Onset of clinical and MRI efficacy of ocrelizumab in relapsing multiple sclerosis. Barkhof, F., Kappos, L., Wolinsky, J. S., Li, D. K. B., Bar-Or, A., Hartung, H., Belachew, S., Han, J., Julian, L., Sauter, A., Napieralski, J., Koendgen, H., & Hauser, S. L. Neurology, 93(19):e1778–e1786, 2019. doi abstract bibtex OBJECTIVE: To assess the onset of ocrelizumab efficacy on brain MRI measures of disease activity in the phase II study in relapsing-remitting multiple sclerosis (RRMS), and relapse rate in the pooled phase III studies in relapsing multiple sclerosis (RMS). METHODS: Brain MRI activity was determined in the phase II trial at monthly intervals in patients with RRMS receiving placebo, ocrelizumab (600 mg), or intramuscular interferon (IFN) β-1a (30 μg). Annualized relapse rate (ARR; over various epochs) and time to first relapse were analyzed in the pooled population of the phase III OPERA (A Study of Ocrelizumab in Comparison With Interferon Beta-1a [Rebif] in Participants With Relapsing Multiple Sclerosis) I and OPERA II trials in patients with RMS receiving ocrelizumab (600 mg) or subcutaneous IFN-β-1a (44 μg). RESULTS: In patients with RRMS, ocrelizumab reduced the number of new T1 gadolinium-enhancing lesions by week 4 vs placebo (p = 0.042) and by week 8 vs intramuscular IFN-β-1a (p \textless 0.001). Ocrelizumab also reduced the number of new or enlarging T2 lesions appearing between weeks 4 and 8 vs both placebo and IFN-β-1a (both p \textless 0.001). In patients with RMS, ocrelizumab significantly reduced ARR (p = 0.005) and the probability of time to first protocol-defined relapse (p = 0.014) vs subcutaneous IFN-β-1a within the first 8 weeks. CONCLUSION: Epoch analysis of MRI-measured lesion activity in the phase II study and relapse rate in the phase III studies consistently revealed a rapid suppression of acute MRI and clinical disease activity following treatment initiation with ocrelizumab in patients with RRMS and RMS, respectively. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with RRMS and RMS, ocrelizumab suppressed MRI activity within 4 weeks and clinical disease activity within 8 weeks.
@article{barkhof_onset_2019,
title = {Onset of clinical and {MRI} efficacy of ocrelizumab in relapsing multiple sclerosis},
volume = {93},
issn = {1526-632X},
doi = {10.1212/WNL.0000000000008189},
abstract = {OBJECTIVE: To assess the onset of ocrelizumab efficacy on brain MRI measures of disease activity in the phase II study in relapsing-remitting multiple sclerosis (RRMS), and relapse rate in the pooled phase III studies in relapsing multiple sclerosis (RMS).
METHODS: Brain MRI activity was determined in the phase II trial at monthly intervals in patients with RRMS receiving placebo, ocrelizumab (600 mg), or intramuscular interferon (IFN) β-1a (30 μg). Annualized relapse rate (ARR; over various epochs) and time to first relapse were analyzed in the pooled population of the phase III OPERA (A Study of Ocrelizumab in Comparison With Interferon Beta-1a [Rebif] in Participants With Relapsing Multiple Sclerosis) I and OPERA II trials in patients with RMS receiving ocrelizumab (600 mg) or subcutaneous IFN-β-1a (44 μg).
RESULTS: In patients with RRMS, ocrelizumab reduced the number of new T1 gadolinium-enhancing lesions by week 4 vs placebo (p = 0.042) and by week 8 vs intramuscular IFN-β-1a (p {\textless} 0.001). Ocrelizumab also reduced the number of new or enlarging T2 lesions appearing between weeks 4 and 8 vs both placebo and IFN-β-1a (both p {\textless} 0.001). In patients with RMS, ocrelizumab significantly reduced ARR (p = 0.005) and the probability of time to first protocol-defined relapse (p = 0.014) vs subcutaneous IFN-β-1a within the first 8 weeks.
CONCLUSION: Epoch analysis of MRI-measured lesion activity in the phase II study and relapse rate in the phase III studies consistently revealed a rapid suppression of acute MRI and clinical disease activity following treatment initiation with ocrelizumab in patients with RRMS and RMS, respectively.
CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with RRMS and RMS, ocrelizumab suppressed MRI activity within 4 weeks and clinical disease activity within 8 weeks.},
language = {eng},
number = {19},
journal = {Neurology},
author = {Barkhof, Frederik and Kappos, Ludwig and Wolinsky, Jerry S. and Li, David K. B. and Bar-Or, Amit and Hartung, Hans-Peter and Belachew, Shibeshih and Han, Jian and Julian, Laura and Sauter, Annette and Napieralski, Julie and Koendgen, Harold and Hauser, Stephen L.},
year = {2019},
pmid = {31484710},
pmcid = {PMC6946481},
keywords = {MS},
pages = {e1778--e1786}
}
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METHODS: Brain MRI activity was determined in the phase II trial at monthly intervals in patients with RRMS receiving placebo, ocrelizumab (600 mg), or intramuscular interferon (IFN) β-1a (30 μg). Annualized relapse rate (ARR; over various epochs) and time to first relapse were analyzed in the pooled population of the phase III OPERA (A Study of Ocrelizumab in Comparison With Interferon Beta-1a [Rebif] in Participants With Relapsing Multiple Sclerosis) I and OPERA II trials in patients with RMS receiving ocrelizumab (600 mg) or subcutaneous IFN-β-1a (44 μg). RESULTS: In patients with RRMS, ocrelizumab reduced the number of new T1 gadolinium-enhancing lesions by week 4 vs placebo (p = 0.042) and by week 8 vs intramuscular IFN-β-1a (p \\textless 0.001). Ocrelizumab also reduced the number of new or enlarging T2 lesions appearing between weeks 4 and 8 vs both placebo and IFN-β-1a (both p \\textless 0.001). In patients with RMS, ocrelizumab significantly reduced ARR (p = 0.005) and the probability of time to first protocol-defined relapse (p = 0.014) vs subcutaneous IFN-β-1a within the first 8 weeks. CONCLUSION: Epoch analysis of MRI-measured lesion activity in the phase II study and relapse rate in the phase III studies consistently revealed a rapid suppression of acute MRI and clinical disease activity following treatment initiation with ocrelizumab in patients with RRMS and RMS, respectively. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with RRMS and RMS, ocrelizumab suppressed MRI activity within 4 weeks and clinical disease activity within 8 weeks.","language":"eng","number":"19","journal":"Neurology","author":[{"propositions":[],"lastnames":["Barkhof"],"firstnames":["Frederik"],"suffixes":[]},{"propositions":[],"lastnames":["Kappos"],"firstnames":["Ludwig"],"suffixes":[]},{"propositions":[],"lastnames":["Wolinsky"],"firstnames":["Jerry","S."],"suffixes":[]},{"propositions":[],"lastnames":["Li"],"firstnames":["David","K.","B."],"suffixes":[]},{"propositions":[],"lastnames":["Bar-Or"],"firstnames":["Amit"],"suffixes":[]},{"propositions":[],"lastnames":["Hartung"],"firstnames":["Hans-Peter"],"suffixes":[]},{"propositions":[],"lastnames":["Belachew"],"firstnames":["Shibeshih"],"suffixes":[]},{"propositions":[],"lastnames":["Han"],"firstnames":["Jian"],"suffixes":[]},{"propositions":[],"lastnames":["Julian"],"firstnames":["Laura"],"suffixes":[]},{"propositions":[],"lastnames":["Sauter"],"firstnames":["Annette"],"suffixes":[]},{"propositions":[],"lastnames":["Napieralski"],"firstnames":["Julie"],"suffixes":[]},{"propositions":[],"lastnames":["Koendgen"],"firstnames":["Harold"],"suffixes":[]},{"propositions":[],"lastnames":["Hauser"],"firstnames":["Stephen","L."],"suffixes":[]}],"year":"2019","pmid":"31484710","pmcid":"PMC6946481","keywords":"MS","pages":"e1778–e1786","bibtex":"@article{barkhof_onset_2019,\n\ttitle = {Onset of clinical and {MRI} efficacy of ocrelizumab in relapsing multiple sclerosis},\n\tvolume = {93},\n\tissn = {1526-632X},\n\tdoi = {10.1212/WNL.0000000000008189},\n\tabstract = {OBJECTIVE: To assess the onset of ocrelizumab efficacy on brain MRI measures of disease activity in the phase II study in relapsing-remitting multiple sclerosis (RRMS), and relapse rate in the pooled phase III studies in relapsing multiple sclerosis (RMS).\nMETHODS: Brain MRI activity was determined in the phase II trial at monthly intervals in patients with RRMS receiving placebo, ocrelizumab (600 mg), or intramuscular interferon (IFN) β-1a (30 μg). Annualized relapse rate (ARR; over various epochs) and time to first relapse were analyzed in the pooled population of the phase III OPERA (A Study of Ocrelizumab in Comparison With Interferon Beta-1a [Rebif] in Participants With Relapsing Multiple Sclerosis) I and OPERA II trials in patients with RMS receiving ocrelizumab (600 mg) or subcutaneous IFN-β-1a (44 μg).\nRESULTS: In patients with RRMS, ocrelizumab reduced the number of new T1 gadolinium-enhancing lesions by week 4 vs placebo (p = 0.042) and by week 8 vs intramuscular IFN-β-1a (p {\\textless} 0.001). Ocrelizumab also reduced the number of new or enlarging T2 lesions appearing between weeks 4 and 8 vs both placebo and IFN-β-1a (both p {\\textless} 0.001). In patients with RMS, ocrelizumab significantly reduced ARR (p = 0.005) and the probability of time to first protocol-defined relapse (p = 0.014) vs subcutaneous IFN-β-1a within the first 8 weeks.\nCONCLUSION: Epoch analysis of MRI-measured lesion activity in the phase II study and relapse rate in the phase III studies consistently revealed a rapid suppression of acute MRI and clinical disease activity following treatment initiation with ocrelizumab in patients with RRMS and RMS, respectively.\nCLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with RRMS and RMS, ocrelizumab suppressed MRI activity within 4 weeks and clinical disease activity within 8 weeks.},\n\tlanguage = {eng},\n\tnumber = {19},\n\tjournal = {Neurology},\n\tauthor = {Barkhof, Frederik and Kappos, Ludwig and Wolinsky, Jerry S. and Li, David K. 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