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 (<span>NCT</span>01276639, <span>NCT</span>01309737).<br /> 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.<br /> 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.<br /> 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.<br /> 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.<br /><br /><em>J Drugs Dermatol.</em> 2016;15(5):568-580.
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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 (<span>NCT</span>01276639, <span>NCT</span>01309737).<br /> 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.<br /> 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.<br /> 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.<br /> 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.<br /><br /><em>J Drugs Dermatol.</em> 2016;15(5):568-580.
Authors: Jasvinder A Singh; Gordon Guyatt; Alexis Ogdie; Dafna D Gladman; Chad Deal; Atul Deodhar; Maureen Dubreuil; Jonathan Dunham; M Elaine Husni; Sarah Kenny; Jennifer Kwan-Morley; Janice Lin; Paula Marchetta; Philip J Mease; Joseph F Merola; Julie Miner; Christopher T Ritchlin; Bernadette Siaton; Benjamin J Smith; Abby S Van Voorhees; Anna Helena Jonsson; Amit Aakash Shah; Nancy Sullivan; Marat Turgunbaev; Laura C Coates; Alice Gottlieb; Marina Magrey; W Benjamin Nowell; Ana-Maria Orbai; Soumya M Reddy; Jose U Scher; Evan Siegel; Michael Siegel; Jessica A Walsh; Amy S Turner; James Reston Journal: Arthritis Rheumatol Date: 2018-11-30 Impact factor: 10.995
Authors: Jasvinder A Singh; Gordon Guyatt; Alexis Ogdie; Dafna D Gladman; Chad Deal; Atul Deodhar; Maureen Dubreuil; Jonathan Dunham; M Elaine Husni; Sarah Kenny; Jennifer Kwan-Morley; Janice Lin; Paula Marchetta; Philip J Mease; Joseph F Merola; Julie Miner; Christopher T Ritchlin; Bernadette Siaton; Benjamin J Smith; Abby S Van Voorhees; Anna Helena Jonsson; Amit Aakash Shah; Nancy Sullivan; Marat Turgunbaev; Laura C Coates; Alice Gottlieb; Marina Magrey; W Benjamin Nowell; Ana-Maria Orbai; Soumya M Reddy; Jose U Scher; Evan Siegel; Michael Siegel; Jessica A Walsh; Amy S Turner; James Reston Journal: Arthritis Care Res (Hoboken) Date: 2018-11-30 Impact factor: 4.794