Efficacy of risankizumab in patients with moderate‐to‐severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa‐1 and UltIMMa‐2 studies

Abstract

Background Risankizumab is a humanized IgG monoclonal antibody that selectively inhibits interleukin-23 through binding the p19 subunit. In Phase 3 trials, risankizumab demonstrated superior efficacy compared with adalimumab and ustekinumab in patients with moderate-to-severe plaque psoriasis. Here, we evaluated the impact of baseline characteristics on efficacy of risankizumab compared with ustekinumab in patients with moderate-to-severe plaque psoriasis. Methods This analysis included all patients initially randomized to risankizumab or ustekinumab from the replicate, double-blinded, randomized, placebo-controlled phase 3 trials, UltIMMa-1 (NCT02684370) and UltIMMa-2 (NCT02684357). Patients received either risankizumab (150 mg) or ustekinumab (weight-based; 45 or 90 mg per label) at weeks 0, 4, 16, 28 and 40. Efficacy was assessed as the proportion of patients achieving ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) at weeks 16 and 52 by baseline patient demographics, disease characteristics and prior biologic exposure. Mean per cent improvement in PASI was calculated by body weight and body mass index at week 52. Missing efficacy data were imputed as non-responders for categorical variables and last observation carried forward for continuous variables. Logistic regression analyses assessed for interactions between treatment and five independent variables (age, sex, weight, baseline PASI score and presence of psoriatic arthritis) at both weeks 16 and 52. Results Baseline patient demographics, disease characteristics and prior biologic exposure were similar between patients randomized to risankizumab (n = 598) and ustekinumab (n = 199). At weeks 16 and 52, risankizumab demonstrated superior efficacy compared with ustekinumab across these patient characteristics (P < 0.01). Logistic regression analyses demonstrated that risankizumab was superior to ustekinumab at weeks 16 and 52 in all models tested (P < 0.0001 for all). Conclusions Risankizumab demonstrated consistent and superior efficacy compared with ustekinumab regardless of patient demographics, disease characteristics or prior biologic exposure.

Risankizumab: A Review in Moderate to Severe Plaque Psoriasis

“…baseline PASI, baseline sPGA and psoriatic arthritis status) and prior therapy exposure (i.e. naïve to biologicals, any biological exposure and failed any biological) [ 23 ]. Similar results were seen for sPGA 0 or 1 and PASI 100 response rates [ 23 ].…”

“…naïve to biologicals, any biological exposure and failed any biological) [ 23 ]. Similar results were seen for sPGA 0 or 1 and PASI 100 response rates [ 23 ]. Among patients initially randomized to placebo who switched to risankizumab at week 16, PASI, sPGA, DLQI and PSS response rates at week 52 were similar to those in patients initially randomized to risankizumab (Table 3 ) [ 15 ].…”

Dermato‐venereology in the year of coronavirus – Hot topics in research and patient care

“…The era of biologics continues to evolve with many articles on various target‐oriented therapeutics in the field of psoriasis being published. Among others, risankizumab was found to be more effective than ustekinumab also in the patients who have shown no response to biologics in previous studies 20 …”

Risankizumab as an effective therapeutic option in severe psoriasis unsuccessfully treated with therapies involving anti- TNF-α and anti-IL-17

“…Furthermore, an analysis of the clinical trials proved that the drug is effective in patients that have been exposed to other prior biologic therapies, such as biologic-naïve patients [18]. Recently, a case report has been published that presented a patient with severe psoriasis, class 3 obesity (BMI > 40 kg/m 2 ), secondary inefficacy of adalimumab and primary inefficacy of etanercept, in whom a therapy involving risankizumab was associated with a complete clinical remission that was maintained during a 14-month treatment [19].…”

“…Analiza badań klinicznych udowodniła również, że lek jest równie skuteczny u pacjentów wcześniej poddawanych innym terapiom biologicznym jak u osób dotąd nieleczonych lekami biologicznymi [18]. Niedawno opublikowano opis przypadku pacjenta z ciężką łuszczycą i otyłością 3. stopnia (BMI > 40 kg/m 2 ) z wtórną nieskutecznością adalimumabu i pierwotną etanerceptu, u którego terapia ryzankizumabem przyniosła całkowitą remisję kliniczną utrzymującą się w czasie 14-miesięcznego leczenia [19].…”