ADALIMUMAB (HUMIRA®) DOSING FREQUENCY IN RA PATIENT ASSISTANCE PROGRAMS

Background: Adalimumab, a fully human monoclonal antibody that targets tumor necrosis factor, has been approved in the United States, multiple European countries, selected countries in South America, and elsewhere for the treatment of adult patients with moderate to severe RA. The recommended dose for all patients is 40 mg every other week (eow), based on results from several randomized, placebo-controlled studies of adalimumab in combination with methotrexate (MTX) or as monotherapy. In the small percentage of patients who do not achieve adequate response with monotherapy, increasing to weekly dosing may achieve optimal response.Objectives: To determine the percentages of patients on eow vs. weekly dosing in a Medicare Assistance Program (MAP) and Patient Assistance Program (PAP) population, as an estimate of these percentages in the entire adalimumab-treated population.Methods: Through two drug access programs provided by Abbott Laboratories in the United States, selected, eligible RA patients in the United States receive adalimumab at no cost. Through MAP, seniors who are Medicare participants and have no prescription drug benefit are eligible to receive adalimumab. Similarly, though PAP, non-Medicare patients who also have no prescription drug coverage and can demonstrate financial need based on program criteria are eligible to receive adalimumab. Approved program patients receive a three-month supply of drug and may re-order at three-month intervals. Starting dose and all dose changes were recorded for each patient who participated in the programs from mid-February 2003 to mid-October 2003, the first 8 months of the programs. No financial barriers to increasing dose exist in these programs. Patients are required to re-enroll annually.Results: 6,784 patients participated in one of the U.S. programs during their initial 8-month period. 6,514 of the program participants, or 96% of the total, received adalimumab 40 mg eow during the entire period. At the end of 8 months, 261 patients, or 3.9% of all participants, were on weekly dosing, and 9 patients (0.1%) were on other dosing regimens. Of the 261 on weekly dosing, 228 (87%) entered the programs already on weekly dosing, and 32 (12%) increased to weekly dosing at some point during the 8 months. Therefore, less than 1% of all program participants on eow dosing changed to weekly dosing during the 8-month period.Conclusion: The recommended and approved dose of adalimumab, 40 mg eow, was used by 96% of the patients in the Medicare and Patient Assistance Programs in the United States. Because of the relatively large number of patients in this retrospective review, this analysis may provide an indication of the total percentage of patients who derive benefit from eow dosing of adalimumab after 8 months. A lack of financial barriers to increasing dosing provides even greater confidence in these results.Citation: , volume , supplement , year 2004, page Session: Rheumatoid arthritis – Treatment