Anti-TNF therapy helped induce clinical remission in patients with refractory ulcerative proctitis, according to study results.
Guillaume Pineton de Chambrun, MD, PhD, of the department of gastroenterology at Saint-Eloi Hospital in France, and colleagues wrote in Clinical Gastroenterology and Hepatology that managing patients with UP, a type of ulcerative colitis, has been difficult in the biologic era.
“These patients are excluded from clinical trials on biologics and available studies on the effectiveness of anti-TNF therapy in a real-life setting are of small sample size,” they wrote. “As UP represents about a third of all cases of UC, [5-aminosalycilic acids (5-ASA)] treatment is often insufficient in moderate to severe UC and azathioprine has modest efficacy in this indication. Further evidence regarding the potential of anti-TNF therapy in treating these patients is eagerly awaited.”
Researchers conducted a nationwide retrospective cohort study of 104 patients with active UP refractory to conventional therapies. The patients all received at least one anti-TNF injection of either Remicade (infliximab, Janssen), Humira (adalimumab, AbbVie) or Simponi (golimumab, Janssen) between 2006 and 2017.
The primary outcome of the study was clinical response to anti-TNF therapy defined as significant improvement in UC-related symptoms. They also assessed clinical remission, defined as complete disappearance of UC-related symptoms.
Pineton de Chambrun and colleagues found that 80 patients achieved clinical response (77%), and 52 patients achieved clinical remission. Of the 63 patients who underwent endoscopic assessment during follow-up, 38 had mucosal healing (60%).
In their analysis, researchers found that extra-intestinal manifestations (OR = 0.24; 95% CI, 0.03–0.7), ongoing treatment with topical steroids (OR = 0.14; 95% CI, 0.03–0.73) and ongoing treatment with topical 5-ASAs (OR = 0.21; 95% CI, 0.07–0.62) were all associated with absence of clinical remission.
“Our data support the use of anti-TNF monoclonal antibodies in patients with refractory UP with 50% of patients achieving clinical remission and 64% showing sustained clinical remission at the end of follow-up,” Pineton de Chambrun and colleagues wrote. “Moreover, our study also demonstrated that anti-TNF agents are able to induce mucosal healing in 60% of patients with refractory UP. Regarding follow-up, about half of the patients were still on anti-TNF therapy at 2 years.” – by Alex Young
Disclosures: Pineton de Chambrun reports receiving lecture fees from AbbVie, MSD, Pfizer and Takeda, as well as consulting fees from Janssen, Takeda and Tillots. Please see the full study for all other authors’ relevant financial disclosures.