TY - JOUR
T1 - Initiation of anti-TNF therapy and the risk of optic neuritis
T2 - From the safety assessment of biologic ThERapy (SABER) study
AU - Winthrop, Kevin L.
AU - Chen, Lang
AU - Fraunfelder, Frederick (Rick)
AU - Ku, Jennifer H.
AU - Varley, Cara D.
AU - Suhler, Eric
AU - Hills, William
AU - Gattey, Devin
AU - Baddley, John W.
AU - Liu, Liyan
AU - Grijalva, Carlos G.
AU - Delzell, Elizabeth
AU - Beukelman, Timothy
AU - Patkar, Nivedita M.
AU - Xie, Fenglong
AU - Herrinton, Lisa J.
AU - Fraunfelder, Frederick (Fritz)
AU - Saag, Kenneth G.
AU - Lewis, James D.
AU - Solomon, Daniel H.
AU - Curtis, Jeffrey R.
N1 - Funding Information:
All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. K.L.W. reports consulting for Genentech, Abbott, and Amgen. E.D. received research support from Amgen. J.W.B. reports consulting for Abbott and Merck. L.J.H. received research support from Centocor, Genentech, and Procter and Gamble. D.H.S. received research support from Amgen, Abbott, and Bristol-Myers Squibb. K.G.S. received research support from Amgen, Genentech, Horizon, and Merck. J.R.C. received consultant fees and research grants from Roche/Genentech , UCB , Centocor , CORRONA , Amgen , Pfizer , BMS , Crescendo , and Abbott . J.D.L. has received research support from Centocor and consultant honoraria from Amgen and Pfizer. T.B. received research support from Pfizer and consultant fees from Novartis. Publication of this article was supported by the Food and Drug Administration (FDA), US Department of Health and Human Services (DHHS), and the Agency for Healthcare Research and Quality (AHRQ; Rockville, Maryland) grant U18 HS17919 . K.L. Winthrop's work on this manuscript was funded by an AHRQ grant ( 1K08HS017552-01 ). Dr Curtis receives support from the National Institutes of Health (NIH; AR053351 ) and AHRQ ( R01HS018517 ). Dr Beukelman was supported by NIH grant 5KL2 RR025776-03 via the University of Alabama at Birmingham Center for Clinical and Translational Science. Drs Grijalva and Griffin receive support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (grant 5P60AR56116 ). Involved in design and conduct of the study (K.W., L.C., F.W.C., J.K., C.V., E.S., W.H., D.G., J.B., L.L., C.G., E.D., T.B., N.P., F.X., L.H., F.T.F., K.G., J.L., D.S., J.C.); collection, management, analysis, and interpretation of the data (K.W., L.C., F.W.C., J.K., C.V., E.S., W.H., D.G., J.B., L.L., C.G., E.D., T.B., N.P., F.X., L.H., F.T.F., K.G., J.L., D.S., J.C.); and preparation, review, or approval of the manuscript (K.W., L.C., F.W.C., J.K., C.V., E.S., W.H., D.G., J.B., L.L., C.G., E.D., T.B., N.P., F.X., L.H., F.T.F., K.G., J.L., D.S., J.C.). All SABER-participating IRBs (The Institutional Review Board at Oregon Health & Science University, the Institutional Review Board for Human Use at University of Alabama at Birmingham, the Institutional Review Board at Kaiser Permanente North California, the Institutional Review Board at Vanderbilt University, the Institutional Review Board at University of Pennsylvania, and the Institutional Review Board at Harvard University) approved the retrospective review of patient data for this study and waived consent requirements.
PY - 2013/1
Y1 - 2013/1
N2 - Purpose: To evaluate the incidence of optic neuritis (ON) in patients using anti-tumor necrosis factor (TNF) alpha therapy. Design: Retrospective, population-based cohort study. Methods: We identified new users of anti-TNF therapy (etanercept, infliximab, or adalimumab) or nonbiologic disease-modifying antirheumatic drugs (DMARDs) during 2000-2007 from the following data sources: Kaiser Permanente Northern California, Pharmaceutical Assistance Contract for the Elderly, Tennessee Medicaid, and National Medicaid/Medicare. Within this cohort, we used validated algorithms to identify ON cases occurring after onset of new drug exposure. We then calculated and compared ON incidence rates between exposure groups. Results: We identified 61 227 eligible inflammatory disease patients with either new anti-TNF or new nonbiologic DMARD use. Among this cohort, we found 3 ON cases among anti-TNF new users, occurring a median of 123 days (range, 37-221 days) after anti-TNF start. The crude incidence rate of ON across all disease indications among anti-TNF new users was 10.4 (95% CI 3.3-32.2) cases per 100 000 person-years. In a sensitivity analysis considering current or past anti-TNF or DMARD use, we identified a total of 6 ON cases: 3 among anti-TNF users and 3 among DMARD users. Crude ON rates were similar among anti-TNF and DMARD groups: 4.5 (95% CI 1.4-13.8) and 5.4 (95% CI 1.7-16.6) per 100 000 person-years, respectively. Conclusion: Optic neuritis is rare among those who initiate anti-TNF therapy and occurs with similar frequency among those with nonbiologic DMARD exposure.
AB - Purpose: To evaluate the incidence of optic neuritis (ON) in patients using anti-tumor necrosis factor (TNF) alpha therapy. Design: Retrospective, population-based cohort study. Methods: We identified new users of anti-TNF therapy (etanercept, infliximab, or adalimumab) or nonbiologic disease-modifying antirheumatic drugs (DMARDs) during 2000-2007 from the following data sources: Kaiser Permanente Northern California, Pharmaceutical Assistance Contract for the Elderly, Tennessee Medicaid, and National Medicaid/Medicare. Within this cohort, we used validated algorithms to identify ON cases occurring after onset of new drug exposure. We then calculated and compared ON incidence rates between exposure groups. Results: We identified 61 227 eligible inflammatory disease patients with either new anti-TNF or new nonbiologic DMARD use. Among this cohort, we found 3 ON cases among anti-TNF new users, occurring a median of 123 days (range, 37-221 days) after anti-TNF start. The crude incidence rate of ON across all disease indications among anti-TNF new users was 10.4 (95% CI 3.3-32.2) cases per 100 000 person-years. In a sensitivity analysis considering current or past anti-TNF or DMARD use, we identified a total of 6 ON cases: 3 among anti-TNF users and 3 among DMARD users. Crude ON rates were similar among anti-TNF and DMARD groups: 4.5 (95% CI 1.4-13.8) and 5.4 (95% CI 1.7-16.6) per 100 000 person-years, respectively. Conclusion: Optic neuritis is rare among those who initiate anti-TNF therapy and occurs with similar frequency among those with nonbiologic DMARD exposure.
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U2 - 10.1016/j.ajo.2012.06.023
DO - 10.1016/j.ajo.2012.06.023
M3 - Article
C2 - 22967869
AN - SCOPUS:84871241925
SN - 0002-9394
VL - 155
SP - 183-189.e1
JO - American journal of ophthalmology
JF - American journal of ophthalmology
IS - 1
ER -