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Early dual biologic therapy may overcome limits in severe IBD


January 24, 2023

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Loftus E. Presentation Sp101: We should use combination dual-targeted therapy early in severe IBD patients; Presented at: Crohn’s and Colitis Congress; Jan 19-21, 2023; Denver (hybrid meeting).

Disclosures:
Loftus reports consulting relationships with AbbVie, Allergan, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion Healthcare, Eli Lilly, Genentech, Gilead, Janssen, Pfizer, Takeda and UCB.

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DENVER — Early data suggest combination therapy with biologics or advanced small-molecules may be safe and effective in patients with inflammatory bowel disease, according to a presenter at the Crohn’s and Colitis Congress.

“We have all these different mechanisms of action right now — in newer development are some of the oral and p-19 [inhibitors],” Edward V. Loftus Jr., MD, the Maxine and Jack Zarrow Family Professor of Gastroenterology at the Mayo Clinic in Rochester, Minnesota, told attendees. “We have all these different targets: Why not combine them?”

edward loftus at CCC 2023
“We have all these different mechanisms of action right now — in newer development are some of the oral and p-19 [inhibitors],” Edward V. Loftus Jr., MD, told attendees. “We have all these different targets: Why not combine them?”
Source: Healio

Current therapies for IBD have many limitations, Loftus said, noting that approximately 66% of patients experience primary or secondary tumor necrosis factor-inhibitor failure through development of antibodies, with a 13% to 30% incidence of primary nonresponse in clinical practice.

Data also show the need for dose intensification after 12 weeks among 23% to 46% of patients, discontinuation among 5% to 13% and relapse after discontinuation at 12 months among 28% of patients with ulcerative colitis, according to Loftus.

“We have these mechanistic failures that we don’t completely understand and, of course, there are adverse events,” he said. “So, how do we get around it? It has been proposed that dual therapy might work.”

Results from a systematic review and meta-analysis from Alayo and colleagues showed certain combinations induced clinical remission while maintaining low rates of adverse events: Vedolizumab (Entyvio, Takeda) plus ustekinumab (Stelara, Janssen) (47%), vedolizumab plus TNF (55%), ustekinumab plus TNF (80%), tofacitinib (Xeljanz, Pfizer) plus ustekinumab (40%), tofacitinib plus vedolizumab (48%) and tofacitinib plus TNF (56%). Adverse event rates were 12.3%, 9.6%, 0%, 0%, 1% and 0%, respectively.

Loftus cited additional results from the VEGA trial, which yielded high clinical response and remission rates at week 12 among patients with UC given combination guselkumab (Tremfya, Janssen) and golimumab (Simponi, Janssen), as well as results from the EXPLORER trial, which demonstrated endoscopic and clinical remission rates of 34.5% and 54.5%, respectively, at 26 weeks among patients with high-risk Crohn’s disease receiving combination vedolizumab, adalimumab (Humira, AbbVie) and methotrexate.

“It’s an interesting concept and we’re going to have more data in the future, especially now that we have pharmaceutical companies that have multiple assets,” Loftus said. “Whether or not we’re going to be able to do this routinely in clinical practice due to insurance hurdles remains to be seen, but we have early reports that this could be efficacious. We’re starting to see more clinical trials.”

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