Long-term Follow-up of Multiple Sclerosis Patients Treated With Cladribine Tablets as De-escalation Strategy From AntiCD20
Claudio Gobbi1, Rosaria Sacco1, Giulio Disanto1, Giulia Mallucci2, Roberto Masciullo3, Aleksandra Maleska4, Jens Kuhle4, Chiara Zecca1
1Istituto Neurocentro della Svizzera Italiana (INSI), Ospedale Regionale di Lugano, Lugano, Switzerland and Faculty of biomedical Sciences, Università della Svizzera Italiana, Via Buffi 13, 6900 Lugano, Switzerland, 2Istituto Neurocentro della Svizzera Italiana (INSI), Ospedale Regionale di Lugano, Lugano, Switzerland., 3Istituto Neurocentro della Svizzera Italiana (INSI), Ospedale Regionale di Lugano, Lugano, Switzerland. Department of Neuroradiology, Neurocenter of Southern Switzerland, EOC, Lugano, Switzerland of biomedical Sciences, Università della Svizzera Italiana, Via Buffi 13, 6900 Lugano, Switzerland, 4Multiple Sclerosis Centre and Research Centre for Clinical Neurimmunology and Neuroscience (RC2NB), Neurology, Departments of Biomedicine and Clinical Research, University Hospital and University of Basel, Basel, Switzerland
Objective:
To investigate safety and effectiveness of switching MS patients from antiCD20 antibodies (antiCD20) to cladribine (CLAD) due to hypogammaglobulinemia and/or infection risk.
Background:
Prolonged treatment with antiCD20 may lead to hypogammaglobulinemia and increased infection risk. Treatment with CLAD is rarely associated with hypogammaglobulinemia.
Design/Methods:
Prospective, observational study including MS patients switched from antiCD20 to CLAD (CLAD-group) for hypogammaglobulinemia (IgG/IgM reduction>10%) and/or recurrent/serious infections, and patients continuing on antiCD20 (antiCD20-group). IgG/IgM, frequency/severity/type of infections, and effectiveness were compared. Wilcoxon-matched pair test and linear mixed-effect models with time*treatment group interaction term were used.
Results:
44 patients were included [27 females, median age 46 (36-55) years, 14 switchers, 30 continuers] and followed over 3.1 years.
In the CLAD group, IgG remained stable (median change: CLAD-group=-0.08 [-0.73-0.88], p=0.944; antiCD20-group=-0.33[-1.28-0.47], p=0.142), with a trend towards less reduction over time in IgG in CLAD-group versus antiCD20-group (time*treatment group: β=0.04; p=0.093). IgM remained stable in CLAD-group (median change=0.02 [-0.08-0.16], p=0.551), while decreasing in antiCD20-group (-0.12[-0.22-0.03], p<0.001), with significant time*treatment group interaction (β=0.10 p<0.001).
Thirty-seven adverse events occurred in antiCD20-group and 18 in CLAD-group, the most common being mild-moderate infections. Five (35.7%) patients in CLAD-group and 4(12.9%) in antiCD20-group had EDSS worsening. No relapses occurred. One patient in CLAD-group had a new T2 spinal lesion; one had a new brain T2 lesion and 2 new T2 spinal lesions in antiCD20-group.
NfL Z scores decreased over time in antiCD20-group, while they remained stable in CLAD-group (treatment*time interaction β= 0.35, p=0.005). GFAP Z scores decreased with time in the overall group (β= -0.32, p<0.001), with no significant difference based on treatment (treatment*time interaction β= 0.20, p=0.107).
Conclusions:
Switching from antiCD20 to CLAD due to hypogammaglobulinemia and/or increased infection risk was associated with a stabilization of IgG and IgM, a good safety profile, and maintained effectiveness.
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