Real-world safety experience with immune checkpoint inhibitors in Saudi Arabia

• Published in: Science progress (1916) 2021-01, Vol.104 (1), p.1-14
• Main Authors: Nuhait, Mohammed Al, Bajnaid, Eshtyag, Otaibi, Abdulmalik Al, Shammari, Abdullah Al, Awlah, Yousef Al
• Format: Article
• Language: English
• Subjects: Abnormalities; Adverse events; Cancer; Diarrhea; Diarrhea - chemically induced; Diarrhea - drug therapy; Drug-Related Side Effects and Adverse Reactions - drug therapy; Emergencies; Emergency medical care; Emergency medical services; Health care; Health services; Humans; Immune checkpoint inhibitors; Immune Checkpoint Inhibitors - adverse effects; Immune system; Immunosuppressive Agents; Immunotherapy; Inhibitors; Liver; Monoclonal antibodies; Nausea; Nausea - chemically induced; Nausea - drug therapy; Neutropenia; Neutropenia - chemically induced; Neutropenia - drug therapy; Nivolumab - adverse effects; Oncology; Patients; Pembrolizumab; Pneumonitis; Population studies; Reagents; Retrospective Studies; Safety; Saudi Arabia; Side effects; Steroid hormones; Steroids; Targeted cancer therapy; Thrombocytopenia; Thrombocytopenia - chemically induced; Thrombocytopenia - drug therapy; Thyroxine; Vomiting; Vomiting - chemically induced; Vomiting - drug therapy
• ISSN: 0036-8504; 2047-7163
• DOI: 10.1177/0036850421997302

Lay abstract Real-world safety experience with immune checkpoint inhibitors in Saudi Arabia: Immune Checkpoint Inhibitors (ICIs) are rapidly growing and changing cancer care. With introduction of ICIs the landscape for cancer treatment has changed significantly. ICIs are known to induce immune-related adverse effects. This research is intended to shed light on ICIs and describe our safety experience with these agents. This study is a retrospective cohort study aimed to determine the safety of ICIs and its related adverse events at a tertiary hospital in Saudi Arabia. The study was conducted in the oncology center at King Abdulaziz Medical City, Riyadh. We identified study participants by using electronic health care system (BestCare)® to involve patients who received ICIs treatment during the study period from January 2016 up to December 2018, to include a total of 53 patients. Most of our patients were on nivolumab (37 patients) followed by atezolizumab (10 patients), and pembrolizumab (6 patients). The average number of emergency room visits after receiving treatment was three visits per patient. Renal adverse events occurred following ICIs use in nine patients, and none of the reported cases experienced a grade ≥3 event. Moreover, 13 patients experienced a hepatic adverse event, of whom only 1 patient experienced a grade ≥3 event leading to treatment discontinuation. As for diarrhea, among all patients who received ICIs, 14 patients experienced diarrhea, and 5 of them had grade ≥3 events. Also, thyroxine abnormalities occurred in seven patients. While, Pneumonitis occurred in four patients following ICIs use. In addition, we noticed other adverse events with ICIs including (skin reaction, nausea, vomiting, thrombocytopenia, neutropenia, and neurological adverse events). Furthermore, 17 patients required steroids to manage ICIs adverse events. And, no patients in our study required additional management with other immunosuppressive agents. Immunotherapies are rapidly growing and changing cancer care. Immune Checkpoint Inhibitors (ICIs) have the ability to block inhibitory checkpoints and restore the functions of the immune system. ICIs are used for the treatment of several types of cancer, and nowadays, many studies are ongoing in order to get approvals for newer indications. ICIs are known to induce immune-related adverse effects. The safety of ICIs and the most common immune-related adverse events are not yet well recognized for our population since th