Outcomes after fingolimod to alemtuzumab treatment shift in relapsing–remitting MS patients: a multicentre cohort study
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A high reactivation of multiple sclerosis (MS) was reported in patients treated with alemtuzumab after fingolimod. We aimed to understand whether this shift enhanced the risk for reactivation in a real-life cohort.
Subjects with relapsing MS, shifting from fingolimod to alemtuzumab were enrolled. We collected the following data: age, sex, disease duration, relapses after fingolimod withdrawal, new T2/gadolinium (Gd)-enhancing lesions in the last magnetic resonance imaging (MRI) during fingolimod and in the first, while on alemtuzumab, lymphocyte counts at alemtuzumab start, and Expanded Disability Status Scale (EDSS) before and after alemtuzumab.
We enrolled 77 patients (women 61 (79%); mean age 36.2 years (SD 9.6), and disease duration 12.3 years (SD 6.8) at fingolimod discontinuation; median washout 1.8 months). The annualised relapse rate was 0.89 during fingolimod, 1.32 during washout, and 0.15 after alemtuzumab (p = 0.001). The EDSS changed from a median of 3 (IQR 2–4) at the end of fingolimod to 2.5 after alemtuzumab (IQR 1.5–4) (p = 0.013). The washout length and the lymphocyte count before alemtuzumab were not associated with EDSS change after alemtuzumab (p = 0.59 and p = 0.33, respectively). MRI activity decreased after alemtuzumab compared to that during fingolimod (p = 0.001). At alemtuzumab start, lymphocyte counts were < 0.8 × 103/mL in 21 patients.
In our cohort, alemtuzumab reduced relapse, new T2/Gd-enhancing lesions, and EDSS score, as compared to the previous periods (fingolimod/washout). These results were not related to washout length or lymphocyte counts. Therefore, a rapid initiation of alemtuzumab after fingolimod does not seem to be a risk factor for MS reactivation.
KeywordsFingolimod Alemtuzumab Real life NEDA
This research did not receive any specific Grant from funding agencies in the public, commercial, or not-for-profit sectors.
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Conflicts of interest
Frau J: serves on scientific advisory boards for Biogen and Genzyme, and has received honoraria as a speaker from Merck Serono, Genzyme, Biogen and Teva. Saccà F: received personal compensations for participating in advisory boards and public speaking, or travel grants from Almirall, Biogen Idec, Forward Pharma, Merk Serono, Novartis, Pomona, Roche, Sanofi Genzyme, and Teva. Signori A: has nothing to disclose. Baroncini D: received travel grants from Genzyme, Merck and Biogen for participation in national and international congresses; he received speaking honoraria from Sanofi and Novartis, and personal compensation from Almirall for scientific publication. Fenu G: has received honoraria for consultancy from Novartis and Biogen, and as a speaker from Merck Serono and Teva. Annovazzi P: received honoraria for lecturing and participation in advisory boards, and/or travel expenses for attending congresses and meetings from Merck, Biogen, Teva, Sanofi-Genzyme, Mylan, Almirall, Roche, and Novartis. Capobianco M: received personal compensation for speaking honoraria or participating in advisory boards from: Almirall, Biogen, Merck, Novartis, Roche, Sanofi, and Teva. Signoriello E: received travel funding and speaker honoraria from Biogen, Novartis, Sanofi Genzyme, Bayer, and Teva. Laroni A: received personal compensation from Novartis, Genzyme, Biogen, Merck and TEVA for public speaking and/or advisory boards. La Gioia S: received grants from Novartis. Sartori A: received funding for travel and/or speaker honoraria from Novartis, Teva, Merk, Genzyme, Almirall, and Roche. Maniscalco GT: has served on advisory boards and/or received travel grants and speaker honoraria from Almirall, Biogen, Merck Serono, Novartis and Teva. Bonavita S: received speaker honoraria and advisory board fee from Teva, Genzyme, Biogen, Merck Serono, Novartis, Roche, and Almirall. Clerico M: received personal compensations for participating in advisory boards, public speaking, editorial commitments or travel grants from Biogen Idec, Merck Serono, Fondazione Serono, Novartis, Pomona, Sanofi-Genzyme, and Teva. Russo CV: participated in scientific advisory boards for Merk Serono and Sanofi Genzyme. Gallo A: received travel grants and consulting fees from Biogen, Merck Serono, Roche, Sanofi-Genzyme, and Teva. Lapucci C: has received travel funds from Roche. Carotenuto A: received unrestricted grant from Almirall. Sormani MP: received consulting fees from TEVA, Biogen, Merck, Sanofi Genzyme, Roche, GeNeuro, Novartis, Medday, Actelion, and Celgene. Cocco E: has received honoraria for consultancy or speaking from Bayer, Biogen, Novartis, Sanofi, Genzyme, Merck, and Teva.