Background: Golimumab is a fully human, IgG1k monoclonal antibody against anti–tumor necrosis factor alpha (anti-TNF) agent approved for the treatment of moderate-to-severely active ulcerative colitis. However, there have been no formal trials to date to assess its utility in Crohn's disease (CD). This study's aim was to assess the efficacy and safety of golimumab in patients with anti–TNF-refractory CD.
Methods: Consecutive patients with CD who were treated at a single IBD center with golimumab between March 2010 and September 2016 were included in a retrospective observational study. Clinical response was defined as a significant reduction in symptoms and biochemical markers of CD, with no requirement for surgery or introduction of immunomodulators. The outcome was assessed after 6, 12 and 36 months and at last clinical follow-up.
Results: Forty-five patients were included, with a median follow-up of 22 months (interquartile range 12–34) following initiation of golimumab. Induction regimens were often higher than the standard protocol with cumulative doses (week 0 and 2) of ≥400 mg and ≥600mg in 75% and 21% of patients, respectively. All patients had previously failed at least 2 anti-TNF agents. In 64% of patients, anti-TNF failure was associated with loss of response and in 23% due to adverse effects. Clinical response at 6 months was achieved in 32/45 (71%) patients. The cumulative probabilities that patients maintained their clinical response for 12 and 36 months after the introduction of golimumab were 79% and 65%, respectively. Through most recent follow-up 59% remained on treatment. Endoscopic improvement and mucosal healing at 1 year were achieved in 73% and 47% of patients, respectively.
Conclusions: This study demonstrates the efficacy of golimumab in CD patients who were previously refractory to at least 2 anti-TNF agents. An initial response is successfully maintained in the majority of patients for up to 3 years. Future studies should be performed in CD to formally assess the efficacy of golimumab in a randomized controlled trial and to establish the optimal dosing regimen.