Adverse Events Induced by Nivolumab Plus Ipilimumab vs. Nivolumab Monotherapy among Cancer Patients: A Systematic Review and Meta-Analysis

Abstract

A systematic review and meta-analysis of randomized controlled trials (RCTs) were performed to examine treatment-related adverse events (TRAEs) for combination of nivolumab (NIVO) and ipilimumab (IPI) compared to NIVO monotherapy among cancer patients. We searched several databases to identify relevant RCTs. Meta-analysis was performed using random-effects model. In fourteen RCTs included in the study, we found that compared to NIVO monotherapy, combination NIVO + IPI increased the risk of any grade (Risk Ratio (RR) = 1.11), and grade 3 or 4 (RR = 1.95) TRAEs. Compared to NIVO, NIVO + IPI had higher risk for any grade colitis (RR = 4.52), pneumonitis (RR = 3.06), and diarrhea (RR = 1.68).

Keywords:

• Nivolumab
• ipilimumab
• immune checkpoint inhibitors
• adverse events
• meta-analysis

Author contributions

SK: Conceptualization, Methodology, Formal Analysis, Data Curation, Investigation, Writing-Original draft, Writing-Reviewing and Editing; JP: Formal Analysis, Data curation, Investigation, Writing-Original draft, Writing-Reviewing, and Editing; BB: Conceptualization, Data Curation, Writing-Reviewing, and Editing; AV: Conceptualization, Methodology, Data Curation, Writing-Reviewing and Editing, Investigation, Supervision.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

Available on request due to privacy/ethical restrictions.

Additional information

Funding

Dr. Vyas was partially supported by Institutional Development award # U54GM115677 from the National Institute of General Medical Sciences (NIGMS) of the National Institutes of Health, which funds Advance Clinical and Translational Research (Advance-CTR). The content is solely the responsibility of the authors and does not necessarily represent the official views of NIGMS. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.