2017
DOI: 10.1056/nejmoa1606468
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Abstract: Among patients with primary progressive multiple sclerosis, ocrelizumab was associated with lower rates of clinical and MRI progression than placebo. Extended observation is required to determine the long-term safety and efficacy of ocrelizumab. (Funded by F. Hoffmann-La Roche; ORATORIO ClinicalTrials.gov number, NCT01194570 .).

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Cited by 1,342 publications
(1,342 citation statements)
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References 26 publications
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“…Likewise, the treatment effect of fingolimod was numerically but not statistically significantly stronger in the subgroup with baseline Gd+ lesions than in the subgroup without baseline Gd+ lesions 24. Similar results for disability progression and a dependence of the treatment effect on the presence of Gd+ lesions were seen in the OLYMPUS and ORATORIO trials 21, 22…”
Section: Discussionsupporting
confidence: 76%
See 1 more Smart Citation
“…Likewise, the treatment effect of fingolimod was numerically but not statistically significantly stronger in the subgroup with baseline Gd+ lesions than in the subgroup without baseline Gd+ lesions 24. Similar results for disability progression and a dependence of the treatment effect on the presence of Gd+ lesions were seen in the OLYMPUS and ORATORIO trials 21, 22…”
Section: Discussionsupporting
confidence: 76%
“…At this mean rate of lesion load increase, assuming a linear accumulation rate at the population level, it would require 58 years to arrive at the observed mean baseline T2 lesion volume; yet the median onset of MS from first symptoms was only 5.7 years. A similar disparity was evident in the ORATORIO trial 21. There is an apparent quantitative disconnect in many patients with PPMS between the low rate of T2 volume increase observed on study, and the substantial T2 lesion volume already present at study entry.…”
Section: Discussionmentioning
confidence: 61%
“…Sensitivity analyses performed in the ITT population (excluding 1 patient with missing baseline EDSS, following the approach originally used in the primary endpoint analysis),12 with imputation for patients who withdrew early for reasons other than “lack of efficacy” or “death” and who had NEPAD at time of study treatment discontinuation, were consistent with the main results (Supplementary Table S4). This was true both for NEPAD imputation of early discontinuers (“best outcome scenario”: ocrelizumab 33.5% versus placebo 13.1%; relative risk [95% CI]: 2.55 [1.80–3.60]; p  < 0.001) and EPAD imputation of early discontinuers (“worst outcome scenario”: ocrelizumab 28.8% versus placebo 9.0%; relative risk [95% CI]: 3.17 [2.08–4.83]; p  < 0.001).…”
Section: Resultssupporting
confidence: 65%
“…Consequently, most recent MS trials adopted composite outcomes, consisting of sustained progression of disability on one of several scales, such as EDSS, 25FT, and 9HPT 15, 16. While such outcomes enhance sensitivity of group comparisons, they do not measure severity of MS progression on a patient level.…”
Section: Discussionmentioning
confidence: 99%