Management of hepatitis B virus prophylaxis in patients treated with disease-modifying therapies for multiple sclerosis: a multicentric Italian retrospective study.
Cladribine
Hepatitis B
Multiple sclerosis
Ocrelizumab
Rituximab
Vaccination
Journal
Journal of neurology
ISSN: 1432-1459
Titre abrégé: J Neurol
Pays: Germany
ID NLM: 0423161
Informations de publication
Date de publication:
Jun 2022
Jun 2022
Historique:
received:
09
12
2021
accepted:
02
02
2022
revised:
01
02
2022
pubmed:
16
2
2022
medline:
24
5
2022
entrez:
15
2
2022
Statut:
ppublish
Résumé
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. Retrospective, multicentric study recruiting Italian MS patients treated with rituximab, ocrelizumab and cladribine. We 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. Baseline 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.
Sections du résumé
BACKGROUND
BACKGROUND
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
METHODS
Retrospective, multicentric study recruiting Italian MS patients treated with rituximab, ocrelizumab and cladribine.
RESULTS
RESULTS
We 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.
CONCLUSIONS
CONCLUSIONS
Baseline 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.
Identifiants
pubmed: 35165767
doi: 10.1007/s00415-022-11009-x
pii: 10.1007/s00415-022-11009-x
pmc: PMC9119877
doi:
Substances chimiques
Antiviral Agents
0
DNA, Viral
0
Cladribine
47M74X9YT5
Rituximab
4F4X42SYQ6
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
3301-3307Commentaires et corrections
Type : ErratumIn
Informations de copyright
© 2022. The Author(s).
Références
Wallin MT, Culpepper WJ, Nichols E et al (2019) Global, regional, and national burden of multiple sclerosis 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 18:269–285. https://doi.org/10.1016/S1474-4422(18)30443-5
doi: 10.1016/S1474-4422(18)30443-5
Battaglia MA, Bezzini D (2016) (2016) Estimated prevalence of multiple sclerosis in Italy in 2015. Neurol Sci 383(38):473–479
Adamczyk-Sowa M, Mado H, Kubicka-Bączyk K et al (2021) SARS-CoV-2/COVID-19 in multiple sclerosis patients receiving disease-modifying therapy. Clin Neurol Neurosurg 201:106451. https://doi.org/10.1016/j.clineuro.2020.106451
doi: 10.1016/j.clineuro.2020.106451
pubmed: 33388661
Trépo C, Chan HLY, Lok A (2014) Hepatitis B virus infection. Lancet 384:2053–2063
doi: 10.1016/S0140-6736(14)60220-8
pubmed: 24954675
Raimondo G, Allain J-P, Brunetto MR et al (2008) Statements from the Taormina expert meeting on occult hepatitis B virus infection. J Hepatol 49:652–657. https://doi.org/10.1016/j.jhep.2008.07.014
doi: 10.1016/j.jhep.2008.07.014
pubmed: 18715666
EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection q
Viganò M, Serra G, Casella G et al (2016) Reactivation of hepatitis B virus during targeted therapies for cancer and immune-mediated disorders. Expert Opin Biol Ther 16:917–926
doi: 10.1080/14712598.2016.1177017
pubmed: 27088278
Chen Y, Chen H, Huang W et al (2019) Reactivation of hepatitis B virus infection following rituximab treatment in HBsAg-negative, HBcAb-positive rheumatoid arthritis patients: a long-term, real-world observation. Int J Rheum Dis 22:1756–1785. https://doi.org/10.1111/1756-185X.13582
doi: 10.1111/1756-185X.13582
Ciardi MR, Iannetta M, Zingaropoli MA et al (2019) Reactivation of hepatitis B virus with immune-escape mutations after ocrelizumab treatment for multiple sclerosis. Open Forum Infect Dis 6:1–3. https://doi.org/10.1093/ofid/ofy356
doi: 10.1093/ofid/ofy356
Buonomo AR, Scotto R, Coppola C et al (2020) Direct acting antivirals treatment for hepatitis C virus infection does not increase the incidence of de novo hepatocellular carcinoma occurrence: Results from an Italian real-life cohort (LINA cohort). Med (United States). https://doi.org/10.1097/MD.0000000000018948
doi: 10.1097/MD.0000000000018948
Mikulska M, Lanini S, Gudiol C et al (2018) ESCMID Study Group for Infections in Compromised Hosts (ESGICH) Consensus Document on the safety of targeted and biological therapies: an infectious diseases perspective (Agents targeting lymphoid cells surface antigens [I]: CD19, CD20 and CD52). Clin Microbiol Infect 24:S71–S82
doi: 10.1016/j.cmi.2018.02.003
pubmed: 29447988
Terrault NA, Lok ASF, McMahon BJ et al (2018) Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology 67:1560–1599. https://doi.org/10.1002/hep.29800
doi: 10.1002/hep.29800
pubmed: 29405329
Busuttil DP, Chasty RC, Fraser M et al (1996) Delayed reactivation of hepatitis B infection after cladribine [8]. Lancet 348:129
doi: 10.1016/S0140-6736(05)64642-9
pubmed: 8676694
Bollettino Seieva. https://www.epicentro.iss.it/epatite/Bollettino-Seieva . Accessed 14 Feb 2021
Ciotti JR, Valtcheva MV, Cross AH (2020) Effects of MS disease-modifying therapies on responses to vaccinations: a review. Mult Scler Relat Disord 45:102439. https://doi.org/10.1016/j.msard.2020.102439
doi: 10.1016/j.msard.2020.102439
pubmed: 32769063
pmcid: 7395588
Goodin DS (2014) The epidemiology of multiple sclerosis insights to disease pathogenesis. Handbook of Clinical Neurology. Elsevier, Amsterdam, pp 231–266
Tien YC, Yen HH, Li CF et al (2018) Changes in hepatitis B virus surface antibody titer and risk of hepatitis B reactivation in HBsAg-negative/HBcAb-positive patients undergoing biologic therapy for rheumatic diseases: A prospective cohort study. Arthritis Res Ther 20:246. https://doi.org/10.1186/s13075-018-1748-z
doi: 10.1186/s13075-018-1748-z
pubmed: 30382902
pmcid: 6235201
Hauser SL, Bar-Or A, Comi G et al (2017) Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med 376:221–234. https://doi.org/10.1056/NEJMOA1601277/SUPPL_FILE/NEJMOA1601277_DISCLOSURES.PDF
doi: 10.1056/NEJMOA1601277/SUPPL_FILE/NEJMOA1601277_DISCLOSURES.PDF
pubmed: 28002679
Riederer F (2017) Ocrelizumab versus placebo in primary progressive multiple sclerosis. J fur Neurol Neurochir und Psychiatr 18:30–31. https://doi.org/10.1056/NEJMOA1606468/SUPPL_FILE/NEJMOA1606468_DISCLOSURES.PDF
doi: 10.1056/NEJMOA1606468/SUPPL_FILE/NEJMOA1606468_DISCLOSURES.PDF
Epstein DJ, Dunn J, Deresinski S (2018) Infectious complications of multiple sclerosis therapies: implications for screening, prophylaxis, and management. Open Forum Infect Dis. https://doi.org/10.1093/OFID/OFY174
doi: 10.1093/OFID/OFY174
pubmed: 30094293
pmcid: 6255663