Golimumab in ulcerative colitis: A multi-centre real-world experience

Golimumab (Simponi) is a TNFα inhibitor approved for patients with ulcerative colitis (UC) since 2013. Pre-clinical work showed superiority to both infliximab and adalimumab in its mechanism of action. Initial trial data showed 51% achieved clinical remission by Week 6 and 47% by Week 54. However, there is no real world data to correlate these findings. We aimed to assess the effectiveness of golimumab in a real world setting. A retrospective multi-centre study was conducted between 2014 to date. Data were obtained from five hospitals around the West Midlands, UK. Inclusion criteria included patients with a diagnosis of moderate-to-severe ulcerative colitis (endoscopic Mayo score ≥2). Dosing was weight dependent (≤80 kg = 50 mg 4-weekly; ≥80 kg = 100 mg 4-weekly following an induction dose). Data were collected using patient notes and endoscopy reports. Fisher’s exact test was used for statistical significance. There were a total of 56 patients with a mean age of 39.2 years (M = 39; F = 17). The majority of patients had left sided disease (48%; n = 27) followed by pancolitis (45%; n = 25) and proctitis (7%; n = 4). 64% were on concurrent immunosuppressants. The mean duration of golimumab treatment was 12 months. One patient developed deranged liver function tests on golimumab. They were switched to vedolizumab. Twenty-two patients (39%) showed endoscopic and clinical remission (proctitis n = 3; left sided n = 9; pancolitis n = 10). There was no statistically significant difference between disease extent and remission (p = 1.00). Of these 22 patients, 17 patients were on the higher dose of 100 mg, with a statistical significance between the dosing (p = 0.03). Three patients who were initially on 50 mg and relapsed had their dose increased to 100 mg. They remain in remission. Of the 50% (n = 28) who switched biologic therapy, 23 were to vedolizumab, 1 to infliximab and 4 to adalimumab. Despite changing to vedolizumab, 3 (13%) patients still required surgery. Patients switched to adalimumab and infliximab are currently in remission. In total, 14% (n = 8) required surgery, of which 3 patients had emergency surgery. Golimumab has not proven as effective in our real world data. Two important inferences were made from this study. Firstly, of those patients that went into remission, 75% were on the higher dose of golimumab. This may be secondary to higher trough levels; however, therapeutic drug monitoring is currently unavailable in the UK for golimumab. Secondly, five patients who were switched to an alternative anti-TNF, where drug monitoring is available, had a good clinical response. This leads us to propose that drug-monitoring is of clinical importance and should be available for golimumab in the UK to help maintain clinical remission.