Jean-Hugues Salmon1,2, Jeanne-Marie Perotin3,4, Jacques Morel5, Moustapha Dramé2,6, Alain Cantagrel7, Liana Euller Ziegler8, Philippe Ravaud9, Jean Sibilia8, Isabelle Pane10,11, Xavier Mariette12,13, Jacques-Eric Gottenberg10,14. 1. Rheumatology Department, Maison Blanche Hospital, Reims University Hospitals, Reims. 2. Faculty of Medicine, University of Reims Champagne-Ardenne, EA, 3797. 3. Department of Respiratory Diseases and Allergology, Maison Blanche Hospital, Reims University Hospitals. 4. INSERM UMRS 903, University of Reims Champagne-Ardenne, Reims. 5. Department of Rheumatology, University of Montpellier and Teaching Hospital Lapeyronie, Montpellier. 6. Department of Research and Innovation, Robert Debré Hospital, Reims University Hospitals, Reims. 7. Rheumatology Department, Purpan Hospital, Paul Sabatier University, Toulouse. 8. Department of Rheumatology, L'Archet Hospital, Nice. 9. Centre de Recherche en Epidémiologie et Statistiques, INSERM U1153, Centre d'Épidémiologie Clinique, Hôpital Hôtel-Dieu, Assistance Publique-Hôpitaux de Paris (AP-HP), Descartes University, Paris. 10. Rheumatology Department, National Center for Rare Systemic Autoimmune Diseases, Hôpitaux Universitaires de Strasbourg, Strasbourg. 11. INSERM UMRS_1109, Université de Strasbourg, Strasbourg. 12. Department of Rheumatology, Hôpitaux Universitaires Paris-Sud, Assistance Publique-Hôpitaux de Paris, Le Kremlin Bicêtre. 13. INSERM U1184, IMVA: Center of Immunology of Viral Infections and Autoimmune Diseases, Le Kremlin Bicêtre. 14. CNRS, Institut de Biologie Moléculaire et Cellulaire, Immunopathologie et Chimie Thérapeutique/Laboratory of Excellence Medalis, Université de Strasbourg, Strasbourg, France.
Abstract
Objective: The aim was to evaluate the incidence of serious infusion-related reactions (SIRRs) in RA treated by non-TNF-targeted biologics. Methods: We analysed data from three independent prospective registers, namely autoimmunity and rituximab, Orencia (abatacept) and RA (ORA) and Registry RoAcTEmra (tocilizumab), promoted by the French Society of Rheumatology and including patients with RA. SIRRs were defined by an occurrence during or within 24 h of an infusion and requiring discontinuation of treatment. Characteristics of patients with SIRRs were extracted from the electronic database. Results: Among the 4145 patients, SIRRs occurred in 100 patients: 56 patients with the rituximab cohort (2.8% or 0.7/100 patient-years), 15 with the abatacept cohort (1.5% or 0.6/100 patient-years) and 29 with tocilizumab (1.9% or 1/100 patient-years). No fatal SIRR occurred. A previous mild infusion reaction to non-TNF-targeted biologics was observed in a quarter of patients with SIRRs. After pooled multivariate analysis, positive anti-CCP was associated with a higher risk of SIRR (odds ratio = 2.5; 95% CI: 1.01, 6.17). Absence of concomitant treatment with a synthetic DMARD tended to be associated with a higher risk of SIRR (odds ratio = 1.67; 95% CI: 1.00, 2.86). Conclusion: In daily practice, SIRRs are slightly more frequent than in clinical trials and rarely life threatening. In common practice, serological status (anti-CCP positivity) and absence of concomitant treatment with a synthetic DMARD increase the risk of SIRR.
Objective: The aim was to evaluate the incidence of serious infusion-related reactions (SIRRs) in RA treated by non-TNF-targeted biologics. Methods: We analysed data from three independent prospective registers, namely autoimmunity and rituximab, Orencia (abatacept) and RA (ORA) and Registry RoAcTEmra (tocilizumab), promoted by the French Society of Rheumatology and including patients with RA. SIRRs were defined by an occurrence during or within 24 h of an infusion and requiring discontinuation of treatment. Characteristics of patients with SIRRs were extracted from the electronic database. Results: Among the 4145 patients, SIRRs occurred in 100 patients: 56 patients with the rituximab cohort (2.8% or 0.7/100 patient-years), 15 with the abatacept cohort (1.5% or 0.6/100 patient-years) and 29 with tocilizumab (1.9% or 1/100 patient-years). No fatal SIRR occurred. A previous mild infusion reaction to non-TNF-targeted biologics was observed in a quarter of patients with SIRRs. After pooled multivariate analysis, positive anti-CCP was associated with a higher risk of SIRR (odds ratio = 2.5; 95% CI: 1.01, 6.17). Absence of concomitant treatment with a synthetic DMARD tended to be associated with a higher risk of SIRR (odds ratio = 1.67; 95% CI: 1.00, 2.86). Conclusion: In daily practice, SIRRs are slightly more frequent than in clinical trials and rarely life threatening. In common practice, serological status (anti-CCP positivity) and absence of concomitant treatment with a synthetic DMARD increase the risk of SIRR.
Authors: Surabhi S Vinod; Annelle B Reed; Jamelle Maxwell; Randy Q Cron; Matthew L Stoll Journal: Pediatr Rheumatol Online J Date: 2018-03-09 Impact factor: 3.054
Authors: Chris Wincup; Madhvi Menon; Edward Smith; Ann Schwartz; David Isenberg; Elizabeth C Jury; Claudia Mauri Journal: Ann Rheum Dis Date: 2019-03-28 Impact factor: 19.103
Authors: Madina Tugizova; Luka Vlahovic; Anna Tomczak; Nora Sandrine Wetzel; May Htwe Han Journal: Curr Treat Options Neurol Date: 2021-03-30 Impact factor: 3.972