![]() Even in patients with early disease (duration of less than or equal to 1 year), ACR20/50 responses with metho-trexate monotherapy ranged from 54%/32% (ASPIRE ) to 63%/46% (PREMIER) to 65%/42% (Etancercept in Early RA ). These cannot be completely explained by differences in median methotrexate doses, use of folic acid supplementation, or enrollment of subjects with early versus well-established disease. ![]() This is perhaps best exemplified by the variability of ACR20/50 (ACR 20%/50% improvement criteria) responses with methotrexate, which range from 46% to 78% at 1 year and from 56% to 84% at 2 years (Table 2). Hopefully, the next decade will bring new agents to address the large unmet needs in other rheumatic diseases.Īcross trials, it is clear that therapeutic responses are not consistent. It is hoped that this precedent will lead to similar advances in other rheumatologic diseases, although to date these remain more elusive. The tremendous progress in clinical development in RA over the past decade has revolutionized rheumatology and significantly benefited our patients. Additionally, identification of rare adverse events in RCTs and confirmed in postmarketing surveillance as well as newer approaches designed to reflect clinical practice more realistically will be discussed. This review will address difficulties in comparing clinical trials, including the importance of comparator groups, background therapy, and means to use placebo controls. Together, these documents set a precedent for requiring longer-term RCTs, of 12 to 24 months in duration, evaluating radiographic progression and patient-reported physical function in addition to accepted outcomes assessing signs and symptoms of disease. This progress in clinical development was driven, in part, by the Guidance Document for Development of New Therapies for Treatment of RA, which was issued by the US Food and Drug Administration (FDA) and finalized in 1998, followed by recommendations from the European Agency for the Evaluation of Medicinal Products in 2004.
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