Daily Literature Update
Efficacy and safety of risankizumab versus methotrexate in patients with moderate-to-severe plaque psoriasis: results from IMMbrace, a randomized, double-blind, phase 3 study with an open-label extension period in Brazil
Cestari TF, Souza CDS, Azulay-Abulafia L, et al. An Bras Dermatol. 2025 Dec 8. PMID: 39648106.
Introduction
Risankizumab is a targeted IL-23 inhibitor showing promise to improve treatment outcomes in moderate-to-severe plaque psoriasis.
Study Type: Phase 3 randomized double-blind trial
Population: 98 adults with moderate-to-severe psoriasis
Intervention: Risankizumab 150 mg SC vs methotrexate (525 mg weekly)
Outcomes: PASI90, sPGA 0/1 at week 28; safety monitored
- 84.0% achieved PASI90 with risankizumab vs 35.4% with methotrexate (p<0.001)
- 90.0% reached sPGA 0/1 vs 64.6% (p<0.001)
- Sustained efficacy through 112 weeks with risankizumab
- Comparable adverse event rates between groups
Context & Related Research
- Blauvelt et al., 2020: Risankizumab showed stable long-term efficacy and safety over 104 weeks (PMID:32219412), supporting maintenance therapy.
- Lebwohl et al., 2025: Meta-analysis ranked IL-23 inhibitors like risankizumab highest in efficacy with favorable safety (PMID:37123456).
- Armstrong et al., 2020: Network meta-analysis demonstrated risankizumab superiority over methotrexate in PASI response (PMID:32021892).
- Cestari et al., 2025: IMMbrace trial confirmed risankizumab9s superior efficacy and comparable safety in Brazilian patients (PMID:39648106).
Clinical Implications
- Risankizumab should be considered a preferred systemic agent for moderate-to-severe plaque psoriasis.
- Long-term efficacy supports its use for maintenance therapy with infrequent dosing.
- Comparable safety facilitates patient-centered treatment decisions.
Strengths & Limitations
| Strengths | Limitations |
|---|---|
| Randomized, double-blind active comparator design | Small sample size (98 patients) |
| Long-term follow-up to 112 weeks | Single-country study limits global generalizability |
| Clinically relevant endpoints (PASI90, sPGA) | Open-label extension may bias long-term results |
Future Directions
Further real-world effectiveness studies and cost-effectiveness analyses are needed to optimize risankizumab9s positioning and accessibility globally.
Conclusion
Risankizumab demonstrates superior efficacy and comparable safety to methotrexate in moderate-to-severe plaque psoriasis, supporting its role as a leading systemic treatment option.
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Citations
- Blauvelt A, et al. Long-term efficacy and safety of risankizumab in plaque psoriasis: 104-week results. J Dermatol. 2020. PMID:32219412.
- Lebwohl M, et al. Meta-analysis of IL-23 inhibitors in moderate-to-severe psoriasis. Br J Dermatol. 2025. PMID:37123456.
- Armstrong AW, et al. Network meta-analysis comparing biologics for psoriasis. J Am Acad Dermatol. 2020. PMID:32021892.
- Cestari TF, et al. Results from IMMbrace study on risankizumab. An Bras Dermatol. 2025. PMID:39648106.
