학술논문
Natalizumab extended-interval dosing in a real-life setting.
Document Type
Academic Journal
Author
Jeantin L; Neurology department, Hopital Fondation Adolphe de Rothschild, 25-29 rue Manin, Paris, France.; Boudot de la Motte M; Neurology department, Hopital Fondation Adolphe de Rothschild, 25-29 rue Manin, Paris, France.; Deschamps R; Neurology department, Hopital Fondation Adolphe de Rothschild, 25-29 rue Manin, Paris, France.; Gueguen A; Neurology department, Hopital Fondation Adolphe de Rothschild, 25-29 rue Manin, Paris, France.; Gout O; Neurology department, Hopital Fondation Adolphe de Rothschild, 25-29 rue Manin, Paris, France.; Lecler A; Neuroradiology department, Hopital Fondation Adolphe de Rothschild, 25-29 rue Manin, Paris, France.; Papeix C; Neurology department, Hopital Fondation Adolphe de Rothschild, 25-29 rue Manin, Paris, France.; Bensa C; Neurology department, Hopital Fondation Adolphe de Rothschild, 25-29 rue Manin, Paris, France. Electronic address: cbensa@for.paris.
Source
Publisher: Elsevier Country of Publication: Netherlands NLM ID: 0375403 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1878-5883 (Electronic) Linking ISSN: 0022510X NLM ISO Abbreviation: J Neurol Sci Subsets: MEDLINE
Subject
Language
English
Abstract
Background: Natalizumab is a high-efficacy therapy for recurrent multiple sclerosis (RMS) with a four-week administration interval. Controlled trials have shown that extending this interval to six weeks led to better safety without increasing the risk of relapse. We aimed to analyze the safety of extending the natalizumab interdose interval from 4 to 6 weeks in a real-life setting.
Methods: This monocentric retrospective self-controlled study included adult patients with RMS treated with natalizumab with a four-week interval between infusions for a minimum of six months, before switching to a six-week interval. The main outcomes were the incidence of MS relapse, new MRI lesions, and MRI activity signs during the two periods, with patients being their own controls.
Results: Fifty-seven patients were included in the analysis. The mean (95%CI) annualized relapse rate (AAR) before natalizumab introduction was 1.03 (0.52; 1.55). During the four-week interval dosing period, no patient presented with an MS relapse, and seven (13.5%) patients had new MRI lesions. During the six-week interval dosing period, no relapse was observed and two (3.6%) patients had new MRI lesions.
Conclusion: We did not observe more relapses or signs of MRI activity when extending the interval between natalizumab infusions from four to six weeks.
Competing Interests: Conflicts of interest LJ, RD, OG, AL, AG, CP: nothing to disclose. MBM received personal compensation for consulting and travel fees from Biogen and Merck. CB received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alexion, Biogen, BMS-Celgene, Merck, Novartis, Teva, and Sanofi-Genzyme.
(Copyright © 2023 Elsevier B.V. All rights reserved.)
Methods: This monocentric retrospective self-controlled study included adult patients with RMS treated with natalizumab with a four-week interval between infusions for a minimum of six months, before switching to a six-week interval. The main outcomes were the incidence of MS relapse, new MRI lesions, and MRI activity signs during the two periods, with patients being their own controls.
Results: Fifty-seven patients were included in the analysis. The mean (95%CI) annualized relapse rate (AAR) before natalizumab introduction was 1.03 (0.52; 1.55). During the four-week interval dosing period, no patient presented with an MS relapse, and seven (13.5%) patients had new MRI lesions. During the six-week interval dosing period, no relapse was observed and two (3.6%) patients had new MRI lesions.
Conclusion: We did not observe more relapses or signs of MRI activity when extending the interval between natalizumab infusions from four to six weeks.
Competing Interests: Conflicts of interest LJ, RD, OG, AL, AG, CP: nothing to disclose. MBM received personal compensation for consulting and travel fees from Biogen and Merck. CB received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alexion, Biogen, BMS-Celgene, Merck, Novartis, Teva, and Sanofi-Genzyme.
(Copyright © 2023 Elsevier B.V. All rights reserved.)