Rheumatologists Agree That the American College of Rheumatology (ACR) 50/70 Clinical End Points Are More Persuasive than ACR 20 When Prescribing a New Drug for Psoriatic Arthritis
Expert Opinion Indicates That Humira and Cimzia Have the Best Clinical Profiles of Key Marketed Therapies, According to Findings from Decision Resources Group
BURLINGTON, Mass., April 30, 2014 /PRNewswire/ –Decision Resources Group finds that, when asked to select the top three most persuasive end points when prescribing a new drug for psoriatic arthritis (PsA), the highest percentages of surveyed United States and European rheumatologists selected the American College of Rheumatology (ACR) 50/70 response at 24 weeks. In contrast, the ACR 20 had less influence on surveyed rheumatologists’ prescribing decisions, despite being the most commonly used primary end point for efficacy assessment leading to regulatory approval. The report also finds that based on clinical data and the opinions of interviewed thought leaders, AbbVie/Eisai’s Humira and UCB/Astellas Pharma’s Cimzia have clinical profiles that are undifferentiated from each other and are the strongest among key marketed products used to treat PsA. While some emerging therapies hold promise, they have efficacy, safety and tolerability, and/or delivery features that prevent them from offering better overall clinical profiles than those of Humira and Cimzia.
Other key findings from the DecisionBase report entitled Psoriatic Arthritis: Opportunity Awaits Therapies Offering Improvements in Efficacy and Safety over Currently Available TNF-Alpha Inhibitors:
-- Apremilast: Surveyed U.S. rheumatologists would prescribe apremilast (Celgene's Otezla) to 10 percent of their disease-modifying antirheumatic drug (DMARD)-treated PsA patients, if it was priced at a 35 percent discount to Amgen/Pfizer/Takeda Pharmaceutical's Enbrel. -- Unmet need: Therapies with a greater ability to reduce the signs and symptoms of axial disease are one of the greatest unmet needs in PsA, according to the responses of surveyed U.S. and European rheumatologists and managed care organization (MCO) pharmacy directors. Clinical data and the opinions of interviewed thought leaders indicate that no emerging therapies have yet demonstrated the potential to fulfill this unmet need. -- Formulary inclusion: Surveyed MCO pharmacy directors are receptive to including new agents offering a lower risk of serious infection than currently available therapies on formulary at a moderate price premium to current agents.
Comments from Decision Resources Group Analyst Laura Croal, Ph.D.:
-- "In line with the responses of surveyed rheumatologists, interviewed experts consider the ACR 50 and ACR 70 response rates to be more meaningful measures of how a drug will perform in clinical practice than the ACR 20 response rate, despite the fact that the ACR 20 facilitates indirect comparisons among therapies owing to its longstanding use in pivotal trials. No drug outside of the TNF-alpha inhibitor class has yet been able to achieve ACR response rates comparable to that achieved by the TNF-alpha inhibitors in clinical trials." -- "Although one-fifth of surveyed U.S. rheumatologists who would prescribe apremilast indicated that they would use it in place of methotrexate, actual practice will likely be tempered by the significant price premium apremilast holds over generically available methotrexate."
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