BACKGROUND: Tofacitinib is an oral Janus kinase inhibitor that improves clinical 
measures of psoriasis.
OBJECTIVE: We sought to assess patient-reported outcomes in tofacitinib-treated 
patients with moderate to severe plaque psoriasis over 52 weeks.
METHODS: In 2 identical, phase III studies (Oral treatment for Psoriasis Trial 
Pivotal 1 [NCT01276639], n = 901, and Pivotal 2 [NCT01309737], n = 960), 
patients were randomized 2:2:1 to receive 5 or 10 mg of tofacitinib or placebo, 
twice daily. At week 16, placebo-treated patients were re-randomized to 
tofacitinib. Dermatology Life Quality Index score, Itch Severity Item score, 
Patient Global Assessment score, and patient satisfaction were assessed.
RESULTS: Baseline Dermatology Life Quality Index score indicated substantial 
health-related quality of life impairment. At week 16, a greater proportion of 
patients achieved Dermatology Life Quality Index score of 1 or less (no effect 
of psoriasis on health-related quality of life) with tofacitinib 5 and 10 mg 
twice daily versus placebo (Oral treatment for Psoriasis Trial Pivotal 1/2: 
26.7%/28.6% and 40.2%/48.2% vs 4.6%/6.0%, respectively; P < .0001); improvements 
were maintained through week 52. Similar patterns were observed with Patient 
Global Assessment. Improvements in itch were particularly rapid, observed 1 day 
after treatment initiation for both tofacitinib doses versus placebo (P < .05). 
At week 16, more patients were satisfied with tofacitinib versus placebo 
(P < .0001).
LIMITATIONS: Clinical nonresponders discontinued at week 28.
CONCLUSIONS: Tofacitinib demonstrated improvement in health-related quality of 
life and patient-reported symptoms that persisted over 52 weeks.