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Effect of Ixekizumab Treatment on Work Productivity for Patients With Moderate-to-Severe Plaque Psoriasis: Analysis of Results From 3 Randomized Phase 3 Clinical Trials. JAMA Dermatol 2016 Jun 01;152(6):661-9

Date

03/10/2016

Pubmed ID

26953848

DOI

10.1001/jamadermatol.2016.0269

Scopus ID

2-s2.0-84975132508 (requires institutional sign-in at Scopus site)   46 Citations

Abstract

IMPORTANCE: Therapies that reduce psoriasis symptoms may improve work productivity.

OBJECTIVE: To assess the effect of ixekizumab therapy on work productivity, measured by the Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO).

DESIGN, SETTING, AND PARTICIPANTS: Three multicenter, randomized double-blind phase 3 trials conducted during the following periods: December 2011 through August 2014 (UNCOVER-1), May 2012 through April 2015 (UNCOVER-2), and August 2012 through July 2014 (UNCOVER-3). Adult outpatients with moderate-to-severe chronic plaque psoriasis were included.

INTERVENTIONS: In UNCOVER-1, patients were randomized 1:1:1 to subcutaneous placebo or 80 mg ixekizumab every 2 weeks (Q2W) or every 4 weeks (Q4W) for 12 weeks; UNCOVER-2 and UNCOVER-3 also had an etanercept arm (50 mg twice weekly). Maintenance of initial ixekizumab response was evaluated in UNCOVER-1 and UNCOVER-2 during a randomized withdrawal period following week 12 through week 60. The WPAI-PSO questionnaire was administered at baseline and week 12 for all patients and at weeks 24, 36, 52, and 60 for patients in UNCOVER-1 and UNCOVER-2.

MAIN OUTCOMES AND MEASURES: Change in work productivity from baseline as measured by WPAI-PSO scores.

RESULTS: Across trials, 5101 patients consented; 3866 were randomized (mean [SD] age, UNCOVER-1, 45.7 [12.9] y, 68.1% male; UNCOVER-2: 45.0 [13.0] y, 67.1% male; UNCOVER-3: 45.8 [13.1] y, 68.2% male). At week 12 in UNCOVER-1, the ixekizumab Q4W and ixekizumab Q2W groups showed significantly greater improvements in WPAI-PSO scores (least squares mean change from baseline [SE]) relative to placebo: absenteeism (-3.5 [0.87], P < .001; -2.6 [0.84], P = .003, respectively, vs 0.2 [0.88]), presenteeism (-18.8 [1.28], P < .001; -18.3 [1.24], P < .001, vs 0.5 [1.30]), work productivity loss (-20.6 [1.38], P < .001; -19.8 [1.33], P < .001, vs -0.8 [1.40]), and activity impairment (-24.5 [1.18], P < .001; -25.2 [1.15], P < .001, vs 0.8 [1.18]). Similar results were obtained for UNCOVER-2 and UNCOVER-3, with the exception of absenteeism with ixekizumab Q4W in UNCOVER-2. Additionally, ixekizumab-treated patients showed significantly greater improvements in WPAI-PSO scores vs etanercept-treated patients: UNCOVER-2: presenteeism, work productivity loss, activity impairment (P < .001 both doses), UNCOVER-3: activity impairment (ie, regular activities outside of work) (ixekizumab Q2W; P = .009). Improvements in WPAI-PSO scores at week 12 were sustained to at least week 60.

CONCLUSIONS AND RELEVANCE: Ixekizumab-treated patients reported short- and long-term improvements in work productivity, which could lead to reduced productivity-related cost burden in patients with psoriasis.

TRIAL REGISTRATION: clinicaltrials.gov Identifiers: NCT01474512, NCT01597245, NCT01646177.

Author List

Armstrong AW, Lynde CW, McBride SR, Ståhle M, Edson-Heredia E, Zhu B, Amato D, Nikaï E, Yang FE, Gordon KB

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

Absenteeism
Adult
Antibodies, Monoclonal, Humanized
Clinical Trials, Phase III as Topic
Dermatologic Agents
Double-Blind Method
Efficiency
Etanercept
Female
Humans
Male
Middle Aged
Presenteeism
Psoriasis
Randomized Controlled Trials as Topic
Severity of Illness Index
Surveys and Questionnaires
Time Factors
Treatment Outcome