| アブストラクト | BACKGROUND: Immune checkpoint inhibitor (ICI) therapy has demonstrated impressive clinical benefits across cancers. However, adverse drug reactions (ADRs) occur in every organ system, often due to autoimmune syndromes. We sought to investigate the association between ICI therapy and nephrotoxicity using a pharmacovigilance database, hypothesizing that inflammatory nephrotoxic syndromes would be reported more frequently in association with ICIs. METHODS: We analyzed VigiBase, the World Health Organization pharmacovigilance database, to identify renal ADRs (rADRs), such as nephritis, nephropathy and vascular disorders, reported in association with ICI therapy. We performed a disproportionality analysis to explore if rADRs were reported at a different rate with one of the ICI drugs compared with rADRs in the entire database, using an empirical Bayes estimator as a significance screen and defining the effect size with a reporting odds ratio (ROR). RESULTS: We found 2341 rADR for all examined ICI drugs, with a disproportionality signal solely for nephritis [ROR = 3.67, 95% confidence interval (CI) 3.34-4.04]. Examining the different drugs separately, pembrolizumab, nivolumab and ipilimumab + nivolumab combination therapy had significantly higher reporting odds of nephritis than the other ICI drugs (ROR = 4.54, 95% CI 3.81-5.4; ROR = 3.94, 95% CI 3.40-4.56; ROR 3.59, 95% CI 2.71-4.76, respectively). CONCLUSIONS: Using a pharmacovigilance method, we found increased odds of nephritis when examining rADRs associated with ICI therapy. Pembrolizumab, nivolumab and a combination of ipilimumab + nivolumab showed the highest odds. Clinicians should consider these findings and be aware of the increased risk of nephritis, especially in patients treated with pembrolizumab, when administering ICI therapy. |
|---|
| ジャーナル名 | Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association |
|---|
| 投稿日 | 2021/5/25 |
|---|
| 投稿者 | Haeuser, Lorine; Marchese, Maya; Cone, Eugene B; Noldus, Joachim; Bayliss, George; Kilbridge, Kerry Laing; Trinh, Quoc-Dien |
|---|
| 組織名 | Division of Urological Surgery and Center for Surgery and Public Health, Brigham;and Women's Hospital, Harvard Medical School, Boston, MA, USA.;Department of Urology and Neuro-Urology, Marien Hospital Herne, Ruhr-University,;Bochum, Germany.;Division of Kidney Diseases and Hypertension, Rhode Island Hospital, Alpert;Medical School, Brown University, Providence, RI, USA.;Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, MA,;USA. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/34028534/ |
|---|
