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 the era of the COVID-19 pandemic, in particular relating to COVID-19 vaccination. ObjectiveWe describe a consensus-based program 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 in clinical practice. MethodsA steering committee (SC) of 10 international MS experts identified seven 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. Clinical recommendations 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 10 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 around dosing 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 clinical practice.
ABSTRACT
We have previously demonstrated a distortion of self-reactive IgG antibody repertoires in patients with multiple sclerosis (MS) compared to controls, by immunoblotting assays, using human brain homogenates. The analysis of the immune profiles against human brain antigens allowed us to distinguish MS patients, and to associate a particular pattern of reactivity for each clinical form of MS. The aim of the present study was to evaluate the evolution of such patterns in patients with relapsing-remitting MS (RRMS). In a first step, we confirmed, by western blotting using human brains as source of antigens, the existence of specific repertoires of IgG reactivity in whole serum collected from healthy subjects (n = 32) and from untreated patients with RRMS (n = 56). In a second step, the evaluation of patterns was performed at baseline and 1 year later in untreated RRMS patients (n = 15), and in RRMS patients treated with IFN-beta (n = 41). In both groups, little change in IgG reactivity in whole serum was found. However, a higher degree of stability was noted in treated versus untreated patients (P < 0.01). Our results have showed a specific and relatively stable pattern of reactivity for each RRMS individual tested against brain antigens even after a 1-year treatment prevailing in treated patients suggesting that IFN-beta could stabilize IgG antibody repertoires.
