For patients with Crohn disease (CD), sustained off-steroid remission was not associated with decreased risk for disease progression, according to study findings published in Clinical Gastroenterology and Hepatology.
The Tailored Treatment With Infliximab for Active Crohn’s Disease (TAILORIX) trial was conducted at 27 sites in Belgium, France, and the Netherlands between 2012 and 2015. For this analysis, risk for long-term disease progression was compared between patients who did and did not achieve sustained corticosteroid-free clinical remission following 1 year of therapy with an immunosuppressant plus infliximab. Progression-free survival of CD was defined as an anal or major abdominal operation, CD-related hospitalization, or new systemic CD therapy.
The study population comprised 95 patients who had a mean age of 37.5±15.5 years, 62% were women, 75% had inflammatory CD, and Crohn’s Disease Activity Index (CDAI) score was 291.7±76.5.
At the end of the study, 45 patients met the primary endpoint. Patients who did not meet the endpoint were associated with a higher CDAI score than patients who achieved remission (P <.01).
During a median follow-up of 64.2 months, 32 patients received a new CD treatment, 31 patients had infliximab intensification, 22 patients were hospitalized, 13 patients underwent luminal operation, 11 stopped infliximab, and 9 underwent anal operation.
Stratified by steroid-free deep remission status at the trial conclusion, no significant difference in disease progression was observed (P =.64). Similarly, steroid-free deep remission status was not associated with survival without major abdominal operation (P =.42), survival without anal operation (P =.95), survival without hospitalization (P =.34), and survival without new treatment (P =.87).
Disease progression was not associated with C-reactive protein greater than 5 mg/L (hazard ratio [HR], 2.022; 95% CI, 0.750-5.449), age over 30 years (HR, 1.522; 95% CI, 0.726-3.190), smoking (HR, 0.628; 95% CI, 0.287-1.378), B1 phenotype (HR, 1.051; 95% CI, 0.481-2.295), or steroid-free response (HR, 0.861; 95% CI, 0.4289-1.7306).
Study limitations include its retrospective design and the fact that 27 patients were lost to follow-up.
“We observed that neither the association of clinical and endoscopic remission nor complete mucosal healing were associated with better disease outcomes,” the study authors noted. “Our data support the early use of powerful treatments to modify the history of CD and also suggest that a more flexible approach of the treat-to-target concept should be taken in daily practice.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Laharie D, D’Haens G, Nachury M, et al. Steroid-free deep remission at one year does not prevent Crohn’s disease progression: long-term data from the TAILORIX trial. Clin Gastroenterol Hepatol. 2022;20(9):2074-2082. doi:10.1016/j.cgh.2021.11.030