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Objective: Biologics have an important role in the treatment of juvenile idiopathic arthritis (JIA). Long‐term safety data are limited. Direct comparison of different agents regarding occurrence of adverse events (AEs), especially of rare events, requires large quantities of patient years. In this analysis, long‐term safety with regard to AE of special interest (AESI) was compared between different biologics.
Methods: Patients with nonsystemic JIA were selected from the German BIKER registry. Safety assessments were based on AE reports. Number of AEs, serious AEs, and 25 predefined AESIs, including medically important infection, uveitis, inflammatory bowel disease, cytopenia, hepatic events, anaphylaxis, depression, pregnancy, malignancy, and death, were analyzed. Event rates and relative risks were calculated using AEs reported after first dose through 70 days after last dose.
Results: A total of 3873 patients entered the analysis with 7467 years of exposure to biologics. The most common AESIs were uveitis (n = 231) and medically important infections (n = 101). Cytopenia and elevation of transaminases were more frequent with tocilizumab (risk ratio [RR] 8.0, 95% confidence interval [CI] 4.2‐15, and RR 4.7, 95% CI 1.8‐12.2, respectively). Anaphylactic events were associated with intravenous route of administration. In patients ever exposed to biologics, eight malignancies were reported. Six pregnancies have been documented in patients with tumor necrosis factor inhibitors. No death occurred in this patient cohort during observation.
Conclusion: Surveillance of pharmacotherapy as provided by the BIKER registry is an import approach, especially for long‐term treatment of children. Overall, tolerance was acceptable. Differences between biologics were noted and should be considered in daily patient care.
Vom 19. bis 21. September fand im Forschungskolleg Humanwissenschaften die bereits dritte Bad Homburg Conference statt. Die Konferenz zum Thema Künstliche Intelligenz brachte Perspektiven aus verschiedenen wissenschaftlichen Disziplinen und der Praxis zusammen. Referentinnen und Referenten u. a. aus Informatik, Rechtswissenschaft, Medizin, Philosophie und Hirnforschung diskutierten mit Vertretern der gesellschaftlichen Praxis: Unternehmern, Industrievertretern, einem Kriminalhauptkommissar des Landeskriminalamts Hessen und einer Bürgerrechtsaktivistin und Politikberaterin aus den USA. Begrüßt wurden die Teilnehmer von ForschungskollegDirektor Prof. Dr. Matthias Lutz-Bachmann, der Vizepräsidentin der Goethe-Universität, Prof. Dr. Simone Fulda, dem Bürgermeister der Stadt Bad Homburg, Meinhard Matern, sowie der Hessischen Ministerin für Digitale Strategie und Entwicklung, Prof. Dr. Kristina Sinemus. Der Abschlusskommentar kam von Christoph Burchard, Professor für Straf- und Strafprozessrecht, Internationales und Europäisches Strafrecht, Rechtsvergleichung und Rechtstheorie an der Goethe-Universität. Der UniReport hatte Gelegenheit, mit Christoph Burchard nach der Konferenz zu sprechen.
Introduction: The Retro-IDEAL (ILUVIEN Implant for chronic DiabEtic MAcuLar edema) study is a retrospective study designed to assess real-world outcomes achieved with the ILUVIEN® (0.19 mg fluocinolone acetonide (FAc)) in patients with chronic diabetic macular edema (DME) in clinical practices in Germany.
Methods: This study was conducted across 16 sites in Germany and involved 81 eyes (63 patients) with persistent or recurrent DME and a prior suboptimal response to a first-line intravitreal therapy (primarily anti-VEGF intravitreal therapies).
Results: Patients were followed-up for 30.8 ± 11.3 months (mean ± standard deviation) and had a mean age of 68.0 ± 10.4 years. Best-recorded visual acuity (BRVA) improved by +5.5 letters at month 9 (P ⩽ 0.005, n=56; from a baseline of 49 letters) and this was maintained through to month 30 (P ⩽ 0.05, n = 42). There was a concurrent improvement in central macular thickness with a reduction from 502 µm at baseline to 338 µm at year 1 (P ⩽ 0.0001, n = 43). This effect was sustained to year 3 (i.e. 318 µm; P ⩽ 0.0001, n = 29). Mean intraocular pressure (IOP) remained constant between baseline and year 3 with a peak change of 1.9 mm Hg occurring at year 1. Elevated IOP was observed in a similar percentage of patients prior to (22.2% of cases) and following (27.2%) treatment with the FAc implant. In the majority of cases, these elevations were managed effectively with IOP medications.
Conclusions: Despite substantial amounts of prior intravitreal treatments – primarily with anti–vascular endothelial growth factor (VEGF) drugs – this real-world study showed that sustained structural and functional improvements can last for up to 3 years with a single FAc implant.
In his widely acclaimed book “Das Kalte Herz” (The Cold Heart), economic historian Werner Plumpe tells the story of the history of capitalism, which in his view represents a sober form of economics which has proved itself superior and higher performing than other systems. To this day, the long tradition of capitalism criticism has not understood that in capitalism, great wealth is utilized to produce goods that are usually affordable for people with small incomes.
Prof. Axel Honneth hat zum Ende des letzten Jahres die Leitung des Instituts für Sozialforschung (IFS) abgegeben; seit 2001 stand er an der Spitze des Instituts, das Max Horkheimer und Theodor W. Adorno berühmt gemacht haben. Der UniReport hatte die Gelegenheit, mit dem Sozialphilosophen, der noch eine Professur an der Columbia University in New York innehat, in der altehrwürdigen Adorno-Bibliothek im Institut zu sprechen.