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, originally used to treat psoriasis. The TxGNN model predicts it may be effective for dermatitis, with 2 clinical trials and 20 publications compiled for this direction. The strongest evidence is a completed Phase 2 trial in atopic dermatitis, which indicated limited efficacy, so the evidence is mixed.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Psoriasis, parapsoriasis (no approved-indication text is available in the Canadian licence records) |
| Predicted New Indication | Dermatitis |
| TxGNN Prediction Score | 0.9998 |
| Evidence Level | L2 |
| Canada Market Status | Marketed (marketed DINs: 5 of 5) |
| Number of DINs | 5 (marketed: 5) |
| Recommended Decision | Hold (treat as a research question) |
Why is This Prediction Reasonable?
Risankizumab is a humanised IgG monoclonal antibody that targets the p19 subunit of IL-23. Detailed mechanism-of-action data is not available in the data compiled for this report, but this class mechanism is well described in the literature. IL-23 drives Th17 responses, which contribute to psoriasis and some other inflammatory skin diseases.
Psoriasis and dermatitis are both inflammatory skin conditions, which helps explain the model’s high score. However, atopic dermatitis, the most common form of dermatitis, is mainly Th2-driven (IL-4/IL-13). The Phase 2 trial of risankizumab in moderate-to-severe atopic dermatitis did not show a clear benefit over placebo.
Any benefit may be limited to IL-23/Th17-dominant dermatitis subtypes or to psoriasis-eczema overlap phenotypes. One case report describes combining dupilumab with risankizumab in a patient with both atopic dermatitis and psoriasis. Several case reports also describe eczematous reactions appearing during risankizumab treatment, which argues against a broad benefit in dermatitis.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | 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; the published results indicate limited efficacy |
| NCT07352566 | Phase 4 | Not yet recruiting | 10 | Tests a rice-grain-sized microdevice that delivers small drug doses into the skin in atopic dermatitis and psoriasis; a method study that provides no efficacy evidence for risankizumab |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 36588137 | 2023 | RCT | Dermatology and Therapy | Phase 2 randomised, placebo-controlled study of risankizumab in moderate-to-severe atopic dermatitis; the rationale was IL-23/IL-22 blockade |
| 40856907 | 2025 | Systematic Review | Am J Clin Dermatol | Systemic therapies for erythrodermic psoriasis, a severe variant that is part of the differential diagnosis with atopic dermatitis |
| 40794374 | 2025 | Systematic Review | Inflammopharmacology | Therapeutic and paradoxical effects of interleukin inhibitors in lichen planus |
| 41822639 | 2026 | Systematic Review | Cureus | Cardiovascular outcomes associated with biologic therapy in inflammatory skin diseases |
| 31098898 | 2019 | Review | Drugs | First global approval of risankizumab (Japan, March 2019) for psoriasis vulgaris, psoriatic arthritis, generalised pustular psoriasis and erythrodermic psoriasis |
| 39201826 | 2024 | Review | Children (Basel) | Biologics and small molecules for paediatric alopecia areata, psoriasis, atopic dermatitis and hidradenitis suppurativa |
| 33078990 | 2020 | Review | Expert Opin Biol Ther | Current and emerging biologics for paediatric atopic dermatitis |
| 38607726 | 2024 | Review | Military Medicine | Systemic immunomodulators for psoriasis and eczema in military personnel |
| 39668419 | 2025 | Cohort / case series | Int J Dermatol | Combined dupilumab and risankizumab in patients with concomitant atopic dermatitis and psoriasis |
| 41645692 | 2026 | Case report | Dermatology Reports | Upadacitinib used for paradoxical eczema induced by IL-23 inhibitors, including risankizumab |
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02552507 | SKYRIZI | Not specified | Not specified |
| 02532093 | SKYRIZI | Not specified | Not specified |
| 02519283 | SKYRIZI | Not specified | Not specified |
| 02519291 | SKYRIZI | Not specified | Not specified |
| 02532107 | SKYRIZI | Not specified | Not specified |
All five authorisations are valid, single-ingredient products.
Safety Considerations
- Drug Interactions: 78 interactions were found in total; the main ones from the data compiled for this report are listed below.
- Major: adalimumab, baricitinib, certolizumab pegol, cladribine. These are mainly combinations with other immunosuppressants, which raise the risk of excess immunosuppression and infection.
- Moderate: roflumilast, tacrolimus, cyclosporine, azathioprine, alefacept, alemtuzumab, anakinra, canakinumab, denosumab, and several vaccines (tetanus toxoid, anthrax, live cholera).
- Minor: zinc salts (sulfate, acetate, gluconate, chloride).
- Eczematous or paradoxical eruptions during risankizumab treatment have been reported in the literature and should be considered when it is used in dermatitis.
Please refer to the package insert for warnings and contraindications, as this information is not available in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The only direct evidence is one completed Phase 2 RCT in atopic dermatitis, which showed limited efficacy. The disease is mainly Th2-driven, and eczematous reactions have been reported with IL-23 inhibitors. The high TxGNN score is therefore not supported by clinical data for the broad dermatitis indication. The other nine predictions (for example dermatomyositis, pityriasis lichenoides) rely on model scores alone, with no trials or literature.
To proceed, the following is needed:
- Review the full efficacy results of NCT03706040 and PMID 36588137.
- Define the specific dermatitis subtype, such as an IL-23/Th17-dominant or psoriasis-eczema overlap phenotype, in which benefit is plausible.
- Obtain the package insert (warnings and contraindications) for the Health Canada products, as well as approved-indication and dosage-form details.
- Obtain detailed mechanism-of-action data.
- Evaluate the infection risk and interaction profile for any combination use with other immunomodulators.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.