PMID- 33052382 OWN - NLM STAT- MEDLINE DCOM- 20210318 LR - 20211120 IS - 2168-6084 (Electronic) IS - 2168-6068 (Print) IS - 2168-6068 (Linking) VI - 156 IP - 12 DP - 2020 Dec 1 TI - Effect of Risankizumab on Patient-Reported Outcomes in Moderate to Severe Psoriasis: The UltIMMa-1 and UltIMMa-2 Randomized Clinical Trials. PG - 1344-1353 LID - 10.1001/jamadermatol.2020.3617 [doi] AB - 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 < .001), and DLQI = 0 or 1 indicating no impact on skin-related HRQL (66.2%, 44.7%, 6.0%, P < .001). Significantly greater proportions of patients treated with risankizumab achieved minimally clinically important difference (MCID) than ustekinumab or placebo for DLQI (94.5% [516/546], 85.1% [149/175], 35.6% [64/180]; both P < .001), EQ-5D-5L (41.7% [249/597] vs 31.5% [62/197], P = .01; vs 19.0% [38/200], P < .001), and HADS (anxiety: 69.1% [381/551] vs 57.1% [104/182], P = .004; vs 35.9% [66/184], P < .001; depression: 71.1% [354/598] vs 60.4% [96/159], P = .01; vs 37.1% [59/159], P < .001). At week 52, improvements in patients treated with risankizumab compared with those treated with ustekinumab were sustained for PSS, DLQI, and EQ-5D-5L. CONCLUSIONS AND RELEVANCE: Risankizumab significantly improved symptoms of moderate to severe psoriasis, improved HRQL, and reduced psychological distress compared with ustekinumab or placebo. TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT02684370 (UltIMMa-1) and NCT02684357 (UltIMMa-2). FAU - Augustin, Matthias AU - Augustin M AD - University Medical Center Hamburg, Hamburg, Germany. FAU - Lambert, Jo AU - Lambert J AD - Ghent University Hospital, Ghent, Belgium. FAU - Zema, Carla AU - Zema C AD - Formerly AbbVie Inc, North Chicago, Illinois. FAU - Thompson, Elizabeth H Z AU - Thompson EHZ AD - Formerly AbbVie Inc, North Chicago, Illinois. FAU - Yang, Min AU - Yang M AD - Analysis Group, Inc, Boston, Massachusetts. FAU - Wu, Eric Q AU - Wu EQ AD - Analysis Group, Inc, Boston, Massachusetts. FAU - Garcia-Horton, Viviana AU - Garcia-Horton V AD - Analysis Group, Inc, New York, New York. FAU - Geng, Ziqian AU - Geng Z AD - AbbVie Inc, North Chicago, Illinois. FAU - Valdes, Joaquin M AU - Valdes JM AD - Formerly AbbVie Inc, North Chicago, Illinois. FAU - Joshi, Avani AU - Joshi A AD - AbbVie Inc, North Chicago, Illinois. FAU - Gordon, Kenneth B AU - Gordon KB AD - Medical College of Wisconsin, Milwaukee. LA - eng SI - ClinicalTrials.gov/NCT02684370 SI - ClinicalTrials.gov/NCT02684357 PT - Clinical Trial, Phase III PT - Equivalence Trial PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - JAMA Dermatol JT - JAMA dermatology JID - 101589530 RN - 0 (Antibodies, Monoclonal) RN - 90ZX3Q3FR7 (risankizumab) RN - FU77B4U5Z0 (Ustekinumab) SB - IM MH - Adult MH - Antibodies, Monoclonal/*administration & dosage/adverse effects MH - Double-Blind Method MH - Female MH - Humans MH - Maintenance Chemotherapy/methods MH - Male MH - Middle Aged MH - *Patient Reported Outcome Measures MH - Psoriasis/complications/diagnosis/*drug therapy/psychology MH - *Psychological Distress MH - Quality of Life MH - Severity of Illness Index MH - Treatment Outcome MH - Ustekinumab/*administration & dosage/adverse effects PMC - PMC7557488 COIS- Conflicts of Interest Disclosures: Dr Augustin has served as consultant to or paid speaker for clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly, GSK, Janssen-Cilag, Leo, Medac, Merck, MSD, Novartis, Pfizer, UCB and Xenoport. Dr Lambert serves as an investigator and/or consultant for AbbVie, Janssen, Lilly, Celgene, Novartis, Pfizer, and LEO Pharma. Dr Gordon has received honoraria for serving as a consultant and/or grants as an investigator from AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermira, Eli Lilly, GlaxoSmithKline, Janssen, Leo, Novartis, Pfizer, Regeneron, Sanofi-Aventis, Sun, and UCB. Drs Joshi and Geng are employees of AbbVie and may own AbbVie stock or stock options. Drs Zema, Thompson, and Valdez are former employees of AbbVie and may own AbbVie stock or stock options. Drs Yang, Wu, and Garcia-Horton are employed by Analysis Group, which received payment from AbbVie to assist with the research process. No other conflicts are reported. EDAT- 2020/10/15 06:00 MHDA- 2021/03/19 06:00 PMCR- 2020/10/14 CRDT- 2020/10/14 12:44 PHST- 2020/10/15 06:00 [pubmed] PHST- 2021/03/19 06:00 [medline] PHST- 2020/10/14 12:44 [entrez] PHST- 2020/10/14 00:00 [pmc-release] AID - 2771625 [pii] AID - doi200056 [pii] AID - 10.1001/jamadermatol.2020.3617 [doi] PST - ppublish SO - JAMA Dermatol. 2020 Dec 1;156(12):1344-1353. doi: 10.1001/jamadermatol.2020.3617.