Safety of Interleukin-23 Inhibitor: A Pharmacovigilance Study From 2014
to 2022 Based on FAERS
Abstract
Background: Interleukin-23 (IL-23) inhibitors are widely used in
clinical practice for Psoriasis , but multiple adverse events (AEs) have
been reported. We aimed to describe the distribution of AEs related
IL-23 inhibitors including Guselkumab, Tildrakizumab, Risankizumab,
Ustekinumab. Methods: Data from January 1, 2014, to September 30, 2022
were extracted from the FDA Adverse Event Reporting System (FAERS).
Disproportionality analysis including reporting odds ratio (ROR) and
information component (IC) was performed to access potential signals. It
was defined a signal when the lower limit of 95% confidence interval
(CI) of ROR (ROR025) more than one or IC(IC025) exceeding zero, with the
number of cases greater than or equal to three at the same time.
Results: A total of 41,408,408 drug-AE reports were extracted from the
FAERS database involving 13271168 people. 704, 13164, 62853, 11399
patients have used Tildrakizumab, Guselkumab, Ustekinumab, Risankizumab
and 8, 20, 107 and 115 signals were found respectively. The “infections
and infestations” has the highest incidence of SOC in
Tildrakizumab(6/8), Guselkumab(5/20), Ustekinumab(50/107),
Risankizumab(25/115). Conclusion: Our pharmacovigilance analysis showed
that a high frequency was reported for AEs triggered by IL-23
inhibitors. IL-23 inhibitors had the potential to impair immune function
resulting in a risk of infections or cancers. We need to pay special
attention to Risankizumab because the drug has more AE occurrences than
Ustekinumab despite Risankizumab has few reports than Ustekinumab and
launched later than Ustekinumab.