A higher proportion of risankizumab users achieved improved measures for symptoms, quality of life, and mental health versus comparators.
Patients with moderate to severe plaque psoriasis who were treated with risankizumab experienced improvements of symptoms and reported improved health-related quality of life and reduced psychological distress, according to results from the UltIMMa-1 and UltIMMa-2 randomized clinical trials.
Positive outcomes related to the interleukin (IL)-23 inhibitor were significant compared with ustekinumab and placebo, the investigators found.
Both studies, led by Matthias Augustin, MD, University Medical Center Hamburg, Germany, assessed Psoriasis Symptom Scale (PSS), Dermatology Life Quality Index (DLQI), 5-level EuroQoL-5D (EQ-5D-5L), and Hospital Anxiety and Depression Scale (HADS) in patients with moderate to severe chronic plaque psoriasis.
These measures were then integrated and compared at baseline, week 16, and week 52.
The UltIMMa-1 and UltIMMa-2 studies were replicate 52-week, phase 3, double-blind, placebo-controlled and active comparator-controlled trials that were conducted in 139 sites—which included hospitals, academic medical centers, clinical research units, and private practices.
In each trial, patients were randomly assigned 3:1:1 to receive 150 mg of risankizumab, 45 mg or 90 mg for 52 weeks, or a matching placebo for 16 weeks, which was then followed by risankizumab.
Included in the patient population were adults with a body surface area (BSA) involvement of ≥10%, Psoriasis Area Severity Index (PASI) scores of ≥12, and static Physician’s Global Assessment (sPGA) scores of ≥3.
Overall, the team assessed a total of 997 patients, with a mean age between 47.2-47.8 across all arms. Between 68.3%-73.0% were men. Furthermore, the investigators noted that patient characteristics and patient-reported outcomes (PROs) were consistent at baseline.
At week 16, 30.3% of risanizumab-treated patients achieved a PSS = 0, which indicated no psoriasis symptoms. Notably, this proportion was significantly greater than those treated with ustekinumab or placebo (15.1% and 1.0%, respectively; P < .001).
Additionally, a high proportion of patients in the risankizumab cohort reported DLQI = 0 (66.2%), an indicator of no impact on skin-related HRPQ. This proportion was higher than the ustekinumab and placebo cohorts (44.7% and 6.0%, respectively; P<.001).
In comparison to ustekinumab and placebo, a greater proportion of risankizumab patients achieved minimally clinically important differences in DLQI (94.5% risankizumab, 85.1% ustekinumab, 35.6% placebo; P < .001) and EQ-5D-5L (41.7% vs 31.5%, P = .01; vs 19.0% placebo, P<.001).
This trend was also seen in HADS. In the risankizumab group, 69.1% were responders in the measurement in anxiety—versus 57.1% in the ustekinumab group (P = .004) and 35.9% in the placebo group (P<.001).
Up to 71.1% of risankizumab users responded on the depression scale, as compared with 60.4% with ustekinumab (P = .01) and 37.1% with placebo (P < .001).
These improvements and comparative trends were sustained for PSS, DLQI, and EQ-5D-5L by week 52.
“In the era of patient-centered care, the use of PRO instruments in clinical trials is an important method to assess treatment efficacy from a patient’s perspective to complement and supplement traditional outcomes measured using biomarkers or physicians' assessments,” Augustin and colleagues wrote.
They acknowledged that the use of PROs is especially relevant for chronic diseases like psoriasis considering the long-term effects of symptoms.
“These findings may further raise standards for treatments and provide promising outcomes for patients suffering from moderate to severe chronic plaque psoriasis,” they concluded.
The study, “Effect of Risankizumab on Patient-Reported Outcomes in Moderate to Severe Psoriasis: The UltIMMa-1 and UltIMMa-2 Randomized Clinical Trials” was published online in JAMA Dermatology.