INTRODUCTION: Ocrelizumab is a newly introduced treatment in multiple sclerosis (MS). There is no data in the pivotal trials about in which extent liver function tests (LFTs) and lymphocyte count are affected before second-half dose of ocrelizumab and in which extent these results will prevent us giving the second-half dose. This study was designed for better understanding of the patient management and to support the data that showed no safety issues about ocrelizumab with real-life data. METHODS: The patients treated with ocrelizumab between May 20 and December 21, 2018 were retrospectively reviewed. Demographic and clinical data, side-effects due to ocrelizumab, laboratory results before and after the treatment were recorded. RESULTS: There were 30 (58.8%) females and 21 (41.2%) males. The mean age was 44.02±9.62 (24-65) years. Twenty-six (51%) of them were followed up with relapsing-remitting MS (RRMS), 18 (35.3%) with secondary progressive MS (SPMS) and 7 (13.7%) with primary progressive MS (PPMS). The mean lymphocyte value one day after the first half-dose was lower than the value before the treatment (p<0.001). The mean lymphocyte level one month after the second half-dose was higher than the value one day after the first half-dose (p=0.001), while it was still lower than the value before treatment (p=0.006). No changes were seen in LFTs. Mild infusion-related reactions were observed in 4 patients. CONCLUSION: From our data, it is evident that ocrelizumab is safe in the short term. Long-term real-life studies are needed to assess the safety of ocrelizumab in the long term. Copyright:
INTRODUCTION: Ocrelizumab is a newly introduced treatment in multiple sclerosis (MS). There is no data in the pivotal trials about in which extent liver function tests (LFTs) and lymphocyte count are affected before second-half dose of ocrelizumab and in which extent these results will prevent us giving the second-half dose. This study was designed for better understanding of the patient management and to support the data that showed no safety issues about ocrelizumab with real-life data. METHODS: The patients treated with ocrelizumab between May 20 and December 21, 2018 were retrospectively reviewed. Demographic and clinical data, side-effects due to ocrelizumab, laboratory results before and after the treatment were recorded. RESULTS: There were 30 (58.8%) females and 21 (41.2%) males. The mean age was 44.02±9.62 (24-65) years. Twenty-six (51%) of them were followed up with relapsing-remitting MS (RRMS), 18 (35.3%) with secondary progressive MS (SPMS) and 7 (13.7%) with primary progressive MS (PPMS). The mean lymphocyte value one day after the first half-dose was lower than the value before the treatment (p<0.001). The mean lymphocyte level one month after the second half-dose was higher than the value one day after the first half-dose (p=0.001), while it was still lower than the value before treatment (p=0.006). No changes were seen in LFTs. Mild infusion-related reactions were observed in 4 patients. CONCLUSION: From our data, it is evident that ocrelizumab is safe in the short term. Long-term real-life studies are needed to assess the safety of ocrelizumab in the long term. Copyright:
Authors: Xavier Montalban; Stephen L Hauser; Ludwig Kappos; Douglas L Arnold; Amit Bar-Or; Giancarlo Comi; Jérôme de Seze; Gavin Giovannoni; Hans-Peter Hartung; Bernhard Hemmer; Fred Lublin; Kottil W Rammohan; Krzysztof Selmaj; Anthony Traboulsee; Annette Sauter; Donna Masterman; Paulo Fontoura; Shibeshih Belachew; Hideki Garren; Nicole Mairon; Peter Chin; Jerry S Wolinsky Journal: N Engl J Med Date: 2016-12-21 Impact factor: 91.245
Authors: Arumugam Palanichamy; Sarah Jahn; Dorothee Nickles; Mia Derstine; Aya Abounasr; Stephen L Hauser; Sergio E Baranzini; David Leppert; H-Christian von Büdingen Journal: J Immunol Date: 2014-06-13 Impact factor: 5.422