Background
The efficacy and safety of complement inhibition in COVID-19 patients is unclear.
Methods
A multicenter randomized controlled, open-label trial. Hospitalized COVID-19 patients with signs of systemic inflammation and hypoxemia (PaO2/FiO2 below 350 mmHg) were randomized (2:1 ratio) to receive standard of care with or without the C5 inhibitor zilucoplan daily for 14 days, under antibiotic prophylaxis. The primary outcome was improvement in oxygenation at day 6 and 15.
Results
81 patients were randomly assigned to zilucoplan (n = 55) or the control group (n = 26). 78 patients were included in the safety and primary analysis. Most were men (87%) and the median age was 63 years. The mean improvement in PaO2/FiO2 from baseline to day 6 was 56.4 mmHg in the zilucoplan group and 20.6 mmHg in the control group (mean difference + 35.8; 95% confidence interval (CI) − 9.4 to 80.9; p = 0.12), an effect also observed at day 15. Day 28 mortality was 9% in the zilucoplan and 21% in the control group (odds ratio 0.4; 95% CI 0.1 to 1.5). At long-term follow up, the distance walked in a 6-min test was 539.7 m in zilucoplan and 490.6 m in the control group (p = 0.18). Zilucoplan lowered serum C5b-9 (p < 0.001) and interleukin-8 (p = 0.03) concentration compared with control. No relevant safety differences between the zilucoplan and control group were identified.
Conclusion
Administration of zilucoplan to COVID-19 patients in this proof-of-concept randomized trial was well tolerated under antibiotic prophylaxis. While not reaching statistical significance, indicators of respiratory function (PaO2/FiO2) and clinical outcome (mortality and 6-min walk test) suggest that C5 inhibition might be beneficial, although this requires further research in larger randomized studies.
4622 Background: Patient adherence to oral therapy is a critical issue in cancer treatment. The aim of this study is to investigate the prevalence and severity of non-adherence to OAD in mRCC and to identify factors predictive of non-adherence. Methods: Prospective observational multicenter trial performed at 11 Belgian academic and non-academic centers. All pts with mRCC starting OADs (sunitinib, pazopanib, everolimus or sorafenib) are eligible for the study. Pts are contacted by phone at baseline and at 1, 3, 6 and 12 months. At each contact, pts are asked to complete questionnaires investigating 1) medication adherence (MMAS), 2) patient satisfaction with treatment (CTSQ) and with treatment education (PS-CaTE), 3) the extent of information desire (EID), 4) quality of life (FACT-G and FKSI) and 5) the role of the pharmacist (SWiP). Adherence is measured using an electronic medication event monitoring system (MEMS, Aardex). Results: Between 02/2011 and 11/2011, 49 pts (m: 33, f: 16) with a median age of 63 years (range 25 - 87) have participated in the IPSOC study. Twenty-nine pts (64%) were treated with an OAD in first-line, 15 pts (33%) in second-line. With a median follow-up of 131 days (range 2 - 313) 45 pts (92%) claimed to be fully adherent to their treatment (based on MMAS and CTSQ data). Four patients indicated to have missed at least one dose, of whom two indicated they occasionally forgot their medication and two others interrupted treatment because of side effects. Based on MEMS data, mean adherence, defined as the percentage of days with at least the prescribed number of dosage taken, was 98.91%. Conclusions: The IPSOC study, the first to examine adherence to OAD among mRCC pts, shows that mRCC pts are almost fully adherent to treatment recommendations. This seems to be in contrast to adherence data for other, long-lasting, anti-cancer treatments. Further investigations will focus on the question whether extensive counseling and participation in side-effect programs contribute to the high percentage of adherence in this study.
Inflammatory bowel disease (IBD) predominantly affects the gastro-intestinal tract. There is however a large array of extra intestinal manifestations (EIM) associated with these diseases. A lesser known EIM is pulmonary involvement, which has been first described in 1973. Since the introduction of HRCT more attention is guided towards this specific involvement. Awareness of pulmonary involvement in IBD-patients may lead to better screening, guide appropriate therapy, and ultimately result in better patient care. When untreated, serious and persisting complications, such as stenosis or strictures of the large airways, as well as bronchiectasis or bronchiolitis obliterans might occur.
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