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.

Abstract

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.

• Authors: Steven R Feldman, Diamant Thaçi, Melinda Gooderham, Matthias Augustin, Claudia de la Cruz, Lotus Mallbris, Marjorie Buonanno, Svitlana Tatulych, Mandeep Kaur, Shuping Lan, Hernan Valdez, Carla Mamolo
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 75 Issue 6 Pg. 1162-1170.e3 (Dec 2016) ISSN: 1097-6787 [Electronic] United States
• PMID: 27692733 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Chemical References

• Piperidines
• Protein Kinase Inhibitors
• Pyrimidines
• Pyrroles
• tofacitinib

Topics

• Adult
• Female
• Humans
• Male
• Middle Aged
• Pain (drug therapy, etiology)
• Patient Satisfaction
• Piperidines (therapeutic use)
• Protein Kinase Inhibitors (therapeutic use)
• Pruritus (drug therapy, etiology)
• Psoriasis (complications, drug therapy)
• Pyrimidines (therapeutic use)
• Pyrroles (therapeutic use)
• Quality of Life
• Severity of Illness Index