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Draft EMA Guidelines Suggest DAS28 May Not Be an Appropriate Measure in Early RA
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A taskforce convened by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases reviewed the measures of disease activity used in early rheumatoid arthritis and recommended American College of Rheumatology emission criteria over DAS28 to evaluate disease activity.
According to a recently published report, the taskforce also noted that patients with exposure to disease-modifying antirheumatic drugs may need to be evaluated differently from patients naïve to those drugs.
The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Disease was invited by the European Medicines Agency to evaluate new recommendations to separate classifications of early rheumatoid arthritis (RA) from advanced RA to allow for earlier treatment of the disease. The panel wrote that patients with exposure to disease-modifying antirheumatic drugs (DMARDs) “usually respond to a lesser extent than patients who are DMARD-naïve” and recommended defining a trial population of patients with early RA naïve to DMARDs for 1 year or less from diagnosis using American College of Rheumatology (ACR) 2015 criteria.
“We acknowledge the importance of evaluating new drugs differently in patients with early RA than in patients with established disease,” the researchers wrote. “In this respect, we suggest considering DMARD-naïve patients with no more than 1-year disease duration as ‘early RA patients’ in clinical investigations of new medicinal products.”
The researchers added that low disease activity criteria, ACR, the Simplified Disease Activity Index or the Clinical Disease Activity Index may be more effective tools than the DAS28 because the DAS28 can be affected by acute phase reactants without demonstrating clinical improvement. - by Shirley Pulawski
Disclosure: Smolen reports grants for his institution from AbbVie, Janssen, Lilly, MSD, Pfizer and Roche; and he has provided expert advice to and/or had speaking engagements with AbbVie, Amgen, Astra-Zeneca, Astro, Celgene, Celtrion, GlaxoSmithKline, ILTOO, Janssen, Lilly, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi and UCB.
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Smolen JS, et al. Ann Rheum Dis. 2016;doi:101136/annrheumdis-2016-209429.
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