Efficacy of tofacitinib for the treatment of moderate-to-severe chronic plaque psoriasis in patient subgroups from two randomised phase 3 trials
Journal
Journal of Drugs in Dermatology
Journal Volume
15
Journal Issue
5
Pages
568-580
Date Issued
2016
Author(s)
Menter M.A.
Papp K.A.
Cather J.
Leonardi C.
Pariser D.M.
Krueger J.G.
Wohlrab J.
Amaya-Guerra M.
Kaszuba A.
Nadashkevich O.
Gupta P.
Tan H.
Valdez H.
Mallbris L.
Tatulych S.
Abstract
Background: Tofacitinib is a Janus kinase inhibitor being investigated for the treatment of moderate-to-severe plaque psoriasis. We report efficacy of tofacitinib in patient subgroups based on pooled data from two Phase 3 trials (NCT01276639, NCT01309737). OBJECTIVES: To assess consistency of treatment effects of tofacitinib versus placebo in subgroups defined by baseline characteristics, and to ascertain whether baseline characteristics are of value in optimizing tofacitinib use. METHODS: Pooled data from the two trials were used to evaluate ?75% reduction in PASI from baseline (PASI75 response) in subgroups defined by age, age at psoriasis onset, gender, race, geographical region, weight, body mass index, diabetes, metabolic syndrome, tobacco/alcohol use, psoriatic arthritis, disease activity, and prior therapy. RESULTS: Week 16 PASI75 response rates (N=1843) were 43%, 59% and 9% with tofacitinib 5 and 10mg twice daily (BID) and placebo, respectively (each P<0.0001 versus placebo). Tofacitinib 5 and 10mg BID were effective regardless of baseline characteristics. Across subgroups, tofacitinib generally produced greater response rates with the 10 versus 5mg BID dosage. Lower absolute response rates were seen in heavier patients and patients with prior biologic experience. CONCLUSIONS: Both tofacitinib dosages demonstrated consistent efficacy versus placebo across subgroups. Lower response rates were seen in heavier patients and those with prior biologic experience. Tofacitinib 10mg BID resulted in a substantial proportion of responders regardless of baseline characteristics. Copyright ? 2017 Journal of Drugs in Dermatology. All Rights Reserved
SDGs
Other Subjects
alcohol; placebo; tofacitinib; piperidine derivative; protein kinase inhibitor; pyrimidine derivative; pyrrole derivative; tofacitinib; adult; alcohol consumption; Article; body mass; body weight; diabetes mellitus; disease activity; disease severity; drug effect; drug efficacy; drug tolerability; female; gender; human; major clinical study; male; metabolic syndrome X; middle aged; onset age; phase 3 clinical trial (topic); psoriasis vulgaris; psoriatic arthritis; race; randomized controlled trial (topic); tobacco use; treatment response; aged; clinical trial; controlled study; drug administration; phase 3 clinical trial; psoriasis; randomized controlled trial; severity of illness index; treatment outcome; Aged; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Piperidines; Protein Kinase Inhibitors; Psoriasis; Pyrimidines; Pyrroles; Severity of Illness Index; Treatment Outcome
Publisher
Journal of Drugs in Dermatology
Type
journal article