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.