Initiation of anti-TNF therapy and the risk of optic neuritis: From the safety assessment of biologic ThERapy (SABER) study

Kevin Winthrop, Lang Chen, Frederick W. Fraunfelder, Jennifer H. Ku, Cara D. Varley, Eric Suhler, William Hills, Devin Gattey, John W. Baddley, Liyan Liu, Carlos G. Grijalva, Elizabeth Delzell, Timothy Beukelman, Nivedita M. Patkar, Fenglong Xie, Lisa J. Herrinton, Frederick (Fritz) Fraunfelder, Kenneth G. Saag, James D. Lewis, Daniel H. SolomonJeffrey R. Curtis

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)183-189
Number of pages7
JournalAmerican Journal of Ophthalmology
Volume155
Issue number1
DOIs
StatePublished - Jan 2013

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Optic Neuritis
Biological Therapy
Tumor Necrosis Factor-alpha
Antirheumatic Agents
Safety
Therapeutics
Medicaid
Incidence
Information Storage and Retrieval
Contracts
Medicare
Drug Users
Pharmaceutical Preparations
Cohort Studies

ASJC Scopus subject areas

  • Ophthalmology

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Initiation of anti-TNF therapy and the risk of optic neuritis : From the safety assessment of biologic ThERapy (SABER) study. / Winthrop, Kevin; Chen, Lang; Fraunfelder, Frederick W.; Ku, Jennifer H.; Varley, Cara D.; Suhler, Eric; Hills, William; Gattey, Devin; Baddley, John W.; Liu, Liyan; Grijalva, Carlos G.; Delzell, Elizabeth; Beukelman, Timothy; Patkar, Nivedita M.; Xie, Fenglong; Herrinton, Lisa J.; Fraunfelder, Frederick (Fritz); Saag, Kenneth G.; Lewis, James D.; Solomon, Daniel H.; Curtis, Jeffrey R.

In: American Journal of Ophthalmology, Vol. 155, No. 1, 01.2013, p. 183-189.

Research output: Contribution to journalArticle

Winthrop, K, Chen, L, Fraunfelder, FW, Ku, JH, Varley, CD, Suhler, E, Hills, W, Gattey, D, Baddley, JW, Liu, L, Grijalva, CG, Delzell, E, Beukelman, T, Patkar, NM, Xie, F, Herrinton, LJ, Fraunfelder, FF, Saag, KG, Lewis, JD, Solomon, DH & Curtis, JR 2013, 'Initiation of anti-TNF therapy and the risk of optic neuritis: From the safety assessment of biologic ThERapy (SABER) study', American Journal of Ophthalmology, vol. 155, no. 1, pp. 183-189. https://doi.org/10.1016/j.ajo.2012.06.023
Winthrop, Kevin ; Chen, Lang ; Fraunfelder, Frederick W. ; Ku, Jennifer H. ; Varley, Cara D. ; Suhler, Eric ; Hills, William ; Gattey, Devin ; Baddley, John W. ; Liu, Liyan ; Grijalva, Carlos G. ; Delzell, Elizabeth ; Beukelman, Timothy ; Patkar, Nivedita M. ; Xie, Fenglong ; Herrinton, Lisa J. ; Fraunfelder, Frederick (Fritz) ; Saag, Kenneth G. ; Lewis, James D. ; Solomon, Daniel H. ; Curtis, Jeffrey R. / Initiation of anti-TNF therapy and the risk of optic neuritis : From the safety assessment of biologic ThERapy (SABER) study. In: American Journal of Ophthalmology. 2013 ; Vol. 155, No. 1. pp. 183-189.
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abstract = "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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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

AU - Chen, Lang

AU - Fraunfelder, Frederick W.

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.

PY - 2013/1

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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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