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

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.

Longitudinal humoral response in MS patients treated with cladribine tablets after receiving the second and third doses of SARS-CoV-2 mRNA vaccine

“…Of note is that it is still unclear what is cutoff IgG level that would provide protection against infection or from severe COVID-19 disease course ( Islamoglu et al, 2021 ). In addition, the cross-sectional natures of the vaccine response studies to date do not reach consensus about the best timing of vaccines and effects of boosters or third doses to maximize humoral and cellular responses ( Rieckmann et al, 2021 ).…”

Multiple sclerosis in the era of COVID-19: disease course, DMTs and SARS-CoV2 vaccinations

“…Although still debated, vaccine responses in pwMS treated with cladribine appeared preserved regardless of timing of treatment and presence of lymphopenia [68,69].…”