20 Jun SIMPONI ARIA (golimumab) Improved Sleep and Pain in Ankylosing Spondylitis Trial
MedicalResearch.com Interview with:
Dr. Deodhar
Atul A. Deodhar, MD, MRCP, FACP, FACR
Professor of Medicine
Medical Director, Rheumatology Clinics
Medical Director, Immunology Infusion Center
Oregon Health & Science University
MedicalResearch.com: What is the background for this study?
Response: The GO-ALIVE study (CNTO148AKS3001) is a multicenter, randomized, double-blind, placebo-controlled study of golimumab, an anti-TNFα monoclonal antibody, administered intravenously (IV), in adult patients with active ankylosing spondylitis (AS). The primary objective is to evaluate the efficacy of golimumab 2 mg/kg in patients with active AS by assessing the reduction in signs and symptoms of AS. The secondary objectives include assessing efficacy related to improving physical function, range of motion, health-related quality of life, and other health outcomes.
A total of 208 patients who had a diagnosis of definite ankylosing spondylitis (per modified New York criteria) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4, total back pain visual analogue scale (VAS) ≥4, and CRP ≥0.3 mg/dL were randomized. Patients were treated with IV golimumab (n=105) at Weeks 0, 4, and every 8 weeks through Week 52 or placebo (n=103) at Weeks 0, 4, and 12, with crossover to IV golimumab at Week 16 and through Week 52.
MedicalResearch.com: What are the main findings?
Response: As presented in a separate abstract at EULAR 2017 (1), IV golimumab 2mg/kg was efficacious in reducing the signs and symptoms of ankylosing spondylitis compared with placebo. Golimumab was well-tolerated through Week 28.
Data presented at EULAR 2017 through Week 28 on the effects of IV golimumab 2 mg/kg on sleep problems, total back pain, and night back pain in adult patients with active AS were presented in the poster by Deodhar, et al (2). Compared to placebo, patients who received IV golimumab had greater mean improvement in sleep problems (as measured using the Medical Outcomes Study Sleep Scale; MOS-SS) at Week 8 and Week 16. Similar results were observed in total back pain and night back pain (measured by VAS). Placebo patients who crossed-over to IV GLM at Week 16 achieved similar improvements in total back pain and night back pain as patient who started IV GLM at baseline. The change in night back pain (but not total back pain) was associated with change in sleep problems.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: Patients with ankylosing spondylitis who received IV golimumab experienced improvements in sleep problems, total back pain, and night back pain. Improvement in night back pain was associated with reduction in sleep problems (that is, better quality of sleep).
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Recommendations for future research include evaluation of the long-term effects of IV golimumab on sleep problems, total back pain, and night back pain, as well as the influence of sleep problem and back pain improvements on physical functioning and other aspects of health-related quality of life.
MedicalResearch.com: Is there anything else you would like to add?
Response: Ankylosing spondylitis patients commonly experience sleep problems and back pain, particularly night back pain. These study findings are encouraging, as patients who received IV golimumab showed improvements in sleep and back pain.
Note: Active AS is not an approved indication for IV golimumab; however an application was submitted to the FDA seeking approval in 2016.
Disclosure: This study was supported by Janssen Research & Development, LLC.
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References:
- https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=341041
- https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=362828
Citation: EULAR 2017
IMPROVEMENTS IN SLEEP PROBLEMS AND PAIN IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS TREATED WITH INTRAVENOUS GOLIMUMAB: 28-WEEK RESULTS OF THE PHASE III GO-ALIVE TRIAL
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
Last Updated on June 20, 2017 by Marie Benz MD FAAD