Article Dans Une Revue Neurology Année : 2024

Anti-CD20 Therapies in Drug-Naive Patients With Primary Progressive Multiple Sclerosis

1 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
2 CIC - Centre d'Investigation Clinique [Rennes]
3 HCL - Hospices Civils de Lyon
4 UCBL - Université Claude Bernard Lyon 1
5 OFSEP - Observatoire Français de la Sclérose En Plaques [Lyon]
6 CRNL - Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center
7 Fondation Eugène Devic EDMUS
8 Service de neurologie [CHRU Nancy]
9 INSPIIRE - INterdisciplinarité en Santé Publique Interventions et Instruments de mesure complexes
10 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
11 Centre d’Investigation Clinique Plurithématique (CIC - P) - CIC Strasbourg
12 U1064 Inserm - CR2TI - Centre de Recherche en Transplantation et Immunologie - Center for Research in Transplantation and Translational Immunology
13 CHU Nantes - Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
14 Service de neurologie [Hôpital Fondation Adolphe de Rothschild]
15 Service de Neurologie générale, vasculaire et dégénérative (CHU de Dijon)
16 CEP - Centre d'épidémiologie des populations
17 Pôle NIRR - Service de Neurologie [CHU Nimes]
18 IGF - Institut de Génomique Fonctionnelle
19 CHU Caen Normandie - CHU Caen Normandie – Centre Hospitalier Universitaire de Caen Normandie
20 UR2CA - Unité de Recherche Clinique Côte d’Azur
21 UniCA - Université Côte d'Azur
22 CHU Nice - Centre Hospitalier Universitaire de Nice
23 Infinity - Institut Toulousain des Maladies Infectieuses et Inflammatoires
24 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
25 CRC-SEP Toulouse - Centre Ressources et Compétences sclérose en plaques (CRC-SEP) [CHU Toulouse]
26 Service de Neurologie [CHRU Besançon]
27 ICM - Institut du Cerveau = Paris Brain Institute
28 CHU Clermont-Ferrand
29 CRC-SEP Auvergne - Centre de Ressources et de Compétences sur la Sclérose en Plaques (CRC-SEP) [Clermont-Ferrand]
30 Neuro-Dol - Neuro-Dol
31 CHU Pitié-Salpêtrière [AP-HP]
32 Centre hospitalier intercommunal de Poissy/Saint-Germain-en-Laye - CHIPS [Poissy]
33 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
34 LilNCog - Lille Neurosciences & Cognition - U 1172
35 CHU Bordeaux - Centre Hospitalier Universitaire de Bordeaux
36 U1215 Inserm - UB - Neurocentre Magendie : Physiopathologie de la Plasticité Neuronale
37 CHUGA - CHU de Grenoble-Alpes - Centre Hospitalier Universitaire CHU Grenoble
38 CHU Reims - Hôpital universitaire Robert Debré [Reims]
39 CHU Amiens-Picardie
40 CHU Rouen
41 TIMONE - Hôpital de la Timone [CHU - APHM]
42 CHU Limoges - Centre Hospitalier Universitaire Dupuytren 1 et 2
43 CHU de Poitiers [La Milétrie] - Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
44 CHU ST-E - Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne]
45 CHRU Tours - Centre Hospitalier Régional Universitaire de Tours
46 Hôpital Henri Mondor
47 Hôpital Foch [Suresnes]
48 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
49 Centre Hospitalier de Saint-Denis [Ile-de-France]
Eric Berger
Elisabeth Maillart
Bertrand Bourre

Résumé

Background and objectives: Although rituximab failed to demonstrate a significant effect on disability progression in primary progressive multiple sclerosis (PPMS), ocrelizumab succeeded. Our main objective was to analyze confirmed disability progression (CDP) in a cohort of patients with PPMS treated with anti-CD20 therapies compared with a weighted untreated control cohort. Methods: This was a retrospective study using data from the French MS registry (Observatoire Français de la Sclérose En Plaques). We included patients with PPMS treated or never treated with anti-CD20 therapies from 2016 to 2021, with an Expanded Disability Status Scale score of ≤6.5 at baseline. The primary outcome was time to first CDP. The secondary outcomes were time to first relapse, MRI activity at 2 years, identification of risk factors associated with CDP, and serious infection incidence rates (IIRs). Each outcome was studied using an inverse probability of treatment weighting method. The outcomes were modeled using a weighted proportional Cox model for the time-to-event outcomes and by a logistic regression regarding the MRI activity. Results: A total of 1,184 patients (426 treated and 758 untreated) fulfilled the inclusion criteria. Median age (Q1-Q3) was 56 years (49.3-63.8), and 52.7% were female. Among treated patients, 295 received rituximab, whereas 131 received ocrelizumab. At baseline, anti-CD20-treated patients were younger (median 51.9 vs 58.6 years, Cohen d = 0.683) and had more active disease (54.5 vs 27.8%, Cohen d = 0.562). 91.6% were drug-naive at inclusion. In time to first CDP analysis, no statistical significance was observed (hazard ratio [HR], 1.13; 95% CI 0.93-1.36, p = 0.2113). In time to first relapse analysis, a nonsignificant trend toward fewer patients relapsing in the treated group was observed (HR 0.83; 95% CI 0.48-1.28, p = 0.0809). For MRI activity, no significant difference was found between the 2 groups. Risk factors associated with CDP in the treated group were male sex and MS duration. IIR was 6.67 (95% CI 3.12-14.25) per 100 person-years in the treated group vs 2.67 (95% CI 0.80-8.86) in the untreated group. Discussion: Time to first CDP was not different between anti-CD20 treated and untreated patients with PPMS. Although our study is retrospective and mainly included patients treated by rituximab, our results indicate that there should be a constant evaluation of all available data to ascertain the best risk/benefit ratio for patients with PPMS. Classification of evidence: This study provides Class III evidence that anti-CD20 therapy of previously untreated patients with PPMS was not superior to no therapy in delaying time to first CDP.

Fichier non déposé

Dates et versions

hal-04719826 , version 1 (03-10-2024)

Identifiants

Citer

Marion Hay, Fabien Rollot, Romain Casey, Anne Kerbrat, Gilles Edan, et al.. Anti-CD20 Therapies in Drug-Naive Patients With Primary Progressive Multiple Sclerosis. Neurology, 2024, 103 (8), pp.e209886. ⟨10.1212/WNL.0000000000209886⟩. ⟨hal-04719826⟩
269 Consultations
0 Téléchargements

Altmetric

Partager

  • More