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3. Safety and efficacy of anakinra as first-line or second-line therapy for systemic onset juvenile idiopathic arthritis - data from the German BIKER registry

Author

Atemnkeng Ntam, V., Klein, A, and Horneff, G.

Abstract

ABSTRACTBackground: 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.

Published
2021
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4. Safety and efficacy of anakinra as first-line or second-line therapy for systemic onset juvenile idiopathic arthritis-data from the German BIKER registry

Author

Atemnkeng Ntam, V., Klein, A., Horneff, G., Atemnkeng Ntam, V., Klein, A., and Horneff, G.

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.

5. Safety and efficacy of anakinra as first-line or second-line therapy for systemic onset juvenile idiopathic arthritis-data from the German BIKER registry

Author

Atemnkeng Ntam, V., Klein, A., Horneff, G., Atemnkeng Ntam, V., Klein, A., and Horneff, G.

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.

6. The influence of age, gender and pharmacogenetic profiles on the perspective on medicines in the German EMPAR study.

Author

Atemnkeng Ntam V, Huebner T, Steffens M, Roethlein C, Haenisch B, Stingl J, Linder R, and Scholl C

Subjects
Humans, Male, Female, Germany, Middle Aged, Adult, Aged, Sex Factors, Surveys and Questionnaires, Age Factors, Drug-Related Side Effects and Adverse Reactions, Retrospective Studies, Young Adult, Adolescent, Aged, 80 and over, Pharmacogenetics
Abstract

Background: Pharmacogenetic testing in routine care could provide benefits for patients, doctors and statutory health insurances. Therefore, the aim of the retrospective, observational study Einfluss metabolischer Profile auf die Arzneimitteltherapiesicherheit in der Routineversorgung (EMPAR) was to analyze the relationship between pharmacogenetic profiles, the risk of adverse drug reactions, and patients' perceptions of drug therapy in 10748 adult (≥18 years) participants in Germany., Methods: A questionnaire was used to assess views and beliefs about medicines and participants individual perception of sensitivity to drug therapies. The questionnaire consisted of the Beliefs about Medicines Questionnaire (BMQ)-General scales (Overuse, Harm, Benefit), the Perceived Sensitivity to Medicines (PSM), Natural Remedy, and Gene Testing scales. The influence of gender, age, study collective, genotype and phenotype of relevant pharmacogenes on participant's perception were evaluated., Results: Overuse, PSM and Benefit scores were significantly higher among patients of the collective International Classification of Diseases and Health Related Disorders (ICD)-10 Y57.9! diagnosis, which indicates complications related to drugs, compared to the anticoagulant/antiplatelet and cholesterol-lowering drug collective. Age and gender also played a significant role in patients' perceptions, with younger patients and female participants more likely to believe in medication overuse according to the Overuse scale score compared to older and male participants. Female participants compared to male participants and the old age group compared to the young and/or middle-age subgroup, scored higher in PSM and/or Harm scales, respectively. Only a tendency of increased Harm, Overuse and PSM scores was observed in the participant group with five or more relevant actionable variants compared to subgroups with 0 up to 4 variants., Conclusions: In conclusion, patients' beliefs about medicines and their drug sensitivity perceptions are influenced by various factors including age, gender, previous complications with medicines, and with some tendency also pharmacogenetic profiles. The higher association with more negative views related to treatment indicates that there is a need to target the underlying issues in affected patient groups in order to improve compliance to treatment and outcomes in routine care. Trial registration: EMPAR was registered in the German Clinical Trials Register (DRKS) on 06 July 2018 (DRKS00013909)., Competing Interests: The authors declare no conflict of commercial or financial interests., (Copyright: © 2024 Atemnkeng Ntam et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Published
2024
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