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LymphoTEC: a Retrospective Real-World Study on Lymphocyte Reconstitution After Lymphopenia in Patients with Multiple Sclerosis Treated with Dimethyl Fumarate in France - Archive ouverte HAL
Article Dans Une Revue Advances in Therapy Année : 2025

LymphoTEC: a Retrospective Real-World Study on Lymphocyte Reconstitution After Lymphopenia in Patients with Multiple Sclerosis Treated with Dimethyl Fumarate in France

1 Centre d’Investigation Clinique Plurithématique (CIC - P) - CIC Strasbourg
2 Service de Neurologie [Strasbourg]
3 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
4 Infinity - Institut Toulousain des Maladies Infectieuses et Inflammatoires
5 Département Immunologie [CHU Toulouse]
6 Centre Hospitalier de Dax
7 CHU Dijon
8 Hôpital Européen [Fondation Ambroise Paré - Marseille]
9 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
10 LilNCog - Lille Neurosciences & Cognition - U 1172
11 HCL - Hospices Civils de Lyon
12 OFSEP - Observatoire Français de la Sclérose En Plaques [Lyon]
13 UCBL - Université Claude Bernard Lyon 1
14 Fondation Eugène Devic EDMUS
15 CRNL - Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center
16 Service de neurologie [CHRU Nancy]
17 INSPIIRE - INterdisciplinarité en Santé Publique Interventions et Instruments de mesure complexes
18 CIC - Centre d'Investigation Clinique [Rennes]
19 CRC-SEP Toulouse - Centre Ressources et Compétences sclérose en plaques (CRC-SEP) [CHU Toulouse]
20 CHU Bordeaux - Centre Hospitalier Universitaire de Bordeaux
21 U1215 Inserm - UB - Neurocentre Magendie : Physiopathologie de la Plasticité Neuronale
22 CHU Pitié-Salpêtrière [AP-HP]
23 Centre de Ressources et de Compétences Sclérose en Plaques (CRC-SEP) Paris
24 CRC-SEP Nord-Pas de Calais - Centre de Ressources et de Compétences sur la Sclérose en Plaques (CRC-SEP) [Lille]
25 Hôpital Fondation Adolphe de Rothschild = Adolphe de Rothschild Foundation Hospital
26 CHU Caen
27 CHU - Hôpital Pasteur [Nice]
28 UR2CA URRIS - UR2CA - URRIS - Unité de Recherche sur le syndrome Radiologique ISolé et maladies apparentées
29 CHU Nantes - Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
30 Team 5 - U1064 Inserm - CR2TI - Team 5 : Neuroinflammation, mechanisms, therapeutic options (NEMO)
31 Service de Neurologie [CHRU Besançon]
32 CHU Clermont-Ferrand
33 Neuro-Dol - Neuro-Dol
34 Pôle NIRR - Service de Neurologie [CHU Nimes]
35 IGF - Institut de Génomique Fonctionnelle
36 Centre hospitalier intercommunal de Poissy/Saint-Germain-en-Laye - CHIPS [Poissy]
37 TIMONE - Hôpital de la Timone [CHU - APHM]
38 AMU - Aix Marseille Université
39 CHU Saint-Antoine [AP-HP]
40 SU - Sorbonne Université
41 CHUGA - Centre Hospitalier Universitaire [CHU Grenoble]
42 TIMC-T-RAIG - Translational Research in Autoimmunity and Inflammation Group
43 CHU Rouen
44 Hôpital Henri Mondor
45 Hôpital Dupuytren [CHU Limoges]
46 CHU ST-E - Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne]
47 Hôpital Bretonneau
48 CRC-SEP - Centre de Ressources et de Compétences Sclérose en Plaques (CRC-SEP) [Tours]
49 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
50 Centre Hospitalier de Saint-Denis [Ile-de-France]
51 CHU de Poitiers [La Milétrie] - Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
52 Centre Hospitalier René Dubos [Pontoise]
53 Biogen International GmbH (Baar)
54 Biogen [Cambridge, Massachusetts, USA]
55 Biogen France SAS (Paris)
Mikel Martinez
  • Fonction : Auteur
  • PersonId : 1516273
Thibault Moreau
Laure Michel
  • Fonction : Auteur
  • PersonId : 1093556
Gilles Defer
  • Fonction : Auteur
  • PersonId : 860250
Eric Berger
  • Fonction : Auteur
  • PersonId : 1516281
Pierre Clavelou
  • Fonction : Auteur
  • PersonId : 919245
Bertrand Bourre
  • Fonction : Auteur
  • PersonId : 1516286
Abir Wahab
  • Fonction : Auteur
  • PersonId : 1516287
Laurent Magy
Corinne Pottier
  • Fonction : Auteur
  • PersonId : 1516293
Pamela Dobay
  • Fonction : Auteur
  • PersonId : 1516294
Seth Levin
  • Fonction : Auteur
  • PersonId : 1516295
Marilyn Gros
Marta Ruiz

Résumé

Introduction: Dimethyl fumarate (DMF) has demonstrated a favorable benefit-risk profile in patients with relapsing-remitting multiple sclerosis (RRMS). Some patients may develop lymphopenia on DMF; therefore, LymphoTEC evaluated absolute lymphocyte count (ALC) reconstitution after DMF discontinuation. Methods: LymphoTEC was a retrospective, multicenter study of patients with RRMS in the Observatoire Français de la Sclérose en Plaques registry. Times to ALC reconstitution and lymphopenia were estimated by the Kaplan-Meier method. Univariate and multivariate analyses evaluated factors associated with ALC reconstitution after DMF discontinuation or lymphopenia after DMF initiation. Patients treated with DMF for ≥ 3 months with ≥ 1 ALC in the 6 months before/close to DMF initiation and ≥ 1 ALC during treatment were included. Results: Overall, 1429 RRMS patients were included; 356 patients developed lymphopenia, of whom 183 discontinued DMF. Overall, ALC decreased by 33% over the first year and plateaued thereafter. The probability of developing lymphopenia was 18.2% after 1 year. In patients with lymphopenia, median times to ALC reconstitution after DMF discontinuation were 3.8 months overall, 4.0 months for Grade 1 lymphopenia, 3.0 months for Grade 2, and 9.7 months for Grade 3. At 12 months, 83.0% had reconstituted ALC. In DMF discontinuers, median time to discontinuation was 1.2 years. There was no increased risk of serious or opportunistic infections in patients with lymphopenia. No cases of progressive multifocal leukoencephalopathy were reported. First ALC reconstitution after DMF discontinuation was associated with diabetes, DMF duration, DMF duration before lymphopenia, and DMF duration after lymphopenia; first lymphopenia after DMF initiation was associated with age and ALC at DMF initiation. Conclusion: LymphoTEC confirms previous reports on DMF-induced lymphopenia; the benefit-risk profile of DMF remains favorable. Most cases of lymphopenia were not severe and ALC reconstitution typically occurred within 4 months of DMF discontinuation. Patients with shorter and milder lymphopenia had faster ALC reconstitution. Trial registration: ClinicalTrials.gov NCT04756687

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Dates et versions

hal-04978826 , version 1 (05-03-2025)

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Jérôme de Sèze, Pierre Labauge, Roland Liblau, Mikel Martinez, Thibault Moreau, et al.. LymphoTEC: a Retrospective Real-World Study on Lymphocyte Reconstitution After Lymphopenia in Patients with Multiple Sclerosis Treated with Dimethyl Fumarate in France. Advances in Therapy, 2025, 42 (4), pp.1760-1782. ⟨10.1007/s12325-024-03092-5⟩. ⟨hal-04978826⟩
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