‘Evidence supports’ de-escalating combination therapy in patients with IBD after 1 year


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January 30, 2023

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Ungaro R. Presentation Sp103: De-escalate combo therapy with immunomodulators to biologic monotherapy after 1 year in all IBD patients. Presented at: Crohn’s and Colitis Congress; Jan. 19-21, 2023; Denver.

Ungaro reports financial relationships with AbbVie, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Janssen, Pfizer and Takeda.

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DENVER — Providers should consider de-escalating combination therapy with immunomodulators to monotherapy after 1 year in patients with inflammatory bowel disease, according to a presenter at the Crohn’s and Colitis Congress.

“We know that combination therapy is one of our most, if not the most, effective therapies: not the combination of biologics, but the combination of the thiopurine and anti-tumor necrosis factor medications, and everyone knows the seminal SONIC trial, infliximab and thiopurines were superior to both monotherapies,” Ryan C. Ungaro, MD, MS, associate professor medicine at the Icahn School of Medicine at Mount Sinai, said. “So why do we consider de-escalating combination therapy in IBD patients if we know it’s so effective?”

Ryan Ungaro
“Evidence supports de-escalating combo therapy to stopping immunomodulators,” Ryan C. Ungaro, MD, MS, said.
Source: Healio

According to Ungaro, practical reasons for de-escalation include safety, patient concern and adherence or ease.

Ungaro cited results from a nationwide cohort study of 190,694 patients with IBD (Kirchgesner J, et al.), which found combination therapy correlated with an increased risk for both serious infection (HR = 1.23; 95% CI, 1.05-1.45) and opportunistic infection (HR = 1.96; 95% CI, 1.32-2.91) compared with anti-TNF monotherapy. Additional research from Lemaitre and colleagues found exposure to combination therapy correlated with an increased risk for lymphoma (adjusted HR = 6.11; 95% CI, 3.46-10.8) compared with no exposure to thiopurines or anti-TNF agents.

Further, a retrospective analyses from Mahmoud and colleagues and the DIAMOND2 study showed no additional risk for loss of response after immunomodulator withdrawal for patients with Crohn’s disease (aHR = 1.17; 95% CI, 0.72-1.9) and ulcerative colitis (aHR = 0.67; 95% CI, 0.29-1.55), as well as similar rates of endoscopic remission among those who continued or discontinued combination therapy, respectively.

Additionally, new data from the SPARE trial reported that among patients who continued anti-TNF therapy or underwent anti-TNF withdrawal or immunosuppression withdrawal, anti-TNF withdrawal associated with a higher relapse rate and reduced time in remission.

“Evidence supports de-escalating combo therapy to stopping immunomodulators,” Ungaro concluded. “One, it decreases the risk for infection and cancer and makes our lives and patients’ a little easier and, two, there is good prospective data that there are similar outcomes with stopping immunomodulators to continuing combination therapy.”


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