Abstract:
OBJECTIVE To conduct data mining and analysis on the adverse events of interleukin-17A inhibitors in the aspects of inflammatory bowel disease(IBD) in order to provide reference for clinical safety application.
METHODS Adverse events of IBD, Crohn’s disease(CD) and ulcerative colitis(UC) were collected from FDA Adverse Event Reporting System(FAERS) during the first quarter of 2004 to the fourth quarter of 2021 with secukinumab, ixekizumab and brodalumab as the primary suspect drugs. The reported odds ratio method(ROR) and proportional reported odds ratio method(PRR) were used to detect and analysis the signal.
RESULTS A total of 2 578 IBD-related reports were collected, including 2 286(88%) for secukinumab, 289(11%) for ixekizumab and 3(1%) for brodalumab, involving 810 patients with psoriasis. The incidence of serious adverse events of the three drugs were 32.47%, 33.11% and 33.33%, which were mainly “Hospitalization/Initial or Prolonged”. The IBD signal that didn’t distinguish CD or UC was the strongest signal with secukinumabROR=4.123, 95%CI(3.564, 4.769), PRR=4.116, 95%CI(3.559, 4.759) and ixekizumabROR=5.503, 95%CI(4.127, 7.336), PRR=5.448, 95%CI(4.12, 7.31), no relevant signal was detected with brodalumab.
CONCLUSION Both secukinumab and ixekizumab have the risk of causing IBD, and the incidence of serious adverse events is high, which may affect the quality of life. Attention should be paid during the application of these drugs, especially for the patients with high-risk of IBD.