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A meta-analysis of the efficacy and tolerability of interferon-beta in multiple sclerosis, overall and by drug and disease type.

Author(s): Nikfar S, Rahimi R, Abdollahi M

Affiliation(s): Department of Pharmacoeconomics and Pharmaceutical Administration, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.

Publication date & source: 2010-10, Clin Ther., 32(11):1871-88.

Publication type: Comparative Study; Meta-Analysis; Review

BACKGROUND: Interferon-beta (IFN-beta) is an immunomodulatory agent that has been approved in >80 countries worldwide for the treatment of multiple sclerosis (MS) with a relapsing course. Several studies have found IFN-beta beneficial in reducing rates of relapse, whereas others have reported no benefit in this regard. OBJECTIVE: A systematic review and meta-analysis of published placebo-controlled clinical trials of IFN-beta was conducted to determine the efficacy and tolerability of IFN-beta in the maintenance of remission of MS and to examine variations in effectiveness according to type of IFN-beta and subtype of MS. METHODS: PubMed, Scopus, and the Cochrane Central Register of Controlled Trials (1966-May 2010) were searched for English-language reports of placebo- controlled trials on the efficacy and/or tolerability of IFN-beta in MS. Three reviewers independently examined the abstracts of identified publications for relevance and extracted pertinent data from the selected reports. The key efficacy outcomes of interest were the number of patients with at least one relapse and the mean change in Expanded Disability Status Scale (EDSS) scores. The key tolerability outcomes were the number of discontinuations due to adverse events, number of deaths, and number of patients with completed suicides or suicide attempts. In addition, specific adverse events of interest (flulike symptoms, injection-site reactions, injection-site inflammation, myalgia, depression, leukopenia, lymphopenia, and increased alanine aminotransferase) were analyzed individually and compared between IFN-beta and placebo. RESULTS: Nine randomized, placebo-controlled clinical trials of IFN-beta met the criteria for inclusion in the meta-analysis. These studies included a total of 3980 patients with MS (2639 with secondary progressive MS, 50 with primary progressive MS, 359 with relapsing MS, and 932 with relapsing-remitting MS; 2552 women, 1428 men; mean age, 40.6 years) randomized to receive either IFN-beta or placebo. Of those randomized to treatment, 1893 received IFN-beta-1a or placebo, 2029 received IFN-beta-1b or placebo, and 58 received natural IFN-beta or placebo. The summary relative risks (RRs) for at least one relapse compared with placebo were as follows: 0.86 (95% CI, 0.76 to 0.97; P = 0.011) for all types of IFN-beta across all subtypes of MS (7 trials); 1.11 (95% CI, 0.79 to 1.55) for all types of IFN-beta in secondary progressive MS (SPMS) (3 trials); and 0.77 (95% CI, 0.57 to 1.05) for all types of IFN-beta in relapsing-remitting MS (2 trials). The summary RR for at least one relapse across all types of MS was 0.97 (95% CI, 0.57 to 1.67) for IFN-beta-1a (3 trials) and 0.92 (95% CI, 0.85 to 1.00; P = 0.042) for IFN-beta-1b (3 trials). The summary RR for at least one relapse was 0.93 (95% CI, 0.75 to 1.14) in patients with SPMS receiving IFN-beta-1b. The pooled effect sizes for the mean change in EDSS score with the IFN-beta doses used in the Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis Accepted for publication August 19, 2010. study were -1.71 (95% CI, -4.70 to 1.28) for the 22-mug dose and -1.71 (95% CI, -4.70 to 1.27) for the 44-mug dose (2 trials). For the tolerability outcomes, the summary RRs were 2.76 (95% CI, 1.97 to 3.89; P < 0.001) for discontinuation due to adverse events (9 trials), 1.53 (95% CI, 0.45 to 5.15) for death (3 trials), and 0.86 (95% CI, 0.41 to 1.79) for completed suicides and suicide attempts (5 trials). The summary RRs for all adverse events of interest (with the exception of depression) were statistically significant for all types of IFN-beta compared with placebo across all types of MS (P < 0.01). CONCLUSIONS: In this meta-analysis of 9 randomized clinical trials, IFN-beta was associated with prevention of relapse compared with placebo across all subtypes of MS. However, the effectiveness of IFN-beta appeared to vary depending on the type of IFN-beta used and the subtype of MS treated. Copyright (c) 2010 Excerpta Medica Inc. All rights reserved.

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