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Outcomes after fingolimod to alemtuzumab treatment shift in relapsing-remitting MS patients: a multicentre cohort study.
J Neurol. 2019 Oct; 266(10):2440-2446.JN

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

Authors+Show Affiliations

Department of Medical Sciences and Public Health, Multiple Sclerosis Centre, University of Cagliari-ATS Sardegna, Via Is Guadazzonis 2, 09126, Cagliari, Italy. jessicafrauneuro@gmail.com.NSRO Department Federico II University, Naples, Italy.Section of Biostatistics, Department of Health Sciences, University of Genoa, Genoa, Italy.Multiple Sclerosis Centre, ASST Valle-Olona, Gallarate Hospital, Gallarate, VA, Italy.Department of Medical Sciences and Public Health, Multiple Sclerosis Centre, University of Cagliari-ATS Sardegna, Via Is Guadazzonis 2, 09126, Cagliari, Italy.Multiple Sclerosis Centre, ASST Valle-Olona, Gallarate Hospital, Gallarate, VA, Italy.SCDO Neurologia-Centro di Riferimento Regionale Sclerosi Multipla, AOU San Luigi Gonzaga, Orbassano, TO, Italy.Multiple Sclerosis Centre Second Division of Neurology, University of Campania Luigi Vanvitelli, Naples, Italy.Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genova, Genoa, Italy. IRCCS Ospedale Policlinico San Martino, Genoa, Italy.ASST Papa Giovanni XXIII, Bergamo, Italy.AOU Ospedali Riuniti di Trieste, Trieste, Italy.Neurology and Stroke Unit, A. Cardarelli Hospital, Naples, Italy.Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.Clinical and Biological Sciences Department, AOU San Luigi Gonzaga University of Turin, Turin, Italy.NSRO Department Federico II University, Naples, Italy.Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genova, Genoa, Italy. IRCCS Ospedale Policlinico San Martino, Genoa, Italy.NSRO Department Federico II University, Naples, Italy.Section of Biostatistics, Department of Health Sciences, University of Genoa, Genoa, Italy.Department of Medical Sciences and Public Health, Multiple Sclerosis Centre, University of Cagliari-ATS Sardegna, Via Is Guadazzonis 2, 09126, Cagliari, Italy.No affiliation info available

Pub Type(s)

Journal Article
Multicenter Study

Language

eng

PubMed ID

31209573

Citation

Frau, Jessica, et al. "Outcomes After Fingolimod to Alemtuzumab Treatment Shift in Relapsing-remitting MS Patients: a Multicentre Cohort Study." Journal of Neurology, vol. 266, no. 10, 2019, pp. 2440-2446.
Frau J, Saccà F, Signori A, et al. Outcomes after fingolimod to alemtuzumab treatment shift in relapsing-remitting MS patients: a multicentre cohort study. J Neurol. 2019;266(10):2440-2446.
Frau, J., Saccà, F., Signori, A., Baroncini, D., Fenu, G., Annovazzi, P., Capobianco, M., Signoriello, E., Laroni, A., La Gioia, S., Sartori, A., Maniscalco, G. T., Bonavita, S., Clerico, M., Russo, C. V., Gallo, A., Lapucci, C., Carotenuto, A., Sormani, M. P., & Cocco, E. (2019). Outcomes after fingolimod to alemtuzumab treatment shift in relapsing-remitting MS patients: a multicentre cohort study. Journal of Neurology, 266(10), 2440-2446. https://doi.org/10.1007/s00415-019-09424-8
Frau J, et al. Outcomes After Fingolimod to Alemtuzumab Treatment Shift in Relapsing-remitting MS Patients: a Multicentre Cohort Study. J Neurol. 2019;266(10):2440-2446. PubMed PMID: 31209573.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Outcomes after fingolimod to alemtuzumab treatment shift in relapsing-remitting MS patients: a multicentre cohort study. AU - Frau,Jessica, AU - Saccà,Francesco, AU - Signori,Alessio, AU - Baroncini,Damiano, AU - Fenu,Giuseppe, AU - Annovazzi,Pietro, AU - Capobianco,Marco, AU - Signoriello,Elisabetta, AU - Laroni,Alice, AU - La Gioia,Sara, AU - Sartori,Arianna, AU - Maniscalco,Giorgia Teresa, AU - Bonavita,Simona, AU - Clerico,Marinella, AU - Russo,Cinzia Valeria, AU - Gallo,Antonio, AU - Lapucci,Caterina, AU - Carotenuto,Antonio, AU - Sormani,Maria Pia, AU - Cocco,Eleonora, AU - ,, Y1 - 2019/06/17/ PY - 2019/04/29/received PY - 2019/06/06/accepted PY - 2019/06/04/revised PY - 2019/6/19/pubmed PY - 2020/2/26/medline PY - 2019/6/19/entrez KW - Alemtuzumab KW - Fingolimod KW - NEDA KW - Real life SP - 2440 EP - 2446 JF - Journal of neurology JO - J. Neurol. VL - 266 IS - 10 N2 - BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. SN - 1432-1459 UR - https://www.unboundmedicine.com/medline/citation/31209573/Outcomes_after_fingolimod_to_alemtuzumab_treatment_shift_in_relapsing_remitting_MS_patients:_a_multicentre_cohort_study_ L2 - https://dx.doi.org/10.1007/s00415-019-09424-8 DB - PRIME DP - Unbound Medicine ER -