Efficacy of Tofacitinib for the Treatment of Moderate-to-Severe Chronic Plaque Psoriasis in Patient Subgroups from Two Randomised Phase 3 Trials
May 2016 | Volume 15 | Issue 5 | Original Article | 568 | Copyright © 2016
M. Alan Menter MD,a Kim A. Papp MD,b Jennifer Cather MD,c Craig Leonardi MD,d David M. Pariser MD,e
James G. Krueger MDM,f Johannes Wohlrab MD,g Mario Amaya-Guerra MD,h Andrzej Kaszuba MD,i
Oleg Nadashkevich MD,j Tsen-Fang Tsai MD,k Pankaj Gupta PhD,l Huaming Tan PhD,l
Hernan Valdez MD,m Lotus Mallbris MD,n and Svitlana Tatulych MDl
aBaylor Research Institute, Dallas, TX
bKA Papp Clinical Research and Probity Medical Research Inc, Waterloo, Ontario, Canada
cModern Research Associates, Probity Medical Research, and Modern Dermatology, A Baylor Health Texas Affiliate, Dallas, TX
dSt. Louis University Department of Dermatology, St Louis, MO
eDepartment of Dermatology, Eastern Virginia Medical School, Norfolk, VA and Virginia Clinical Research, Inc., Norfolk, VA
fRockefeller University, New York, NY
gMartin Luther University Halle-Wittenberg, Halle, Germany
hCentro Medico San Lucas, University of Monterrey, Monterrey, Mexico
iMedical University of Lodz, Lodz, Poland
jLviv National Medical University, Lviv, Ukraine
kNational Taiwan University Hospital, Taipei, Taiwan
lPfizer Inc, Groton, CT
mPfizer Inc, New York, NY
nPfizer Inc, Collegeville, PA (Affiliation at the time of the analysis and manuscript development.)
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.
J Drugs Dermatol. 2016;15(5):568-580.
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Psoriasis is a chronic, systemic, immune-mediated disorder with skin manifestations, estimated to affect approximately 1–3% of the population.1 Psoriasis negatively impacts quality of life,2 and is associated with several comorbidities, including diabetes, obesity, cardiovascular disease, and psoriatic arthritis.3
Current treatments for moderate-to-severe psoriasis (eg phototherapy, conventional systemic agents, biologics), while frequently providing good-to-excellent disease control, may lose effectiveness over time, and long-term exposure can be associated with safety issues.4,5 Patient dissatisfaction with available therapies or discontinuation are also frequent.6,7 Thus, there remains