Inflammatory bowel disease among patients with psoriasis treated with ixekizumab: A presentation of adjudicated data from an integrated database of 7 randomized controlled and uncontrolled trials

Abstract

From an integrated database of 7 ixekizumab psoriasis trials, CD and UC cases were uncommon (<1%).

Systematic review with meta‐analysis: risk of new onset IBD with the use of anti‐interleukin‐17 agents

“…Overall, a total of 12 cases of IBD were reported among 12 614 patients in the treatment arms corresponding to an incidence of 2.4 cases per 1000 patient‐year, whereas zero cases of new onset IBD were reported among 4076 patients in the placebo group. The low incident rate reported in the current meta‐analysis is similar to a rate of 1.9/1000 patient‐year, which was reported by a group that investigated the risk of IBD associated with ixekizumab in both RCTs and uncontrolled trials . Similar incident rate has also been observed in a long‐term safety study of secukinumab in patients with plaque psoriasis .…”

“…which was reported by a group that investigated the risk of IBD associated with ixekizumab in both RCTs and uncontrolled trials. 47 Similar incident rate has also been observed in a long-term safety study of secukinumab in patients with plaque psoriasis. 48 The incidence rate of 2.4 per 1000 patient-years found in our study falls within the reported range of 0.29 to 4.6 per 1000 person-years among observational studies assessing the risk of IBD among psoriasis patients, but appears to be much higher compared to the incidence of 0.18 per 1000 person-years of the US general population.…”

“…Longer treatment periods may increase the likelihood of developing IBD; however, treatment period was not associated with a higher risk of developing IBD based on the meta‐regression analysis. Several extension studies of the original trials with over 2‐year follow‐up also did not reveal significantly higher rates of IBD, suggesting that exposure time did not modify the relationship between anti‐IL‐17 agents and the risk of developing IBD . Majority of case reports also describe that the onset of IBD after anti‐IL‐17 agent use occurred soon after initiation of therapy supporting that studies with longer period would likely not affect the results of our meta‐analysis.…”

Long‐term safety profile of ixekizumab in patients with moderate‐to‐severe plaque psoriasis: an integrated analysis from 11 clinical trials

“…Studies have shown that the prevalence of Crohn's disease and ulcerative colitis has increased in patients with psoriasis. [21][22][23][24] However, Reich et al 25 reported that Crohn's disease and ulcerative colitis cases were uncommon (<1%) in ixekizumab-treated patients, based on the integrated database of seven ixekizumab psoriasis trials. These results are consistent with those observed in the present analysis of integrated database of 11 ixekizumab psoriasis trials.…”

The current state of the art for biological therapies and new small molecules in inflammatory bowel disease

“…Notably, a review of an integrated database of seven ixekizumab (another anti-IL-17A monoclonal antibody) psoriasis trials, including 4209 patients (6480 patient-exposure years), suggested incident cases of CD or UC were uncommon (<1%). 174 …”