New ulcerative colitis and Crohnâ€™s disease cases were uncommon in plaque psoriasis patients administered ixekizumab.
A recent study squashed increasing concerns that plaque psoriasis medications trigger inflammatory bowel disease (IBD).
IBD and plaque psoriasis have significant genetic overlap, and prior studies show IBD occurs more frequently in patients with psoriasis. The underlying pathogenesis of this co-occurrence remains unknown, however.
In a study published in the American Journal of Dermatology, investigators sought to report adjudicated IBD cases in patients exposed to ixekizumab (Taltz). Ixekizumab is an antibody approved to treat plaque psoriasis. It is designed to target a cytokine believed to play a role in the development of IBD.
To determine if there was a correlation between the 2 disease states, investigators analyzed adverse events (AEs) integrated from 7 randomized controlled and uncontrolled clinical trials. The data were analyzed for the controlled induction period, controlled maintenance period, and all patients treated with ixekizumab.
Cases suspected of IBD were reviewed by blinded external experts who used internationally recognized criteria.
Investigators included data from a total of 4029 patients with moderate-to-severe plaque psoriasis exposed to any dose of ixekizumab in the 7 ongoing and complete trials. According to the study, follow-up was up to 256 weeks, comprising 6480 patient-exposure years.
The results of the study from the overall safety population showed 29 patients reported suspected Crohn’s disease or ulcerative colitis. Nineteen were adjudicated as definite or probable.
The rates of new IBD cases were uncommon, only occurring in less than 1% of patients with plaque psoriasis who received ixekizumab, according to the study. Furthermore, flares of preexisting disease were also found to be a rare occurrence.
Limitations to the study were the post-hoc nature of the adjudication—–which may have limited the data needed for IBD confirmation––and the case report forms lacked specific questions for patient and family IBD history.
“Moving forward, ongoing and future ixekizumab trials include a comprehensive data-collection process that will provide greater detail for evaluation of potential IBD cases,” the authors concluded. “This continued vigilance and postmarketing surveillance will help improve understanding of IBD incidence rates during treatment with this IL-17A antagonist.”