V Atemnkeng Ntam1, A Klein1,2, G Horneff1,2. 1. Asklepios Clinic Sankt Augustin, Centre of Pediatric Rheumatology , Sankt Augustin, Germany. 2. Department of Pediatrics, University Clinic, University of Cologne , Germany.
Abstract
Background: The IL-1 receptor-antagonist anakinra is recommended for the treatment of systemic juvenile idiopathic arthritis (sJIA) and was recently approved for first-line treatment. Long-term data from clinical practise are scarce. Methods: SJIA patients from the German biologics in pediatric rheumatology (BIKER) registry starting anakinra were grouped into two cohorts: Patients in the first-line cohort received no prior sJIA treatment except NSAID and a maximum of 3 days of steroids. Second-line cohort patients were pre-treated with steroids; DMARDs or biologics. Patient characteristics, disease-activity parameters, efficacy, and safety-parameters were compared. Results: Until December 2018, 51 anakinra patients were documented, representing 117.96 patient-years. Mean disease duration was 3.5 (± 3.8) years. At baseline, all anakinra first-line users had active systemic disease compared to 82% in the second-line users. Significant JADAS-10 improvement at last follow-up was observed in both cohorts (p = 0.02, p = 0.0014). Substantial numbers of patients in both groups reached JADAS-MDA/JADAS-remission/inactive disease (66.7%50%50% in first-liners and 60%45%70% in second-liners). Rates of serious adverse events were comparable and consistent with the overall AE profile of anakinra in patients. Conclusion: This analysis adds to the established safety profile of anakinra and demonstrates that anakinra is effective as first-line or second-line treatment.
Background: The IL-1 receptor-antagonist anakinra is recommended for the treatment of systemic juvenile idiopathic arthritis (sJIA) and was recently approved for first-line treatment. Long-term data from clinical practise are scarce. Methods: SJIA patients from the German biologics in pediatric rheumatology (BIKER) registry starting anakinra were grouped into two cohorts: Patients in the first-line cohort received no prior sJIA treatment except NSAID and a maximum of 3 days of steroids. Second-line cohort patients were pre-treated with steroids; DMARDs or biologics. Patient characteristics, disease-activity parameters, efficacy, and safety-parameters were compared. Results: Until December 2018, 51 anakinra patients were documented, representing 117.96 patient-years. Mean disease duration was 3.5 (± 3.8) years. At baseline, all anakinra first-line users had active systemic disease compared to 82% in the second-line users. Significant JADAS-10 improvement at last follow-up was observed in both cohorts (p = 0.02, p = 0.0014). Substantial numbers of patients in both groups reached JADAS-MDA/JADAS-remission/inactive disease (66.7%50%50% in first-liners and 60%45%70% in second-liners). Rates of serious adverse events were comparable and consistent with the overall AE profile of anakinra in patients. Conclusion: This analysis adds to the established safety profile of anakinra and demonstrates that anakinra is effective as first-line or second-line treatment.
Authors: Antonio Vitale; Francesca Della Casa; Giuseppe Lopalco; Rosa Maria Pereira; Piero Ruscitti; Roberto Giacomelli; Gaafar Ragab; Francesco La Torre; Elena Bartoloni; Emanuela Del Giudice; Claudia Lomater; Giacomo Emmi; Marcello Govoni; Maria Cristina Maggio; Armin Maier; Joanna Makowska; Benson Ogunjimi; Petros P Sfikakis; Paolo Sfriso; Carla Gaggiano; Florenzo Iannone; Marília A Dagostin; Ilenia Di Cola; Luca Navarini; Ayman Abdelmonem Ahmed Mahmoud; Fabio Cardinale; Ilenia Riccucci; Maria Pia Paroli; Elena Maria Marucco; Irene Mattioli; Jurgen Sota; Anna Abbruzzese; Isabele P B Antonelli; Paola Cipriani; Abdurrahman Tufan; Claudia Fabiani; Mustafa Mahmoud Ramadan; Marco Cattalini; Riza Can Kardas; Gian Domenico Sebastiani; Henrique A Mayrink Giardini; José Hernández-Rodríguez; Violetta Mastrorilli; Ewa Więsik-Szewczyk; Micol Frassi; Valeria Caggiano; Salvatore Telesca; Heitor F Giordano; Emmanuele Guadalupi; Teresa Giani; Alessandra Renieri; Sergio Colella; Giulia Cataldi; Martina Gentile; Alessandra Fabbiani; Ibrahim A Al-Maghlouth; Bruno Frediani; Alberto Balistreri; Donato Rigante; Luca Cantarini Journal: Front Med (Lausanne) Date: 2022-04-07