PMID- 32799563
OWN - NLM
STAT- MEDLINE
DCOM- 20210203
LR  - 20220417
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 19
IP  - 9
DP  - 2020 Sep
TI  - Safety profile of ocrelizumab for the treatment of multiple sclerosis: a 
      systematic review.
PG  - 1069-1094
LID - 10.1080/14740338.2020.1807002 [doi]
AB  - INTRODUCTION: We systematically reviewed adverse events (AEs) for ocrelizumab for 
      multiple sclerosis (MS). AREAS COVERED: We searched Medline, Embase, Web of 
      Science, and Toxicology Data Network-TOXLINE (inception to 8-July-2020), clinical 
      trial registries, and product monographs for any clinical trials, observational 
      studies or case reports examining AEs to ocrelizumab. Studies with/without a 
      comparator drug or placebo were eligible. EXPERT OPINION: Seventy-eight records 
      were included (4 randomized controlled trials (RCTs), 4 open-label trials, 29 
      observational studies, and 27 case reports). AEs affected 2756/4498 (61.3%) of 
      ocrelizumab-exposed patients. The most common AEs were infections (n=1342, 39.2% 
      of ocrelizumab-exposed patients) and infusion-related reactions (n=1391, 26.2%). 
      Compared to beta-interferon, infections were more likely in ocrelizumab-exposed 
      patients (Risk Ratio (RR)=1.10; 95% confidence interval (CI):1.01-1.19), 
      including: herpes-related (RR=1.75; 95%CI:1.11-2.76), respiratory tract-related 
      (RR=1.42; 95%CI:1.10-1.84 and RR=1.61; 95%CI:1.10-2.35), nasopharyngitis 
      (RR=1.47; 95%CI:1.13-1.90), and rhinitis (RR=4.00; 95%CI:1.13-14.14). 
      Infusion-related reactions (RR range: 1.57-4.42) were more common for ocrelizumab 
      versus placebo or beta-interferon. From pooled analyses (three RCTs), the risk of 
      'any' serious AE did not differ significantly between the ocrelizumab and 
      comparator groups. However, insufficient data were available to assess 
      longer-term AEs, e.g., malignancy.
FAU - Ng, Huah Shin
AU  - Ng HS
AUID- ORCID: 0000-0001-8381-5253
AD  - Department of Medicine, Division of Neurology and the Djavad Mowafaghian Centre 
      for Brain Health, University of British Columbia , Vancouver, BC, Canada.
FAU - Rosenbult, Constanza Luzon
AU  - Rosenbult CL
AD  - School of Population and Public Health, University of British Columbia , 
      Vancouver, BC, Canada.
FAU - Tremlett, Helen
AU  - Tremlett H
AUID- ORCID: 0000-0001-5804-2535
AD  - Department of Medicine, Division of Neurology and the Djavad Mowafaghian Centre 
      for Brain Health, University of British Columbia , Vancouver, BC, Canada.
LA  - eng
PT  - Journal Article
PT  - Systematic Review
DEP - 20200831
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Immunologic Factors)
RN  - A10SJL62JY (ocrelizumab)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/*adverse effects
MH  - Humans
MH  - Immunologic Factors/administration & dosage/*adverse effects
MH  - Multiple Sclerosis/*drug therapy/physiopathology
MH  - Randomized Controlled Trials as Topic
OTO - NOTNLM
OT  - Adverse events
OT  - multiple sclerosis
OT  - ocrelizumab
OT  - patient safety
OT  - systematic review
EDAT- 2020/08/18 06:00
MHDA- 2021/02/04 06:00
CRDT- 2020/08/18 06:00
PHST- 2020/08/18 06:00 [pubmed]
PHST- 2021/02/04 06:00 [medline]
PHST- 2020/08/18 06:00 [entrez]
AID - 10.1080/14740338.2020.1807002 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2020 Sep;19(9):1069-1094. doi: 
      10.1080/14740338.2020.1807002. Epub 2020 Aug 31.