Elisabetta Signoriello1, Giacomo Lus1, Simona Bonavita1, Roberta Lanzillo2, Francesco Saccà2, Doriana Landi3, Jessica Frau4, Damiano Baroncini5, Mauro Zaffaroni5, Giorgia Teresa Maniscalco6, Erica Curti7, Arianna Sartori8, Simone Cepparulo1, Girolama Alessandra Marfia3, Carolina Gabri Nicoletti3, Antonio Carotenuto2, Viviana Nociti9, Francesca Caleri10, Maria Pia Sormani11, Alessio Signori11. 1. Multiple Sclerosis Center, Second Division of Neurology, Department of Advanced Medical and Surgical Sciences, University of Campania 'Luigi Vanvitelli', Naples, Italy. 2. Department of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University, Naples, Italy. 3. Multiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, Tor Vergata University, Rome, Italy. 4. Centro Sclerosi Multipla, ASSL Cagliari (ATS Sardegna)/Dipartimento di Scienze Mediche e Sanità Pubblica, University of Cagliari, Cagliari, Italy. 5. Multiple Sclerosis Center, ASST della Valle Olona, Hospital of Gallarate, Gallarate, Italy. 6. Multiple Sclerosis Center, 'A. Cardarelli' Hospital, Naples, Italy. 7. Multiple Sclerosis Center, Neurology Unit, University Hospital of Parma, Parma, Italy. 8. Multiple Sclerosis Center, Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, ASUGI, University of Trieste, Trieste, Italy. 9. Multiple Sclerosis Center, Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, Rome, Italy. 10. Neurology Department, F. Tappeiner Hospital Meran (BZ), Meran, Italy. 11. Department of Health Sciences, University of Genova, Genova, Italy.
Abstract
OBJECTIVES: Switching between treatments is an opportunity for patients with multiple sclerosis (MS) to ameliorate disease control or safety. The aim of this study was to investigate the impact of switching from fingolimod (FTY) or natalizumab (NTZ) to ocrelizumab (OCR) on disease activity. METHODS: We retrospectively enrolled 165 patients treated with OCR from 11 MS centres. We assessed the association of demographic and clinical characteristics on relapse rate (RR) and activity on magnetic resonance imaging (MRI) during wash-out and after 6 months of treatment with OCR through univariable and multivariable negative binomial regression models. RESULTS: We registered a total of 35 relapses during the wash-out period. Previous treatment with FTY, relapses in the previous year, and relapsing-remitting course were associated with higher RR. In the first 6 months of OCR, 12 patients had clinical or MRI disease activity. Higher Expanded Disability Status Scale (EDSS) and higher lymphocyte count at OCR start were associated with a reduced probability of relapse. DISCUSSION AND CONCLUSION: This study confirms that withdrawal from sequestering agents as FTY increases the risk of relapses in the wash-out period. Nevertheless, starting OCR before achieving complete immune reconstitution could limit its effectiveness in the first 6 months probably because trapped lymphocytes escape the CD20-mediated depletion.
OBJECTIVES: Switching between treatments is an opportunity for patients with multiple sclerosis (MS) to ameliorate disease control or safety. The aim of this study was to investigate the impact of switching from fingolimod (FTY) or natalizumab (NTZ) to ocrelizumab (OCR) on disease activity. METHODS: We retrospectively enrolled 165 patients treated with OCR from 11 MS centres. We assessed the association of demographic and clinical characteristics on relapse rate (RR) and activity on magnetic resonance imaging (MRI) during wash-out and after 6 months of treatment with OCR through univariable and multivariable negative binomial regression models. RESULTS: We registered a total of 35 relapses during the wash-out period. Previous treatment with FTY, relapses in the previous year, and relapsing-remitting course were associated with higher RR. In the first 6 months of OCR, 12 patients had clinical or MRI disease activity. Higher Expanded Disability Status Scale (EDSS) and higher lymphocyte count at OCR start were associated with a reduced probability of relapse. DISCUSSION AND CONCLUSION: This study confirms that withdrawal from sequestering agents as FTY increases the risk of relapses in the wash-out period. Nevertheless, starting OCR before achieving complete immune reconstitution could limit its effectiveness in the first 6 months probably because trapped lymphocytes escape the CD20-mediated depletion.