Apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of Japanese patients with moderate to severe plaque psoriasis: Efficacy, safety and tolerability results from a phase 2b randomized controlled trial

Autor: Robert M. Day, Osamu Nemoto, Mayumi Komine, Mamitaro Ohtsuki, Allan Maroli, Peng Chen, Yukari Okubo, Rosemary Petric, Shinichi Imafuku
Rok vydání: 2017
Předmět:
Male
apremilast
Administration
Oral
phosphodiesterase 4
Severity of Illness Index
Gastroenterology
law.invention
Placebos
030207 dermatology & venereal diseases
Psoriasis Area and Severity Index
0302 clinical medicine
Japan
Randomized controlled trial
law
Incidence
Incidence (epidemiology)
Anti-Inflammatory Agents
Non-Steroidal
General Medicine
Middle Aged
Thalidomide
Treatment Outcome
Tolerability
030220 oncology & carcinogenesis
Original Article
Female
medicine.drug
Adult
Diarrhea
medicine.medical_specialty
Dermatology
Placebo
03 medical and health sciences
Double-Blind Method
Internal medicine
Psoriasis
medicine
Humans
Adverse effect
Dose-Response Relationship
Drug
business.industry
Original Articles
medicine.disease
Surgery
Nasopharyngitis
Phosphodiesterase 4 Inhibitors
Apremilast
business
phosphodiesterase 4 inhibitor
Zdroj: The Journal of Dermatology
ISSN: 0385-2407
DOI: 10.1111/1346-8138.13829
Popis: Apremilast, an oral, small‐molecule phosphodiesterase 4 inhibitor, works intracellularly within immune cells to regulate inflammatory mediators. This phase 2b randomized, placebo‐controlled study evaluated efficacy and safety of apremilast among Japanese patients with moderate to severe plaque psoriasis. In total, 254 patients were randomized to placebo, apremilast 20 mg b.i.d. (apremilast 20) or apremilast 30 mg b.i.d. (apremilast 30) through week 16; thereafter, all placebo patients were re‐randomized to apremilast 20 or 30 through week 68. Efficacy assessments included achievement of 75% or more reduction from baseline in Psoriasis Area and Severity Index score (PASI‐75; primary) and achievement of static Physician Global Assessment (sPGA; secondary) score of 0 (clear) or 1 (minimal) at week 16. Safety was assessed through week 68. At week 16, PASI‐75 response rates were 7.1% (placebo), 23.5% (apremilast 20; P = 0.0032 vs placebo) and 28.2% (apremilast 30; P = 0.0003 vs placebo); sPGA response rates (score of 0 or 1) were 8.8% (placebo), 23.9% (apremilast 20; P = 0.0165 vs placebo) and 29.6% (apremilast 30; P = 0.0020 vs placebo). Responses were maintained with apremilast through week 68. Most common adverse events (AEs) with placebo, apremilast 20 and apremilast 30 (0–16 weeks) were nasopharyngitis (8.3%, 11.8%, 11.8%), diarrhea (1.2%, 8.2%, 9.4%), and abdominal discomfort (1.2%, 1.2%, 7.1%), respectively. Exposure‐adjusted incidence of these AEs did not increase with continued apremilast treatment (up to 68 weeks). Apremilast demonstrated efficacy and safety in Japanese patients with moderate to severe plaque psoriasis through 68 weeks that was generally consistent with prior studies.
Databáze: OpenAIRE
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