Faculty Collaboration Database

Ixekizumab treatment and the impact on SF-36: results from three pivotal phase III randomised controlled trials in patients with moderate-to-severe plaque psoriasis. Qual Life Res 2020 Feb;29(2):369-380

Date

10/28/2019

Pubmed ID

31655974

DOI

10.1007/s11136-019-02296-5

Scopus ID

2-s2.0-85074468701 (requires institutional sign-in at Scopus site)   4 Citations

Abstract

PURPOSE: To assess improvements in health-related quality of life (HRQoL) with ixekizumab treatment in patients with moderate-to-severe psoriasis.

METHODS: Adults with plaque psoriasis were enrolled in phase III, double-blind, randomised, controlled trials (UNCOVER-1, UNCOVER-2, or UNCOVER-3). All 3 protocols included a 12-week, placebo-controlled induction period; UNCOVER-2 and UNCOVER-3 also had an active-control group (50 mg etanercept) during induction. After induction, patients in UNCOVER-1 and UNCOVER-2 entered a 48-week withdrawal (maintenance) period (Weeks 12-60), during which Week-12 sPGA (0,1) responders were rerandomized to receive placebo, or 80 mg ixekizumab every 4 weeks (Q4W) or 12 weeks. As a secondary objective, HRQoL was measured by the generic Medical Outcomes Survey Short Form-36 (SF-36) at baseline and Weeks 12 and 60. Changes in mean SF-36 Physical and Mental Component Summary (PCS and MCS) and domain scores and proportions of patients reporting improvements ≥ minimal important differences in SF-36 scores were compared between groups.

RESULTS: At Week 12, ixekizumab-treated patients (both dose groups in UNCOVER-1, -2, and -3) reported statistically significantly greater improvements in mean SF-36 PCS and MCS and all 8 SF-36 domain scores versus placebo. Further, more ixekizumab-treated patients than placebo-treated patients reported at least minimal treatment responses in SF-36 PCS and MCS scores and domain scores. Overall improvements in SF-36 PCS and MCS scores were maintained through Week 60.

CONCLUSIONS: Ixekizumab-treated patients reported statistically significant improvements in HRQoL at 12 weeks that persisted through 1 year.

Author List

Langley RGB, Reich K, Strand V, Feldman SR, Paul C, Gordon K, Warren RB, Toth D, Nikaï E, Zhu B, Goldblum O, Edson-Heredia E, Carlier H, Burge R, Lin CY, Hollister K, Augustin M

Author

Kenneth Brian Gordon MD Chair, Professor in the Dermatology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Antibodies, Monoclonal, Humanized
Dermatologic Agents
Female
Humans
Interleukin-17
Male
Middle Aged
Psoriasis
Quality of Life
Treatment Outcome