Sleep quality and other patient-reported outcomes improve after patients with psoriasis with suboptimal response to other systemic therapies are switched to adalimumab: results from PROGRESS, an open-label Phase IIIB trial
Funding sources: This study was supported by Abbott Laboratories, Abbott Park, IL, U.S.A.
Conflicts of interest: B.E.S. has served on the advisory board and as an investigator for Abbott, Amgen, Centocor, Astellas, Novartis, Pfizer, Leo and Genentech and has served on the speakers bureau for Abbott, Amgen, and Johnson and Johnson. J.M.S. has served on the advisory board and speakers bureau and as an investigator for Amgen, Abbott and Centocor. K.C.D. has served as a consultant for Amgen, Eli Lilly, NovoNordisk, VBL and Wyeth/Pfizer; has served on the speakers bureau for Abbott, Amgen and Centocor; and has served as an investigator for Abbott, Amgen, Centocor, Graceway, Incyte, NovoNordisk, Pfizer, VBL and Yaupon. A.G. and H.Y. are employees of Analysis Group, under contract with Abbott Laboratories. Y.B., O.G., M.M.O. and P.M.M. are employees of Abbott Laboratories and hold stock in Abbott Laboratories.
Summary
Background Psoriasis is associated with poor health-related quality of life, including sleep impairment.
Objective To assess the extent of sleep impairment, the effect of adalimumab on sleep and other patient-reported outcomes, and correlations between changes in these outcomes and sleep quality in patients with psoriasis.
Methods Patients in the 16-week, open-label, Phase IIIb PROGRESS trial had chronic plaque psoriasis and suboptimal response to prior therapy (etanercept, methotrexate or narrowband ultraviolet B phototherapy). Adalimumab was self-injected subcutaneously (80 mg at week 0, then 40 mg every other week from week 1). The focus for this analysis was the Medical Outcomes Study Sleep Scale. Other patient-reported outcomes included the Dermatology Life Quality Index (DLQI), Psoriasis Area and Severity Index (PASI), Physician’s Global Assessment, a visual analogue scale for psoriasis/psoriatic arthritis (PsA) pain, and the Work Productivity and Activity Index Questionnaire-Specific Health Problems.
Results Patients with psoriasis had impaired sleep at baseline. The degree of sleep impairment was significantly associated with the extent of work productivity for all sleep measures and, for some sleep measures, was associated with DLQI impairment, clinical severity measured by PASI, the presence of PsA, and depression. Adalimumab treatment significantly improved sleep quality by 15% from baseline, as well as DLQI score, pain and work productivity. The improvement in sleep was partially explained (R2 = 0·16, P < 0·001) by improvements in the objectively measured psoriasis signs in PASI.
Conclusions Adalimumab treatment improved sleep outcomes and other patient-reported outcomes including health-related quality of life, work productivity, daily activity and disease-related pain.
