Extraintestinal manifestations develop, worsen after Entyvio for IBD
AUSTIN, Texas — Approximately 30% of patients with inflammatory bowel disease developed new or worsening extraintestinal manifestations after receiving Entyvio, according to data presented at Crohn’s & Colitis Congress extraintestinal manifestations.
The previous use of biologics and concomitant immunomodulator therapy had no significant effect on extraintestinal manifestations (EIMs) after receiving vedolizumab (Entyvio, Takeda), according to the study results.
“We wanted to investigate how a gut selective agent would affect extraintestinal manifestations in inflammatory bowel disease,” Badr Al Bawardy, MD, a gastroenterologist, at Yale Medicine, and senior author of the study, told Healio Gastroenterology and Liver Disease. “Previous literature on this topic included a claims dataset study by Dubinsky and colleagues. In this study, patients treated with vedolizumab were 28% more likely to develop EIMs compared to anti-TNF treated patients.”
To evaluate the impact of vedolizumab on extraintestinal manifestations in patients with IBD, Christina Dimopoulos, MD, a resident at Yale Medicine, and colleagues conducted a single center retrospective chart from January 2014 to August 2019.
The rate of new or worsening EIMs after receiving vedolizumab therapy served as the primary outcome. A secondary outcome was to assess factors that were associated with new or worsening EIMs after patients received vedolizumab.
A total of 142 patients (median age, 39 years; 49.3% female) were included in the chart review. More than half of the patients (53.5%) had Crohn’s disease. More than half (51.4%) had reported steroid use at the start of receiving vedolizumab, and 85.2% had previous exposure to biologics.
The most common EIMs in the patients were peripheral arthritis (39%), sacroiliitis (16%) and erythema nodosum/pyoderma gangrenosum (9%). Seventy-six of the patients had an EIM and 20 had more than one.
The researchers linked the use of steroids at vedolizumab induction with stable or improved EIM (OR = 0.2; 95% CI, 0.06-0.63).
In a multivariable analysis, they showed EIMs more likely in women (OR = 3.19; 95% CI, 1.52-6.72), tobacco users (OR = 4.84; 95% CI, 1.45-16.23) and those who had prior biologic exposure (OR = 4.3; 95% CI, 1.3-14.2).
“The study found that up to one-third of patients will develop new or worsening EIMs after starting vedolizumab,” he said. “Concomitant immunomodulator therapy or previous biologic exposure did not affect the rate of new or worsening EIMs. However, corticosteroid use at the time of vedolizumab induction was associated with a lower rate of EIMs.”
Al Bawardy noted that more research is needed to analyze the data further.
“Larger studies are needed to elucidate the effects of vedolizumab on individual different types of EIMs,” he said. “We are currently in the process of combining our data with another tertiary center for this purpose.” – by Ryan McDonald
Reference: Dimopoulos C, et al. Abstract 23. Presented at: Crohn’s and Colitis Congress; Jan. 23-25, 2020; Austin, Texas.
Disclosure: The authors report no relevant financial disclosures.