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91.
BackgroundAlthough colitis has been reported in patients treated with immune checkpoint inhibitors (ICIs), associations between colitis and ICIs had not been thoroughly assessed in real-world studies. Here, we identified and characterized significant colitis-associated with ICIs.MethodsBased on the Food and Drug Administration Adverse Event Reporting System (FAERS) from January 2004 to December 2019, the disproportionality analysis and Bayesian analysis, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN) and the multi-item gamma Poisson shrinker (MGPS) algorithms were adopted to data mining of the suspected adverse events of colitis after ICIs administrating. Clinical characteristics of patients with ICIs-associated colitis and the time to onset of colitis following different ICI regimens were collected.ResultsA total of 3786 reports of colitis adverse events were identified with ICIs. Seven ICI monotherapies were associated with the reporting of colitis. Statistically significant ROR, PRR, information component (IC), and empirical Bayesian geometric mean (EBGM) emerged for all ICI monotherapies and combination therapies. ICIs-associated colitis affected mostly male (53.51%), with a wide mean age range (60.65 to 72 years). Colitis adverse events were commonly reported in patients with melanoma and lung cancer. Adverse outcomes of colitis concerning ICI were mainly outcomes of hospitalization-initiated or prolonged and other serious. Among colitis cases, 17.43% cases of colitis concerning ICI lead to death. The adverse event of colitis occurred earliest in ipilimumab monotherapy with a median time to onset of 64.21 days (IQR: 27–69 days) among all monotherapies.ConclusionsICI may lead to severe and disabling ICIs-associated colitis during therapy. Analysis of FAERS data identified signals for adverse events of colitis with ICI regimens. Practitioners should consider the factors that may increase the likelihood of colitis. The findings support a continued surveillance and risk factor identification studies. 相似文献
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Several pharmacological agents to prevent the progression of diabetic kidney disease (DKD) have been tested in patients with type 2 diabetes mellitus (T2DM) in the past two decades. With the exception of renin-angiotensin system blockers that have shown a significant reduction in the progression of DKD in 2001, no other pharmacological agent tested in the past two decades have shown any clinically meaningful result. Recently, the sodium-glucose cotransporter-2 inhibitor (SGLT-2i), canagliflozin, has shown a significant reduction in the composite of hard renal and cardiovascular (CV) endpoints including progression of end-stage kidney disease in patients with DKD with T2DM at the top of renin-angiotensin system blocker use. Another SGLT-2i, dapagliflozin, has also shown a significant reduction in the composite of renal and CV endpoints including death in patients with chronic kidney disease (CKD), regardless of T2DM status. Similar positive findings on renal outcomes were recently reported as a top-line result of the empagliflozin trial in patients with CKD regardless of T2DM. However, the full results of this trial have not yet been published. While the use of older steroidal mineralocorticoid receptor antagonists (MRAs) such as spironolactone in DKD is associated with a significant reduction in albuminuria outcomes, a novel non-steroidal MRA finerenone has additionally shown a significant reduction in the composite of hard renal and CV endpoints in patients with DKD and T2DM, with reasonably acceptable side effects. 相似文献
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Ruben S.A. Goedegebuure Madelon Q. Wentink Hans J. van der Vliet Peter Timmerman Arjan W. Griffioen Tanja D. de Gruijl Henk M.W. Verheul 《The oncologist》2021,26(2):e218-e229
Lessons Learned
- The novel therapeutic vaccine hVEGF26–104/RFASE was found to be safe and well tolerated in patients with cancer.
- hVEGF26–104/RFASE failed to induce seroconversion against native hVEGF165 and, accordingly, neither a decrease in circulating vascular endothelial growth factor (VEGF) levels nor clinical benefit was observed.
- Remarkably, hVEGF26–104/RFASE induced VEGF165-neutralizing antibodies in a nonhuman primate model. The absence of seroconversion in human calls for caution in the interpretation of efficacy of human vaccines in nonhuman primates.
98.
Xiaofei Ye Fangyuan Hu Yinghong Zhai Yingyi Qin Jinfang Xu Xiaojing Guo Yonglong Zhuang Jia He 《Hematological oncology》2020,38(4):565-575
Immune checkpoint inhibitors (ICIs) have shown remarkable clinical effects in many cancer types. However, ICIs could also induce severe organ system toxicities, including those of the hematological system. The present study aimed to extensively characterize the hematological toxicities of ICIs immunotherapy. Data were extracted from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from January 1, 2014, to March 31, 2019. Disproportionality analysis, including information component (IC) and reporting odds ratio (ROR), was used to detect potential disproportionality signal. The lower boundary of the 95% confidence interval of IC (IC025) exceeding zero or that of ROR (ROR025) exceeding one was considered statistically significant for detecting disproportionality signal. A total of 29 294 335 records were extracted from the database, with 132 573 related to ICIs. Overall, hematological adverse events (AEs) were more frequently reported in ICIs (IC025: 0.81; ROR025: 1.80). On further analysis, hematological AEs were overreported in female patients (female vs male, ROR025: 1.04) and anti-CTLA-4 monotherapy groups (anti-CTLA-4 vs anti-PD-1, ROR025: 1.33) and polytherapy groups (polytherapy vs monotherapy, ROR: 1.20, ROR025: 1.11). Moreover, class-specific hematological AEs were also detected and differed in unique ICI regimens. Notably, disseminated intravascular coagulation had the highest proportion of death outcomes among the top 10 most frequently reported ICI-associated hematological AEs. Our study shows a high reporting frequency of hematological AEs induced by ICI monotherapy (especially by anti-CTLA-4 therapy) and reinforced by polytherapy. A spectrum of class-specific disproportionality signal was also detected; some were fatal and reported for the first time. The heterogeneous clinical spectrum of hematological toxicities, including the non-negligible proportion of death as reported outcome, are warranted to be reminded by clinicians. Early recognition and management of ICI-related hematological AEs are highly important and further studies are needed to confirm the results of our study. 相似文献
99.
卵巢癌是威胁女性健康和生命的重大疾病之一。近年来,聚腺苷二磷酸核糖聚合酶抑制剂[poly (ADP-ribose)polymerase inhibitors,PARPi]作为一类新型的靶向治疗药物为卵巢癌患者带来获益,并被国内外多项临床指南、规范推荐用于铂敏感复发卵巢癌患者的维持治疗及术后的维持治疗。但与此同时带来的安全性问题,尤其是血液学毒性值得关注。从作用机制、药代动力学出发,对比目前已上市的3种PARPi的特征及其血液学毒性差异,以期为复发性卵巢癌患者临床用药提供参考。 相似文献
100.
Cristina Masini Maria Giuseppa Vitale Marco Maruzzo Giuseppe Procopio Ugo de Giorgi Sebastiano Buti Sabrina Rossetti Roberto Iacovelli Francesco Atzori Laura Cosmai Francesca Vignani Giuseppe Prati Sarah Scagliarini Annalisa Guida Annalisa Berselli Carmine Pinto 《Clinical genitourinary cancer》2019,17(1):e150-e155