P690 Clinical and endoscopic outcomes of one year golimumab treatment in patients with active ulcerative colitis: A real-life observational study

Abstract

Background: Golimumab (GLM) is a subcutaneous anti‐TNF agent for treatment of ulcerative colitis (UC). Most studies that investigated associations between therapeutic efficacy and GLM serum concentrations focused on induction therapy. Our aim was to assess clinical and endoscopic efficacy of GLM after 1 year treatment. Methods: In this prospective trial, patients with moderate‐severe UC (endoscopic Mayo (eMayo) score ≥2 received induction treatment with GLM 200 mg SQ (at week (w) 0) and 100 mg (at w2)) followed by maintenance treatment with 50 or 100 mg (every 4w), in patients with a bodyweight of less or more than 80 kg, respectively. Serum GLM concentrations were measured with an enzyme‐linked immunoassay (Sanquin Laboratories). The therapeutic effect of GLM was assessed at 8‐10 weeks after start and after 1 year of treatment. Endoscopic response was defined as ≥1 point reduction in eMayo score and endoscopic remission was defined as eMayo score ≤1. Clinical response and remission were defined as a decrease in Simple Clinical Colitis Activity Index (SCCAI) ≥ 3 points and a SCCAI score of ≤2, respectively. Results: Twenty patients were enrolled with median ([interquartile range]) baseline CRP 4.5 mg/l [1.1‐13.7], albumin 44 g/l [40‐45] and SCCAI of 7 [5‐9]. After induction treatment, 12/19 patients (63%) achieved endoscopic response at week 8‐10 and continued GLM therapy. Median trough concentrations at w6 were numerically higher in endoscopic responders at w8‐10 compared with patients without endoscopic response (3.7 μg/ml [2.4‐6.0] vs. 3.1 μg/ml [1.1‐3.8], p = 0.3). After 1 year of treatment, 1/12 patients was lost to follow‐up. Five out of 11 patients lost clinical response during maintenance therapy after a median of 18w. Concentration‐time curves are depicted in Figure 1. Patients with endoscopic response at week 52 showed no difference in trough concentrations compared with patients without endoscopic response (week 18: 1.7 μg/ml [0.5‐2] (n = 3) vs. 2 μg/ml [1.2‐3.3] (n = 7), p = 0.4, week 30: 1.2 μg/ml [0.4‐2.0] (n = 3) vs. 1.3 ��g/ml [0.2‐2.4] (n = 2). Six out of 11 patients continued GLM beyond 1 year, and 5 patients underwent an endoscopy at week 52. At week 52, 3/5 patients showed endoscopic remission and 4/6 patients were in clinical remission. (Figure presented) Conclusions: Endoscopic response to GLM induction treatment was observed in 63% of the patients. Almost half of the patients who continued GLM maintenance therapy showed secondary loss of response. There were no significant differences in GLM trough concentrations with regard to endoscopic response.