Background The immunogenicity of infliximab (IFX) is a major reason for secondary loss of response to intravenous (IV) IFX treatment. A lower incidence of anti-drug antibodies (ADA) with subcutaneous (SC) IFX treatment compared to IFX IV has been described1,2. Furthermore, data on four patients with immunogenic failure or allergic reactions to IFX IV documented safety of exposure to IFX SC3. Here, we analyzed the efficacy and safety of IFX SC in IBD patients with previous immunogenic/allergic failure to IFX IV in a monocentric analysis conducted at the Dresden University Hospital. Methods Immunogenic failure was defined as presence of ADA and low/undetectable IFX trough levels during IFX IV therapy. Patients received IFX SC 120 mg every other week (EOW). HBI and partial Mayo, IFX trough levels, free ADA, and fecal calprotectin (FCP) were determined at wk 0 and wk 12. Clinical remission was defined as HBI<5 or partial Mayo≤1. FCP<250ug/g was considered biochemical remission. Results Ten patients (7/10 with active IBD and 3/10 in remission) were included. All patients had previously developed ADA during IFX IV treatment. Two patients had suffered an IFX infusion-related allergic reaction. Baseline demographic parameters are shown in table 1. Patients were extensively pretreated (5/10 had previous treatment with ≥3 biologics). 5/10 patients were switched from ongoing IV application to IFX SC, while 5/10 were started on IFX SC without IFX IV induction. During follow up, 6/10 patients did not reach IFX trough levels≥3ug/ml, of whom four patients showed detectable ADA. 2/10 patients developed mild injection site reactions. No severe immediate hypersensitivity reactions were observed. Treatment persistence across wk 12 was 70% (7/10), while 3/10 patients discontinued IFX SC due to lack of efficacy. In the active IBD group, clinical remission at wk 12 was achieved in 1/7 patients. 2/7 patients showed a decrease in FCP from baseline to wk 12. Among the three patients who entered the study in remission, all maintained clinical and biochemical remission until wk 12 (3/3). Conclusion In this cohort, exposure of patients with previous immunogenic/allergic failure of IFX IV was well tolerated and safe. However, only a minority of patients established significant IFX through levels with EOW IFX SC therapy and clinical responses were heterogeneous. Further studies are required to assess the safety and efficacy of IFX SC in patients with previous immunogenic IFX failure and to investigate the value of dose intensification and/or interval shortening of IFX SC in this patient population. References: 1 Smith et al, J Crohn Colitis, 2022 2 Schreiber et al, Gastroenterol, 2021 3 Caron et al, Aliment Pharmacol Ther, 2022
In media coverage, the context of the German energy transition, also referred to as Energiewende, casts a spotlight not only on various technology options (e.g. wind or coal power) but also on more abstract topics such as security of supply or electricity prices. Thereby, the public's assessment of energy-related issues may greatly rely on perceived risks. Focusing on the quality of energy-related risk reporting, this contribution therefore is intended to explore the German print and TV media discourse on energy options or topics. In our sample, one in three articles connects an energy option or topic with an evident or potential unwanted event. Although the media's effect on actual risk perception involves some controversies, researchers tend to criticize the media as being susceptible to framing and for failing to place unwanted events in perspective, e.g. by not presenting the corresponding likelihood of occurrence, which is necessary to define risk. If this critique holds true, accurate public risk assessment is partly hampered because media coverage implies uncertainty rather than providing all information available. We examined seven indicators of quality reporting derived from literature research: intensity, likelihood, controllability, desired uncertainty, sensationalism, emotional language, and type of unwanted event. Based on German energy media coverage in 2013, we found a relatively high occurrence of intensity and controllability, whereas likelihood and desired uncertainty were reported less often. By aggregating the indicators into a risk-reporting quality index, we did not observe a poor quality of risk reporting on energy issues. In contrast to previous research, the overall quality of energy-related risk reporting can be assessed as at least moderate, implying that the media depicts risks more precisely than assumed. The occurrence of quality indicators thereby significantly depends on the type of unwanted event rather than on the energy option considered. MotivationAlthough energy-related risks have always been a major public interest and media coverage concern, the advancing transition of the German energy system toward a more sustainable quality (Federal Ministry of Economics and Technology 2012) has added further complexity to the energy technology discourse. This contribution intends to explore the German media discourse on energy issues with a focus on its quality of risk reporting, thus not only contributing to risk communication research in general but also providing valuable insights into the current energy technology discourse.
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