1. Predicting Infection Risk in Multiple Sclerosis Patients Treated with Ocrelizumab: A Retrospective Cohort Study
- Author
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Sifat Sharmin, Katherine Buzzard, Izanne Roos, Kymble Spriggs, Claire Meaton, Ai Lan Nguyen, Trevor J. Kilpatrick, Tomas Kalincik, Vivien Li, Chris Dwyer, Roberts Atvars, Kelsey Tunnell, Lisa Taylor, Nicola Taylor, Mastura Monif, Mark Marriott, Josephine Baker, John Carey, and Nabil Seery
- Subjects
Adult ,Male ,medicine.medical_specialty ,Multiple Sclerosis ,Logistic regression ,Antibodies, Monoclonal, Humanized ,Infections ,Cohort Studies ,03 medical and health sciences ,0302 clinical medicine ,Anti-Infective Agents ,Risk Factors ,Internal medicine ,medicine ,Humans ,Immunologic Factors ,Pharmacology (medical) ,Original Research Article ,Retrospective Studies ,Univariate analysis ,Expanded Disability Status Scale ,business.industry ,Multiple sclerosis ,Age Factors ,Retrospective cohort study ,Middle Aged ,medicine.disease ,030227 psychiatry ,Immunoglobulin A ,Psychiatry and Mental health ,Clinical research ,Immunoglobulin G ,Ocrelizumab ,Female ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,Cohort study ,medicine.drug - 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. Supplementary Information The online version contains supplementary material available at 10.1007/s40263-021-00810-3.
- Published
- 2021