The anti–tumor necrosis factor–alpha agent golimumab significantly reduced sleep disturbance and improved health-related quality of life in a randomized placebo-controlled trial of 356 patients with ankylosing spondylitis.
The investigators assessed sleep disturbance using the Jenkins Sleep Evaluation Questionnaire (JSEQ), which asks patients how many times in the past month they have had trouble falling asleep, awakened several times per night, had trouble staying asleep (including waking far too early), and/or awakened after their usual amount of sleep feeling tired and worn out. On the scale, the possible answers for each question were 0 (not at all), 1 (1-3 days), 2 (4-7 days), 3 (8-14 days), 4 (15-21 days), and 5 (22-31 days). Thus, the total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance.
Study participants, who had moderate to severe sleep disturbance at baseline because of underlying pain associated with ankylosing spondylitis (AS), were randomized to receive either placebo or treatment with 50 mg or 100 mg of golimumab subcutaneously every 4 weeks.
Men made up most of the patients in the placebo and treatment groups. Their mean time since AS diagnosis was 11 years for the placebo group and 8 years for each golimumab group. The mean baseline JSEQ score was 9.9 for the placebo group, 10.3 for the 50-mg group, and 11.1 for the 100-mg group.
Compared with those in the placebo group, those in the golimumab groups had significantly greater median improvement from baseline on the 0- to 20-point JSEQ at the 14-week follow-up (–3.0 vs. 0.0 point change), and the improvement was sustained at 24-week follow-up (–3.0 vs. –1.0 point change), Dr. Atul Deodhar, medical director of the rheumatology clinic at the Oregon Health & Science University, Portland, and colleagues reported in the September issue of Arthritis Care & Research.
The effect was similar with both the 50- and 100-mg golimumab dose, the investigators noted (Arthritis Care & Research 2010:62:1266-71).
Sleep disturbance resulting from axial pain and stiffness is characteristic of the inflammatory back pain in patients with AS, and it contributes to daytime fatigue. The findings of this study – which is a secondary analysis of the previously reported GO-RAISE study that evaluated golimumab in AS patients – also showed that changes in the JSEQ scores during the course of the study significantly correlated with changes from baseline on Short Form–36 Health Survey summary scores, Bath AS Functional Index scores, Bath AS Disease Activity Index, inflammation assessments, and total and night back-pain scores.
Improvements in the night back-pain scores were the strongest predictor of improvement in sleep disturbance as measured by JSEQ scores. This finding is consistent with those from prior studies showing that sleep disturbance is predicted by pain at bedtime and during the night, the investigators noted.
Golimumab (Simponi) has Food and Drug Administration approval for treatment – with methotrexate – of moderately to severely active rheumatoid arthritis in adults; in the treatment of active psoriatic arthritis, in which it can be given with or without methotrexate; and in the treatment of active ankylosing spondylitis.
The European Medicines Agency has approved the use of golimumab for treatment of moderate to severe active RA in combination with methotrexate in patients who have not responded adequately to other treatments, including methotrexate. EMEA has also approved golimumab for the treatment of active and progressive psoriatic arthritis in patients who have not responded adequately to other treatments; it can be used alone or in combination with methotrexate. Finally, EMEA has approved it to treat severely active ankylosing spondylitis. Golimumab is used in patients who have not responded adequately to other treatments.
This study was funded by Centocor Research and Development and the Schering-Plough Research Institute. Dr. Deodhar disclosed that he has received payments from, and served on the advisory board for Centocor. Other authors on the study disclosed receiving consultancy fees, speaking fees, and/or honoraria from Centocor, Schering-Plough, Wyeth , Amgen, Abbott, Bristol-Myers Squibb, UCB, Roche, Chugai, Pfizer, MSD, and/or Sanofi-Aventis, and/or owning stock or options in Johnson & Johnson.