Journal of Clinical Case Reports

Eligibility Criteria to Natalizumab Therapy in Patients with Relapsingremitting Multiple Sclerosis: A Real-life Study in an Italian Population-based Cohort

Abstract

Franco Granella, Eleonora Baldi, Sara Montepietra, Caterina Senesi, Luisa Motti, Maria Rosaria Tola and Paolo Immovilli

Background: Many patients with relapsing-remitting MS (RRMS) show a suboptimal response to first-line disease-modifying drugs. In these patients treatment with natalizumab is highly effective, however its use has been limited due to safety concerns. Objective: To evaluate the consistency between the eligibility to natalizumab according to Italian Drug Agency (AIFA), European Medicines Agency (EMA) and Food and Drug Administration (FDA) criteria, and its use in clinical practice. Methods: Medical records of 402 patients from four Italian MS Centres were reviewed to identify patients eligible to natalizumab according to AIFA, EMA, and FDA criteria and verify how many of them were currently treated or had been previously treated in practice. Results: Of 316 RRMS patients, 13.3% were currently or had been previously treated with natalizumab, while additional 7.0%, 14.2%, and 27.2% were not receiving the drug although they were eligible according to AIFA, EMA, and FDA criteria, respectively. Compared to patients treated with natalizumab, subject who were eligible but remained untreated were older and with shorter education. Conclusion: In a cohort of RRMS patients, 20.3%, 27.5%, and 40.5% were eligible to natalizumab according to AIFA, EMA, and FDA, respectively, although only part of them were actually treated.