Abstract

BackgroundPatients with multiple sclerosis (MS) often receive disease-modifying therapies (DMTs) that can expose them to reactivation of potential occult hepatitis B virus (HBV) infection (pOBI). We aimed to evaluate the MS Centers behavior regarding HBV screening and prophylaxis in a large cohort of MS patients receiving anti-CD20 or cladribine.MethodsRetrospective, multicentric study recruiting Italian MS patients treated with rituximab, ocrelizumab and cladribine.ResultsWe included 931 MS patients from 15 centers. All but 38 patients performed a complete HBV screening. Patients’ age > 50 years was significantly associated with no history of vaccination and HBsAb titres < 100 mIU at baseline (p < 0.001). No significant correlation was found between post-vaccination HBsAb titres and type of treatment (p = 0.5), pre-or post-therapy vaccination (p = 0.2) and number of previous DMTs (p = 0.2). Among pOBI patients (n = 53), 21 received antiviral prophylaxis, while only 13 had HBV DNA monitoring and 19 patients neither monitored HBV DNA nor received prophylaxis.ConclusionsBaseline HBV screening in patients receiving anti-CD20 and cladribine is a consolidated practice. Nonetheless, HBV vaccination coverage is still lacking in such population and age is a significant factor associated with low HBV protection. Rituximab, ocrelizumab and cladribine did not impair HBV vaccine response. Almost 35% of pOBI patients fail to receive HBVr prevention. Management of HBV prophylaxis could be improved in MS patients and further prospective studies are needed to assess the effectiveness of prophylactic strategies in such patients.

Highlights

  • Patients with multiple sclerosis (MS) often receive disease-modifying therapies (DMTs) that can expose them to reactivation of potential occult hepatitis B virus (HBV) infection

  • We aimed to evaluate in a population of patients with MS and receiving ocrelizumab, rituximab or cladribine the following variables: (i) the proportion of MS patients who received complete HBV serological screening before commencing on ocrelizumab, rituximab or cladribine, defined as the availability in the clinical records of HBsAg, HBcAbIgG and HBsAb before starting the DMT; (ii) the proportion of patients vaccinated for HBV before starting DMT therapy; (iii) the difference in pre- and post-vaccination HBsAb titers and its association with timing of vaccination, therapeutic history and age; (iv) choice of HBV reactivation prevention strategy in pOBIs and its association with baseline HBsAb titers

  • We showed that patients affected by MS treated with B cells depleting DMTs are very likely to receive complete HBV screening before commencing treatment in clinical practice

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Summary

Introduction

Patients with multiple sclerosis (MS) often receive disease-modifying therapies (DMTs) that can expose them to reactivation of potential occult hepatitis B virus (HBV) infection (pOBI). We aimed to evaluate the MS Centers behavior regarding HBV screening and prophylaxis in a large cohort of MS patients receiving anti-CD20 or cladribine. Methods Retrospective, multicentric study recruiting Italian MS patients treated with rituximab, ocrelizumab and cladribine. Conclusions Baseline HBV screening in patients receiving anti-CD20 and cladribine is a consolidated practice. Ocrelizumab and cladribine did not impair HBV vaccine response. Disease-modifying therapies (DMTs) for MS have an immunomodulatory effect, reducing inflammation without depleting lymphocytes, or an immunosuppressive effect, as it occurs with preferential B-cells depleting nucleoside analogs (cladribine) or selective B-cell depleting monoclonal antibodies (rituximab, ocrelizumab) [3]. Occult HBV infection (OBI) is defined as the presence of HBV DNA in the liver—with or without detectable serum HBV DNA—in the absence of

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