Tofacitinib improves pruritus and health-related quality of life up to 52 weeks: Results from 2 randomized phase III trials in patients with moderate to severe plaque psoriasis

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• 作者：Steven R. Feldman ; MD ; PhD^a ; Diamant Thaç ; i ; MD ; PhD^b ; Melinda Gooderham ; MD ; MSc^c ; Matthias Augustin ; MD^d ; Claudia de la Cruz ; MD^e ; Lotus Mallbris ; MD ; PhD^f ; ^&lowast ; ; Marjorie Buonanno ; MSN^g ; Svitlana Tatulych ; MD^g ; Mandeep Kaur ; MD ; MS^f ; Shuping Lan ; MS ; MPH^g ; Hernan Valdez ; MD^h ; Carla Mamolo ; PhD^g ; ^{carla.m.mamolo@pfizer.com" class="auth_mail" title="E-mail the corresponding author}
• 关键词：health-related quality of life ; patient-reported outcomes ; plaque psoriasis ; pruritus ; tofacitinib ; treatment satisfaction
• 刊名：Journal of the American Academy of Dermatology
• 出版年：2016
• 出版时间：December 2016
• 年：2016
• 卷：75
• 期：6
• 页码：1162-1170.e3
• 全文大小：590 K

文摘

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.