COPP-MS: COrticosteroids during the Post-Partum in relapsing Multiple Sclerosis patients.


Journal

Journal of neurology
ISSN: 1432-1459
Titre abrégé: J Neurol
Pays: Germany
ID NLM: 0423161

Informations de publication

Date de publication:
Oct 2022
Historique:
received: 10 03 2022
accepted: 03 06 2022
revised: 02 06 2022
pubmed: 24 6 2022
medline: 15 9 2022
entrez: 23 6 2022
Statut: ppublish

Résumé

No specific treatment has demonstrated its effectiveness to prevent post-partum relapses for multiple sclerosis (MS) women. To assess the effectiveness of preventive high-dose corticosteroids in the post-partum period by comparing two strategies: (1) no preventive treatment and (2) standardized preventive treatment. We selected five French Multiple Sclerosis centers using the same post-partum strategy for their patients-either high-dose steroids (treating centers TC) or no treatment (non-treating centers NTC). We included relapsing-remitting multiple sclerosis women who delivered between January 2007 and January 2017. Our primary outcomes were the time from delivery to first relapse, EDSS progression and MRI activity between patients of treating centers and non-treating centers, after propensity-score weighting. 350 patients were included (116 from treating centers, 234 from non-treating centers). For both groups, the annualized relapse rate decreased during pregnancy (0.28 in treating centers and 0.34 in non-treating centers during the third trimester) and increased during the first post-partum trimester (0.45 and 0.69, respectively) with 11% and 14% (NS) of patients facing at least one relapse, respectively. Our primary outcomes were not statistically different between both groups. This study provides class III evidence that systematic high-dose corticosteroids are not associated with a reduced inflammatory activity during the post-partum period in multiple sclerosis patients.

Sections du résumé

BACKGROUND BACKGROUND
No specific treatment has demonstrated its effectiveness to prevent post-partum relapses for multiple sclerosis (MS) women.
OBJECTIVE OBJECTIVE
To assess the effectiveness of preventive high-dose corticosteroids in the post-partum period by comparing two strategies: (1) no preventive treatment and (2) standardized preventive treatment.
METHODS METHODS
We selected five French Multiple Sclerosis centers using the same post-partum strategy for their patients-either high-dose steroids (treating centers TC) or no treatment (non-treating centers NTC). We included relapsing-remitting multiple sclerosis women who delivered between January 2007 and January 2017. Our primary outcomes were the time from delivery to first relapse, EDSS progression and MRI activity between patients of treating centers and non-treating centers, after propensity-score weighting.
RESULTS RESULTS
350 patients were included (116 from treating centers, 234 from non-treating centers). For both groups, the annualized relapse rate decreased during pregnancy (0.28 in treating centers and 0.34 in non-treating centers during the third trimester) and increased during the first post-partum trimester (0.45 and 0.69, respectively) with 11% and 14% (NS) of patients facing at least one relapse, respectively. Our primary outcomes were not statistically different between both groups.
CONCLUSION CONCLUSIONS
This study provides class III evidence that systematic high-dose corticosteroids are not associated with a reduced inflammatory activity during the post-partum period in multiple sclerosis patients.

Identifiants

pubmed: 35737108
doi: 10.1007/s00415-022-11215-7
pii: 10.1007/s00415-022-11215-7
doi:

Substances chimiques

Adrenal Cortex Hormones 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

5571-5581

Informations de copyright

© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

Références

Confavreux C, Hutchinson M, Hours MM, Cortinovis-Tourniaire P, Moreau T (1998) Rate of pregnancy-related relapse in multiple sclerosis. Pregnancy in Multiple Sclerosis Group. N Engl J Med 339:285–291
doi: 10.1056/NEJM199807303390501
Vukusic S, Hutchinson M, Hours M, Moreau T, Cortinovis-Tourniaire P, Adeleine P et al (2004) Pregnancy and multiple sclerosis (the PRIMS study): clinical predictors of post-partum relapse. Brain 127(Pt 6):1353–1360
doi: 10.1093/brain/awh152
Vukusic S, Ionescu I, Cornu C, Bossard N, Durand-Dubief F, Cotton F et al (2020) Oral nomegestrol acetate and transdermal 17-beta-estradiol for preventing post-partum relapses in multiple sclerosis: the POPARTMUS study. Mult Scler 27:1458–1463
doi: 10.1177/1352458520978218
Hughes SE, Spelman T, Gray OM, Boz C, Trojano M, Lugaresi A et al (2014) Predictors and dynamics of postpartum relapses in women with multiple sclerosis. Mult Scler 20:739–746
doi: 10.1177/1352458513507816
Fragoso YD, Boggild M, Macias-Islas MA, Carra A, Schaerer KD, Aguayo A et al (2013) The effects of long-term exposure to disease-modifying drugs during pregnancy in multiple sclerosis. Clin Neurol Neurosurg 115:154–159
doi: 10.1016/j.clineuro.2012.04.024
Hellwig K, Haghikia A, Rockhoff M, Gold R (2012) Multiple sclerosis and pregnancy: experience from a nationwide database in Germany. Ther Adv Neurol Disord 5:247–253
doi: 10.1177/1756285612453192
Alroughani R, Alowayesh MS, Ahmed SF, Behbehani R, Al-Hashel J (2018) Relapse occurrence in women with multiple sclerosis during pregnancy in the new treatment era. Neurology 90:e840–e846
doi: 10.1212/WNL.0000000000005065
Bsteh G, Algrang L, Hegen H, Auer M, Wurth S, Di Pauli F et al (2020) Pregnancy and multiple sclerosis in the DMT era: a cohort study in Western Austria. Mult Scler 26:69–78
doi: 10.1177/1352458518816614
Berenguer-Ruiz L, Gimenez-Martinez J, Palazón-Bru A, Sempere AP (2019) Relapses and obstetric outcomes in women with multiple sclerosis planning pregnancy. J Neurol 266:2512–2517
doi: 10.1007/s00415-019-09450-6
Finkelsztejn A, Fragoso YD, Ferreira MLB, Lana-Peixoto MA, Alves-Leon SV, Gomes S et al (2011) The Brazilian database on pregnancy in multiple sclerosis. Clin Neurol Neurosurg 113:277–280
doi: 10.1016/j.clineuro.2010.11.016
Jesus-Ribeiro J, Correia I, Martins AI, Fonseca M, Marques I, Batista S et al (2017) Pregnancy in Multiple Sclerosis: a Portuguese cohort study. Mult Scler Relat Disord 17:63–68
doi: 10.1016/j.msard.2017.07.002
Langer-Gould A, Smith JB, Albers KB, Xiang AH, Wu J, Kerezsi EH et al (2020) Pregnancy-related relapses and breastfeeding in a contemporary multiple sclerosis cohort. Neurology 94:e1939–e1949
doi: 10.1212/WNL.0000000000009374
Vukusic S, Durand-Dubief F, Benoit A, Marignier R, Frangoulis B, Confavreux C (2015) Natalizumab for the prevention of post-partum relapses in women with multiple sclerosis. Mult Scler 21:953–955
doi: 10.1177/1352458514554056
Portaccio E, Moiola L, Martinelli V, Annovazzi P, Ghezzi A, Zaffaroni M et al (2018) Pregnancy decision-making in women with multiple sclerosis treated with natalizumab: II: maternal risks. Neurology 90:e832–e839
doi: 10.1212/WNL.0000000000005068
Canibaño B, Deleu D, Mesraoua B, Melikyan G, Ibrahim F, Hanssens Y (2020) Pregnancy-related issues in women with multiple sclerosis: an evidence-based review with practical recommendations. J Drug Assess 9:20–36
doi: 10.1080/21556660.2020.1721507
de Seze J, Chapelotte M, Delalande S, Ferriby D, Stojkovic T, Vermersch P (2004) Intravenous corticosteroids in the postpartum period for reduction of acute exacerbations in multiple sclerosis. Mult Scler J 10:596–597
doi: 10.1191/1352458504ms1079sr
Avila-Ornelas J, Avila M, Stosic M, Robles L, Prieto PG, Hutton GJ et al (2011) The role of postpartum intravenous corticosteroids in the prevention of relapses in multiple sclerosis. Int J MS Care 13:91–93
doi: 10.7224/1537-2073-13.2.91
Hellwig K, Beste C, Schimrigk S, Chan A (2009) Immunomodulation and postpartum relapses in patients with multiple sclerosis. Ther Adv Neurol Disord 2:7–11
doi: 10.1177/1756285608100416
Brandt-Wouters E, Gerlach OHH, Hupperts RMM (2016) The effect of postpartum intravenous immunoglobulins on the relapse rate among patients with multiple sclerosis. Int J Gynaecol Obstet 134:194–196
doi: 10.1016/j.ijgo.2016.01.008
Rosa GR, O’Brien AT, de Nogueira EAG, de Carvalho VM, Paz SC, Fragoso YD (2018) There is no benefit in the use of postnatal intravenous immunoglobulin for the prevention of relapses of multiple sclerosis: findings from a systematic review and meta-analysis. Arq Neuropsiquiatr 76:361–366
doi: 10.1590/0004-282x20180041
Horvat Ledinek A, Brecl Jakob G, Jerše J, Ruška B, Pavičić T, Gabelić T et al (2020) Intravenous immunoglobulins for the prevention of postpartum relapses in multiple sclerosis. Mult Scler Relat Disord 38:101519
doi: 10.1016/j.msard.2019.101519
Winkelmann A, Rommer PS, Hecker M, Zettl UK (2018) Intravenous immunoglobulin treatment in multiple sclerosis: a prospective, rater-blinded analysis of relapse rates during pregnancy and the postnatal period. CNS Neurosci Ther 25:78–85
doi: 10.1111/cns.12985
Portaccio E, Ghezzi A, Hakiki B, Sturchio A, Martinelli V, Moiola L et al (2014) Postpartum relapses increase the risk of disability progression in multiple sclerosis: the role of disease modifying drugs. J Neurol Neurosurg Psychiatry 85:845–850
doi: 10.1136/jnnp-2013-306054
Vukusic S, Casey R, Rollot F, Brochet B, Pelletier J, Laplaud D-A et al (2020) Observatoire Français de la Sclérose en Plaques (OFSEP): a unique multimodal nationwide MS registry in France. Mult Scler 26:118–122
doi: 10.1177/1352458518815602
Confavreux C, Compston DA, Hommes OR, McDonald WI, Thompson AJ (1992) EDMUS, a European database for multiple sclerosis. J Neurol Neurosurg Psychiatry 55:671–676
doi: 10.1136/jnnp.55.8.671
Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M et al (2011) Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol 69:292–302
doi: 10.1002/ana.22366
Brookhart MA, Schneeweiss S, Rothman KJ, Glynn RJ, Avorn J, Stürmer T (2006) Variable selection for propensity score models. Am J Epidemiol 163:1149–1156
doi: 10.1093/aje/kwj149
Karim ME, Pellegrini F, Platt RW, Simoneau G, Rouette J, de Moor C. The use and quality of reporting of propensity score methods in multiple sclerosis literature: a review. Mult Scler. 2020;1352458520972557
Simoneau G, Pellegrini F, Debray TP, Rouette J, Muñoz J, Platt RW et al (2022) Recommendations for the use of propensity score methods in multiple sclerosis research. Mult Scler. https://doi.org/10.1177/13524585221085732
doi: 10.1177/13524585221085732 pubmed: 35387508 pmcid: 9260471
Zhao L, Claggett B, Tian L, Uno H, Pfeffer MA, Solomon SD et al (2016) On the restricted mean survival time curve in survival analysis. Biometrics 72:215–221
doi: 10.1111/biom.12384
RISCA: Causal Inference and Prediction in Cohort-Based Analyses version 0.9 from CRAN. https://rdrr.io/cran/RISCA/ . Accessed 26 Feb 2021
Voskuhl RR, Wang H, Wu TCJ, Sicotte NL, Nakamura K, Kurth F et al (2016) Estriol combined with glatiramer acetate for women with relapsing-remitting multiple sclerosis: a randomised, placebo-controlled, phase 2 trial. Lancet Neurol 15:35–46
doi: 10.1016/S1474-4422(15)00322-1
Hellwig K, Rockhoff M, Herbstritt S, Borisow N, Haghikia A, Elias-Hamp B et al (2015) Exclusive breastfeeding and the effect on postpartum multiple sclerosis relapses. JAMA Neurol 72:1132–1138
doi: 10.1001/jamaneurol.2015.1806
Krysko KM, Rutatangwa A, Graves J, Lazar A, Waubant E (2020) Association between breastfeeding and postpartum multiple sclerosis relapses: a systematic review and meta-analysis. JAMA Neurol 77:327–338
doi: 10.1001/jamaneurol.2019.4173
Couvrat-Desvergnes G, Foucher Y, Le Borgne F, Dion A, Mourad G, Garrigue V et al (2019) Comparison of graft and patient survival according to the transplantation centre policy for 1-year screening biopsy among stable kidney recipients: a propensity score-based study. Nephrol Dial Transplant 34:703–711
doi: 10.1093/ndt/gfy221
Edan G, Miller D, Clanet M, Confavreux C, Lyon-Caen O, Lubetzki C et al (1997) Therapeutic effect of mitoxantrone combined with methylprednisolone in multiple sclerosis: a randomised multicentre study of active disease using MRI and clinical criteria. J Neurol Neurosurg Psychiatry 62:112–118
doi: 10.1136/jnnp.62.2.112

Auteurs

Soizic Leguy (S)

Neurology Department, CRC-SEP Rennes, Rennes Clinical Investigation Center, Rennes University Hospital Rennes University INSERM, CHU Pontchaillou, 35033, Rennes, France.

Mathilde Lefort (M)

EHESP, CNRS, Inserm, Arènes, UMR 6051, RSMS (Recherche sur les Services et Management en Santé), University Rennes, U 1309, 35000, Rennes, France.
CHU Rennes, Inserm, CIC 1414 [(Centre d'Investigation Clinique de Rennes)], University Rennes, 35000, Rennes, France.

Lucile Lescot (L)

Neurology Department, CRC-SEP Rennes, Rennes Clinical Investigation Center, Rennes University Hospital Rennes University INSERM, CHU Pontchaillou, 35033, Rennes, France.

Audrey Michaud (A)

EHESP, CNRS, Inserm, Arènes, UMR 6051, RSMS (Recherche sur les Services et Management en Santé), University Rennes, U 1309, 35000, Rennes, France.

Sandra Vukusic (S)

Service de Neurologie, Sclérose en Plaques, Pathologies de la Myéline et Neuro-Inflammation et Centre de Recherche, Ressources et Compétences sur la Sclérose en Plaques, Hospices Civils de Lyon, 69677, Bron, France.
Inserm 1028 et CNRS UMR 5292, Observatoire Français de la Sclérose en Plaques, Centre de Recherche en Neurosciences de Lyon, 69003, Lyon, France.
Université de Lyon, université Claude-Bernard Lyon 1, 69000, Lyon, France.
Eugène Devic EDMUS Foundation Against Multiple Sclerosis, state-approved foundation, 69677, Bron, France.

Emmanuelle Le Page (E)

Neurology Department, CRC-SEP Rennes, Rennes Clinical Investigation Center, Rennes University Hospital Rennes University INSERM, CHU Pontchaillou, 35033, Rennes, France.
CHU Rennes, Inserm, CIC 1414 [(Centre d'Investigation Clinique de Rennes)], University Rennes, 35000, Rennes, France.

Gilles Edan (G)

Neurology Department, CRC-SEP Rennes, Rennes Clinical Investigation Center, Rennes University Hospital Rennes University INSERM, CHU Pontchaillou, 35033, Rennes, France.
CHU Rennes, Inserm, CIC 1414 [(Centre d'Investigation Clinique de Rennes)], University Rennes, 35000, Rennes, France.

Anne Kerbrat (A)

Neurology Department, CRC-SEP Rennes, Rennes Clinical Investigation Center, Rennes University Hospital Rennes University INSERM, CHU Pontchaillou, 35033, Rennes, France.
CHU Rennes, Inserm, CIC 1414 [(Centre d'Investigation Clinique de Rennes)], University Rennes, 35000, Rennes, France.

Christine Lebrun-Frenay (C)

CRCSEP, CHU de Nice Pasteur 2, Université Nice Côte d'Azur UR2CA URRIS, Nice, France.

Jérôme De Sèze (J)

CRCSEP, CHU de Nice Pasteur 2, Université Nice Côte d'Azur UR2CA URRIS, Nice, France.
Centre d'investigation Clinique, INSERM U1434, Centre Hospitalier Universitaire de Strasbourg, 1 Place de l'Hôpital, 67000, Strasbourg, France.

David-Axel Laplaud (DA)

Centre de Recherche en Transplantation et Immunologie UMR1064, INSERM; Université de Nantes, CHU de Nantes France, Nantes, France.

Sandrine Wiertlewski (S)

Centre de Recherche en Transplantation et Immunologie UMR1064, INSERM; Université de Nantes, CHU de Nantes France, Nantes, France.

Emmanuelle Leray (E)

EHESP, CNRS, Inserm, Arènes, UMR 6051, RSMS (Recherche sur les Services et Management en Santé), University Rennes, U 1309, 35000, Rennes, France.
CHU Rennes, Inserm, CIC 1414 [(Centre d'Investigation Clinique de Rennes)], University Rennes, 35000, Rennes, France.

Laure Michel (L)

Neurology Department, CRC-SEP Rennes, Rennes Clinical Investigation Center, Rennes University Hospital Rennes University INSERM, CHU Pontchaillou, 35033, Rennes, France. laure.michel@chu-rennes.fr.
CHU Rennes, Inserm, CIC 1414 [(Centre d'Investigation Clinique de Rennes)], University Rennes, 35000, Rennes, France. laure.michel@chu-rennes.fr.
Microenvironment, Cell Differentiation, Immunology and Cancer Unit, INSERM, Rennes I University, French Blood Agency, Rennes, France. laure.michel@chu-rennes.fr.

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