Background: Golimumab (GLB) is a subcutaneous anti-tumour necrosis factor alpha (anti-TNF) therapy. Randomised controlled trials have demonstrated GLB efficacy in the induction and maintenance of remission in ulcerative colitis (UC). Data are few on the outcome of GLB therapy for UC in routine clinical practice.
Aims: To describe the outcome of GLB therapy for UC in routine clinical practice in Ireland.
Methods: Patients receiving GLB as therapy for UC were identified (n=77) from six Irish Medical centers. Only ambulatory outpatients, with 6 months of follow up post GLB initiation were included (n=69). Baseline clinical, demographic and laboratory data were collected. The primary endpoints were factors associated with durability of GLB response measured by time to drug discontinuation; 3-month clinical response; and 6-month corticosteroid free remission rates. Clinical response was defined as a decrease from baseline in partial Mayo score of at least 3 points and ongoing receipt of GLB. Clinical remission was defined as a partial Mayo score of less than or equal to 2 and continuing receipt of GLB. Secondary endpoints included rates of dose optimisation, dose intervention strategy and adverse events. Raw p values are reported with p values <0.006 (Bonferroni correction) considered significant
Results: The study cohort comprised n=69 UC patients. Baseline characteristics were as follows (continuous variables, median [range]): Age 41.4 years [20.3–76.8]; 55% male; disease duration 6.5 years [0–29.9]; clinical Mayo subscore 6 [0–9]; proctitis, left-sided and extensive colitis in 8%, 54% and 38% respectively; baseline CRP 4.4 mg/L [0.2–134.6]; baseline albumin 42 g/L (16–51). Proportions on concomitant medications at GLB initiation were as follows: 5-aminosalicylate therapy 78%, concomitant immunomodulator 45%, systemic corticosteroids 40% (prednisolone dose, 35mg [5–40]). 36% of subjects were anti-TNF naïve. Proportions receiving 50mg and 100mg 4-weekly maintenance regimes were 44% and 56% respectively. 3-month clinical response and 6-month corticosteroid free clinical remission rates were 42% and 42% respectively. 41% of patients required GLB dose optimisation (median [95% CI] time to dose optimisation: 6.5 months [1.4–11.6]); 44% dose increase and 56% interval shortening. Baseline CRP of ≥5mg/L is associated with a shorter time to GLB discontinuation, hazard ratio 3.1 (95% CI 1.4–6.7], p=0.005. Significant adverse events occurred in 3% of patients.
Conclusions: These real world clinical data demonstrate GLB is an effective and safe induction and maintenance agent for UC. GLB dose optimisation is frequently required. A high baseline CRP, likely reflective of increased inflammatory burden, is associated with a less durable GLB response.