| Risk of malignancies in patients with rheumatoid arthritis treated with biologic therapy: a meta-analysis. | |
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MedLine Citation:
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PMID: 22948700 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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CONTEXT: Concerns exist regarding the potential development of malignancies in patients with rheumatoid arthritis (RA) who are receiving biologic response modifiers (BRMs). OBJECTIVE: To assess the risk of malignancy in patients with RA enrolled in randomized controlled trials (RCTs) of BRMs. DATA SOURCES: Electronic databases, conference proceedings, and websites of regulatory agencies were searched for RCTs evaluating abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, and tocilizumab in RA from inception through July 9, 2012. STUDY SELECTION: Independent selection of studies included RCTs that compared the safety of any BRMs used in RA patients with placebo and/or any traditional disease-modifying antirheumatic drugs with a minimum of 24 weeks of follow-up. DATA EXTRACTION: Independent reviewers selected studies and extracted data on quality and outcomes. Pooled estimates and 95% confidence intervals were calculated for each BRM. RESULTS: Sixty-three RCTs with 29,423 patients were analyzed. No statistically significant increased risk of developing malignancy was observed. Of the 29,423 patients, 211 developed a malignancy during the trial (118 solid tumors, 48 skin cancers, 14 lymphomas, 5 hematologic nonlymphomas, and 26 not specified). The incidence rate for any malignancy during the first year of therapy was very low in the BRM plus methotrexate group (0.77%; 95% CI, 0.65%-0.92%), the BRM monotherapy group (0.64%; 95% CI, 0.42%-0.95%), and the controls (0.66%; 95% CI, 0.52%-0.84%). Anakinra plus methotrexate showed lower odds compared with methotrexate alone (Peto odds ratio, 0.11; 95% CI, 0.03-0.45). No statistically significant risk was observed for specific cancer sites, although the Peto odds ratio for lymphoma was 2.1 (95% CI, 0.55-8.4) in patients receiving tumor necrosis factor inhibitors compared with controls. CONCLUSION: The use of BRMs among patients with RA included in RCTs of at least 6 months' duration was not significantly associated with an increased risk of malignancy compared with other disease-modifying antirheumatic drugs or with placebo. |
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Authors:
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Maria A Lopez-Olivo; Jean H Tayar; Juan A Martinez-Lopez; Eduardo N Pollono; Jose Polo Cueto; M Rosa Gonzales-Crespo; Stephanie Fulton; Maria E Suarez-Almazor |
Publication Detail:
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Type: Journal Article; Meta-Analysis; Research Support, N.I.H., Extramural |
Journal Detail:
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Title: JAMA : the journal of the American Medical Association Volume: 308 ISSN: 1538-3598 ISO Abbreviation: JAMA Publication Date: 2012 Sep |
Date Detail:
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Created Date: 2012-09-05 Completed Date: 2012-09-05 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7501160 Medline TA: JAMA Country: United States |
Other Details:
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Languages: eng Pagination: 898-908 Citation Subset: AIM; IM |
Affiliation:
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University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Arthritis, Rheumatoid
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drug therapy* Humans Immunologic Factors / adverse effects*, therapeutic use Neoplasms / chemically induced, epidemiology* Odds Ratio Randomized Controlled Trials as Topic Risk |
| Grant Support | |
ID/Acronym/Agency:
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K24 AR053593/AR/NIAMS NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Immunologic Factors |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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