title: A systematic review and meta-analysis of the efficacy and safety of adalimumab for treating rheumatoid arthritis.
abstract: Adalimumab (ADA) is a monoclonal antibody. Published studies indicate that its use in patients with rheumatoid arthritis can be efficient in providing long-term benefits. The aim of this study is to evaluate the efficacy and safety of ADA for treating rheumatoid arthritis. A systematic review was performed to search for randomized clinical trials that compare subcutaneous doses of ADA 20 mg weekly or 40 mg every other week with placebo, with or without concomitant methotrexate. Only studies of moderate or high quality were included. A meta-analysis was conducted to assess the efficacy (based in changes of American College of Rheumatology ACR criteria) and the safety (based in serious adverse events, serious infections, malignancy and deaths) of ADA use. Withdrawals due to adverse events or lack of efficacy were also evaluated. Eight studies met the inclusion criteria, comprising 2,692 patients. In the efficacy meta-analysis, a greater number of ADA-treated patients relative to those in placebo group achieved ACR20, ACR50 and ACR70 values from 6 months to 2 years of treatment. For safety results, there were no statistically significant differences between the groups. Withdrawals due to adverse events were higher in ADA group relative to the placebo group, and withdrawals due to the lack of efficacy were higher in placebo group relative to the ADA-treated group. This meta-analysis shows a higher efficacy of ADA relative to placebo, but clinicians should be careful regarding adverse events in ADA-treated patients.
authors.affiliation: Pharmaceutical Practice Research Group, Pharmacy Department, Universidade Federal do Paraná, Av. Pref. Lothário Meissner, 632, Jardim Botânico, Curitiba, Paraná, Brazil. cassyano@ufpr.com.br
authors.forename: Astrid
authors.initials: A
authors.lastname: Wiens
authors.forename: Cassyano Januário
authors.initials: CJ
authors.lastname: Correr
authors.forename: Rafael
authors.initials: R
authors.lastname: Venson
authors.forename: Michel Fleith
authors.initials: MF
authors.lastname: Otuki
authors.forename: Roberto
authors.initials: R
authors.lastname: Pontarolo
mesh_terms: D000068879:Adalimumab; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D010919:Placebos; D000068879:Adalimumab
references.citation: Ann Rheum Dis. 2004 May;63(5):508-16
references.pmid: 15082480
references.citation: Arthritis Rheum. 1995 Jun;38(6):727-35
references.pmid: 7779114
references.citation: Control Clin Trials. 1996 Feb;17(1):1-12
references.pmid: 8721797
references.citation: Ann Rheum Dis. 2006 Jan;65(1):30-4
references.pmid: 15901635
references.citation: Arthritis Rheum. 2003 Jan;48(1):35-45
references.pmid: 12528101
references.citation: Arthritis Rheum. 2004 May;50(5):1400-11
references.pmid: 15146409
references.citation: Mod Rheumatol. 2008;18(3):252-62
references.pmid: 18330677
references.citation: Clin Ther. 2008 Jul;30(7):1375-84
references.pmid: 18691998
references.citation: Ann Rheum Dis. 2003 Dec;62(12):1168-77
references.pmid: 14644854
references.citation: J Rheumatol. 2006 Aug;33(8):1710; author reply 1710
references.pmid: 16881134
references.citation: J Rheumatol. 2003 Dec;30(12):2563-71
references.pmid: 14719195
references.citation: Expert Opin Pharmacother. 2007 Sep;8(13):2089-107
references.pmid: 17714062
references.citation: Clin Immunol. 2008 Feb;126(2):121-36
references.pmid: 17916444
references.citation: N Engl J Med. 1999 Jan 28;340(4):253-9
references.pmid: 9920948
references.citation: Nat Rev Immunol. 2007 Jun;7(6):429-42
references.pmid: 17525752
references.citation: Nihon Rinsho. 2007 Jul;65(7):1179-84
references.pmid: 17642229
references.citation: Rheumatology (Oxford). 2007 Jul;46(7):1148-52
references.pmid: 17478471
references.citation: Psychol Methods. 2006 Jun;11(2):193-206
references.pmid: 16784338
references.citation: Arthritis Rheum. 2006 Jan;54(1):26-37
references.pmid: 16385520
references.citation: Rheumatology (Oxford). 2000 Jun;39 Suppl 1:43-7
references.pmid: 11001379
references.citation: Rev Assoc Med Bras (1992). 2007 Sep-Oct;53(5):465-70
references.pmid: 17952359
references.citation: J Rheumatol. 2006 Jun;33(6):1075-81
references.pmid: 16652437