Risk of disease relapse, safety and tolerability of SARS‐CoV‐2 vaccination in patients with chronic inflammatory neuropathies

Author:

Doneddu Pietro Emiliano12ORCID,Briani Chiara3ORCID,Cocito Dario4ORCID,Manganelli Fiore5ORCID,Fabrizi Gian Maria6,Matà Sabrina7,Mazzeo Anna8,Fazio Raffaella9,Benedetti Luana10ORCID,Luigetti Marco1112ORCID,Inghilleri Maurizio13,Ruiu Elisa14,Siciliano Gabriele15,Cosentino Giuseppe1617,Marfia Girolama Alessandra18,Carpo Marinella19,Filosto Massimiliano20ORCID,Antonini Giovanni21,Notturno Francesca22,Sotgiu Stefano23,Cucurachi Laura24,Dell'Aquila Claudia25,Bianchi Elisa26,Rosso Tiziana27,Giordano Andrea1,Fernandes Marco1,Campagnolo Marta3,Peci Erdita4,Spina Emanuele5,Tagliapietra Matteo6ORCID,Sperti Martina7,Gentile Luca8,Strano Camilla9,Germano Francesco10,Romozzi Marina1112ORCID,Moret Federica13,Zarbo Ignazio Roberto1428,Viola Divina Valeria15,Vegezzi Elisa16ORCID,Mataluni Giorgia18,Cotti‐Piccinelli Stefano20,Leonardi Luca21ORCID,Carta Alessandra23,Nobile‐Orazio Eduardo129ORCID,

Affiliation:

1. Neuromuscular and Neuroimmunology Unit IRCCS Humanitas Research Hospital Rozzano, Milan Italy

2. Department of Biomedical Sciences Humanitas University Pieve Emanuele, Milan Italy

3. Neurology Unit, Department of Neuroscience University of Padova Padova Italy

4. SSD Patologie Neurologiche Specialistiche AOU San Luigi Torino Italy

5. Department of Neuroscience, Reproductive Sciences and Odontostomatology University of Naples 'Federico II' Naples Italy

6. Department of Neuroscience, UOC Neurology B University Hospital GB Rossi, AOUI and University of Verona Verona Italy

7. Department of Neurological and Psychiatric Sciences Azienda Ospedaliero‐Universitaria di Careggi Florence Italy

8. Unit of Neurology, Department of Clinical and Experimental Medicine University of Messina Messina Italy

9. Division of Neuroscience, Department of Neurology Institute of Experimental Neurology (INSPE), San Raffaele Scientific Institute Milan Italy

10. IRCCS Ospedale Policlinico San Martino Genoa Italy

11. Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Neurologia Rome Italy

12. Università Cattolica del Sacro Cuore, Sede di Roma Rome Italy

13. Department of Human Neurosciences Sapienza University of Rome Rome Italy

14. Neurology Unit Azienda Ospedaliera Universitaria di Sassari Sassari Italy

15. Neurology Unit, Department of Clinical and Experimental Medicine University of Pisa Pisa Italy

16. IRCCS Mondino Foundation Pavia Italy

17. Department of Brain and Behavioral Sciences University of Pavia Pavia Italy

18. Dysimmune Neuropathies Unit, Department of Systems Medicine Tor Vergata University of Rome Rome Italy

19. ASST Bergamo Ovest‐Ospedale Treviglio Treviglio Italy

20. Department of Clinical and Experimental Sciences NeMO‐Brescia Clinical Center for Neuromuscular Diseases, University of Brescia Brescia Italy

21. Unit of Neurophysiopathology, Department of Neurology Mental Health and Sensory Organs (NESMOS), Faculty of Medicine and Psychology 'Sapienza' University of Rome, Sant'Andrea Hospital Rome Italy

22. Unit of Neurology ‘Floraspe Renzetti’ Hospital Lanciano Italy

23. Child Neuropsychiatry Division, Department of Medical, Surgical and Experimental Sciences University of Sassari Sassari Italy

24. U.O Neurologia, Ospedale "S. Chiara" Trento Italy

25. Neurology Unit Di Venere Hospital Bari Italy

26. Laboratorio di Malattie Neurologiche Istituto di Ricerche Farmacologiche Mario Negri IRCCS Milan Italy

27. UOC di Neurologia Ospedale San Bassiano Bassano del Grappa, Vicenza Italy

28. Department of Medicine, Surgery and Pharmacy University of Sassari Sassari Italy

29. Department of Medical Biotechnology and Translational Medicine Milan University Milan Italy

Abstract

AbstractBackground and purposeThe aim was to evaluate the risk of relapse after severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) vaccination, and its safety and tolerability, in patients with chronic inflammatory neuropathies.MethodsIn this multicenter, cohort and case‐crossover study, the risk of relapse associated with SARS‐CoV‐2 vaccination was assessed by comparing the frequency of relapse in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN) patients who underwent or did not undergo vaccination. Frequency of relapse in the 3 months prior to and after vaccination, and safety and tolerability of SARS‐CoV‐2 vaccination, were also assessed.ResultsIn all, 336 patients were included (278 CIDP, 58 MMN). Three hundred and seven (91%) patients underwent SARS‐CoV‐2 vaccination. Twenty‐nine patients (9%) did not undergo vaccination. Mild and transient relapses were observed in 16 (5%) patients (13 CIDP, 3 MMN) after SARS‐CoV‐2 vaccination and in none of the patients who did not undergo vaccination (relative risk [RR] 3.21, 95% confidence interval [CI] 0.19–52.25). There was no increase in the specific risk of relapse associated with type of vaccine or diagnosis. Comparison with the 3‐month control period preceding vaccination revealed an increased risk of relapse after vaccination (RR 4.00, 95% CI 1.35–11.82), which was restricted to CIDP patients (RR 3.25, 95% CI 1.07–9.84). The safety profile of SARS‐CoV‐2 vaccination was characterized by short‐term, mild‐to‐moderate local and systemic adverse events.ConclusionsSevere acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) vaccination in CIDP and MMN patients does not seem to be associated with an increased risk of relapse at the primary end‐point, although a slightly increased risk in CIDP patients was found compared to the 3 months before vaccination.

Funder

CSL Behring

GBS/CIDP Foundation International

Regione Lombardia

Publisher

Wiley

Subject

Neurology (clinical),Neurology

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