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 antibody, originally used to treat psoriasis (including related conditions such as parapsoriasis). The TxGNN model predicts it may be effective for dermatitis, and the data compiled for this report include 2 clinical trials (one completed Phase 2 randomized controlled trial in atopic dermatitis) and 20 publications. The evidence is early-stage: the mechanistic fit is weaker than for psoriasis, and efficacy results still need to be verified.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Psoriasis, parapsoriasis (from the TxGNN knowledge graph; the Singapore licence records contain no indication text) |
| Predicted New Indication | Dermatitis |
| TxGNN Prediction Score | 99.98% |
| Evidence Level | L2 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 4 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Risankizumab is a humanised IgG monoclonal antibody that targets the p19 subunit of interleukin-23 (IL-23). IL-23 supports the Th17 pathway, which drives psoriasis. Detailed mechanism-of-action data are not available in the data compiled for this report, but the published drug profile describes this IL-23 p19 mechanism, and the drug is approved for several psoriasis forms.
Atopic dermatitis and other eczematous diseases are driven mainly by type 2 signalling (IL-4/IL-13), so IL-23 blockade is a weaker mechanistic fit than it is for psoriasis. Partial rationale comes from Th17/Th22 contributions and from the overlap between psoriasis and eczema in some patients. A Phase 2 randomized controlled trial tested risankizumab directly in moderate-to-severe atopic dermatitis. Its published report (PMID 36588137) was available only by title, so no efficacy conclusion is drawn here.
Case-level reports describe combined dupilumab plus risankizumab use in patients with both atopic dermatitis and psoriasis, and risankizumab as a switch option after brodalumab-induced eczematous reactions. These reports only generate hypotheses. Other reports describe eczematous eruptions or paradoxical eczema appearing during risankizumab treatment (incidence estimated at 1–3% of psoriasis patients on biologics), which argues for caution.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT03706040 | Phase 2 | Completed | 172 | Multicenter, randomized, placebo-controlled, double-blind study of safety and efficacy of risankizumab in adults and adolescents with moderate-to-severe atopic dermatitis; outcome data should be confirmed from the publication or registry results |
| NCT07352566 | Phase 4 | Not yet recruiting | 10 | Tests a rice-grain-sized microdevice that releases small amounts of approved drugs into the skin of people with atopic dermatitis and psoriasis; a methodological study with limited relevance to efficacy |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 36588137 | 2023 | RCT | Dermatology and Therapy | Phase 2 randomized, double-blind, placebo-controlled study of risankizumab in moderate-to-severe atopic dermatitis; the rationale was IL-23 and IL-22 blockade (results not summarized in the data compiled) |
| 40856907 | 2025 | Systematic review | American Journal of Clinical Dermatology | Systemic therapies for erythrodermic psoriasis, a severe and potentially life-threatening variant |
| 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, generalized pustular psoriasis and erythrodermic psoriasis |
| 39201826 | 2024 | Review | Children (Basel) | Biologics and small-molecule therapies for pediatric alopecia areata, psoriasis, atopic dermatitis and hidradenitis suppurativa |
| 39668419 | 2025 | Case report/series | International Journal of Dermatology | Combined dupilumab and risankizumab in concomitant atopic dermatitis and psoriasis |
| 37014149 | 2023 | Case series | Journal of Cutaneous Medicine and Surgery | Three psoriasis patients with brodalumab-induced eczematous reactions managed by switching to risankizumab |
| 33185530 | 2020 | Case report/series | European Journal of Dermatology | Eczematous eruption in psoriasis patients during risankizumab treatment |
| 41645692 | 2026 | Letter | Dermatology Reports | Upadacitinib used for paradoxical eczema induced by IL-23 inhibitors, including risankizumab |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN16869P | SKYRIZI Concentrate for Solution for Infusion 600mg/10ml | Infusion, solution concentrate | Not stated in the licence data |
| SIN16339P | SKYRIZI Solution for Injection in Pre-filled Pen 150mg/ml | Injection, solution | Not stated in the licence data |
| SIN16338P | SKYRIZI Solution for Injection in Pre-filled Syringe 150mg/ml | Injection, solution | Not stated in the licence data |
| SIN16870P | SKYRIZI Solution for Injection in Pre-filled Cartridge with On-body Injector 360mg/2.4ml | Injection, solution | Not stated in the licence data |
Safety Considerations
- Drug Interactions: 78 interactions were recorded. Those listed below are the Major-level ones found in the first 20 entries retrieved; the full list may include more.
- Major: adalimumab, baricitinib, certolizumab pegol, cladribine (combined immunosuppression)
- Moderate (examples): tacrolimus, cyclosporine, azathioprine, roflumilast, alefacept, alemtuzumab, anakinra, canakinumab, denosumab, and some vaccines (tetanus toxoid, anthrax, live cholera vaccine)
- Minor: zinc salts (sulfate, acetate, gluconate, chloride)
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: A completed Phase 2 randomized controlled trial in atopic dermatitis supports an L2 evidence level, but the data compiled here give no efficacy results from it. The mechanistic fit is weaker than for psoriasis, and some reports describe eczema flares during risankizumab treatment. The other nine predictions (for example, neonatal dermatomyositis and amyopathic dermatomyositis) rely on model scores alone (L5) and also warrant Hold.
To proceed, the following is needed:
- Efficacy and safety results from NCT03706040 and the full text of PMID 36588137
- Package insert warnings and contraindications from the Singapore Health Sciences Authority (HSA), along with the approved indication text for the four licences
- Detailed mechanism-of-action data
- A review of the eczematous and paradoxical reactions reported with IL-23 inhibitors
- Comparison with established atopic dermatitis therapies, including type 2-targeted biologics, to define any niche (for example, patients with both psoriasis and eczema)
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.