Conflict of interest
Effects of briakinumab treatment for moderate to severe psoriasis on health-related quality of life and work productivity and activity impairment: results from a randomized phase III study
Article first published online: 17 MAY 2013
© 2013 European Academy of Dermatology and Venereology
Journal of the European Academy of Dermatology and Venereology
Volume 28, Issue 6, pages 790–798, June 2014
How to Cite
Papp, K.A., Sundaram, M., Bao, Y., Williams, D.A., Gu, Y., Signorovitch, J.E., Wang, Y., Valdes, J.M. and Mulani, P.M. (2014), Effects of briakinumab treatment for moderate to severe psoriasis on health-related quality of life and work productivity and activity impairment: results from a randomized phase III study. Journal of the European Academy of Dermatology and Venereology, 28: 790–798. doi: 10.1111/jdv.12177
Dr Papp is an investigator and consultant for AbbVie Inc. Dr Sundaram, Dr Bao, Dr Williams, Ms Gu, Ms Wang, Dr Valdes and Dr Mulani are employees of AbbVie Inc. and may own stock or stock options. Dr Signorovitch is an employee of Analysis Group, which received payment from AbbVie Inc. to assist with creation of the manuscript.
Design, study conduct, and financial support for the study were provided by AbbVie Inc. Joann Hettasch, PhD, of Arbor Communications, Inc., Ann Arbor, MI, provided medical writing and editing services in the development of this manuscript.
Trial Registration: Clinicaltrials.gov Identifier: NCT00570986.
- Issue published online: 10 MAY 2014
- Article first published online: 17 MAY 2013
- Manuscript Accepted: 8 APR 2013
- Manuscript Received: 8 NOV 2012
- AbbVie Inc.
- Arbor Communications, Inc.
Psoriasis is known to have a significant negative impact on a patient's health-related quality of life, including social, recreational and work activities.
To evaluate the effects of briakinumab on quality of life and work productivity measures in patients with moderate to severe psoriasis.
Patients received either briakinumab (n = 981) or placebo (n = 484) during the 12-week induction phase of trial M06-890. At week 12, patients with a Physician's Global Assessment score of ‘Clear’ or ‘Minimal’ entered the 40-week maintenance phase and were to receive briakinumab every 4 weeks, briakinumab every 12 weeks, or placebo. At weeks 12 and 52, treatment groups were compared using mean change from baseline in health-related quality of life and Work Productivity and Activity Impairment Questionnaire scores and the percentage of patients with minimum clinically important differences.
At week 12, more than half of the briakinumab-treated patients achieved improvements meeting or exceeding minimum clinically important differences for Dermatology Life Quality Index (75.9%), and psoriasis- (64.8%), and psoriatic arthritis-related (54.1%) pain scores; 48.4% achieved improvements for activity impairment. Although improvements in quality of life and work productivity measures were maintained at week 52 for both briakinumab regimens, responder rates were consistently greater in the every-4-week group than in the every-12-week group.
Briakinumab treatment resulted in clinically significant improvements in quality of life and work productivity in adults with moderate to severe psoriasis. Maintenance therapy was associated with a more pronounced benefit for the every-4-week briakinumab regimen.