Background: Golimumab is the third anti-TNF agent which received marketing authorization for the treatment of ulcerative colitis (UC) patients who are refractory to conventional therapies. To date, only few data are available regarding its efficacy in UC patients in clinical practice. The aim of our study was to evaluate the efficacy of golimumab for the treatment of UC patients in two tertiary French referral centers.
Methods: This was a retrospective cohort study including all consecutive UC patients treated with golimumab for induction of clinical remission in two French tertiary referral centers from August 2014 to April 2016. Clinical response and clinical remission during the induction phase was defined according to physician judgment. Previous treatments, duration, optimization and withdrawal of golimumab were also collected.
Results: Twenty-four UC patients (13 Female and 11 Male) were included in the study. Montreal classification in UC patients at the time of golimumab introduction was a proctitis in 4% (1/24) of the patients, a left-sided colitis in 38% (9/24) and a pancolitis in 58% (14/24). Median delay between UC diagnosis and golimumab introduction was 81.7 months (IQR 1–3: 45–158). Golimumab was started in 7 (29%) patients who were naïve from biotherapies, in 4 (17%) patients who already received another anti-TNF and in 13 (54%) who already received more the one anti-TNF. Golimumab was associated with a concomitant immunosuppressant in 25% (6/24) of the cases. Short-term clinical response was achieved in 60% (13/22) of the patients. Clinical remission evaluated after a median treatment duration of 5 months (IQR 1–3: 3–5.3) was achieved in 29% (7/24) of the patients. A secondary loss of response was observed in 28% (2/7) of the UC patients who achieved clinical remission. Among UC patients with primary non-response to golimumab, 4 (24%) patients had an optimization of golimumab therapy with a clinical efficacy in 25% of the cases (1/4). Cumulative probability of golimumab withdrawal free survival was 27.4% ± 9.9 at one year. In univariate analysis, there was no association between failure of golimumab (withdrawal and/or optimization) and previous exposure to anti-TNF or disease extent. However, there was a trend regarding the association between the concomitant use of an immunosuppressant and the maintenance of golimumab therapy without optimization (RR=0.4; CI 95%: 0.12–1.4, p=0.163).
Conclusions: In our cohort, golimumab was maintained with clinical efficacy in about 30% of the UC patients at one year. Previous exposure to anti-TNF seems to have non influence on treatment efficacy. Use of concomitant immunosuppressant may increase the efficacy of golimumab in the treatment of UC in clinical practice.