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Deodhar, A.; Braun, J.; Inman, R.D.; Mack, M.; Parasuraman, S.; Buchanan, J.; ... ; Heijde, D. van der (2010)

Golimumab Reduces Sleep Disturbance in Patients With Active Ankylosing Spondylitis: Results From a Randomized, Placebo-Controlled Trial

Article / Letter to editor
Objective. To evaluate the effect of golimumab on sleep disturbance in patients with active ankylosing spondylitis (AS). Methods. Golimumab was studied in a multicenter, randomized, placebo-controlled study (GO-RAISE). At baseline, 356 patients were randomly assigned in a 1.8:1.8:1 ratio to subcutaneous golimumab 50 mg, 100 mg, or placebo every 4 weeks. Sleep disturbance was assessed using the Jenkins Sleep Evaluation Questionnaire (JSEQ), which was administered at baseline, week 14, and week 24. Treatment effect was evaluated using analysis of variance on the van der Waerden normal scores. Results. Median JSEQ scores at baseline were 9.0 in the placebo group, 10.0 in the 50-mg group, and 11.0 in the 100-mg group, indicating moderate to severe sleep disturbance. Patients who received golimumab showed significantly greater median improvement from baseline in JSEQ scores compared with placebo at week 14 (-3.0 versus 0.0; P < 0.001) and week 24 (-3.0 versus -1.0; P < 0.001). Changes...Show moreObjective. To evaluate the effect of golimumab on sleep disturbance in patients with active ankylosing spondylitis (AS). Methods. Golimumab was studied in a multicenter, randomized, placebo-controlled study (GO-RAISE). At baseline, 356 patients were randomly assigned in a 1.8:1.8:1 ratio to subcutaneous golimumab 50 mg, 100 mg, or placebo every 4 weeks. Sleep disturbance was assessed using the Jenkins Sleep Evaluation Questionnaire (JSEQ), which was administered at baseline, week 14, and week 24. Treatment effect was evaluated using analysis of variance on the van der Waerden normal scores. Results. Median JSEQ scores at baseline were 9.0 in the placebo group, 10.0 in the 50-mg group, and 11.0 in the 100-mg group, indicating moderate to severe sleep disturbance. Patients who received golimumab showed significantly greater median improvement from baseline in JSEQ scores compared with placebo at week 14 (-3.0 versus 0.0; P < 0.001) and week 24 (-3.0 versus -1.0; P < 0.001). Changes from baseline in JSEQ scores significantly correlated with changes from baseline in Short Form 36 summary scores, Bath AS Functional Index scores, total back pain, night back pain, and Bath AS Disease Activity Index scores. Multiple regression analyses indicated that improvement in the night back pain score was the most consistent predictor of change in JSEQ score or reduction in sleep disturbance. Conclusion. Patients with active AS showed significant sleep disturbance at baseline due to underlying pain associated with AS. Treatment with subcutaneous golimumab every 4 weeks significantly reduced sleep disturbance and improved health-related quality of life.Show less
fatigue quality index depression efficacy safety pain
All authors
Deodhar, A.; Braun, J.; Inman, R.D.; Mack, M.; Parasuraman, S.; Buchanan, J.; Hsu, B.; Gathany, T.; Heijde, D. van der
Date
2010-09-30
Journal
Arthritis Care and Research
Volume
62
Issue
9
Pages
1266 - 1271
DOI
doi:10.1002/acr.20233