Pierre de Flon1, Martin Gunnarsson2, Katarina Laurell2, Lars Söderström2, Richard Birgander2, Thomas Lindqvist2, Wolfgang Krauss2, Ann Dring2, Joakim Bergman2, Peter Sundström2, Anders Svenningsson2. 1. From the Department of Pharmacology and Clinical Neuroscience, Unit of Neurology, Östersund (P.d.F., K.L.), Umeå University; Department of Radiation Sciences, Diagnostic Radiology (R.B., T.L.), and Department of Pharmacology and Clinical Neuroscience (A.D., J.B., P.S., A.S.), Umeå University; Department of Neurology, School of Medical Sciences (M.G.), Department of Radiology (W.K.), Faculty of Medicine and Health, Örebro University; Unit of Research, Education and Development (L.S.), Region Jämtland Härjedalen; and Department of Clinical Sciences (A.S.), Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden. pierre.deflon@regionjh.se. 2. From the Department of Pharmacology and Clinical Neuroscience, Unit of Neurology, Östersund (P.d.F., K.L.), Umeå University; Department of Radiation Sciences, Diagnostic Radiology (R.B., T.L.), and Department of Pharmacology and Clinical Neuroscience (A.D., J.B., P.S., A.S.), Umeå University; Department of Neurology, School of Medical Sciences (M.G.), Department of Radiology (W.K.), Faculty of Medicine and Health, Örebro University; Unit of Research, Education and Development (L.S.), Region Jämtland Härjedalen; and Department of Clinical Sciences (A.S.), Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.
Abstract
OBJECTIVE: To describe the effects of switching treatment from ongoing first-line injectable therapies to rituximab on inflammatory activity measured by MRI and levels of CSF neurofilament light chain (CSF-NFL) in a cohort of patients with clinically stable relapsing-remitting multiple sclerosis (RRMS). METHOD: Seventy-five patients with clinically stable RRMS treated with the first-line injectables interferon-β (IFN-β) and glatiramer acetate (GA) at 3 Swedish centers were switched to rituximab in this open-label phase II multicenter study. After a run-in period of 3 months, 2 IV doses of 1,000 mg rituximab were given 2 weeks apart followed by repeated clinical assessment, MRI, and CSF-NFL for 24 months. RESULTS: The mean cumulated number of gadolinium-enhancing lesions per patient at months 3 and 6 after treatment shift to rituximab was reduced compared to the run-in period (0.028 vs 0.36, p = 0.029). During the first year after treatment shift, the mean number of new or enlarged T2 lesions per patient was reduced (0.01 vs 0.28, p = 0.004) and mean CSF-NFL levels were reduced by 21% (p = 0.01). CONCLUSIONS: For patients with RRMS, a treatment switch from IFN or GA to rituximab is associated with reduced inflammatory activity measured by MRI and CSF-NFL. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that rituximab has an equal or superior effect in reducing inflammatory activity in RRMS measured by MRI and CSF-NFL compared to first-line injectables during the first year after treatment shift.
OBJECTIVE: To describe the effects of switching treatment from ongoing first-line injectable therapies to rituximab on inflammatory activity measured by MRI and levels of CSF neurofilament light chain (CSF-NFL) in a cohort of patients with clinically stable relapsing-remitting multiple sclerosis (RRMS). METHOD: Seventy-five patients with clinically stable RRMS treated with the first-line injectables interferon-β (IFN-β) and glatiramer acetate (GA) at 3 Swedish centers were switched to rituximab in this open-label phase II multicenter study. After a run-in period of 3 months, 2 IV doses of 1,000 mg rituximab were given 2 weeks apart followed by repeated clinical assessment, MRI, and CSF-NFL for 24 months. RESULTS: The mean cumulated number of gadolinium-enhancing lesions per patient at months 3 and 6 after treatment shift to rituximab was reduced compared to the run-in period (0.028 vs 0.36, p = 0.029). During the first year after treatment shift, the mean number of new or enlarged T2 lesions per patient was reduced (0.01 vs 0.28, p = 0.004) and mean CSF-NFL levels were reduced by 21% (p = 0.01). CONCLUSIONS: For patients with RRMS, a treatment switch from IFN or GA to rituximab is associated with reduced inflammatory activity measured by MRI and CSF-NFL. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that rituximab has an equal or superior effect in reducing inflammatory activity in RRMS measured by MRI and CSF-NFL compared to first-line injectables during the first year after treatment shift.
Authors: Sarah Harris; Giancarlo Comi; Bruce A C Cree; Douglas L Arnold; Lawrence Steinman; James K Sheffield; Harry Southworth; Ludwig Kappos; Jeffrey A Cohen Journal: Eur J Neurol Date: 2021-08-23 Impact factor: 6.288
Authors: Irene Eriksson; Thomas Cars; Fredrik Piehl; Rickard E Malmström; Björn Wettermark; Mia von Euler Journal: Eur J Clin Pharmacol Date: 2017-11-11 Impact factor: 2.953