P248. Infliximab in steroid-dependent ulcerative colitis: Efficacy and predictors of clinical and endoscopic remission
A. Armuzzi1, D. Pugliese1, S. Danese2, G. Rizzo1, C. Felice1, M. Marzo1, G. Andrisani1, G. Fiorino2, G. Mocci1, I. De Vitis1, A. Papa1, G.L. Rapaccini1, L. Guidi1
1Internal Medicine and Gastroenterology Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy; 2IBD Unit, Istituto Clinico Humanitas, Rozzano, Italy
Background: Up to 40% of ulcerative colitis (UC) patients need steroids during their course and 20% of them become steroid-dependent. Immunosuppression with thiopurines is the most used therapy in steroid-dependent UC, but their efficacy is debated. Data exploring the use of infliximab (IFX) in patients with steroid-dependent UC are scarce. Aims of our study were to evaluate the efficacy and safety of IFX in active steroid-dependent UC and to identify predictive factors of steroid-free clinical remission, mucosal healing and colectomy.
Methods: Consecutive patients with active steroid-dependent UC were enrolled and intentionally treated with IFX (standard induction and maintenance treatment). The prospectively designed analyses evaluated: (1) steroid-free clinical remission at 6 and 12 months; (2) mucosal healing (MH) at 12 months; (3) colectomy within 12 months. Clinical remission was defined as Powell-Tuck index of 0 and mucosal healing as a Baron index of 01.
Results: 126 active steroid-dependent UC patients were studied. 70% of patients were taking steroids at baseline, with a median prednisone dose of 25 mg (IQR 1530). 45% of patients were naïve to thiopurines and 56% were started on concomitant thiopurines. Steroid-free clinical remission was 53% and 47% at 6 and 12 months, respectively. Thiopurines-naïve status and combination therapy were identified as predictors of steroid-free clinical remission at 6 months (OR: 2.9; p = 0.03 and OR: 3.07; p = 0.03, respectively). At 12 months, 32% of patients were in steroid-free clinical remission and MH. Thiopurine-naïve status was confirmed as predictor of steroid-free clinical remission and MH (OR: 3.6; p = 0.01). A higher C‑reactive protein (CRP) level after induction was predictive of lower rates of: steroid-free clinical remission at 6 (OR: 0.1; p = 0.0001) and 12 months (OR: 0.14; p = 0.0005) and steroid-free clinical remission and MH at 12 months (OR: 0.17; p = 0.009). 12 patients (9.5%) underwent colectomy after a median of 4.7 months (IQR 2.28). Patients who were able to spare steroids had a reduced risk of colectomy within the first year (HR: 6.3; p = 0.005). Adverse events were recorded in 16 patients (13%), but only 10 (8%) withdrew from treatment.
Conclusions: IFX appears effective and safe in the treatment of steroid-dependent UC. Thiopurine-naïve patients have higher rates of clinical remission at 6 months and endoscopic remission at 12 months. Combination therapy appears more effective until the first 6 months. Steroid-sparing is protective from colectomy.