e-Article
The Response Study: A French registry on pregnancy in women with MS and related disorders and their children up to 6 years-Protocol, recruitment status, and baseline characteristics.
Document Type
Academic Journal
Author
Vukusic S; Hospices Civils de Lyon, Service de Neurologie, Sclérose en Plaques, Pathologies de la Myéline et Neuro-Inflammation-Hôpital Neurologique Pierre Wertheimer, Bron Cedex, France.; Observatoire Français de la Sclérose en Plaques, Centre de Recherche en Neurosciences de Lyon, INSERM 1028 et CNRS UMR 5292, Lyon, France.; Université de Lyon, Université Claude Bernard Lyon 1, Lyon, France.; Eugène Devic EDMUS Foundation Against Multiple Sclerosis, State-Approved Foundation, Bron Cedex, France.; Bourre B; Department of Neurology, CHU Rouen, Rouen, France.; Casey R; Hospices Civils de Lyon, Service de Neurologie, Sclérose en Plaques, Pathologies de la Myéline et Neuro-Inflammation-Hôpital Neurologique Pierre Wertheimer, Bron Cedex, France.; Observatoire Français de la Sclérose en Plaques, Centre de Recherche en Neurosciences de Lyon, INSERM 1028 et CNRS UMR 5292, Lyon, France.; Université de Lyon, Université Claude Bernard Lyon 1, Lyon, France.; Eugène Devic EDMUS Foundation Against Multiple Sclerosis, State-Approved Foundation, Bron Cedex, France.; Deiva K; Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Paris Saclay, Site Bicêtre, Service de Neurologie Pédiatrique, CRMR Maladies Inflammatoires Rares du Cerveau et de la Moelle (MIRCEM), UMR 1184, Le Kremlin-Bicêtre, France.; Guennoc AM; CRC SEP, Department of neurology, CHU de Tours, Tours, France.; Lebrun-Frenay C; CRCSEP Côte d'Azur, CHU de Nice Pasteur 2, Nice, France.; UR2CA-URRIS, Université Nice Côte d'Azur, Nice, France.; Leray E; Université de Rennes, EHESP, CNRS, Inserm, Arènes-UMR 6051, RSMS (Recherche sur les Services et Management en Santé)-U 1309, Rennes, France.; Rollot F; Hospices Civils de Lyon, Service de Neurologie, Sclérose en Plaques, Pathologies de la Myéline et Neuro-Inflammation-Hôpital Neurologique Pierre Wertheimer, Bron Cedex, France.; Observatoire Français de la Sclérose en Plaques, Centre de Recherche en Neurosciences de Lyon, INSERM 1028 et CNRS UMR 5292, Lyon, France.; Université de Lyon, Université Claude Bernard Lyon 1, Lyon, France.; Eugène Devic EDMUS Foundation Against Multiple Sclerosis, State-Approved Foundation, Bron Cedex, France.; Benyahya L; Hospices Civils de Lyon, Service de Neurologie, Sclérose en Plaques, Pathologies de la Myéline et Neuro-Inflammation-Hôpital Neurologique Pierre Wertheimer, Bron Cedex, France.; Hospices Civils de Lyon, Hôpital Neurologique Pierre Wertheimer, Centre de Référence des Maladies Inflammatoires Rares du Cerveau et de la Moelle (MIRCEM), Bron Cedex, France.; Girod C; Hospices Civils de Lyon, Service de Neurologie, Sclérose en Plaques, Pathologies de la Myéline et Neuro-Inflammation-Hôpital Neurologique Pierre Wertheimer, Bron Cedex, France.; Marignier R; Hospices Civils de Lyon, Service de Neurologie, Sclérose en Plaques, Pathologies de la Myéline et Neuro-Inflammation-Hôpital Neurologique Pierre Wertheimer, Bron Cedex, France.; Hospices Civils de Lyon, Hôpital Neurologique Pierre Wertheimer, Centre de Référence des Maladies Inflammatoires Rares du Cerveau et de la Moelle (MIRCEM), Bron Cedex, France.; Centre des Neurosciences de Lyon-FORGETTING Team, INSERM 1028 et CNRS UMR5292, Lyon, France.; Université Claude Bernard Lyon 1, Lyon, France.; Maillart E; Department of Neurology, Pitié-Salpêtrière Hospital, APHP, Paris, France.
Source
Publisher: SAGE Publications Country of Publication: England NLM ID: 9509185 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1477-0970 (Electronic) Linking ISSN: 13524585 NLM ISO Abbreviation: Mult Scler Subsets: MEDLINE
Subject
Language
English
Abstract
Background: Counseling on pregnancy is still challenging, particularly regarding the use of disease-modifying treatments (DMTs). We are lacking long-term outcomes in children exposed to DMTs.
Objectives: This study aimed to set up a French pregnancy registry for women with multiple sclerosis (MS) and related disorders nested within the Observatoire Français de la Sclérose en Plaques (OFSEP) cohort.
Methods: Prospective, observational, multicentric, epidemiological study in France. Neurological visits are organized according to routine practice. Data are collected on the OFSEP minimal datasheet. Auto-questionnaires on pregnancy are completed by patients at Months 5-6 and 8 during pregnancy, and Months 3, 6, and 12 postpartum. A specific survey on analgesia is completed by anesthesiologists. Pediatric data are collected from the child's health book, where visits on Day 8, Month 9, and 24 are mandatory. Parents complete neurodevelopmental questionnaires at Year 1, Years 2 and 6.
Results: The RESPONSE study started in August 2019. On 7 April 2023, 515 women were included. Baseline demographics are presented.
Conclusions: RESPONSE will provide rich information on the global management of pregnancy in France and prospective data on children until the age of 6 years, exposed or not to a DMT, including data on neurodevelopment that can be compared to the general population.
Study Funding: EDMUS and ARSEP Foundation, Biogen, Roche.
Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: S.V. has received consulting and lecturing fees, travel grants, and unconditional research support from Biogen, Janssen, Merck, Novartis, Roche, Sandoz, and Sanofi. B.B. has received consulting and lecturing fees, travel grants, and unconditional research support from Alexion, Biogen, Horizon, Janssen, Merck, Novartis, Roche, Sandoz, and Sanofi. R.C. has no financial disclosure to declare. K.D. has received consulting and lecturing fees, travel grants, and consulting fees for advisory boards from Alexion, Biogen, Horizon, Novartis, Roche, and Sanofi. A.M.G. has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Novartis, Merck, Sanofi, and Roche. F.R. and C.L.F. have no financial disclosure to declare. E.L. has received consulting and lecturing fees, and travel grants from Alexion, Merck, Novartis, Roche, and Sanofi. L.B. and C.G. have no financial disclosure to declare. R.M. has received personal fees from Horizon Therapeutics, Alexion, Roche, and UCB and non-financial support from Horizon Therapeutics, Merck, Biogen, and Roche, outside the submitted work. E.M. reports research support from Biogen and ARSEP foundation and personal fees for lectures and advisory boards from Biogen, Janssen, Merck, Novartis, Roche, Sanofi, and Teva.
Objectives: This study aimed to set up a French pregnancy registry for women with multiple sclerosis (MS) and related disorders nested within the Observatoire Français de la Sclérose en Plaques (OFSEP) cohort.
Methods: Prospective, observational, multicentric, epidemiological study in France. Neurological visits are organized according to routine practice. Data are collected on the OFSEP minimal datasheet. Auto-questionnaires on pregnancy are completed by patients at Months 5-6 and 8 during pregnancy, and Months 3, 6, and 12 postpartum. A specific survey on analgesia is completed by anesthesiologists. Pediatric data are collected from the child's health book, where visits on Day 8, Month 9, and 24 are mandatory. Parents complete neurodevelopmental questionnaires at Year 1, Years 2 and 6.
Results: The RESPONSE study started in August 2019. On 7 April 2023, 515 women were included. Baseline demographics are presented.
Conclusions: RESPONSE will provide rich information on the global management of pregnancy in France and prospective data on children until the age of 6 years, exposed or not to a DMT, including data on neurodevelopment that can be compared to the general population.
Study Funding: EDMUS and ARSEP Foundation, Biogen, Roche.
Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: S.V. has received consulting and lecturing fees, travel grants, and unconditional research support from Biogen, Janssen, Merck, Novartis, Roche, Sandoz, and Sanofi. B.B. has received consulting and lecturing fees, travel grants, and unconditional research support from Alexion, Biogen, Horizon, Janssen, Merck, Novartis, Roche, Sandoz, and Sanofi. R.C. has no financial disclosure to declare. K.D. has received consulting and lecturing fees, travel grants, and consulting fees for advisory boards from Alexion, Biogen, Horizon, Novartis, Roche, and Sanofi. A.M.G. has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Novartis, Merck, Sanofi, and Roche. F.R. and C.L.F. have no financial disclosure to declare. E.L. has received consulting and lecturing fees, and travel grants from Alexion, Merck, Novartis, Roche, and Sanofi. L.B. and C.G. have no financial disclosure to declare. R.M. has received personal fees from Horizon Therapeutics, Alexion, Roche, and UCB and non-financial support from Horizon Therapeutics, Merck, Biogen, and Roche, outside the submitted work. E.M. reports research support from Biogen and ARSEP foundation and personal fees for lectures and advisory boards from Biogen, Janssen, Merck, Novartis, Roche, Sanofi, and Teva.