0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Original Investigation |

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

April W. Armstrong, MD, MPH1; Charles W. Lynde, MD, FRCP2; Sandy R. McBride, MBBS, FRCP, MD3; Mona Ståhle, MD, PhD4; Emily Edson-Heredia, MPH5; Baojin Zhu, PhD5; David Amato, DO5; Enkeleida Nikaï, MSc, EMM&A6; Fan Emily Yang, PhD5; Kenneth B. Gordon, MD7
[+] Author Affiliations
1Keck School of Medicine at USC, University of Southern California, Los Angeles
2Department of Medicine, University of Toronto, Toronto, Ontario, Canada
3Royal Free London NHS Foundation Trust, London, England
4Dermatology Unit B2:01, Karolinska University Hospital, Solna, Stockholm, Sweden
5Eli Lilly and Company, Indianapolis, Indiana
6Eli Lilly Benelux, Brussels, Belgium
7Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
JAMA Dermatol. 2016;152(6):661-669. doi:10.1001/jamadermatol.2016.0269.
Text Size: A A A
Published online

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

Figures in this Article

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

Figures

Place holder to copy figure label and caption
Figure 1.
Change From Baseline to Week 12 of Work Productivity Loss

Work Productivity and Activity Impairment–Psoriasis (WPAI-PSO) scores were expressed as percent work productivity loss due to psoriasis. Treatment group comparisons of least squares mean score change from baseline (last observation carried forward [LOCF]) are presented. Baseline is defined as the last nonmissing assessment recorded on or prior to the date of first study drug injection at week 0. No. indicates number of patients (LOCF) in the change from baseline to week 12 calculation. P values shown are for each treatment vs placebo comparison and ixekizumab vs etanercept comparison at each visit using an analysis of covariance (ANCOVA) model including treatment, geographic region, previous nonbiologic systemic therapy, baseline weight category, and baseline WPAI-PSO value in the model for UNCOVER-1. For UNCOVER-2 and UNCOVER-3, the ANCOVA model includes treatment, pooled center, and baseline WPAI-PSO value.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 2.
Work Productivity and Activity Impairment–Psoriasis Scores From Week 0 (Baseline) to Week 60 in UNCOVER-1

Data points are observed mean. Baseline was defined as the last nonmissing assessment recorded on or prior to the date of first study drug injection at week 0. Ixekizumab/placebo, n = 226; ixekizumab/ixekizumab 80 mg every 4 weeks, n = 229. P values shown are for least squares (LS) mean (last observation carried forward) treatment comparison vs ixekizumab/placebo at each visit and used an analysis of covariance model including baseline as a covariate, treatment group and baseline weight category as factors in the model.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 3.
Work Productivity and Activity Impairment–Psoriasis Scores From Week 0 (Baseline) to Week 60 in UNCOVER-2

Data points are observed mean. Baseline was defined as the last nonmissing assessment recorded on or prior to the date of first study drug injection at week 0. Ixekizumab/placebo, N = 176; ixekizumab/ixekizumab every 4 weeks, N = 187. P values shown are for least squares (LS) mean (last observation carried forward) treatment comparison vs ixekizumab/placebo at each visit and used an analysis of covariance model including baseline as a covariate, treatment group as a factor in the model.

Graphic Jump Location

Tables

References

Correspondence

CME
Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.

Multimedia

Some tools below are only available to our subscribers or users with an online account.

2,289 Views
0 Citations
×

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Collections
Jobs
brightcove.createExperiences();