Risk of hypogammaglobulinemia in long-term treatment with rituximab in multiple sclerosis
ECTRIMS Online Library. Hallberg S. Sep 11, 2019; 279398; 64
Susanna Hallberg
Susanna Hallberg

Abstract: 64

Type: Scientific Session

Abstract Category: Therapy - Risk management for disease modifying treatments

S. Hallberg1, M. Boremalm2, B. Evertsson3, E. Lillvall4, F. Johansson1, J. Lycke4, F. Piehl3, J. Salzer2, A. Svenningsson1

1Department of Clinical Sciences, KIDS, Karolinska Institutet, Stockholm, 2Department of Pharmacology and Clinical Neuroscience, Umeå Universitet, Umeå, 3Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, 4Department of Clinical Neuroscience, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

Introduction: Rituximab is an anti-CD20-therapy used off-label for multiple sclerosis (MS) with high efficacy and tolerability. From studies in rheumatology and in Neuromyelitis Optica Spectrum Disorders (NMOSD), hypogammaglobulinemia is a well-known side effect which can lead to treatment discontinuation and susceptibility for infections.
Objectives: To investigate the risk of developing decreasing levels of IgG during long-term treatment with rituximab in MS.
Methods: 251 patients followed at Danderyd Hospital, Stockholm, Sweden, and treated with at least one dose of rituximab were identified via the Swedish Neuro Registry (NEUROreg). Clinical data regarding age, doses and laboratory results (IgG levels and neutrophil count) were collected retrospectively from medical records.
Results: The mean time on rituximab treatment was 29,1 months. The prevailing treatment schedule was 1000 mg followed by 500 mg every 6 months for three years, thereafter individualized treatment schedule. The mean decrease in s-IgG levels was 0.39 g/L (confidence interval 0.25 - 0.53) in all patients. 6,0% of patients (n = 15) developed s-IgG levels below 6.7 g/L. 17.2 % (n = 43) patients had a decrease in s-IgG levels of 2,0 g/L or more. There was no significant difference in between age groups (< 40, 40-50, >50 years) for a decrease in s-IgG level >2,0 g/L.
Conclusions: The findings are in line with previously studied cohorts with rituximab treatment for NMOSD and rheumatic diseases. The risk of hypogammaglobulinemia is an important side-effect in long-term rituximab treatment in MS, therefore monitoring IgG levels should be done regularly. Data will be presented from an extended cohort involving four large MS centers in Sweden and also the results of several predictive factors, such as accumulated rituximab dose, B-cell depletion rate, age and previous immunomodulatory treatment.
Disclosure: Susanna Hallberg has received honoraria for advisory boards from Merck AB and Biogen. Malin Boremalm: nothing to disclose. Björn Evertsson: nothing to disclose. Ellen Lillvall: nothing to disclose. Fredrik Johansson: nothing to disclose. Jan Lycke: nothing to disclose. Fredrik Piehl has received research grants from Biogen, Genzyme, Merck KGaA and Novartis, and fees for serving as Chair of DMC in clinical trials with Parexel. Jonatan Salzer: nothing to disclose. Anders Svenningsson: nothing to disclose.

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