Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: Long-term efficacy and safety results from 2 randomized phase-III studies and 1 open-label long-term extension study. Academic Article uri icon

Overview

abstract

  • BACKGROUND: Tofacitinib is an oral Janus kinase inhibitor being investigated for psoriasis. OBJECTIVES: We sought to report longer-term tofacitinib efficacy and safety in patients with moderate to severe psoriasis. METHODS: Data from 2 identical phase-III studies, Oral-treatment Psoriasis Trial Pivotal 1 and 2, were pooled with data from these patients in an ongoing open-label long-term extension study. Patients (n = 1861) were randomized 2:2:1 to tofacitinib 5 mg, 10 mg, or placebo twice daily (BID). At week 16, placebo patients were rerandomized to tofacitinib. Pivotal study participants could enroll into the long-term extension where they received tofacitinib at 10 mg BID for 3 months, after which dosing could be 5 or 10 mg BID. RESULTS: At week 28, the proportions of patients randomized to tofacitinib 5 and 10 mg BID achieving 75% or greater reduction in Psoriasis Area and Severity Index score from baseline were 55.6% and 68.8%, and achieving Physician Global Assessment of clear or almost clear were 54.7% and 65.9%. Efficacy was maintained in most patients through 24 months. Serious adverse events and discontinuations because of adverse events were reported in less than 11% of patients over 33 months of tofacitinib exposure. LIMITATIONS: There was no dose comparison beyond week 52. CONCLUSIONS: Oral tofacitinib demonstrated sustained efficacy in patients with psoriasis through 2 years, with 10 mg BID providing greater efficacy than 5 mg BID. No unexpected safety findings were observed.

authors

  • Papp, Kim A
  • Krueger, James Glenn
  • Feldman, Steven R
  • Langley, Richard G
  • Thaci, Diamant
  • Torii, Hideshi
  • Tyring, Stephen
  • Wolk, Robert
  • Gardner, Annie
  • Mebus, Charles
  • Tan, Huaming
  • Luo, Yingchun
  • Gupta, Pankaj
  • Mallbris, Lotus
  • Tatulych, Svitlana

publication date

  • February 19, 2016

Research

keywords

  • Janus Kinases
  • Piperidines
  • Protein Kinase Inhibitors
  • Psoriasis
  • Pyrimidines
  • Pyrroles
  • Quality of Life

Identity

Scopus Document Identifier

  • 84963632371

Digital Object Identifier (DOI)

  • 10.1016/j.jaad.2016.01.013

PubMed ID

  • 26899199

Additional Document Info

volume

  • 74

issue

  • 5