Abstract
Amaç: B-hücresi tüketen tedaviler, potansiyel viral enfeksiyon riskleri ile ilişkilidir. Hepatit B virüsü (HBV) enfeksiyonu en yaygın kronik viral enfeksiyondur ve dünya nüfusunun tahminen %30'unun mevcut veya geçmiş enfeksiyona ilişkin serolojik kanıtlara sahip olduğu tahmin edilmektedir.
Gereç ve Yöntemler: Çalışmamız tek merkezli, retrospektif, kesitsel bir çalışmadır. ocrelizumab alan Multiple Skleroz (MS) hastalarının klinik kayıtlarını geriye dönük olarak inceledik. Hastaların demografik ve klinik özellikleri, Ortalama Expanded Disability Status Scale (EDSS), MS için ocrelizumab öncesi ilaç geçmişi; ortalama ocrelizumab alma süreleri, sigara kullanım durumu, Hepatit C virüs, HIV serolojik durumları, HBV serolojik durumu, HBV tedavi durumu kaydedildi.
Bulgular: Çalışmaya ocrelizumab ile tedavi edilen 64 MS hastası dahil edildi. Ortalama yaş 41.6±9.8 yıl (min-max: 21-62 yıl) idi. Olguların %75’i kadın (n:48), %25’i erkek (n:16) idi. Olguların tümünde HIV, Hepatit C virüs serolojik testleri negatif idi. HBsAg %1.6 (n:1), Anti HBcIgG %12.5 (n:8) oranında pozitif saptandı. Hepatit B tedavisi başlanan hasta sayısı %12.5 (n:8) olup, 2 hastaya (%25) tenofovir disoproksil, 5 hastaya (%62.5) entekavir, 1 hastaya (12.5) tenofovir alafenamid tedavisi başlanmıştır. Hastaların ortalama ocrelizumab alma süreleri 28.5±13.1 ay (min-max:6-46 ay) olarak saptandı.
Sonuç: Sonuç olarak, ocrelizumab tedavisine başlamadan önce tüm hastalarda HBV taraması yapılmalıdır. Hem HBsAg hem de Anti-HBcIg testleri kullanılmalıdır. Anti-HBcIg G’nin varlığı HBV reaktivasyonunu engellemez, bu nedenle immünosupresif tedaviden önce Anti-HBcIg açısından mutlaka taranmalıdır.
Keywords
References
- Trépo C, Chan HLY, Lok A. Hepatit B virüsü enfeksiyonu. Lanset 2014;384:2053–2063.
- Ng HS, Rosenbult CL, Tremlett H. Safety profile of ocrelizumab for the treatment of multiple sclerosis: a systematic review. Expert Opinion on Drug Safety 2020;19(9):1069-1094.
- Buonomo AR, Viceconte G, Calabrese M, De Luca G, Tomassini V, Cavalla P, et al. Management of hepatitis B virus prophylaxis in patients treated with disease-modifying therapies for multiple sclerosis: a multicentric Italian retrospective study. J of Neurol 2022;1-7.
- Epstein DJ, Dunn J, Deresinski S. Infectious complications of multiple sclerosis therapies: implications for screening, prophylaxis, and management. In Open forum infectious diseases 2018;5(8):174. US: Oxford University Press.
- Lamb YN. Ocrelizumab: A review in multiple sclerosis. Drugs 2022;1-12.
- Evens AM, Jovanovic BD, Su YC, Raisch DW, Ganger D, Belknap SM, et al. Rituximab-associated hepatitis B virus (HBV) reactivation in lymphoproliferative diseases: Metaanalysis and examination of FDA safety reports. Ann Oncol 2011;22:1170–1180.
- Onorato L, Pisaturo M, Camaioni C, Grimaldi P, Codella A. V, Calò F, et al. Risk and Prevention of Hepatitis B Virus Reactivation during Immunosuppression for Non-Oncological Diseases. Jof Clin Med 2021;10(21):5201.
- Emery P, Rigby W, Tak PP, Dörner T, Olech E, Martin C, et al. Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program. PLoS ONE. 2014;9(2):e87379.
- Ciardi MR, Iannetta M, Zingaropoli MA, Salpini R, Aragri M, Annecca R, et al. Reactivation of hepatitis B virus with immune-escape mutations after ocrelizumab treatment for multiple sclerosis. In Open Forum Infectious Diseases 2019;6(1):356 US:Oxford University Press.
- Biolato M, Bianco A, Lucchini M, Gasbarrini A, Mirabella M, Grieco A. The Disease-Modifying Therapies of Relapsing-Remitting Multiple Sclerosis and Liver Injury: A Narrative Review. CNS drugs, 2021;35(8):861-880.
Abstract
Objective: B-cell depleting treatments are associated with potential risks of viral infections. Hepatitis B virus (HBV) infection is the most common chronic viral infection and it is estimated that 30% of the world population has serological evidence of current or past infection.
Material and Methods: Our study is a single-center, cross-sectional study. We retrospectively reviewed the clinical records of MS patients receiving ocrelizumab. Demographic and clinical characteristics of patients, Expanded Disability Status Scale (EDSS), drug history before ocrelizumab for MS; Mean ocrelizumab intake times, smoking status, hepatitis C virus, HIV serological status, HBV serological status, HBV treatment status were recorded.
Results: The study included 64 MS patients treated with Ocrelizumab. The mean age was 41.6±9.8 years (min-max: 21-62 years). 75% of the cases were female (n:48), 25% were male (n:16). HIV and hepatitis C virus serological tests were negative in all cases. HBsAg was found to be positive in 1.6% (n:1) and Anti-HBcIgG in 12.5% (n:8). The number of patients who were started on hepatitis B treatment was 12.5% (n:8), and tenofovir disoproxil was started in 2 patients (25%), entecavir in 5 patients (62.5%), and tenofovir alafenamide in 1 patient (12.5). The mean duration of taking ocrelizumab for the patients was 28.5±13.1 months (min-max: 6-46 months).
Conclusion: In conclusion, all patients should be screened for HBV before starting ocrelizumab therapy. Both HBsAg and Anti-HBcIg G tests should be used. The isolated presence of Anti-HBcIg G may cause HBV reactivation. Therefore, Anti-HBcIg G should be screened before immunosuppressive therapy
References
- Trépo C, Chan HLY, Lok A. Hepatit B virüsü enfeksiyonu. Lanset 2014;384:2053–2063.
- Ng HS, Rosenbult CL, Tremlett H. Safety profile of ocrelizumab for the treatment of multiple sclerosis: a systematic review. Expert Opinion on Drug Safety 2020;19(9):1069-1094.
- Buonomo AR, Viceconte G, Calabrese M, De Luca G, Tomassini V, Cavalla P, et al. Management of hepatitis B virus prophylaxis in patients treated with disease-modifying therapies for multiple sclerosis: a multicentric Italian retrospective study. J of Neurol 2022;1-7.
- Epstein DJ, Dunn J, Deresinski S. Infectious complications of multiple sclerosis therapies: implications for screening, prophylaxis, and management. In Open forum infectious diseases 2018;5(8):174. US: Oxford University Press.
- Lamb YN. Ocrelizumab: A review in multiple sclerosis. Drugs 2022;1-12.
- Evens AM, Jovanovic BD, Su YC, Raisch DW, Ganger D, Belknap SM, et al. Rituximab-associated hepatitis B virus (HBV) reactivation in lymphoproliferative diseases: Metaanalysis and examination of FDA safety reports. Ann Oncol 2011;22:1170–1180.
- Onorato L, Pisaturo M, Camaioni C, Grimaldi P, Codella A. V, Calò F, et al. Risk and Prevention of Hepatitis B Virus Reactivation during Immunosuppression for Non-Oncological Diseases. Jof Clin Med 2021;10(21):5201.
- Emery P, Rigby W, Tak PP, Dörner T, Olech E, Martin C, et al. Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program. PLoS ONE. 2014;9(2):e87379.
- Ciardi MR, Iannetta M, Zingaropoli MA, Salpini R, Aragri M, Annecca R, et al. Reactivation of hepatitis B virus with immune-escape mutations after ocrelizumab treatment for multiple sclerosis. In Open Forum Infectious Diseases 2019;6(1):356 US:Oxford University Press.
- Biolato M, Bianco A, Lucchini M, Gasbarrini A, Mirabella M, Grieco A. The Disease-Modifying Therapies of Relapsing-Remitting Multiple Sclerosis and Liver Injury: A Narrative Review. CNS drugs, 2021;35(8):861-880.
Details
| Primary Language | English |
|---|---|
| Subjects | Health Care Administration |
| Journal Section | Araştırma Makaleleri |
| Authors | |
| Early Pub Date | November 10, 2023 |
| Publication Date | November 20, 2023 |
| Submission Date | August 6, 2022 |
| Acceptance Date | September 13, 2022 |
| Published in Issue | Year 2023 Volume: 18 Issue: 3 |
