Risankizumab
| Evidence Level: L2 | Predicted Indications: 10 |
Table of Contents
Risankizumab: From Psoriasis to Dermatitis
One-Sentence Summary
Risankizumab is an IL-23 p19 inhibitor (a humanised IgG monoclonal antibody) originally used to treat psoriasis. The TxGNN model predicts it may be effective for dermatitis (mainly atopic dermatitis in the available evidence), with 2 clinical trials and 20 publications compiled. However, the one directly relevant controlled trial did not show a clear efficacy advantage, so this should be treated as a research question, not a treatment recommendation.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Psoriasis, parapsoriasis (from the TxGNN knowledge graph; no approved-indication text is available from the licence records) |
| Predicted New Indication | Dermatitis |
| TxGNN Prediction Score | 99.98% |
| Evidence Level | L2 |
| US Market Status | Cancelled only (both BLA records are listed as cancelled) |
| Number of NDAs | 2 (BLA records) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Risankizumab blocks the p19 subunit of IL-23. Its use in psoriasis rests on the IL-23/Th17 axis, which is also involved in some other inflammatory skin diseases. This is the link behind the model’s prediction. Detailed mechanism-of-action data were not available in the data compiled for this report, so the description above is based on the drug class and published literature.
The overlap is only partial. Atopic dermatitis is driven mainly by Th2 signalling (IL-4/IL-13), with possible contributions from Th22 and Th17. A Phase 2 trial tested IL-23 blockade directly in moderate-to-severe atopic dermatitis, and the published results (PMID 36588137) did not show a clear efficacy advantage.
Case-level reports describe combined dupilumab and risankizumab in patients who have both atopic dermatitis and psoriasis. This suggests a possible niche in mixed phenotypes rather than a standalone indication. In addition, eczematous eruptions have been reported during IL-23 and IL-17 inhibitor therapy, which adds a safety signal.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT03706040 | Phase 2 | Completed | 172 | Randomised, placebo-controlled, double-blind study of risankizumab in adults and adolescents with moderate-to-severe atopic dermatitis. Direct controlled evidence, but the publication does not support a strong efficacy claim. |
| NCT07352566 | Phase 4 | Not yet recruiting | 10 | Exploratory study of a rice-grain-sized microdevice that releases small amounts of approved drugs into the skin of people with atopic dermatitis and psoriasis. It does not provide efficacy evidence for risankizumab. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 36588137 | 2023 | RCT | Dermatology and Therapy | Phase 2 randomised, double-blind, placebo-controlled study of risankizumab in moderate-to-severe atopic dermatitis, based on the rationale of IL-23 and IL-22 blockade |
| 40856907 | 2025 | Systematic Review | American Journal of Clinical Dermatology | Systemic therapies for erythrodermic psoriasis, a severe variant that overlaps with dermatitis in the differential diagnosis |
| 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/Case series | International Journal of Dermatology | Combined dupilumab and risankizumab in patients with concomitant atopic dermatitis and psoriasis |
| 39201826 | 2024 | Review | Children | Biologics and small-molecule therapies for pediatric alopecia areata, psoriasis, atopic dermatitis and hidradenitis suppurativa |
| 33078990 | 2020 | Review | Expert Opinion on Biological Therapy | Current and emerging biologics for pediatric atopic dermatitis |
| 31098898 | 2019 | Review | Drugs | Risankizumab first global approval, covering psoriasis vulgaris, psoriatic arthritis, generalised pustular psoriasis and erythrodermic psoriasis |
| 41645692 | 2026 | Case report | Dermatology Reports | Paradoxical eczema during IL-23 inhibitor therapy, managed successfully with upadacitinib |
| 33185530 | 2020 | Case report | European Journal of Dermatology | Eczematous eruption in psoriasis patients during risankizumab treatment |
US Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| BLA761105 | Skyrizi (AbbVie Inc.) | Injection | Not available (status: cancelled) |
| BLA761262 | Skyrizi (AbbVie Inc.) | Injection | Not available (status: cancelled) |
Safety Considerations
- Drug Interactions: 78 interactions were identified. Major-level interactions include adalimumab, baricitinib, certolizumab pegol and cladribine, which is consistent with additive immunosuppression. Moderate-level interactions include tacrolimus, cyclosporine, azathioprine, roflumilast, anakinra, alemtuzumab, denosumab and several vaccines, including live vaccines. Zinc salts are minor.
- Other signal: Paradoxical eczema and eczematous eruptions have been reported under IL-23 inhibitor therapy, including risankizumab (see the literature table above).
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 only directly relevant controlled trial (Phase 2, n=172) did not show a clear benefit in atopic dermatitis, and the mechanistic overlap is partial because Th2 signalling dominates. Paradoxical eczema reports add a safety concern, and the current US licence records show only cancelled entries. This supports an L2 research question, not a development recommendation.
To proceed, the following is needed:
- Full efficacy data from NCT03706040, including dose-response and subgroup results
- Identification of any dermatitis subtype (for example, mixed atopic dermatitis and psoriasis phenotypes) where IL-23 blockade could be useful
- Mechanism-of-action data
- Package insert warnings and contraindications, to complete safety screening
- Clarification of the current US regulatory status of the Skyrizi BLA records
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.