TY - JOUR
T1 - Comparison Between Methotrexate and Mycophenolate Mofetil Monotherapy for the Control of Noninfectious Ocular Inflammatory Diseases
AU - SITE Cohort Research Group
AU - Gangaputra, Sapna S.
AU - Newcomb, Craig W.
AU - Joffe, Marshall M.
AU - Dreger, Kurt
AU - Begum, Hosne
AU - Artornsombudh, Pichaporn
AU - Pujari, Siddharth S.
AU - Daniel, Ebenezer
AU - Sen, H. Nida
AU - Suhler, Eric B.
AU - Thorne, Jennifer E.
AU - Bhatt, Nirali P.
AU - Foster, C. Stephen
AU - Jabs, Douglas A.
AU - Nussenblatt, Robert B.
AU - Rosenbaum, James T.
AU - Levy-Clarke, Grace A.
AU - Kempen, John H.
N1 - Funding Information:
Funding Support: This study was supported primarily by National Eye Institute Grant EY014943 (J.H.K.). Additional support was provided by Research to Prevent Blindness , the Paul and Evanina Mackall Foundation, and the Lois Pope Life Foundation. J.H.K. was an RPB James S. Adams Special Scholar Award recipient, J.E.T. was an RPB Harrington Special Scholar Award recipient, and D.A.J. and J.T.R. were Research to Prevent Blindness Senior Scientific Investigator Award recipients during the course of the study. G.A.L.-C. and R.B.N. were previously supported by and H.N.S. continues to be supported by intramural funds of the National Eye Institute . E.B.S. receives support from the Department of Veterans Affairs . None of the sponsors had any role in the design and conduct of the report; in the collection, management, analysis, and interpretation of the data; or in the preparation, review, and approval of this manuscript. Financial Disclosures: The author(s) have made the following disclosure(s): Sapna Gangaputra: (grant recipient) Research to Prevent Blindness , USAID . C. Stephen Foster: (equity owner) Eyegate, (consultant, lecturer) Allergan, Bausch & Lomb; (consultant) Sirion; (lecturer) Alcon, Inspire, Ista, Centocor. James Rosenbaum: (consultant) Abbvie; UCB , Gilead , Regeneron , Eyevensys; (grant recipient) Pfizer; (equity owner) Novartis; (royalties) UpToDate. Jennifer Thorne: (consultant) AbbVie, Gilead, Santen; (grant recipient) National Eye Institute , Allergan . John H. Kempen: (consultant) Clearside, Gilead, and Santen; (grant recipient) National Eye Institute , Sight for Souls, Christian Blind Mission International, EyeGate Pharma. All of the other authors have no financial disclosures. All authors attest that they meet the current ICMJE criteria for authorship.
Funding Information:
Funding Support: This study was supported primarily by National Eye Institute Grant EY014943 (J.H.K.). Additional support was provided by Research to Prevent Blindness, the Paul and Evanina Mackall Foundation, and the Lois Pope Life Foundation. J.H.K. was an RPB James S. Adams Special Scholar Award recipient, J.E.T. was an RPB Harrington Special Scholar Award recipient, and D.A.J. and J.T.R. were Research to Prevent Blindness Senior Scientific Investigator Award recipients during the course of the study. G.A.L.-C. and R.B.N. were previously supported by and H.N.S. continues to be supported by intramural funds of the National Eye Institute. E.B.S. receives support from the Department of Veterans Affairs. None of the sponsors had any role in the design and conduct of the report; in the collection, management, analysis, and interpretation of the data; or in the preparation, review, and approval of this manuscript. Financial Disclosures: The author(s) have made the following disclosure(s): Sapna Gangaputra: (grant recipient) Research to Prevent Blindness, USAID. C. Stephen Foster: (equity owner) Eyegate, (consultant, lecturer) Allergan, Bausch & Lomb; (consultant) Sirion; (lecturer) Alcon, Inspire, Ista, Centocor. James Rosenbaum: (consultant) Abbvie; UCB, Gilead, Regeneron, Eyevensys; (grant recipient) Pfizer; (equity owner) Novartis; (royalties) UpToDate. Jennifer Thorne: (consultant) AbbVie, Gilead, Santen; (grant recipient) National Eye Institute, Allergan. John H. Kempen: (consultant) Clearside, Gilead, and Santen; (grant recipient) National Eye Institute, Sight for Souls, Christian Blind Mission International, EyeGate Pharma. All of the other authors have no financial disclosures. All authors attest that they meet the current ICMJE criteria for authorship. A list of the members of the SITE Cohort Research Group is included as an Appendix (Supplemental Material available at AJO.com).
Publisher Copyright:
© 2019 Elsevier Inc.
PY - 2019/12
Y1 - 2019/12
N2 - Purpose: To compare mycophenolate mofetil (MMF) to methotrexate (MTX) as corticosteroid-sparing therapy for ocular inflammatory diseases. Design: Retrospective analysis of cohort study data. Methods: Participants were identified from the Systemic Immunosuppressive Therapy for Eye Diseases Cohort Study. Demographic and clinical characteristics were obtained via medical record review. The study included 352 patients who were taking single-agent immunosuppression with MTX or MMF at 4 tertiary uveitis clinics. Marginal structural models (MSM)-derived statistical weighting created a virtual population with covariates and censoring patterns balanced across alternative treatments. With this methodological approach, the results estimate what would have happened had none of the patients stopped their treatment. Survival analysis with stabilized MSM-derived weights simulated a clinical trial comparing MMF vs MTX for noninfectious inflammatory eye disorders. The primary outcome was complete control of inflammation on prednisone ≤10 mg/day, sustained for ≥30 days. Results: The time to success was shorter (more favorable) for MMF than MTX (hazard ratio = 0.68, 95% confidence interval: 0.46-0.99). Adjusting for covariates, the proportion achieving success was higher at every point in time for MMF than MTX from 2 to 8 months, then converges at 9 months. The onset of corticosteroid-sparing success took more than 3 months for most patients in both groups. Outcomes of treatment (MMF vs MTX) were similar across all anatomic sites of inflammation. The incidence of stopping therapy for toxicity was similar in both groups. Conclusions: Our results suggest that, on average, MMF may be faster than MTX in achieving corticosteroid-sparing success in ocular inflammatory diseases.
AB - Purpose: To compare mycophenolate mofetil (MMF) to methotrexate (MTX) as corticosteroid-sparing therapy for ocular inflammatory diseases. Design: Retrospective analysis of cohort study data. Methods: Participants were identified from the Systemic Immunosuppressive Therapy for Eye Diseases Cohort Study. Demographic and clinical characteristics were obtained via medical record review. The study included 352 patients who were taking single-agent immunosuppression with MTX or MMF at 4 tertiary uveitis clinics. Marginal structural models (MSM)-derived statistical weighting created a virtual population with covariates and censoring patterns balanced across alternative treatments. With this methodological approach, the results estimate what would have happened had none of the patients stopped their treatment. Survival analysis with stabilized MSM-derived weights simulated a clinical trial comparing MMF vs MTX for noninfectious inflammatory eye disorders. The primary outcome was complete control of inflammation on prednisone ≤10 mg/day, sustained for ≥30 days. Results: The time to success was shorter (more favorable) for MMF than MTX (hazard ratio = 0.68, 95% confidence interval: 0.46-0.99). Adjusting for covariates, the proportion achieving success was higher at every point in time for MMF than MTX from 2 to 8 months, then converges at 9 months. The onset of corticosteroid-sparing success took more than 3 months for most patients in both groups. Outcomes of treatment (MMF vs MTX) were similar across all anatomic sites of inflammation. The incidence of stopping therapy for toxicity was similar in both groups. Conclusions: Our results suggest that, on average, MMF may be faster than MTX in achieving corticosteroid-sparing success in ocular inflammatory diseases.
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U2 - 10.1016/j.ajo.2019.07.008
DO - 10.1016/j.ajo.2019.07.008
M3 - Article
C2 - 31344346
AN - SCOPUS:85070894655
SN - 0002-9394
VL - 208
SP - 68
EP - 75
JO - American journal of ophthalmology
JF - American journal of ophthalmology
ER -