RESEARCH - Impact of Orencia on sleep quality in patients with RA

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Ann Rheum Dis. 2010 Jul 7. [Epub ahead of print]

Investigation into the impact of abatacept on sleep quality in

patients with rheumatoid arthritis, and the validity of the MOS-Sleep

questionnaire Sleep Disturbance Scale.

Wells G, Li T, Tugwell P.

1Department of Epidemiology and Community Medicine, University of

Ottawa Heart Institute, Ottawa, Ontario, Canada.

Abstract

OBJECTIVES: To assess the impact of abatacept on sleep quality in

patients with rheumatoid arthritis (RA), and the validity of the sleep

disturbance scale of the Medical Outcomes Study Sleep Questionnaire

(MOS-Sleep).

METHODS: Data from two randomised, double-blind, placebo-controlled

abatacept trials (Abatacept Trial in Treatment of Antitumor necrosis

factor IN adequate responders (ATTAIN) and Abatacept in Inadequate

responders to Methotrexate (AIM)) were analysed. Sleep quality was

assessed using the MOS-Sleep. Changes in the Sleep Disturbance Scale

were assessed according to clinical responses (including American

College of Rheumatology (ACR) and Disease Activity Score 28 C-reactive

protein criteria). Correlations between sleep disturbance and

patient-reported outcomes were assessed. The sensitivity to change of

sleep disturbance was assessed by calculating the standardised

response means (SRMs).

RESULTS: 258 abatacept- and 133 placebo-treated patients in ATTAIN and

433 abatacept- and 219 placebo-treated patients in AIM were analysed.

In ATTAIN, mean improvements to month 6 were significantly greater for

patients treated with abatacept than for placebo patients in sleep

disturbance (11.3 vs 2.9, p<0.001), sleep adequacy (9.0 vs 0.6,

p<0.05), somnolence (10.5 vs 1.6, p<0.001) and Sleep Problems Index

(SPI) I (9.5 vs 1.4, p<0.0001) and II (9.8 vs 2.1, p<0.001); mean

improvements in AIM to year 1 were statistically significant for sleep

disturbance (12.9 vs 8.9, p<0.05) and SPI I (9.4 vs 6.7, p<0.05) and

II (10.4 vs 7.3, p<0.05). Associations between mean improvements in

sleep disturbance and clinical responses were statistically

significant (3.8, 12.7, 18.0, p<0.001 and 5.0, 11.5, 15.7, p<0.001 for

European League Against Rheumatism responses, none, moderate and good

in ATTAIN and AIM, respectively; 10.2, 14.4, 22.8, p=0.007 and 10.9,

14.9, 17.7, p=0.006 for ACR 20, 50 and 70 responses in ATTAIN and AIM,

respectively). SRMs for sleep disturbance were 0.38 (ATTAIN) and 0.19

(AIM).

CONCLUSIONS: Abatacept treatment provides significant improvements in

multiple aspects of sleep in patients with RA. The Sleep Disturbance

Scale of the MOS-Sleep shows validity, reliability and sensitivity to

change.

PMID: 20610444

http://www.ncbi.nlm.nih.gov/pubmed/20610444

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