Background: The paradigm for treatment for inflammatory bowel disease (IBD) is shifting from resolving symptoms toward objective measures such as mucosal healing (MH). Several studies suggest that MH is associated with an increased rate of long-term clinical remission and a decreased rate of surgery. However, few studies investigated the impacts of MH on clinical outcomes in patients with refractory ulcerative colitis (UC) on tacrolimus or biologics. This retrospective study was to investigate the impacts of MH achieved during tacrolimus and biologic therapy for refractory UC on long-term clinical remission and need for surgery.
Methods: One hundred patients with moderately-to-severely active UC were studied. Fifty patients were treated with oral tacrolimus (TAC group). The other 50 patients were treated with anti-tumour necrosis factor (TNF) agents (anti-TNF group): infliximab 40, adalimumab 10. At baseline, endoscopic examination was performed in all patients. Endoscopic severity was assessed according to the mucosal appearance score in the UC-disease activity index (DAI). After the 12-week treatment, endoscopic examination was performed if patient condition permitted. MH was defined as endoscopic score of 0 or 1 in the UC-DAI, and endoscopic improvement (including MH) a decrease in the endoscopic score.
Results: At week 12, MH was achieved in 12/37 patients (32%) in the TAC group vs 10/36 patients (28%) in the anti-TNF group (p=0.86). Overall, 22/73 patients (30%) achieved MH in this study. Seventeen of the 22 patients (77%) who achieved MH at week 12 and 21 of 52 patients (41%) without MH maintained clinical remission during a 40-week follow-up after endoscopic evaluation (p=0.005). The colectomy-free rate was 95% in the MH group vs 82% in the non-MH group (p=0.14).
Conclusions: MH was associated with an increased rate of long-term clinical remission and a decreased rate of surgery during the subsequent 40 weeks. MH may therefore be a reasonable therapeutic target in the management of refractory UC.