IMMpactful: Risankizumab Shows Greater Clinical Response to Deucravacitinib in Psoriasis

Risankizumab therapy provided greater clinical response versus deucravacitinib in adult patients with moderate psoriasis, new data suggest, and safety findings are comparable with the known safety profiles of both drugs.1,2

These data were presented during the 2026 Maui Derm Hawaii conference, with the poster being titled, ‘A Phase 4 Multicenter, Randomized, Open-Label, Efficacy Assessor-Blinded Study of Risankizumab Compared With Deucravacitinib for the Treatment of Adult Patients With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy: 16-Week Results From IMMpactful.’

These data were authored by such investigators as Nina Magnolo, MD, from the University Hospital of Münster Department of Dermatology and Venereology. Magnolo et al highlighted the long-term, immune-driven inflammatory condition as being characterized by erythematous, thickened, and scaly skin plaques. They noted multiple biologic and oral systemic options are available for psoriasis, but selection is complicated by differences in safety and efficacy, especially in the absence of direct comparative research.

Risankizumab was designed as a monoclonal antibody targeting interleukin (IL)-23. Both risankizumab and deucravacitinib, an oral tyrosine kinase 2 inhibitor, are both approved for individuals with moderate-to-severe psoriasis. In Magnolo et al’s study, they sought to directly compare the efficacy and safety of risankizumab versus deucravacitinib in adults with moderate disease who had not previously been given biologics.

IMMpactful, a global, phase 4 study, used a randomized, open-label, active-comparator study design. The analysis involved a blinded efficacy assessment (NCT06333860) of these 2 therapies, and those deemed eligible to take part were at least 18 years of age, biologic naïve, and candidates for systemic options. Additionally, they showed body surface area involvement between 10% - 15%, a Psoriasis Area and Severity Index (PASI) score of 12 or more, and a static Physician Global Assessment (sPGA) score of 3. There were 2 phases and the study lasted 52 weeks.

In period A (weeks 0–16), those taking part as subjects were randomized in a 1:2 ratio to be treated either with subcutaneous risankizumab 150 mg at baseline and Week 4 or oral deucravacitinib 6 mg once-per-day. During period B, from Weeks 16 - 52, subjects initially assigned to the deucravacitinib arm continued use every 12 weeks, while those initially on deucravacitinib were re-randomized 1:1 to either switch to risankizumab or continue with deucravacitinib. Stratification was based on PASI 90 response status at the 16-week mark.

Magnolo and colleagues’ co-primary endpoints in period A were the proportion of individuals attaining at least a 90% improvement in PASI (PASI 90) and the proportion attaining an sPGA score of 0 or 1 with a minimum 2-grade improvement from the point of baseline at 16 weeks. Among their key ranked secondary endpoints, they looked at PASI 100 and achievement of sPGA 0 with a 2-grade improvement. The team addressed missing information via non-responder imputation with multiple imputation methods. Only results from period A were reported.

There were 393 enrolled participants. 131 subjects, all of whom had a mean age of 47.3 years, were randomized to risankizumab. 262 individuals with a mean age of 44.8 years were assigned to deucravacitinib. Magnolo et al described baseline disease severity and demographic data as comparable between cohorts. At the 16-week mark, risankizumab demonstrated significantly superior efficacy versus deucravacitinib. There were higher rates of PASI 90 (57.3% versus 22.9%, P < .0001), sPGA 0/1 (80.2% versus 39.7%, P < .0001), PASI 100 (27.5% versus 6.5%, P < .0001), and sPGA 0 (27.5% versus 6.9%, P < .0001).

Occurrences of treatment-emergent adverse events appeared in 33.6% of those on risankizumab and 42.9% of those on deucravacitinib. The investigative team noted study drug–related adverse events (AEs) in 6.1% and 15.3% of participants, respectively. There was a single serious AE, a joint injury in a patient treated with risankizumab, which was reported and considered unrelated to study medication. A lack of deaths during the study period was also highlighted,

Overall, the study suggests risankizumab therapy produced more robust clinical responses than deucravacitinib in biologic-naïve adults with moderate psoriasis.

References

1. Magnolo N, Soung J, Warren R, et al. A Phase 4 Multicenter, Randomized, Open-Label, Efficacy Assessor-Blinded Study of Risankizumab Compared With Deucravacitinib for the Treatment of Adult Patients With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy: 16-Week Results From IMMpactful. Presented at: Maui Derm Hawaii 2026; January 25-29, 2026; Maui, Hawaii.

2. Armstrong AW, Soliman AM, Gisondi P, Fang S, Patel M, Strober B. Matching-Adjusted Indirect Comparison of Risankizumab Versus Deucravacitinib in Patients with Moderate-to-Severe Plaque Psoriasis. Dermatol Ther (Heidelb). 2024 Oct 25. doi: 10.1007/s13555-024-01293-y. Epub ahead of print. PMID: 39453596.