Scientific Publications by FDA Staff
Arthritis Care Res 2013 Jul;65(7):1085-94
Initiation of Tumor Necrosis Factor alpha Antagonists and Risk of Fractures in Patients With Selected Rheumatic and Autoimmune Diseases.
Kawai VK, Grijalva CG, Arbogast PG, Curtis JR, Solomon DH, Delzell E, Chen L, Ouellet-Hellstrom R, Herrinton L, Liu L, Mitchell EF Jr, Stein CM, Griffin MR
OBJECTIVES: We tested the hypothesis that initiation of TNFalpha antagonists reduced the risk of fractures compared to nonbiologic comparator in patients with autoimmune diseases. METHODS: Using four large administrative databases, we assembled retrospective cohorts of patients with autoimmune diseases who initiated either a TNFalpha antagonist or a nonbiologic medication. We identified 3 mutually exclusive disease groups: rheumatoid arthritis (RA); inflammatory bowel disease (IBD); and psoriasis, psoriatic arthritis or ankylosing spondylitis (PsO-PsA-AS). We used baseline covariate data to calculate propensity scores (PS) for each disease group and used Cox regression to calculate hazard ratios (HR) and 95% confidence intervals (95%CI). We compared the risk of combined hip, radius/ulna, humerus, or pelvic fractures between PS-matched cohorts of new users of TNFalpha antagonists and nonbiologic comparator. RESULTS: We identified 9,020, 2,014 and 2,663 new PS matched episodes of TNFalpha 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 TNFalpha 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 dose of prednisone equivalents >10 mg/day at baseline compared with no glucocorticoid (HR: 1.54, 95%CI [1.03, 2.30]). CONCLUSIONS: The risk of fractures did not differ between initiators of a biologic and a nonbiologic comparator for any disease studied. Among RA patients, use of >10mg/day of prednisone equivalents at baseline increased the fracture risk.
|Category: Journal Article|
|PubMed ID: #23281339||DOI: 10.1002/acr.21937|
|Includes FDA Authors from Scientific Area(s): Drugs|
|Entry Created: 2013-01-15||Entry Last Modified: 2016-03-21|