Key result
Immune checkpoint inhibitors linked to significant overreporting of capillary leak syndrome versus other drugs.
Why the study?
Although a few case reports suggested immune checkpoint inhibitors may induce capillary leak syndrome, an incidental finding could not be ruled out.
Do immune checkpoint inhibitors increase the risk of capillary leak syndrome compared to all other drugs?
Systematic Review (n=47)
Yes
Do immune checkpoint inhibitors increase the risk of capillary leak syndrome compared to all other drugs?
Effect estimate: IC 2.4 (95% CI 1.8 to 2.8)
Immune checkpoint inhibitors are associated with a significant safety signal for capillary leak syndrome, which presents with a delayed onset and carries a high mortality rate.
Alerts clinicians to monitor for capillary leak syndrome with immune checkpoint inhibitors; extends pharmacovigilance signals but leaves causality open.
BACKGROUND: Although a few case reports have shown that immune checkpoint inhibitors (ICIs) are potential inducers of capillary leak syndrome (CLS), an incidental finding cannot be ruled out. The aim of this study was to describe the clinical characteristics of ICI-induced CLS through a systematic review and to assess a potential safety signal. METHODS: Medline/PubMed, Embase, and Reactions Weekly were screened, and a global disproportionality study was performed using the World Health Organization pharmacovigilance database through January 15, 2023. A signal of disproportionate reporting was defined as a Bayesian information component (IC) with a 95% credibility interval (CrI) lower boundary that exceeds 0. RESULTS: A total of 47 cases of ICI-associated CLS were included, 14 from the systematic review (of 61 screened articles) and 33 from VigiBase (of 34,058,481 reports of adverse drug reactions). The median time to CLS onset from the start of ICI was 12 weeks (interquartile range 8-49, n = 24). A total of 57% (8/14) of patients experienced an immune-related adverse event (irAE) before CLS. A fatal outcome was reported in 23% (7/31) of patients. A significant overreporting of CLS was found with ICIs compared with all other drugs (IC 2.4, 95% CrI from 1.8 to 2.8). CONCLUSION: This study showed a significant signal of disproportionality reporting for ICI-induced CLS, characterized by a long time to onset, and compared with the idiopathic form of the disease with a less abrupt onset and a less consistent hemoconcentration pattern.
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So et al. (2023) conducted a systematic review in Immune checkpoint inhibitor-associated capillary leak syndrome (n=47). Immune checkpoint inhibitors vs. All other drugs was evaluated on Signal of disproportionate reporting for capillary leak syndrome (IC 2.4, 95% CI 1.8 to 2.8). Immune checkpoint inhibitors were associated with a significant overreporting of capillary leak syndrome compared with all other drugs (IC 2.4; 95% CrI 1.8-2.8).
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