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News — Relatively short-term use of immunosuppressant medications to control an inflammatory disease was not associated with an increased risk of later developing cancer, according to new research led by scientists at the and , a member of the health care system, and published today in the journal .

The findings should provide reassurance to patients and clinicians who may hesitate to prescribe the medications because they are known to increase the risk of cancer in people who take them over many years or a lifetime to prevent dire consequences, such as organ rejection in transplant recipients.

“When we got these results, I was reassured, and I hope patients will be, too,” said lead author Jeanine Buchanich, Ph.D., associate dean for and associate professor of at . “Immunosuppressants are widely used and transformative for care of patients with inflammatory diseases, but the potential concern that they carry a cancer risk has forced people to make difficult decisions without enough information. Alleviating that concern with use for inflammatory diseases will help people make the treatment decision that’s right for them.”

The  new findings were from the Systemic Immunosuppressive Therapy for Eye Diseases (SITE) Cohort, which began two decades ago when principal investigator , senior scientist and director of epidemiology for ophthalmology at Mass Eye and Ear and professor of ophthalmology at , approached Buchanich, who directs , to partner in evaluating cancer risk for people with non-infectious ocular inflammatory diseases taking immunosuppressants. These eye diseases are caused by immune dysfunction and do not themselves cause cancer but can be very serious, with blindness as a possible outcome.

The diseases are commonly treated with immunosuppressive medications, which patients generally take for several months to several years.

This new research adds evidence to the limited cancer risk associated with immunosuppressant treatments uncovered by the SITE study consortium. In a study published last month in , the researchers found no increased risk in cancer-related and overall mortality in individuals taking commonly used immunosuppressants. The study included 15,938 SITE participants who were tracked for an average of 10 years.

The BMJ Oncology study included 10,872 participants, ultimately encompassing 84% of the enrolled SITE participants who lived in one of the 12 states from which the research team obtained data linking participants to each state’s cancer registries. Though most states track cancer incidence, there is no centralized federal cancer registry, and different states require different permissions and use different interfaces to share data. For this reason, it is difficult to do large-scale epidemiological cancer studies in the U.S., making this study incorporating years of data from multiple states a rarity.

The research team tracked each participant for an average of 10 years after they took immunosuppressant medications, or for a similar amount of time for those not taking immunosuppression, to see if they ever developed cancer. Four different categories of immunosuppressants – TNF-inhibitors, antimetabolites, alkylating agents and calcineurin inhibitors – were covered by the study, with some patients taking more than one type. Patients were on the medications for a median of one year.

Across all four classes of immunosuppressant medications the scientists found no evidence of excess risk of cancer in patients who took them on a short-term basis, regardless of medication dose.

While the study only looked at people with noninfectious eye diseases and the researchers caution that the results aren’t generalizable to everyone taking immunosuppressants, the results probably are generalizable to patients with inflammatory diseases, Kempen said.

“The patients in our study actually tended to have a lower incidence of cancer than non-immunosuppressed patients, suggesting that an increased risk of overall cancer from commonly used immunosuppressants given for the short- to medium-term is very unlikely,” said Kempen. “This result is foundational for a large number of patients with inflammatory eye conditions and a broad range of patients with other inflammatory diseases.”

Additional researchers on this study are Craig Newcomb, M.S., Nirali Bhatt, M.D., Tonetta Fitzgerald, Ebenezer Daniel, Ph.D., and Naira Khachatryan, M.D., Dr.P.H., all of the University of Pennsylvania (Penn); Terri Washington, of Pitt; C. Stephen Foster, M.D., of the Massachusetts Eye Research and Surgery Institution (MERSI) and Harvard Medical School; Lucia Sobrin, M.D., of Mass Eye and Ear and Harvard Medical School; Jennifer Thorne, M.D., Ph.D., Douglas Jabs, M.D., M.B.A., Kurt Dreger, Hosne Begum and Kathy Helzlsouer, M.D., all of Johns Hopkins University; Eric Suhler, M.D., M.P.H., James Rosenbaum, M.D., and Teresa Liesegang, all of the Oregon Health & Science University; H. Nida Sen, M.D., of George Washington University; Grace Levy-Clarke, M.D., of West Virginia University; the late Robert Nussenblatt, M.D., of the National Eye Institute; Careen Lowder, M.D., Ph.D., of the Cleveland Clinic; Debra Goldstein, M.D., of Northwestern University; Yannek Leiderman, M.D., Ph.D., of the University of Illinois, Chicago; Nisha Acharya, M.D., of the University of California San Francisco; Gary Holland, M.D., of the University of California Los Angeles; Russel Read, M.D., Ph.D., of the University of Alabama at Birmingham; James Dunn, M.D., of the Wills Eye Hospital; Pichaporn Artornsombudh, M.D., of Somdech Phra Pinkloa Hospital, Thailand; Srishti Kothari, of Penn and MERSI; Abhishek Payal, M.D., of Mahatme EyeBank Eye Hospital, India; Sapna Gangaputra, M.D., of Vanderbilt University Medical Center; R. Oktay Kacmaz, M.D., of Santen Pharmaceutical Co Ltd; Siddharth Pujari, M.D., of Siddharth Netralaya Superspecialty Eye Hospital, India; Armin Maghsoudlou, M.D., of Northwell Health; Hilkiah Suga, M.D., Myungsung Christian Medical Center (MCM), Ethiopia; and Clara Pak, of MCM and University of Rochester.

This research was supported by (NIH) grants R01 EY14943 and R21 EY02617, NIH University of Pennsylvania Core Grant for Vision Research 2P30EYEY001583, the , and .

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