Document Detail


Initiation of tumor necrosis factor α antagonists and risk of fractures in patients with selected rheumatic and autoimmune diseases.
MedLine Citation:
PMID:  23281339     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: We tested the hypothesis that initiation of tumor necrosis factor α (TNFα) antagonists reduced the risk of fractures compared to nonbiologic comparators in patients with autoimmune diseases.
METHODS: Using 4 large administrative databases, we assembled retrospective cohorts of patients with autoimmune diseases who initiated either a TNFα antagonist or a nonbiologic medication. We identified 3 mutually exclusive disease groups: rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and a combined group: psoriasis (PsO), psoriatic arthritis (PsA), or ankylosing spondylitis (AS). We used baseline covariate data to calculate propensity scores (PS) for each disease group and used Cox regression to calculate hazard ratios (HRs) and 95% confidence intervals (95% CIs). We compared the risk of combined hip, radius/ulna, humerus, or pelvic fractures between PS-matched cohorts of new users of TNFα antagonists and nonbiologic comparators.
RESULTS: We identified 9,020, 2,014, and 2,663 new PS-matched episodes of TNFα antagonist and nonbiologic comparator use in RA, IBD, and PsO-PsA-AS cohorts, respectively. The risk of combined fractures was similar between new users of TNFα antagonists and nonbiologic comparators for each disease (HR 1.17, 95% CI 0.91-1.51; HR 1.49, 95% CI 0.72-3.11; and HR 0.92, 95% CI 0.47-1.82 for RA, IBD, and PsO-PsA-AS, respectively). In RA, the risk of combined fractures was associated with an average daily dosage of prednisone equivalents >10 mg/day at baseline compared with no glucocorticoid (HR 1.54, 95% CI 1.03-2.30).
CONCLUSION: The risk of fractures did not differ between initiators of a biologic agent and a nonbiologic comparator for any disease studied. Among RA patients, use of >10 mg/day of prednisone equivalents at baseline increased the fracture risk.
Authors:
Vivian K Kawai; Carlos G Grijalva; Patrick G Arbogast; Jeffrey R Curtis; Daniel H Solomon; Elizabeth Delzell; Lang Chen; Rita Ouellet-Hellstrom; Lisa Herrinton; Liyan Liu; Edward F Mitchell; C Michael Stein; Marie R Griffin
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Arthritis care & research     Volume:  65     ISSN:  2151-4658     ISO Abbreviation:  Arthritis Care Res (Hoboken)     Publication Date:  2013 Jul 
Date Detail:
Created Date:  2013-07-02     Completed Date:  2013-09-05     Revised Date:  2014-07-02    
Medline Journal Info:
Nlm Unique ID:  101518086     Medline TA:  Arthritis Care Res (Hoboken)     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1085-94     Citation Subset:  IM    
Copyright Information:
Copyright © 2013 by the American College of Rheumatology.
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MeSH Terms
Descriptor/Qualifier:
Aged
Antirheumatic Agents / adverse effects,  therapeutic use*
Autoimmune Diseases / complications,  diagnosis,  drug therapy*,  immunology
Biological Products / adverse effects,  therapeutic use*
Female
Fractures, Bone / etiology,  prevention & control*
Glucocorticoids / adverse effects
Humans
Immunosuppressive Agents / adverse effects,  therapeutic use*
Logistic Models
Male
Middle Aged
Prednisone / adverse effects
Propensity Score
Proportional Hazards Models
Retrospective Studies
Rheumatic Diseases / complications,  diagnosis,  drug therapy*,  immunology
Risk Assessment
Risk Factors
Tumor Necrosis Factor-alpha / antagonists & inhibitors*,  metabolism
United States
Grant Support
ID/Acronym/Agency:
AR-053351/AR/NIAMS NIH HHS; P60 AR056116/AR/NIAMS NIH HHS; P60-AR-56116/AR/NIAMS NIH HHS; R01 HS018517/HS/AHRQ HHS; R01-HS018517/HS/AHRQ HHS; T32 GM007569/GM/NIGMS NIH HHS; T32-GM-007569/GM/NIGMS NIH HHS; U18-HS017919/HS/AHRQ HHS
Chemical
Reg. No./Substance:
0/Antirheumatic Agents; 0/Biological Products; 0/Glucocorticoids; 0/Immunosuppressive Agents; 0/Tumor Necrosis Factor-alpha; VB0R961HZT/Prednisone
Comments/Corrections

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