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P407 Prospective evaluation of clinical efficacy and safety of golimumab in biologic experienced and naïve patients with moderate to severe ulcerative colitis: experience from a tertiary referral centre

Orlandini B., Dragoni G., Bagnoli S., Deiana S., Macrì G., Rogai F.

Careggi, Gastroenterology, Florence, Italy

Background

Golimumab is a fully human monoclonal antibody to TNFα approved for the treatment of patients with moderate to severe ulcerative colitis (UC) with inadequate response or intolerance to corticosteroids or immunosuppressive therapy. The aim of this study is to evaluate the efficacy and tolerability profile of golimumab in both biologic naïve (BN) and biologic experienced (BE) patients.

Methods

Data were prospectively collected from a cohort of UC patients treated with golimumab from March 2015 to November 2016 at our Centre. Descriptive analyses were obtained from two patient cohorts, namely patients who were naive to anti-TNFα therapies (BN) and patients who have already failed biologic treatment with infliximab or adalimumab (BE) or both. Patients received golimumab 200 mg subcutaneously at week 0, 100 mg sc. at week 2, then 50 mg or 100 mg sc. every 4 weeks depending on body weight. The primary outcomes of interest were clinical response to treatment and rate of adverse events (AE).

Results

Overall, 27 patients were enrolled. Of these, 11 (41%) were BN and 16 (59%) BE. Baseline patient characteristics and main results are shown in Table 1. The majority of patients received >5 cycles of systemic steroids before starting golimumab (91% and 82% in the BN and BE groups, respectively). According to the Montreal classification of disease extension, most patients were E2 (55% in BN group, 25% in BE group) or E3 (45% and 75% of the BN and BE groups, respectively). Endoscopic disease activity was scored as Mayo 3 in 82% and 80% for BN and BE patients, respectively. Median (range) duration of golimumab therapy was 3 (1–6) months in the BN group and 3 (1–16) months in the BE group. In 3 (27%) patients in the BN group and 4 (25%) in the BE group AEs were recorded, most of which were skin/genito-urinary infections. Of note, two cases of basal cell carcinoma were registered. The overall remission rate was 45% and 25% in the BN and BE patients, respectively. The main cause of golimumab discontinuation was lack or loss of clinical response (specifically in 71% of BN patients and 92% of BE patients). Among unresponder patients, proctocolectomy was performed in 3 cases.

Table 1

Conclusion

In our cohort, clinical remission was obtained in almost half of BN patients but only one quarter of BE patients, with a similar rate of AEs. However, treatment duration was highly variable in our series. Although our findings need to be confirmed in larger series, golimumab therapy seems to achieve better disease control in the biologic naïve setting.