Julien Henry1, Jacques-Eric Gottenberg2, Stéphanie Rouanet3, Stephan Pavy1, Jeremie Sellam4, Florence Tubach5, Rakiba Belkhir1, Xavier Mariette1, Raphaèle Seror1. 1. Institut pour la Santé et la Recherche Médicale (INSERM) U1184, Rhumatologie, Université Paris-Sud, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux universitaires Paris-Sud, Center of Immunology of Viral Infections and Autoimmune Diseases (IMVA), Le Kremlin Bicêtre, Paris. 2. Rhumatologie, Centre National de Référence des Maladies Auto-Immunes Rares, INSERM UMRS_1109, Fédération de Médecine Translationnelle de Strasbourg (FMTS), Strasbourg university Hospital, Université de Strasbourg, Strasbourg. 3. Statistician Unit, StatEthic, Levallois-Perret. 4. Rhumatologie, Université Paris 06, Assistance Publique-Hôpitaux de Paris (AP-HP), Sorbonne Universités, Inserm UMRS_938, DHU i2B, Hôpital Saint Antoine. 5. Département Biostatistique, Santé Publique et Information Médicale, Univ Paris 06, Sorbonne Universités, Assistance Publique-Hôpitaux de Paris (AP-HP), Inserm UMRS1123, Hôpital Pitié-Salpêtrière, Paris, France.
Abstract
Objective: To investigate maintenance of rituximab (RTX) in RA patients re-treated with reduced doses compared with standard dose in a real life setting. Methods: The Autoimmunity and Rituximab (AIR) registry is a nationwide prospective observational cohort investigating the long-term safety and efficacy of RTX in RA. The present study included patients from the AIR registry that have been re-treated with RTX after a first course of RTX standard dose (1000 mg × 2). Two groups were defined according to dose of RTX of the first retreatment course (i.e. second course): standard dose group and reduced dose group. Five years' maintenance and rate of serious infections of the retreatment period were compared between standard dose and reduced dose groups. Analyses used the inverse probability of treatment weighting propensity score adjusted method. Results: Among the 1986 patients from the AIR registry, 1278 were included, 1093 (85.5%) treated with standard dose and 185 (14.5%) with reduced doses. Maintenance of RTX at 5 years in the standard and reduced groups was 55.5 and 53.8%, respectively, and did not significantly differ between groups in adjusted analyses (hazard ratio = 1.03; 95% CI: 0.81, 1.30), but the cumulative RTX dose received for retreatment [1.4 (0.6) vs 2.3 (1.0) g/year, P < 0.001] and the rate of serious infections were significantly lower in the reduced dose group (adjusted hazard ratio = 0.50; 95% CI: 0.27, 0.92; P = 0.02). Conclusion: Use of reduced doses of RTX for retreatment did not alter the maintenance of RTX at 5 years in RA patients, but allowed a 39% total dose reduction and a lower rate of serious infections.
Objective: To investigate maintenance of rituximab (RTX) in RApatients re-treated with reduced doses compared with standard dose in a real life setting. Methods: The Autoimmunity and Rituximab (AIR) registry is a nationwide prospective observational cohort investigating the long-term safety and efficacy of RTX in RA. The present study included patients from the AIR registry that have been re-treated with RTX after a first course of RTX standard dose (1000 mg × 2). Two groups were defined according to dose of RTX of the first retreatment course (i.e. second course): standard dose group and reduced dose group. Five years' maintenance and rate of serious infections of the retreatment period were compared between standard dose and reduced dose groups. Analyses used the inverse probability of treatment weighting propensity score adjusted method. Results: Among the 1986 patients from the AIR registry, 1278 were included, 1093 (85.5%) treated with standard dose and 185 (14.5%) with reduced doses. Maintenance of RTX at 5 years in the standard and reduced groups was 55.5 and 53.8%, respectively, and did not significantly differ between groups in adjusted analyses (hazard ratio = 1.03; 95% CI: 0.81, 1.30), but the cumulative RTX dose received for retreatment [1.4 (0.6) vs 2.3 (1.0) g/year, P < 0.001] and the rate of serious infections were significantly lower in the reduced dose group (adjusted hazard ratio = 0.50; 95% CI: 0.27, 0.92; P = 0.02). Conclusion: Use of reduced doses of RTX for retreatment did not alter the maintenance of RTX at 5 years in RApatients, but allowed a 39% total dose reduction and a lower rate of serious infections.
Authors: Fabiola Atzeni; Javier Rodríguez-Carrio; Călin D Popa; Michael T Nurmohamed; Gabriella Szűcs; Zoltán Szekanecz Journal: Nat Rev Rheumatol Date: 2021-04-08 Impact factor: 20.543