Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2021 Aug;35(8):907-918.
doi: 10.1007/s40263-021-00810-3. Epub 2021 Apr 13.

Predicting Infection Risk in Multiple Sclerosis Patients Treated with Ocrelizumab: A Retrospective Cohort Study

Nabil Seery  1 , Sifat Sharmin  2   3 , Vivien Li  1   4 , Ai-Lan Nguyen  1   2   3 , Claire Meaton  1 , Roberts Atvars  1 , Nicola Taylor  5 , Kelsey Tunnell  5 , John Carey  5 , Mark P Marriott  1   6 , Katherine A Buzzard  1   6 , Izanne Roos  1   2   3 , Chris Dwyer  1   4 , Josephine Baker  1 , Lisa Taylor  1 , Kymble Spriggs  3   7 , Trevor J Kilpatrick  1   4 , Tomas Kalincik  1   2   3 , Mastura Monif  8   9   10
Affiliations
Observational Study

Predicting Infection Risk in Multiple Sclerosis Patients Treated with Ocrelizumab: A Retrospective Cohort Study

Nabil Seery et al. CNS Drugs. 2021 Aug.

Abstract

Background: Ocrelizumab safety outcomes have been well evaluated in clinical trials and open-label extension (OLE) studies. However, risk factors for infection in patients with multiple sclerosis (MS) receiving ocrelizumab have not been extensively studied in the real-world setting.

Objective: The aim of this study was to examine factors determining risk of self-reported infections and antimicrobial use in patients receiving ocrelizumab for MS.

Methods: A retrospective, observational cohort study was conducted in patients receiving ocrelizumab at the Royal Melbourne Hospital. Infection type and number were reported by patients, and the associations of potential clinical and laboratory risk factors with self-reported infection and antimicrobial use were estimated using univariate and multivariable logistic regression models.

Results: A total of 185 patients were included in the study; a total of 176 infections were reported in 89 patients (46.1%), and antimicrobial use was identified in 47 patients (25.3%). In univariate analyses, a higher serum IgA was associated with reduced odds of infection (OR 0.44, 95% CI 0.25-0.76). In multivariable analyses, older age (OR 0.94, 95% CI 0.88-0.99), higher serum IgA (OR 0.37, 95% CI 0.17-0.80) and higher serum IgG (OR 0.81, 95% CI 0.67-0.99) were associated with reduced odds of infection. Older age (OR 0.85, 95% CI 0.75-0.96) and higher serum IgA (OR 0.23, 95% CI 0.07-0.79) were associated with reduced odds of antimicrobial use, whilst longer MS disease duration (OR 1.22, 95% CI 1.06-1.41) and higher Expanded Disability Status Scale (EDSS) score (OR 1.99, 95% CI 1.02-3.86) were associated with increased odds of antimicrobial use.

Conclusions: Higher serum IgA and IgG and older age were associated with reduced odds of infection. Our findings highlight that infection risk is not uniform in patients with MS receiving ocrelizumab and substantiate the need to monitor immunoglobulin levels pre-treatment and whilst on therapy.

PubMed Disclaimer

Conflict of interest statement

NS has received conference fee sponsorship from Roche. TK served on scientific advisory boards for Roche, Celgene, Sanofi-Genzyme, Novartis, Merck and Biogen; a steering committee for Brain Atrophy Initiative by Sanofi-Genzyme; received conference travel support and/or speaker honoraria from WebMD Global, Novartis, Biogen, Sanofi-Genzyme, Teva, BioCSL and Merck and received research support from Biogen. MMo has served on advisory board for Merck, and has received speaker honoraria from Merck and Biogen. Her institution receives funding from Merck, Australian National Health Medical Research Council, Brain Foundation, Charles and Sylvia Viertel Foundation, and MS Research Australia. The other authors declare no conflicts of interest.

References

    1. Harding K, Williams O, Willis M, Hrastelj J, Rimmer A, Joseph F, et al. Clinical outcomes of escalation vs early intensive disease-modifying therapy in patients with multiple sclerosis. JAMA Neurol. 2019;76(5):536–541. doi: 10.1001/jamaneurol.2018.4905. - DOI - PMC - PubMed
    1. Buron MD, Chalmer TA, Sellebjerg F, Barzinji I, Christensen JR, Christensen MK, et al. Initial high-efficacy disease-modifying therapy in multiple sclerosis: a nationwide cohort study. Neurology. 2020;95(8):e1041–e1051. doi: 10.1212/WNL.0000000000010135. - DOI - PubMed
    1. Brown JWL, Coles A, Horakova D, Havrdova E, Izquierdo G, Prat A, et al. Association of initial disease-modifying therapy with later conversion to secondary progressive multiple sclerosis. JAMA. 2019;321(2):175–187. doi: 10.1001/jama.2018.20588. - DOI - PMC - PubMed
    1. Persson R, Lee S, Ulcickas YM, Wagner UMCM, Minton N, Niemcryk S, et al. Infections in patients diagnosed with multiple sclerosis: a multi-database study. Mult Scler Relat Disord. 2020;41:101982. doi: 10.1016/j.msard.2020.101982. - DOI - PubMed
    1. Wijnands JM, Kingwell E, Zhu F, Zhao Y, Fisk JD, Evans C, et al. Infection-related health care utilization among people with and without multiple sclerosis. Mult Scler. 2017;23(11):1506–1516. doi: 10.1177/1352458516681198. - DOI - PubMed

Publication types

MeSH terms