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Improvement in aspects of sleep with etanercept and optional adjunctive topical therapy in patients with moderate-to-severe psoriasis: results from the PRISTINE trial

Authors


  • Conflicts of interest

    Author Thaçi has been a consultant, advisory board member and lecturer for Abbott, Biogen, Pfizer, MSD, Jansen-Cilag, Leo and Novartis and has received an unrestricted educational grant from Pfizer, the funds from which were not paid to the author but to his institution. Authors Galimberti and Amaya-Guerra have nothing to declare. Author Rosenbach has been paid as a consultant by Pfizer, Janssen Cilag, Novartis and Abbott, and has been paid for lectures by Pfizer, Biogen Idec, Abbott, and Janssen Cilag. Authors Robertson and Pedersen are employees of Pfizer Inc. Authors Yang, Kuligowski and Boggs were employees of Pfizer Inc during this study and the development of this manuscript.

  • Funding sources

    The PRISTINE study was funded by Wyeth, which was acquired by Pfizer Inc in October 2009.

Abstract

Background

Impaired sleep in patients with moderate-to-severe psoriasis and improvement on therapy has not been widely studied.

Objective

Quantify baseline aspects of sleep and improvement in patients with psoriasis receiving etanercept (ETN) when allowed concomitant topical medications (PRISTINE study).

Methods

Patients with moderate-to-severe psoriasis were randomized to 50 mg ETN once weekly (QW/QW) or 50 mg ETN twice weekly (BIW/QW) for weeks 1–12, followed by 50 mg QW for weeks 13–24; a broad range of topical therapies were permitted during weeks 13–24. Sleep impairment was measured by the Medical Outcomes Study (MOS) sleep questionnaire Index II (population norm = 25.8; minimum clinically important difference = 5.1); quality of life (QoL) measures included Dermatology Life Quality Index (DLQI), EuroQoL 5 Dimension (EQ-5D) Utility Index and Visual Analogue Scale (VAS) and Functional Activity in Chronic Therapy-Fatigue (FACIT-Fatigue). ancova and Fisher's exact test or chi-squared tests were used for between-group testing.

Results

Mean baseline MOS-Sleep scores were 34.0 for both groups indicating impairment (N = 270; QW/QW n = 137; BIW/QW n = 133, approximately 64% had impaired sleep). At week 12 of treatment, MOS-Sleep scores improved to 30.8 and 30.1, and at week 24, to 28.4 and 28.2 respectively. Poor sleep was significantly associated with clinically important problems in EQ-5D utility, VAS and FACIT-Fatigue; sleep improvement was associated with improved EQ-5D utility and FACIT-Fatigue (P < 0.001).

Conclusion

This study confirms that most patients with moderate-to-severe psoriasis have impaired sleep which is associated with impaired QoL. Treatment with etanercept significantly improved sleep, with most improvement occurring before a broad range of topicals were allowed. Sleep improvement was associated with improved QoL.

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