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Breakthrough SARS-CoV-2 infections in MS patients on disease modifying therapies
Irene Schiavetti; Cinzia Cordioli; Maria Laura Stromillo; Maria Teresa Ferro; Alice Laroni; Eleonora Cocco; Gaia Cola; Livia Pasquali; Maria Teresa Rilla; Elisabetta Signoriello; Rosa Iodice; Alessia Di Sapio; Roberta Lanzillo; Francesca Caleri; Pietro Annovazzi; Antonella Conte; Giuseppe Liberatore; Francesca Ruscica; Renato Docimo; Simona Bonavita; Monica Ulivelli; Paola Cavalla; Francesco Patti; Diana Ferraro; Marinella Clerico; Paolo Immovilli; Massimiliano Di Filippo; Marco Salvetti; Maria Pia Sormani; - the "Breakthrough infections in MS" study group.
Affiliation
  • Irene Schiavetti; Department of Health Sciences, Section of Biostatistics, University of Genova, Italy
  • Cinzia Cordioli; Centro Sclerosi Multipla ASST Spedali Civili di Brescia
  • Maria Laura Stromillo; Clinica Neurologica e Malattie Neurometaboliche, Universita degli Studi di Siena
  • Maria Teresa Ferro; Neuroimmunology, Center for Multiple Sclerosis, Cardiocerebrovascular Department, Neurological Unit, ASST Crema
  • Alice Laroni; IRCCS Ospedale Policlinico San Martino, Genova, Italy. Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, Universi
  • Eleonora Cocco; Centro Sclerosi Multipla Ospedale Binaghi Cagliari
  • Gaia Cola; Department of Systems Medicine, Multiple Sclerosis Clinical and Research Unit, Tor Vergata, University, Rome, Italy
  • Livia Pasquali; Department of Clinical and Experimental Medicine, Neurology Unit, University of Pisa, Italy
  • Maria Teresa Rilla; Department of Neurology, Imperia Hospital, Imperia, Italy
  • Elisabetta Signoriello; II Division of Neurology, University of Campania Luigi Vanvitelli
  • Rosa Iodice; Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples "Federico II", Naples, Italy
  • Alessia Di Sapio; Department of Neurology, Regina Montis Regalis Hospital, Mondovi, Italy
  • Roberta Lanzillo; Federico II University of Naples
  • Francesca Caleri; Department of Neurology, MS Center, F. Tappeiner Hospital Meran (BZ), Italy
  • Pietro Annovazzi; UOC Centro Sclerosi Multipla, ASST Valle-Olona, PO di Gallarate (VA)
  • Antonella Conte; Department of Human Neuroscience, Sapienza, University of Rome, Italy. IRCCS Neuromed, Pozzilli (IS), Italy
  • Giuseppe Liberatore; Neuromuscular and Neuroimmunology Unit, IRCCS Humanitas Research Hospital, Rozzano, Italy
  • Francesca Ruscica; U.O.C. Neurologia e Centro SM - Fondazione Istituto G. Giglio, Cefalu (Italy)
  • Renato Docimo; Multiple Sclerosis Center, Aversa Hospital "San Giuseppe Moscati", ASL Caserta, Aversa (Ce) Italy
  • Simona Bonavita; Dipartimento di Scienze Mediche e Chirurgiche avanzate, Universita della Campania Luigi Vanvitelli, Naples-Italy
  • Monica Ulivelli; Department of Medical Sciences, Surgery and Neurosciences, University of Siena
  • Paola Cavalla; Multiple Sclerosis Center and 1st Division of Neurology, Department of Neuroscience, City of Health and Science University Hospital of Turin, Italy
  • Francesco Patti; Department of Medical and Surgical Sciences and Advanced Technologies, GF Ingrassia, University of Catania, Catania, Italy.
  • Diana Ferraro; Department of Biomedical, Metabolic and Neurosciences, University of Modena and Reggio Emilia, Modena, Italy.
  • Marinella Clerico; Clinical and Biological Sciences Department, University of Torino
  • Paolo Immovilli; Guglielmo da Saliceto Hospital, Piacenza
  • Massimiliano Di Filippo; Department of Medicine and Surgery, Section of Neurology, University of Perugia, Perugia, Italy
  • Marco Salvetti; Department of Neuroscience, Mental Health and Sensory Organs, Sapienza University of Rome, Rome, Italy. IRCCS Neuromed, Pozzilli (IS), Italy
  • Maria Pia Sormani; Department of Health Sciences, Section of Biostatistics, University of Genova, Italy. IRCCS Ospedale Policlinico San Martino, Genova, Italy
  • - the "Breakthrough infections in MS" study group; -
Preprint in English | medRxiv | ID: ppmedrxiv-22269630
ABSTRACT
BackgroundPatients with Multiple Sclerosis (pwMS) treated with anti-CD20 or fingolimod showed a reduced humoral response to SARS-CoV-2 vaccines. In this study we aimed to monitor the risk of breakthrough SARS-CoV-2 infection in pwMS on different Disease Modifying Therapy (DMT). MethodsData on number of vaccinated patients and of patients with a breakthrough infection were retrospectively collected in 27 Italian MS centers. We estimated the rate of breakthrough infections and of infection requiring hospitalization per DMT. Findings19641 vaccinated pwMS were included in the database. After a median follow-up of 8 months, we observed 137 breakthrough infections. As compared to the other DMTs, the rate of breakthrough infections was significantly higher on ocrelizumab (0.57% vs 2.00%, RR=3.55,95%CI=2.74-4.58, p<0.001) and fingolimod (0.58% vs 1.62%, RR=2.65,95%CI=1.75-4.00, p<0.001), while there were no significant differences in any other DMT group. In the ocrelizumab group the hospitalization rate was 16.7% vs 19.4% in the pre-vaccination era (RR=0.86,p=0.74) and it was 3.9% in all the other DMT groups vs 11.9% in the pre-vaccination period (RR=0.33,p=0.02). InterpretationThe risk of breakthrough SARS-CoV-2 infections is higher in patients treated with ocrelizumab and fingolimod, and the rate of severe infections was significantly reduced in all the DMTs excluding ocrelizumab.
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Full text: Available Collection: Preprints Database: medRxiv Type of study: Cohort_studies / Experimental_studies / Prognostic study / Rct Language: English Year: 2022 Document type: Preprint
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Full text: Available Collection: Preprints Database: medRxiv Type of study: Cohort_studies / Experimental_studies / Prognostic study / Rct Language: English Year: 2022 Document type: Preprint