Deucravacitinib in moderate-to-severe plaque psoriasis: Pooled safety and tolerability over 52 weeks from two phase 3 trials (POETYK PSO-1 and PSO-2).

Autor: Strober B; Department of Dermatology, Yale University, New Haven, Connecticut, USA.; Central Connecticut Dermatology Research, Cromwell, Connecticut, USA., Blauvelt A; Oregon Medical Research Center, Portland, Oregon, USA., Warren RB; Dermatology Centre, Northern Care Alliance NHS Foundation Trust, Manchester, UK.; Manchester NIHR Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK., Papp KA; Alliance Clinical Trials and Probity Medical Research, Waterloo, Ontario, Canada.; Division of Dermatology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada., Armstrong AW; Department of Dermatology, University of California Los Angeles, Los Angeles, California, USA., Gordon KB; Dermatology - Froedtert Cancer Center, Medical College of Wisconsin, Milwaukee, Wisconsin, USA., Morita A; Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan., Alexis AF; Department of Dermatology, Weill Cornell Medicine, New York, New York, USA., Lebwohl M; Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Foley P; Skin Health Institute and Probity Medical Research, Melbourne, Victoria, Australia., Kisa RM; Bristol Myers Squibb, Princeton, New Jersey, USA., Colston E; Bristol Myers Squibb, Princeton, New Jersey, USA., Wang T; Bristol Myers Squibb, Princeton, New Jersey, USA., Banerjee S; Bristol Myers Squibb, Princeton, New Jersey, USA., Thaçi D; Institute and Comprehensive Centre for Inflammation Medicine, University of Luebeck, Luebeck, Germany.
Jazyk: angličtina
Zdroj: Journal of the European Academy of Dermatology and Venereology : JEADV [J Eur Acad Dermatol Venereol] 2024 Aug; Vol. 38 (8), pp. 1543-1554. Date of Electronic Publication: 2024 Mar 07.
DOI: 10.1111/jdv.19925
Abstrakt: Background: Two phase 3 trials, POETYK PSO-1 and PSO-2, previously established the efficacy and overall safety of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, in plaque psoriasis.
Objectives: To further assess the safety of deucravacitinib over 52 weeks in the pooled population from these two trials.
Methods: Pooled safety data were evaluated from PSO-1 and PSO-2 in which patients with moderate-to-severe plaque psoriasis were randomized 1:2:1 to receive oral placebo, deucravacitinib or apremilast.
Results: A total of 1683 patients were included in the pooled analysis. Adverse event (AE) incidence rates were similar in each treatment group, serious AEs were low and balanced across groups, and discontinuation rates were lower with deucravacitinib versus placebo or apremilast. No new safety signals emerged with longer deucravacitinib treatment. Exposure-adjusted incidence rates of AEs of interest with placebo, deucravacitinib and apremilast, respectively, were as follows: serious infections (0.8/100 person-years [PY], 1.7/100 PY, and 1.8/100 PY), major adverse cardiovascular events (1.2/100 PY, 0.3/100 PY, and 0.9/100 PY), venous thromboembolic events (0, 0.2/100 PY, and 0), malignancies (0, 1.0/100 PY and 0.9/100 PY), herpes zoster (0.4/100 PY, 0.8/100 PY, and 0), acne (0.4/100 PY, 2.9/100 PY, and 0) and folliculitis (0, 2.8/100 PY, and 0.9/100 PY). No clinically meaningful changes from baseline in mean levels, or shifts from baseline to CTCAE grade ≥3 abnormalities, were reported in laboratory parameters with deucravacitinib.
Conclusions: Deucravacitinib was well-tolerated with acceptable safety over 52 weeks in patients with psoriasis.
(© 2024 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)
Databáze: MEDLINE
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