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Pharmacotherapy of multiple sclerosis: the PROOF trial

Background: Currently approved disease-modifying therapies for relapsing-remitting multiple sclerosis (RRMS) include two different interferon beta-1a (IFNB-1a) preparations: subcutaneous IFNB-1a (Rebif©) 44 μg three times weekly and intramuscular IFNB-1a (Avonex©) 30 μg once weekly. Objective: This evaluation is of the Prospective and Retrospective Long-Term Observational Study of Avonex and Rebif (PROOF), which intended to compare relative efficacy and tolerability of the two INFB-1a products. Methods: PROOF was analyzed in light of previous head-to-head studies comparing high- and low-frequency IFNB therapies. Results/conclusions: Several limitations, including a retrospective-prospective design, retrospective assessment of variables without predefined criteria, limited prospective evaluation, and inadequate sample size, necessitate careful interpretation of their Results. Ultimately, the question of long-term efficacy of high- versus low-frequency INFB therapies remains unanswered.