratory studies if pityriasis lichenoides is pursued
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.