Data from two replicate phase 3 clinical trials revealed that a significant proportion of patients receiving risankizumab achieved improvements in psoriasis severity, quality of life, and mental health measures vs patients who received ustekinumab or placebo.1 The results, published in JAMA Dermatology, further build the evidence for risankizumab as a clinically superior therapy for patients with moderate to severe plaque psoriasis.2-4
Risankizumab is a novel humanized IgG1 monoclonal antibody that selectively targets IL-23p19. It gained FDA approval in April 2019.
The trials, UltIMMa-1 and UltIMMa-2, were 52-week, randomized, double-blind, and placebo- and active comparator-controlled trials conducted at 139 sites across the globe. This particular study1 compared the patient-reported outcomes of psoriasis symptoms, health-related quality of life (HRQL), and mental health of patients receiving either risankizumab, ustekinumab, or placebo.
In total, the study included 997 patients aged 18 years or older who had moderate to severe chronic plaque psoriasis with a body surface area (BSA) involvement of 10% or more, a Psoriasis Area Severity Index (PASI) score of 12 or greater, and a statis Physician Global Assessment (sPGA) score of 3 or higher. Patients were randomized 3:1:1 to receive either 150 mg of risankizumab or 45 mg or 90 mg of ustekinumab per weight-based dosing instructions for 52 weeks, or matching placebo for 16 weeks followed by risankizumab for the study remainder.
The main outcomes measured were Psoriasis Symptom Scale (PSS), including the total score as well as the item scores for pain, redness, itchiness, and burning; Dermatology Life Quality Index (DLQI); 5-level EuroQoL-5D (EQ-5D-5L); and Hospital Anxiety and Depression Scale (HADS). Outcomes were compared at baseline and again at weeks 16 and 52 of treatment.
At baseline, patient characteristics and reported outcomes were similar across all groups. However, at week 16, a significantly greater proportion of patients treated with risankizumab achieved a PSS score of 0 (no psoriasis symptoms) and DLQI score of 0 or 1 (no impact on skin-related HRQL) compared with the patients treated with ustekinumab or placebo. Further, a significantly greater proportion of the risankizumab group achieved minimally clinically important difference for DLQI, EQ-5D-5L, and HADS (anxiety, depression) at week 16 vs ustekinumab and placebo.
At week 52, these improvements were sustained for PSS, DLQI, and EQ-5D-5L.
The authors1 acknowledged potential limitations to the study, including limited generalizability to patients outside of the clinical trial setting, last observation carried forward imputation impacting continuous measures data, and nonresponder imputation affecting true rate of response.
These results of the UltIMMa-1 and UltIMMa-2 trials on patient-reported outcomes demonstrated the superiority of risankizumab in reducing or even eliminating psoriasis symptoms and psychological distress vs ustekinumab and placebo. The findings, along with previously reported data, demonstrate that risankizumab is an efficacious novel biologic therapy that can lead to clinically meaningful improvements in quality of life in patients with plaque psoriasis.
1. Augustin M, Lambert J, Zema C, et al. Effect of risankizumab on patient-reported outcomes in moderate to severe psoriasis. JAMA Dermatol. Published online October 14, 2020. doi:10.1001/jamadermatol.2020.3617
2. Risankizumab demonstrates superiority for treatment of adults with moderate to severe plaque psoriasis in head-to-head phase 3 trial. The Dermatologist. Accessed October 30, 2020. https://www.the-dermatologist.com/advances/risankizumab-demonstrates-superiority-primary-secondary-endpoints-adults-moderate-severe
3. Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650-661. doi:10.1016/S0140-6736(18)31713-6
4. Reich K, Gooderham M, Thaçi D, et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019;394(10198):576-586. doi:10.1016/S0140-6736(19)30952-3