This article is more than 5 years old. Information may no longer be current.
Stopping 5-ASA safe upon anti-TNF induction for Crohn’s disease
Click Here to Manage Email Alerts
SAN DIEGO — Discontinuing 5-aminosalicylate therapy after starting anti-TNF therapy did not heighten the risk for adverse clinical events among patients with Crohn’s disease, according to a study presented at Digestive Disease Week.
“5-aminosalycilates (5-ASA) are often used in the treatment of ulcerative colitis and Crohn’s disease,” Ryan C. Ungaro, MD, from the Icahn School of Medicine at Mount Sinai, said during his presentation. “However, data suggests that 5-ASAs have limited efficacy in Crohn’s disease and generally are not recommended in clinical guidelines, both in the United States and Europe. Despite this, 5-ASA remain one of the more commonly prescribed medications for Crohn’s disease in the United States.”
Currently, there are no data on whether or not it is safe to stop 5-ASA in patients with Crohn’s disease who need escalation of therapy with an anti-TNF agent, he said.
Ungaro and colleagues assessed data from the U.S. Truven Health MarketScan health claims database and the Denmark health registers. The researchers enrolled 3,178 patients with Crohn’s disease who had initiated anti-TNF agents following treatment with oral 5-ASA for a minimum of 90 days. A total of 2,960 patients were in the U.S. cohort and 218 were in the Danish cohort.
Stopping 5-ASA was defined as terminating treatment within 90 days of initiating an anti-TNF. The composite primary outcome of any adverse event included novel use of corticosteroids, hospitalization for Crohn’s disease symptoms and surgery.
Kaplan-Meier analyses and multivariable Cox regression models controlled for various factors, including age, gender, 5-ASA therapy duration prior to starting an anti-TNF agent, previous surgery for Crohn’s disease symptoms, duration of disease (for the Danish cohort only) and health care use, which included corticosteroid use, hospitalizations and emergency department visits in the year prior to beginning anti-TNF therapy.
Overall, 1,150 patients stopped using 5-ASAs (1,044 in the U.S. cohort and 106 in the Danish cohort).
Cumulative rates of the composite primary outcome did not differ among patients who stopped 5-ASA compared with those who continued 5-ASA in both the U.S. and Danish cohorts. Multivariable analysis demonstrated no correlation between stopping 5-ASA and a greater risk for adverse clinical events in either the U.S. cohort (aHR = 0.89; 95% CI, 0.77-1.03) or in the Danish cohort (aHR = 1.13; 95% CI, 0.68-1.87).
Sensitivity analyses that examined concomitant immunomodulator use and length of 5-ASA therapy prior to beginning anti-TNF demonstrated similar findings.
“These results suggest that patients with Crohn’s disease may safely discontinue 5-ASA after starting biologic therapy,” Ungaro said. “However, our results need to be validated in prospective studies.” – by Alaina Tedesco
Reference:
Ungaro RC, et al. Abstract 110. Presented at: Digestive Disease Week; May 18-21, 2019; San Diego.
Disclosures: Ungaro reports receiving consulting fees from and participating in advisory committees and review panels for Janssen, Pfizer and Takeda. Please see the abstract for all other authors’ relevant financial disclosures.