A real life comparison of the efficacy of adalimumab versus golimumab in moderate-to-severe ulcerative colitis. A multicenter experience from the sicilian network for inflammatory bowel disease (SN-IBD)

Abstract

Introduction: Adalimumab (ADA) and golimumab (GOL) are effective in the induction and maintenance treatment of moderate-to-severe ulcerative colitis (UC). No comparable data between the 2 drugs are available up to now. Aims & Methods: We reported the Sicilian Network experience on the comparative efficacy of ADA and GOL in patients (pts) with moderate-to-severe UC. From June 2015 until April 2017, 197 consecutive pts with moderate to severe UC were treated with ADA or GOL. The efficacy was evaluated at 8 week and at the end of the follow up considering ‘‘clinical response’’ (reduction of at least 2 points of Partial Mayo Score with concomitant steroid reduction or discontinuation) and “clinical remission” (Partial Mayo Score 52 without steroids). The presence of clinical response or clinical remission was defined as “clinical benefit”. Endoscopic Mayo Score was evaluated at the end of the follow up in pts who underwent colonoscopy. Results: 118 pts were treated with ADA and 79 with GOL for a median follow up of 40.21 [20.32, 69.14] weeks for ADA and 34.00 [17.43, 54.79] weeks for GOL (p ¼ 0.08). Eighty-eight pts were naive to anti-TNF (59 ADA, 29 GOL, p = 0.09). No difference in Mayo Score value was observed between the 2 groups at the time of first drug injection (p = 0.92). After 8 weeks clinical benefit was achieved in 93/118 (78.8%) pts treated with ADA and 50/79 (63.3%) pts treated with GOL (p = 0.026). Clinical remission was achieved in 48/118 (40.7%) pts treated with ADA and 20/79 (25.3%) pts treated with GOL (p = 0.038). At the end of the follow up clinical benefit was achieved in 79/118 (66.9%) pts treated with ADA and 37/79 (46.8%) pts treated with GOL (p = 0.008). Clinical remission was achieved in 50/118 (42.4%) pts treated with ADA and 23/79 (29.1%) pts treated with GOL (p = 0.082). No difference was observed in clinical outcomes at 8 weeks and at the end of the follow up between naive and non naive pts (p = 0.187). At the end of the follow up the median Endoscopic Mayo Score was 3.00 [0.00, 5.00] in pts treated with ADA and 4.00 [1.00, 7.00] in pts treated with GOL (p = 0.025). Univariable analysis revealed that age4 40 years at the time of first drug injection and age5 40 years at the diagnosis were associated with higher remission rate in pts treated with ADA respect to pts treated with GOL at 8 weeks and at the end of the follow up (p = 0.034 and p = 0.016 respectively). Disease duration 45 years was associated with a higher remission rate in pts treated with ADA respect to pts treated with GOL at 8 weeks and at the end of the follow up (p = 0.017). Conclusion: This is the first study where the comparable efficacy of ADA and GOL was evaluated. These real life data confirmed the efficacy of subcutaneous anti-TNF in the treatment of moderate to severe UC. ADA resulted to be more effective than GOL in inducing and maintaining clinical benefit. Larger prospective studies with longer follow up are warranted to confirm this data