Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis

Sørensen, Per Soelberg; Lisby, Steen; Grove, Richard; Derosier, Frederick J.; Shackelford, S. D.; Havrdová, Eva; Drulović, Jelena; Filippi, Massimo

doi:10.1212/wnl.0000000000000125

Cited by 265 publications

(234 citation statements)

References 30 publications

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“…Heterogeneity existed among the included studies (I 2 =48%, P=0.68). Serious adverse events were reported in five studies (11)(12)(13)(14). As above, the overall results of the meta-analysis revealed that patients receiving anti-B-cell mAbs exhibited no significant difference in serious adverse events compared with those in the placebo group (OR=1.13; 95% CI= 0.70-1.80; P= 0.62; Fig.…”

Section: Volume Change Of Lesions From Baseline On T2-weighted Mrimentioning

confidence: 69%

“…After reviewing the full text of the remaining 11 studies, four studies, including five trials (one study was regarded separately as two trials due to different dosages) with a total of 745 patients contained sufficient information to be included in the statistical analysis, and compared anti-B-cell mAbs with a placebo (11)(12)(13)(14). The most common reasons for exclusion were that studies were reviews, contained patients not diagnosed with MS, non-randomized clinical trials, use of a mAb other than rituximab, ocrelizumab or ofatumumab as a treatment intervention, and insufficient data (Fig.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Four trials involving 306 patients described the proportion of patients who relapsed (11,13,14). Meta-analysis demonstrated that the proportion of patients who had at least one relapse of MS was significantly reduced by anti-B-cell mAb treatment (OR=0.25; 95% CI=0.14-0.44; P<0.001; Fig.…”

Section: Volume Change Of Lesions From Baseline On T2-weighted Mrimentioning

confidence: 99%

“…All of the five studies reported on adverse events (11)(12)(13)(14). Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.…”

Section: Volume Change Of Lesions From Baseline On T2-weighted Mrimentioning

confidence: 99%

“…In the respective trial (14), the most common adverse event was an infusion-associated reaction; most adverse reactions were mild and were common on the first day of ofatumumab dosing, but were not observed on the second day of infusion. The percentage of patients with infection was similar between the mAb and placebo groups and most infections were mild or moderate.…”

mentioning

confidence: 99%

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A meta-analysis to determine the efficacy and tolerability of anti-B-cell monoclonal antibodies in multiple sclerosis

Xie

Sun

et al. 2017

Experimental and Therapeutic Medicine

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Abstract. The present study performed a meta-analysis of randomized controlled trials in multiple sclerosis (MS) patients to evaluate the efficacy and safety of anti-B-cell monoclonal antibodies (mAbs). To the best of our knowledge, no previous meta-analysis has evaluated this. Relevant studies published until March 2015 were retrieved from the PubMed, EMBASE and Cochrane Library using the following keywords: 'Clinical trial', 'randomized', 'multiple sclerosis' or 'MS' and 'monoclonal antibodies' or 'mAbs'. Two authors independently selected the articles and extracted the data. The meta-analysis was performed using Review Manager version 5.3 software. Four randomized clinical trials comprising a total of 745 patients were selected. Anti-B-cell mAb treatment reduced the formation of gadolinium-enhancing lesions [mean difference (MD)=-5.62; 95% confidence interval (CI)=-8.00 to -3.24; P<0.001) and was associated with smaller volume changes of lesions on T2-weighted magnetic resonance imaging (MD=-604.40; 95% CI=-941.23 to -267.57; P<0.001). It also significantly reduced the proportion of MS patients having at least one relapse [odds ratio (OR)=0.25; 95% CI=0.14-0.44; P<0.001). Compared to placebo, anti-B-cell mAb treatment did not increase the frequency of adverse events (OR=0.90; 95% CI= 0.54-1.49; P= 0.68) and serious adverse events (OR=1.13; 95% CI= 0.70-1.80; P= 0.62). In conclusion, the present meta-analysis suggested that anti-B-cell mAbs are a relatively effective and safe treatment for MS.

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Section: Volume Change Of Lesions From Baseline On T2-weighted Mrimentioning

confidence: 69%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Volume Change Of Lesions From Baseline On T2-weighted Mrimentioning

confidence: 99%

Section: Volume Change Of Lesions From Baseline On T2-weighted Mrimentioning

confidence: 99%

mentioning

confidence: 99%

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A meta-analysis to determine the efficacy and tolerability of anti-B-cell monoclonal antibodies in multiple sclerosis

Xie

Sun

et al. 2017

Experimental and Therapeutic Medicine

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Effect of Multiple Sclerosis Disease-Modifying Therapies on B Cells and Humoral Immunity

Longbrake

Cross

2016

JAMA Neurol

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Association of Rituximab Treatment With Disability Progression Among Patients With Secondary Progressive Multiple Sclerosis

Naegelin

Felten

et al. 2019

JAMA Neurol

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Importance: Therapeutic options for patients with secondary progressive multiple sclerosis (SPMS) are limited. Objective: To analyze disability progression in patients with SPMS treated with rituximab compared with matched control patients never treated with rituximab. Design, Setting, and Participants: This retrospective cohort study analyzed data obtained from patients with SPMS at 3 multiple sclerosis centers located in Basel and Lugano, Switzerland, and Amsterdam, the Netherlands, from 2004 to 2017. Patients were included for analysis if they had received a diagnosis of SPMS, were treated (57 eligible; 54 included) or never treated (504 eligible; 59 included) with rituximab, and had at least 1 follow-up visit. The variables used for propensity score matching were sex, age, Expanded Disability Status Scale (EDSS) score, and disease duration. Follow-up duration was up to 10 years, with a mean (SD) of 3.5 (2.6) years for rituximab-treated patients and 5.4 (2.4) years for controls in the total cohort and a mean (SD) of 3.5 (2.7) years for rituximab-treated patients and 4.8 (2.2) years for controls in the matched cohort. Exposures: Comparing EDSS score progression in patients with SPMS (treated with rituximab vs not treated with rituximab) using propensity score matching. Main Outcomes and Measures: The primary end point was progression of EDSS score after baseline, and the secondary end point was time to confirmed disability progression. Results: After 1:1 propensity score matching, 44 matched pairs (88 patients) were included in the analysis. At baseline, patients treated with rituximab had a mean (SD) age of 49.7 (10.0) years, mean (SD) disease duration of 18.2 (9.4) years, and mean (SD) EDSS score of 5.9 (1.4), and 26 (59%) were women, whereas controls had a mean (SD) age of 51.3 (7.4) years, mean (SD) disease duration of 19.4 (8.7) years, and mean (SD) EDSS score of 5.70 (1.29), and 27 (61%) were women. In the covariate-adjusted analysis of the matched set, patients with SPMS who were treated with rituximab had a significantly lower EDSS score during a mean (SD) follow-up of 3.5 (2.7) years (mean difference, -0.52; 95% CI, -0.79 to -0.26; P < .001). Time to confirmed disability progression was significantly delayed in the rituximab-treated group (hazard ratio, 0.49; 95% CI, 0.26-0.93; P = .03). Conclusions and Relevance: In this study, patients with SPMS treated with rituximab had a significantly lower EDSS score for up to 10 years of follow-up and a significantly delayed confirmed progression compared with matched controls, suggesting that B-cell depletion by rituximab may be therapeutically beneficial in these patients. A prospective randomized clinical trial with a better level of evidence is needed to confirm the efficacy of rituximab in such patients.

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Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis

Abstract: This study provides Class II evidence that in patients with RRMS, ofatumumab compared with placebo does not increase the number of serious adverse events and decreases the number of new MRI lesions.

Cited by 265 publications

References 30 publications

A meta-analysis to determine the efficacy and tolerability of anti-B-cell monoclonal antibodies in multiple sclerosis

A meta-analysis to determine the efficacy and tolerability of anti-B-cell monoclonal antibodies in multiple sclerosis

Effect of Multiple Sclerosis Disease-Modifying Therapies on B Cells and Humoral Immunity

Association of Rituximab Treatment With Disability Progression Among Patients With Secondary Progressive Multiple Sclerosis

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