Morgan Schultz 1, Stephanie Keeling 2, Steven Katz 2, Walter Maksymowych 2, Dean Eurich 3, Jill Hall 1 1 Faculty of Pharmacy and Pharmaceutical Sciences, 2 Faciluty of Medicine and Dentistry, 3 School of Public Health, University of Alberta Presented by: Morgan Schultz BSc(Pharm), PharmD Student University of Alberta September 12 th, 2015
Presenter Disclosure Presenter s Name: Morgan Schultz I have no current or past relationships with commercial entities Speaking Fees for current program: I have received no speaker s fee for this learning activity
Commercial Support Disclosure This program has received no financial or in-kind support from any commercial or other organization
Objectives To inform pharmacists of a research project being completed in the area of rheumatology at the University of Alberta To describe the proportion of patients self reporting achievement of a clinically meaningful response with leflunomide therapy To inform pharmacists of reported side effects and discontinuation rates with leflunomide in patients with rheumatoid arthritis
Background Leflunomide is a disease modifying anti-rheumatic drug (DMARD) Indicated for treatment of rheumatoid arthritis
Canadian Rheumatology Association Recommendations
Problem In 7 of 10 provinces, including Alberta, patients must fail leflunomide therapy prior to receiving provincial drug coverage of biologic DMARDs However, no guidelines (Canadian, American, European) specifically recommend that leflunomide should be trialled before initiating biologic therapy Risks of leflunomide therapy: Hepatic toxicity Led to FDA Black Box warning in 2010
Research Objectives To assess the proportion of patients achieving a clinically meaningful response with leflunomide at 3 months Defined as remission or low disease activity To assess the proportion of patients experiencing adverse effects (AEs) including: Those requiring therapy discontinuation Description of adverse effects Infections Liver toxicities
Methods Development of selfreported, standardized questionnaire Selection of populationbased cohort from RAPPORT database Distribution to n = 1,956 recipients during February & March 2015 RAPPORT: Rheumatoid Arthritis Pharmacovigilance Program
Results N = 714 completed the survey 36.5% response rate Of those who provided information regarding type of inflammatory arthritis: 82.6% had Rheumatoid Arthritis 15.7% had Psoriatic Arthritis The majority (72.4%) reported an initial dose of 20mg daily The majority (97.4%) reported previously taking methotrexate Of the 392 respondents who disclosed their insurance coverage: 22% reported having Alberta Blue Cross coverage
Clinical Response Of the 395 respondents who reported taking leflunomide for at least 3 months: 38% reported a clinical response Defined as remission or low disease activity
Discontinuation Rates Of the 407 respondents, 236 (58%) discontinued therapy Of those who reported rationale for discontinuation (n=230): 36.1% discontinued due to AEs 28.7% discontinued due to lack of efficacy 24.8% discontinued due to both AEs and lack of efficacy
Adverse Effects Of the 226 respondents that described their adverse effects: 52.2% reported nuisance side effects (hair loss, nausea, stomach pain) 38.5% reported diarrhea 7.1% reported liver toxicity 5.8% reported a serious infection
Discussion & Conclusion Achievement of a clinically meaningful response with leflunomide was self-reported by a minority of survey respondents, with a greater proportion reporting AEs Serious AEs were rare, however a substantial number of patients discontinued leflunomide due to AEs Current policies requiring failure of leflunomide therapy prior to coverage of biologic DMARDs should be reassessed
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