Real-world Study of Lenvatinib-related Colitis Based on FAERS Database

OBJECTIVE To investigate the relationship between lenvatinib and colitis based on the FAERS database. METHODS Based on FAERS data from 2015 q1 to 2021q3, the cases of colitis reported following lenvatinib were retrievaled and the disproportionality and Bayesian analysis were employed for data mining. The onset time to colitis, the dose of lenvatinib using and the patient outcomes were also evaluated. RESULTS A total of 101 cases of lenvatinib-associated colitis were retrieved. The number of reported cases of colitis following lenvatinib had increased year by year, and most of these cases were submitted by physicians. Hospitalization or prolonged hospitalization(77, 76.24%) was the most common adverse event reported outcome. All 4 methods found an association between lenvatinib and colitis(ROR=3.66, 95%CI=3.01-4.46; PRR=3.63, χ²=189.96; IC=1.86, IC025=1.53; EBGM=3.62, EBGM05=3.07). The 66 patients(82.50%) received lenvatinib dose more than 12 mg. Most of the colitis occurred within 60 d, accounting for 58.21%. CONCLUSION There is a correlation between lenvatinib and colitis. When lenvatinib is used, colitis should be considered and patients receiving lenvatinib should be carefully monitored for signs of colitis or abdominal symptoms.