Expert Opinion on COVID-19 Vaccination and the Use of Cladribine Tablets in Clinical Practice (preprint)

ABSTRACT

BackgroundGaps in current evidence and guidance leave clinicians with unanswered questions on the use of cladribine tablets for the treatment of multiple sclerosis (MS) in theera of the COVID-19 pandemic, in particular relating to COVID-19 vaccination. ObjectiveWe describe a consensus-based programme led by international MS experts with the aim of supplementing current guidelines and treatment labels by providing timely recommendations relating to COVID-19 vaccination and the use of cladribine tablets inclinical practice. MethodsA steering committee (SC) of 10 international MS experts identified 7 clinical questions to answer concerning the use of cladribine tablets and COVID-19 vaccination, which addressed issues relating to patient selection, timing and efficacy, and safety. Clinicalrecommendations to address each question were drafted using available evidence combined with expert opinion from the SC. An extended faculty of 28 MS experts, representing 19 countries, in addition to the SC members, voted on the recommendations. Consensus on recommendations was achieved when [≥]75% of respondents expressed an agreement score of 7-9, on a 9-point scale. ResultsConsensus was achieved on all 13 recommendations. Clinical recommendations are provided on whether all patients with MS receiving cladribine tablets should be vaccinated against COVID-19, and whether they should be prioritized; the timing of vaccination arounddosing of cladribine tablets (i.e., before and after a treatment course); and the safety of COVID-19 vaccination for these patients. ConclusionsThese expert recommendations provide timely guidance on COVID-19 vaccination in patients receiving cladribine tablets, which is relevant to everyday clinicalpractice.