Abstract: Background: Rebound of multiple sclerosis (MS) activity has been described after the withdrawal of high-efficacy drugs, but its impact during pregnancy is less known. We describe a series of cases of rebound syndrome after the cessation of fingolimod due to pregnancy planning.
Methods: The clinical and radiological data of 7 MS patients who discontinued fingolimod therapy between May 2012 and March 2018 to plan a pregnancy was analysed.
Results: Three (42.8%) of the 7 patients experienced a rebound effect, all of whom became pregnant. During pregnancy, the 3 patients had a mean (SD) of 5.3 (1.3) relapses, and 13 of the 15 relapses were treated with intravenous steroids and/or immunoglobulin. These patients experienced a median increase of 3 points in the Expanded Disability Status Scale (range, 2-4), as well as a median increase of 27 new gadolinium-enhancing lesions (range, 9-40) and 38 new T2 lesions in a post-partum MRI (range, 21-70). The 3 pregnancies resulted in the delivery of healthy babies. A strong correlation was found between the lymphocyte count at fingolimod onset and the annual relapse rate in the period without therapy (r= -0.84, p = 0.005). The time to first relapse was shorter in patients who had <300/μl lymphocytes at fingolimod onset (median time 46 vs 426 days, p = 0.010).
Conclusion: Rebound activity after fingolimod suspension represents a severe long-lasting inflammatory syndrome that may affect up to 40% of female MS patient who discontinue therapy due to pregnancy planning. Lymphopenia (<300/μl) in the first 3 months of fingolimod onset may predispose patients to suffer earlier and higher disease activity upon cessation.
Competing Interests: Declaration of Competing Interest Maria Sepúlveda received speaker honoraria from Novartis, Genzyme and Biogen and travel reimbursement from Genzyme and Biogen. Carmen Montejo, David Reyes, Eugenia Martinez-Hernandez, Helena Ariño and Nuria Baños declare no conflict of interest. Sara Llufriu received speaker honoraria from Biogen, Novartis, TEVA, Genzyme and Merck. Nuria Sola-Valls received compensation for consulting services and speaker honoraria from Genzyme-Sanofi, Biogen, Merck Serono and Bayer-Schering. Elena H. Martinez-Lapiscina received speaker honoraria from Biogen, Genzyme, Novartis and Roche. Irati Zubizarreta received compensation for consulting services from Bayer-Schering and received travel reimbursement from Genzyme, Biogen, Merck for national and international meetings over the last 3 years. Irene Pulido-Valdeolivas has received travel reimbursement from Roche and Genzyme-Sanofi for international and national meetings over the last 3 years; she holds a patent for an affordable eye tracking system to measure eye movement in neurologic diseases and holds stock options in Aura Innovative Robotics; she has received travel reimbursement from European Academy of Neurology and European Committee for Treatment and Research in Multiple Sclerosis. Albert Saiz received compensation for consulting services and speaker honoraria from Bayer-Schering, Merck-Serono, Biogen, Genzyme-Sanofi, TEVA, Novartis, and Roche. Yolanda Blanco has received speaker honoraria from Novartis, Roche, Genzyme-Sanofi and Biogen.
(Copyright © 2019 Elsevier B.V. All rights reserved.)
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