title: Safety and efficacy of adalimumab treatment in Japanese patients with psoriasis: Results of SALSA study.
abstract: The safety and efficacy of adalimumab were evaluated over 24 weeks in Japanese patients with psoriasis in routine clinical practice. In this multicenter, observational, open-label, postmarketing study, primary efficacy measures included the Psoriasis Area and Severity Index (PASI) and the Dermatology Life Quality Index (DLQI) in all patients with psoriasis. In patients with psoriatic arthritis (PsA), the 28-joint Disease Activity Score (DAS28) and the visual analog scale (VAS) pain were also evaluated. Safety was assessed based on the frequency of adverse drug reactions (ADR). Among patients with psoriasis evaluated for efficacy (n = 604), significant improvements from baseline were observed in mean PASI and DLQI scores at weeks 16 and 24 (all P < 0.0001). Furthermore, in psoriasis patients without PsA, the PASI 75/90 response rates were 55.9%/28.4% at week 16 (n = 306) and 65.6%/43.3% at week 24 (n = 270), respectively. In patients with PsA evaluable for effectiveness, significant improvements from baseline were observed in PASI, DAS28 erythrocyte sedimentation rate, DAS28 C-reactive protein and VAS pain at weeks 16 and 24 (all P < 0.0001). ADR and serious ADR were reported by 26.1% and 3.3%, respectively, of 731 safety evaluable patients with psoriasis; no unexpected safety findings were noted. The safety profile and effectiveness of adalimumab for the treatment of psoriasis in a routine clinical setting were as expected in Japanese patients.
authors.affiliation: The Jikei University School of Medicine, Tokyo, Japan. asahina-tky@umin.ac.jp.
authors.forename: Akihiko
authors.initials: A
authors.lastname: Asahina
authors.affiliation: Tokyo Yamate Medical Center, Tokyo, Japan.
authors.forename: Hideshi
authors.initials: H
authors.lastname: Torii
authors.affiliation: Jichi Medical University, Tochigi, Japan.
authors.forename: Mamitaro
authors.initials: M
authors.lastname: Ohtsuki
authors.affiliation: AbbVie, Tokyo, Japan.
authors.forename: Toshimitsu
authors.initials: T
authors.lastname: Tokimoto
authors.affiliation: AbbVie, Tokyo, Japan.
authors.forename: Hidenori
authors.initials: H
authors.lastname: Hase
authors.affiliation: AbbVie, Tokyo, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Tsuchiya
authors.affiliation: AbbVie, Tokyo, Japan.
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Shinmura
authors.affiliation: AbbVie Farmacéuticos SA de CV, Mexico City, Mexico.
authors.forename: Ofelia
authors.initials: O
authors.lastname: Reyes Servin
authors.affiliation: The Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Hidemi
authors.initials: H
authors.lastname: Nakagawa
mesh_terms: D000068879:Adalimumab / Q000009:adverse effects*; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011565:Psoriasis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000068879:Adalimumab
keywords: drug surveillance; postmarketing; psoriasis; safety; treatment outcome