Effect of risankizumab on patient-reported outcomes in moderate to severe psoriasis : the UltIMMa-1 and UltIMMa-2 randomized clinical trials
| Autor: | Joaquin Mario Valdes, Min Yang, Jo Lambert, Ziqian Geng, Elizabeth H Z Thompson, Viviana Garcia-Horton, Matthias Augustin, Avani Joshi, Eric Q. Wu, Kenneth B. Gordon, Carla Zema |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Adult
Male medicine.medical_specialty PLAQUE PSORIASIS IMPROVEMENT Dermatology HOSPITAL ANXIETY Psychological Distress Placebo Hospital Anxiety and Depression Scale Severity of Illness Index Maintenance Chemotherapy law.invention 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law QUALITY-OF-LIFE Psoriasis Internal medicine Severity of illness Ustekinumab medicine Medicine and Health Sciences Humans TO-SEVERE PSORIASIS Patient Reported Outcome Measures VALIDITY Original Investigation Risankizumab business.industry Antibodies Monoclonal Dermatology Life Quality Index Middle Aged medicine.disease EFFICACY PHASE-III BRODALUMAB Treatment Outcome 030220 oncology & carcinogenesis Quality of Life Female business medicine.drug ADALIMUMAB |
| Zdroj: | JAMA DERMATOLOGY JAMA Dermatol |
| ISSN: | 2168-6068 2168-6084 |
| Popis: | IMPORTANCE: Demonstrating the value of therapies from a patient’s perspective is increasingly important for patient-centered care. OBJECTIVE: To compare patient-reported outcomes (PROs) with risankizumab vs ustekinumab and placebo in psoriasis symptoms, health-related quality of life (HRQL), and mental health among patients with moderate to severe psoriasis. DESIGN, SETTING, AND PARTICIPANTS: The UltIMMa-1 and UltIMMa-2 studies were replicate 52-week phase 3, randomized, multisite, double-blind, placebo-controlled and active comparator-controlled trials conducted in 139 sites (including hospitals, academic medical centers, clinical research units, and private practices) globally in Asia-Pacific, Japan, Europe, and North America. Adults (≥18 years) with moderate to severe chronic plaque psoriasis with body surface area (BSA) involvement of 10% or more, Psoriasis Area Severity Index (PASI) scores of 12 or higher, and static Physician’s Global Assessment (sPGA) scores of 3 or higher were included. INTERVENTIONS: In each trial, patients were randomly assigned (3:1:1) to 150 mg of risankizumab, 45 mg or 90 mg of ustekinumab (weight-based per label) for 52 weeks, or matching placebo for 16 weeks followed by risankizumab. MAIN OUTCOMES AND MEASURES: Integrated data from 2 trials were used to compare Psoriasis Symptom Scale (PSS) (total score and 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), at baseline, week 16, and week 52. RESULTS: A total of 997 patients with moderate to severe chronic plaque psoriasis were analyzed. Across all arms, the mean age was 47.2 to 47.8 years and 68.3% (136/199 for ustekinumab) to 73.0% (146/200 for placebo) were men. Patients’ characteristics and PROs were comparable across all treatment arms at baseline (n = 598, 199, 200 for risankizumab, ustekinumab, and placebo, respectively). At week 16, a significantly greater proportion of patients treated with risankizumab than those treated with ustekinumab or placebo achieved PSS = 0, indicating no psoriasis symptoms (30.3% [181/598], 15.1% [30/199], 1.0% [2/200], both P |
| Databáze: | OpenAIRE |
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