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- Title
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.
- Authors
Langley, Richard G. B.; Reich, Kristian; Strand, Vibeke; Feldman, Steven R.; Paul, Carle; Gordon, Kenneth; Warren, Richard B.; Toth, Darryl; Nikaï, Enkeleida; Zhu, Baojin; Goldblum, Orin; Edson-Heredia, Emily; Carlier, Hilde; Burge, Russel; Lin, Chen-Yen; Hollister, Kristin; Augustin, Matthias
- Abstract
<bold>Purpose: </bold>To assess improvements in health-related quality of life (HRQoL) with ixekizumab treatment in patients with moderate-to-severe psoriasis.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>Ixekizumab-treated patients reported statistically significant improvements in HRQoL at 12 weeks that persisted through 1 year.
- Subjects
PSORIASIS; QUALITY of life
- Publication
Quality of Life Research, 2020, Vol 29, Issue 2, p369
- ISSN
0962-9343
- Publication type
journal article
- DOI
10.1007/s11136-019-02296-5