Patients with ulcerative colitis who discontinue 5-aminosalicylate therapy once they begin anti-TNF therapy do not appear at great risk for adverse clinical events, according to research published in Gut.
Ryan C. Ungaro, MD, of the division of gastroenterology at the Icahn School of Medicine at Mount Sinai, and colleagues wrote that the benefit of continuing or stopping 5-ASA therapy once a patient starts biologics has not been previously explored.
“This is of significant interest to patients and payers as 5-ASA agents are costly and often require taking multiple pills a day,” they wrote. “Patients who discontinue or are non-adherent to 5-ASA appear to be at increased risk of flares although this has not been specifically studied with concomitant biologic agents.”
Researchers analyzed data from 3,589 patients with UC taken from two national cohorts: the United States Truven MarketScan health claims database and the Danish health registers. They included patients who started taking anti-TNF after having been on 5-ASAs for at least 90 days and grouped them based on whether they discontinued 5-ASA therapy. The primary outcome of the study was any adverse clinical event defined as composite of new corticosteroid use, UC-related hospitalization or surgery.
Of 2,890 patients in the U.S. cohort, 1,951 continued 5-ASA and 939 stopped. In Denmark, 474 continued and 225 withdrew.
Investigators found that stopping 5-ASA therapy after starting anti-TNF was not associated with an increased risk for adverse clinical events in either the U.S. (adjusted HR = 1.04; 95% CI, 0.9–1.21) or Danish cohorts (aHR = 1.09; 95% CI, 0.8–1.49).
Ungaro and colleagues wrote that their findings help support discontinuing 5-ASA treatment once patients move on to anti-TNF, which could be helpful to patients based on the benefits of discontinuation, including decreased costs and lower risk for medication-related side effects.
“Our findings suggest that patients with UC can safely discontinue 5-ASA after escalating therapy to an anti-TNF,” they wrote. “Prospective studies investigating the benefits and risks of 5-ASA discontinuation after biologic initiation are needed to confirm our findings.” – by Alex Young
Disclosures: Ungaro reports receiving a research grant from AbbVie and serving as an advisory board member for Janssen, Pfizer and Takeda. Please see the full study for all other authors’ relevant financial disclosures.