Real-world evidence from Türkiye on cancer risk and treatment exposure in multiple sclerosis: A histopathology-verified, registry-based study.
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BACKGROUND: Multiple sclerosis (MS) is a chronic, immune-mediated neurological disease with potential malignancy risks linked to disease-modifying therapies (DMTs) or immunosuppressants. This study aims to evaluate the epidemiology of malignancies in MS patients across T..rkiye and examine the impact of DMT/Immunosuppressant exposure on cancer risk. METHODS: The study used the Turkish Ministry of Health's electronic database to identify 82,025 MS patients through ICD-10 codes. Inclusion required ≥3 MS diagnoses or one MS diagnosis with at least one MS-specific DMT or immunosuppressants prescription which can be used for MS treatments (interferons, glatiramer acetate, fingolimod, natalizumab, ocrelizumab, alemtuzumab, dimethyl fumarate, teriflunomide, azathioprine, cyclophosphamide, methotrexate, mitoxantrone, mycophenolic acid, and rituximab). Malignancies were classified based on histopathological confirmation, using ICD-O codes in pathology reports. Systemic distributions of cancers in MS patients were analyzed by sex and compared with age-adjusted cancer incidence rates from the general population, as reported in the Turkish Ministry of Health database. We also compared cancer rates in patients exposed to a specific treatment with those observed in patients not exposed to that drug. RESULTS: Of the 82,025 patients with MS, 68.3 % were females and 31.7 % males, with an average diagnosis age of 34.8 ± 13.0 years. Among them, 1212 developed cancers, with females accounting for 73.5 % of the cases. Breast cancer was most common in females (29.2 %), while males primarily developed cancers of the respiratory, gastrointestinal, and urinary systems. The age-adjusted incidence rates of skin, female genital, breast, thyroid, and overall cancers in MS patients were similar to those reported in the general population. Notably, azathioprine use was linked to a significantly higher cancer risk (OR: 1.24, 95 % CI: 1.01-1.51, p = 0.032), whereas treatments like cladribine, dimethyl fumarate, and B-cell therapies showed a lower cancer incidence. CONCLUSIONS: This study demonstrated that Multiple sclerosis does not appear to increase the risk of cancer compared to the general population and none of the MS treatments, except for azathioprine, were associated with an increased risk of cancer.