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IBD Patients on Entyvio May Have Higher Risk for Extraintestinal Manifestations vs. Anti-TNFs
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ORLANDO — Patients with inflammatory bowel disease who are treated with Entyvio may have an increased risk for developing extraintestinal manifestations compared with those treated with anti-tumor necrosis factor agents, according to a poster presented at AIBD 2016.
“This abstract may help to explain why some patients who are switched from anti-TNF to [Entyvio (vedolizumab, Takeda)] experience extraintestinal manifestations, as perhaps the systemic vs. gut selective anti-inflammatory effects were actually helpful for these EIMs,” Marla Dubinsky, MD, chief of pediatric gastroenterology and hepatology, and co-director of the Susan and Leonard Feinstein IBD Center at Icahn School of Medicine, Mount Sinai, New York, told Healio Gastroenterology.
Aiming to compare the effects of vedolizumab, the first gut-selective, leukocyte migration inhibitor, with the effects of systemically acting anti-TNFs on EIMs, Dubinsky and colleagues identified adults with IBD who had at least two claims of vedolizumab or anti-TNFs within the Truven MarketScan claims database from September 28, 2012, through April 2016, followed up to two lines of therapy with either agent, and compared EIM incidences, adjusting for demographics and IBD severity at baseline.
They identified 597 patients with Crohn’s disease and 417 patients with ulcerative colitis who were treated with vedolizumab, and 16,058 patients with Crohn’s disease and 7,083 patients with ulcerative colitis who were treated with anti-TNFs.
EIMs in Crohn’s disease
They found that patients with Crohn’s disease who were treated with first- or second-line vedolizumab had a higher likelihood of developing EIMs compared with Crohn’s patients treated with anti-TNFs (IRR = 1.73; 95% CI, 1.33-2.24), even after adjusting for IBD severity (HR = 1.37; 95% CI, 1.06-1.78).
These patients had higher odds of developing erythema nodosum (IRR = 5.1; 95% CI, 1.85-14.05), aphthous stomatitis (IRR = 4.54; 95% CI, 1.66-12.47), arthropathy (IRR = 1.69; 95% CI, 1.31-2.2), and primary sclerosing cholangitis (IRR = 5.47; 95% CI, 1.7-17.68).
EIMs in ulcerative colitis
Conversely, patients with ulcerative colitis who were treated with first- or second-line vedolizumab did not appear to have a significantly higher likelihood of developing EIMs in general compared with those treated with anti-TNFs. However, they were specifically more likely to develop episcleritis (IRR = 4.9; 95% CI, 1.48-16.24) and pyoderma gangrenosum (IRR = 7.45; 95% CI, 1.65-33.61).
The investigators acknowledged that patients treated with vedolizumab may have more severe IBD due to their increased steroid and immunomodulator use before beginning treatment with vedolizumab, which may be a confounding factor.
“However, the [vedolizumab] cohort still experienced higher risk of developing EIMs compared to the anti-TNF cohort after adjusting for proxy disease severity,” they wrote. “Similar results were observed when stratifying by line of therapy.”
Monitoring the safety of novel therapies is important as real-world data accumulates, they concluded. – by Adam Leitenberger
Reference:
Dubinsky MC, et al. Abstract P-039. Presented at: Advances in Inflammatory Bowel Diseases; Dec. 8-10, 2016; Orlando, Fla.
Disclosures: Dubinsky reports consulting relationships with Janssen, Prometheus Labs, Celgene, Boehringer Ingelheim, Takeda and UCB, and grant/research support and other financial relationships with AbbVie.