Risankizumab is a Safe and Effective Long-Term Treatment for Plaque Psoriasis - Dermatology Advisor

Risankizumab is safe and effective for the long-term treatment of moderate-to-severe plaque psoriasis, according to study findings published in the Journal of the European Academy & Venereology.

Researchers previously demonstrated the efficacy and safety of risankizumab for the treatment of moderate to severe plaque psoriasis over a 52-week period in 2 phase 3 UltiMMa-1/2 studies (ClinicalTrials.gov identifier: NCT02684370/ NCT02684357). However, data regarding the efficacy of risankizumab beyond 52 weeks are limited.

Therefore, researchers conducted a phase 3 open-label extension study (LIMMitless; ClinicalTrials.gov identifier: NCT03047395) to evaluate the long-term efficacy of risankizumab for the treatment of psoriasis and its disease manifestation subtypes: nail, scalp, and palmoplantar psoriasis. Included patients (N=525) completed the UltiMMa-1/2 studies and subsequently enrolled in the LIMMitless study. Adults with moderate to severe plaque psoriasis were randomly assigned to receive risankizumab 150 mg at weeks 0, 4, 16, 28, and 40 in the UltiMMa-1/2 studies (blinded from baseline to week 52), and every 12 weeks after week 52 in the open label extension. The researchers used the Psoriasis Area and Severity Index (PASI) to evaluate treatment efficacy (≥90% or 100% PASI improvement [PASI 90/100]).

Patients in the extension trial were a mean (SD) age of 47.7 (13.3) years, and 69.3% were men. The mean (SD) patient weight was 89.9 (22.1) kg. The mean (SD) PASI at baseline was 20.4 (7.6), and 27.2% had psoriatic arthritis. At baseline, 62.3% of patients had nail psoriasis, 90.9% had scalp psoriasis, and 31.2% had palmoplantar psoriasis.

These findings demonstrate the ability of risankizumab to comprehensively address psoriatic symptoms, including difficult-to-treat manifestations in specialized areas, and highlight the versatility of risankizumab treatment across a wide range of patient phenotypes.

Over 256 weeks of continuous risankizumab treatment, a similar proportion of patients of different ages, sex, BMI, weight, Psoriasis Area and Severity Index (PASI), or psoriatic arthritis status achieved PASI 90 or PASI 100, which was the primary measurement for treatment efficacy.

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At week 256, among the 327 patients with nail psoriasis, over 66% achieved a score of 0 (no psoriasis) on the Nail Psoriasis Severity Index (NAPSI). There was a mean improvement of over 81% from baseline in NAPSI.

At week 256, among the 477 patients with scalp psoriasis at baseline, over 73% achieved a score of 0 (no psoriasis) on the Psoriasis Scalp Severity Index (PSSI). There was a mean improvement of over 94% from baseline in PSSI.

Among the 164 patients with palmoplantar psoriasis, over 81% achieved a score of 0 (no psoriasis) on the Palmoplantar Psoriasis Area and Severity Index (PPASI) at Week 256. There was a mean improvement of over 97% from baseline in PPASI.

Many patients with psoriatic disease experience multiple manifestations beyond just skin symptoms. In the analysis, 58.7% had both nail and scalp psoriasis, while 28.8% had both scalp and palmoplantar psoriasis, 24.0% had both nail and palmoplantar psoriasis, and 23.0% had all 3 manifestations. Over 51% of patients with 2 of these 3 psoriatic disease manifestations achieved complete clearance in both at Week 256. Among the 121 patients with all 3 manifestations at baseline, 44.6% achieved simultaneous clearance of all 3 at Week 256, as measured by NAPSI, PSSI, and PPASI scores.

Study limitations include the post hoc analysis of primary clinical trial data, the lack of a comparator group, and the open-label study design from Weeks 52 through 256.

The researchers concluded, "These findings demonstrate the ability of risankizumab to comprehensively address psoriatic symptoms, including difficult-to-treat manifestations in specialized areas, and highlight the versatility of risankizumab treatment across a wide range of patient phenotypes."

Disclosure: This research was supported by AbbVie. Please see the original reference for a full list of disclosures.

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