Patient-reported outcomes better with risankizumab in moderate to severe psoriasis

Risankizumab was associated with significant improvement over ustekinumab and placebo in a number of quality-of-life parameters in a cohort of patients with psoriasis, according to a study.

“Demonstrating the value of therapies from a patient’s perspective is increasingly important for patient-centered care,” Matthias Augustin, MD, of University Medical Center Hamburg, Germany, and colleagues wrote.

They compared a cross-section of patient-reported outcomes for Skyrizi (risankizumab, AbbVie) compared with Stelara (ustekinumab, Janssen) and placebo.

In the replicate phase 3 UltIMMa-1 and UltIMMa-2 studies, 997 patients were assigned risankizumab 150 mg for 52 weeks, ustekinumab 45 mg or 90 mg (weight-based per label) for 52 weeks or matching placebo for 16 weeks followed by risankizumab. There were 598 patients in the risankizumab arm, 199 in the ustekinumab arm and 200 in the placebo arm.

The trials were conducted at 139 sites in Japan, Europe, North America and the Asia-Pacific region. Eligible participants were aged 18 years or older with moderate to severe chronic plaque psoriasis covering a body surface area of 10% or more. Participants also reported Psoriasis Area Severity Index scores of 12 or higher and static Physician’s Global Assessment scores of 3 or higher.

Comparison assessed by the Psoriasis Symptom Scale (PSS) served as the primary outcome measure, along with Dermatology Life Quality Index (DLQI), 5-level EuroQoL-5D (EQ-5D-5L) and Hospital Anxiety and Depression Scale (HADS). Assessments were made at baseline and then at weeks 16 and 52.

Findings at 16 weeks showed that 30.3% of patients treated with risankizumab achieved PSS of 0 — no psoriasis symptoms — compared with 15.1% of those treated with ustekinumab and 1% of those in the placebo group (P < .001).

A similar outcome was reported for DLQI with scores of 0 or 1 — no impact on skin-related health-related quality of life — with risankizumab yielding a rate of 66.2% compared with 44.7% for ustekinumab and 6% for placebo (P < .001).

The trend continued with a minimally clinically important difference in DLQI, with risankizumab reaching a rate of 94.5%, ustekinumab 85.1% and placebo 35.6% (P < .001 for both).

EQ-5D-5L rates were 41.7% in the risankizumab group and 31.5% in the ustekinumab group (P = .01) compared with 19% in the placebo group (P < .001).

In the analysis for HADS, anxiety rates were 69.1% in the risankizumab arm vs. 57.1% for ustekinumab (P = .004), while placebo yielded a rate of 35.9% (P < .001). For HADS depression, the rates were 71.1% vs. 60.4% for risankizumab and ustekinumab (P = .01), compared with 37.1% in the placebo group (P < .001).

All of these trends persisted, as assessed by PSS, DLQI, and EQ-5D-5L, through 52 weeks.

“Risankizumab significantly improved symptoms of moderate to severe psoriasis, improved [health-related quality of life] and reduced psychological distress compared with ustekinumab or placebo,” Augustin and colleagues wrote.