Letter: a prospective real life comparison of the efficacy of adalimumab vs. golimumab in moderate to severe ulcerative colitis.

Abstract

Effectiveness of subcutaneous anti-tumour necrosis factor (TNF)-α antibodies, adalimumab (ADA) and golimumab (GOL), in the treatment of moderate to severe ulcerative colitis (UC), was shown in two randomised trials.1, 2 However, to our knowledge, no direct comparison of the two drugs has been published, while network meta-analyses have reported3-6 variable results. We agree with the results of the meta-analysis published by Stidham et al.,6 where infliximab (IFX), ADA and GOL were all effective in UC. We report our experience on the efficacy of ADA and GOL in patients with moderate to severe UC. From June 2015 until April 2016, we prospectively evaluated 40 patients: 21 treated with ADA at the induction dosage of 160/80 mg followed by 40 mg every other week, 19 treated with GOL at the induction dosage of 200/100 mg followed by 50 or 100 mg, according to body weight, every 4 weeks. Patient characteristics, Mayo score and main results are shown in Table 1. Nineteen patients were naïve to anti-TNFα treatment: fourteen and five in the ADA and GOL group, respectively. Twenty-one patients had been previously treated with IFX: eleven discontinued for adverse events, eight for no response or loss of response, and two for previous remission. At 8 weeks, clinical remission was achieved in 15/40 patients (37.5%): 9/19 (47.3%) naïve and 6/21 (28.5%) non-naïve to anti-TNFα treatment. Clinical remission was reached in 9/21 (43%) patients treated with ADA and in 6/19 (31.5%) patients treated with GOL. This difference was not statistically significant (P = 0.46). When patients were stratified in naïve and non-naïve to anti-TNFα, the difference in the rate of clinical remission at 8 weeks was not statistically significant: naïve ADA 50% vs. naïve GOL 40% (P = 0.70), non-naïve ADA 28% vs. non-naïve GOL 28%. Twenty-nine patients continued treatment for over 16 weeks (16 ADA and 13 GOL). Clinical remission was maintained in 13 patients (8 ADA, 5 GOL). One patient needed ADA dose intensification to maintain the benefit. After univariate analysis, older age was associated with higher remission rate at 8 weeks (mean age of responsive vs. unresponsive patients: 50.2 ± 11.2 vs. 43.0 ± 10.8; p = 0.05). When patients were stratified according to the drug, this association remained significant only for ADA (P = 0.03). No other predictors of response were identified. This is the first report comparing prospectively efficacy of ADA and GOL in a consecutive series of patients with moderate to severe UC. These preliminary real life data confirm the efficacy of subcutaneous anti-TNFα in the treatment of UC with higher remission rates compared with clinical trials1, 2 and no difference in clinical remission rates between the two drugs at 8 weeks. Due to the small number of patients, no other conclusions can be drawn. Larger prospective randomised studies with longer follow-up are warranted. Declaration of personal and funding interests: None.