Real world predictors of hypogammaglobulinemia and serious infections in patients receiving ocrelizumab or ofatumumab for the treatment of multiple sclerosis: The REPLACE-MS study.

INTRODUCTION

Ocrelizumab (OCR) and ofatumumab (OFB) are disease-modifying therapies (DMTs) for multiple sclerosis (MS). Patients on these DMT's are at higher risk of hypogammaglobulinemia (HGG), which may increase the risk of infections.

OBJECTIVES

To investigate the impact of OCR and OFB and patient-specific, independent factors in developing HGG and serious infections.

METHODS

This multicenter, cohort retrospective study included patients who had received induction dosing with OCR or OFB. The primary outcome was the incidence and predictors of HGG.

RESULTS

A total of 911 patients (732 OCR, 179 OFB) were included. The mean (±SD) age was 45.4 (±12.8 years), and 68.6% were female. A total of 9.8% of patients developed HGG. Univariate analysis associated older age, Caucasian race, longer time on therapy, and lower baseline immunoglobulin G (IgG) levels as potential risk factors for HGG. Multivariable regression identified age ⩾50 years (p = 0.039), Caucasian race (p = 0.0002), and time on therapy ⩾3 years (p = 0.0094) as independent risk factors for HGG. Eight percent of patients experienced a serious infection. Multivariable regression identified HGG, lymphopenia, time on therapy ⩾3 years, previous DMT use, and progressive phenotype as independent risk factors for serious infection. A propensity-score-matching analysis found no differences in HGG and serious infection rates between OCR and OFB.

CONCLUSIONS

Age over 50, Caucasian race, time on therapy 3 or more years were risk factors for HGG.