title: Oral tofacitinib efficacy, safety and tolerability in Japanese patients with moderate to severe plaque psoriasis and psoriatic arthritis: A randomized, double-blind, phase 3 study.
abstract: Tofacitinib is an oral Janus kinase inhibitor that is being investigated for psoriasis and psoriatic arthritis. Japanese patients aged 20 years or more with moderate to severe plaque psoriasis and/or psoriatic arthritis were double-blindly randomized 1:1 to tofacitinib 5 or 10 mg b.i.d. for 16 weeks, open-label 10 mg b.i.d. for 4 weeks, then variable 5 or 10 mg b.i.d. to Week 52. Primary end-points at Week 16 were the proportion of patients achieving at least a 75% reduction in Psoriasis Area and Severity Index (PASI75) and Physician's Global Assessment of "clear" or "almost clear" (PGA response) for psoriasis, and 20% or more improvement in American College of Rheumatology criteria (ACR20) for patients with psoriatic arthritis. Safety was assessed throughout. Eighty-seven patients met eligibility criteria for moderate to severe plaque psoriasis (5 mg b.i.d., n = 43; 10 mg b.i.d., n = 44), 12 met eligibility criteria for psoriatic arthritis (5 mg b.i.d., n = 4; 10 mg b.i.d., n = 8) including five who met both criteria (10 mg b.i.d.). At Week 16, 62.8% and 72.7% of patients achieved PASI75 with tofacitinib 5 and 10 mg b.i.d., respectively; 67.4% and 68.2% achieved PGA responses; all patients with psoriatic arthritis achieved ACR20. Responses were maintained through Week 52. Adverse events occurred in 83% of patients through Week 52, including four (4.3%) serious adverse events and three (3.2%) serious infections (all herpes zoster). No malignancies, cardiovascular events or deaths occurred. Tofacitinib (both doses) demonstrated efficacy in patients with moderate to severe plaque psoriasis and/or psoriatic arthritis through 52 weeks; safety findings were generally consistent with prior studies.
authors.affiliation: Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Akihiko
authors.initials: A
authors.lastname: Asahina
authors.affiliation: Department of Dermatology, Tokyo Teishin Hospital, Tokyo, Japan.
authors.forename: Takafumi
authors.initials: T
authors.lastname: Etoh
authors.affiliation: Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.
authors.forename: Atsuyuki
authors.initials: A
authors.lastname: Igarashi
authors.affiliation: Department of Dermatology, Fukuoka University Faculty of Medicine, Fukuoka, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Imafuku
authors.affiliation: Department of Dermatology, Nippon Medical School, Tokyo, Japan.
authors.forename: Hidehisa
authors.initials: H
authors.lastname: Saeki
authors.affiliation: Pfizer Japan Inc., Tokyo, Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Shibasaki
authors.affiliation: Pfizer Japan Inc., Tokyo, Japan.
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Tomochika
authors.affiliation: Pfizer Japan Inc., Tokyo, Japan.
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Toyoizumi
authors.affiliation: Pfizer Japan Inc., Tokyo, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Nagaoka
authors.affiliation: Department of Dermatology, Jichi Medical University, Tochigi, Japan.
authors.forename: Mamitaro
authors.initials: M
authors.lastname: Ohtsuki
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000284:Administration, Oral; D015535:Arthritis, Psoriatic / Q000188:drug therapy; D004311:Double-Blind Method; D006562:Herpes Zoster / Q000209:etiology; D007564:Japan; D010880:Piperidines / Q000008:administration & dosage / Q000009:adverse effects; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D011565:Psoriasis / Q000188:drug therapy; D011743:Pyrimidines / Q000008:administration & dosage / Q000009:adverse effects; D011758:Pyrroles / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D010880:Piperidines; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D011758:Pyrroles; C479163:tofacitinib
keywords: Japan; kinase inhibitor; plaque psoriasis; psoriatic arthritis; tofacitinib