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Certolizumab Pegol Shows Long-term Safety in Treating RA
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In patients with rheumatoid arthritis, certolizumab pegol — as monotherapy or combined with methotrexate — led to improvements in clinical and patient-reported outcomes that were maintained through 304 weeks and had a safety profile that was no different from previous studies, according to published findings.
Roy Fleischmann, MD , from the Metroplex Clinical Research Center at the University of Texas Southwestern Medical Center, and colleagues assessed 427 patients who received 400 mg certolizumab pegol (Cimzia, UCB) every 4 weeks with or without methotrexate. They determined exposure-adjusted event rates per 100 patient-years of adverse events and serious adverse events for all patients who received at least one dose of certolizumab from a 24-week randomized controlled trial or an open-label extension study. They also assessed ACR20, ACR50 and ACR70 response rates, tender joint count, swollen joint count, Health Assessment Questionnaire-Disability Index (HAQ-DI), patient’s global assessment of disease activity, pain and fatigue up to week 304. Post hoc, they examined simple disease activity index and clinical disease activity index.
Researchers found adverse events were 408.1 per 100 patient-years and serious adverse events were 25.2 per 100 patient-years. Overall, 11 patients had an adverse event that led to death. Improvements for both clinical and patient-reported outcomes during the 24-week randomized controlled trials were maintained through week 304, which remained similar for all patient subpopulations, the researchers wrote. – by Will Offit
Disclosure: UCB Pharma funded the study. Fleischmann reports receiving research grants and/or consultant fees from Abbott, Amgen, AstraZeneca Bristol-Myers Squibb, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi and UCB. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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