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P363 Efficacy and safety of golimumab in patients with ulcerative colitis: a prospective multicentre study

D. Varvara1, G. Costantino2, A.C. Privitera3, B. Principi4, M. Cappello5, S. Mazzuoli6, P. Paiano7, A. Tursi8, P. Paese9, W. Fries10, A. Andriulli1, F. Bossa*1

1IRCCS Casa Sollievo della Sofferenza, Gastroenterology, San Giovanni Rotondo, Italy, 2University of Messina, Clinical and experimental Medicine, Messina, Italy, 3Ospedale Cannizzaro, Chirurgia, Catania, Italy, 4University of Bari, Gastroenterology, Bari, Italy, 5University of Palermo, Gastroenterology, Palermo, Italy, 6Ospedale San Nicola Pellegrino, Gastroenterology, Trani, Italy, 7Ospedale di poggiardo, Gastroenterology, Poggiardo, Italy, 8ASL BAT, Gastroenterology, Andria, Italy, 9Ospedale Annunziata, Gastroenterology, Cosenza, Italy, 10University of Messina, Clinical and Experimental Medicine, Messina, Italy

Background

Golimumab is an anti-TNF alpha antibody recently available for the treatment of patients with ulcerative colitis (UC). Data on its efficacy and safety derive from registration trials, but information on its use in the daily clinical practice are still scanty. The aim of this study is to prospectively value the efficacy and safety of golimumab in a large cohort of UC patients in the daily clinical practice.

Methods

All patients with UC treated with golimumab observed between June 2015 and June 2016 in 9 IBD centres of the south of Italy will be consecutively enrolled. Retrospective information (demographics, date of diagnosis of UC, maximal extension of the disease, previous therapy, comorbidities, and concomitant therapies) were collected. Prospective data on clinical, endoscopic and laboratory activity, concomitant therapies, and adverse events during the therapy with golimumab will be collected every 3 months until the end of the first year of treatment.

Results

We report the preliminary data of the 51 enrolled patients (28 males). The mean age at diagnosis was 38.6 ± 14.4 (range 17–69 years) and mean disease duration at study inclusion was 8.8 ± 7.1 (range 1–28 years): 36 patients (70.7%) had a pancolitis; 11 patients (23.5%) had a distal colitis; and 3 patients (5.8%) had a proctitis. Further, 25 patients were previously treated with anti-TNF alpha antibodies before golimumab (14 with infliximab, 1 with adalimumab, and 10 with infliximab and adalimumab). The main indications for golimumab were steroid-resistance (11 patients), steroid-dependence (27 patients), extraintestinal manifestations (3 patients), and failure to anti-TNF alpha therapy (10 patients). At study inclusion, the mean total mayo scores were 7.4 ± 2.7 (range 0–12) with a mean Mayo endoscopic score of 2.3 ± 0.7 (range 1–3). Mean values of ESR, CRP and faecal calprotectine were respectively 34.6 ± 22.2 (range 4–100), 4.5 ± 4.3 (range 0.3–24 mg/dl), and 476 ± 763 (range 56–3 086 microg/g).

After 3 months of therapy the total Mayo score (available in only 23 patients) was 4.3 ± 2.4 (range 0–9), significantly lower compared with the baseline (p < 0.0001), with 18 patients (78.3%) with score ≤ 5 (remission or mild activity). No significant differences between ESR and CRP values were observed after 3 months of therapy. Moreover, 5 patients (10%) experienced one or more adverse events (1 serious), and 2 refractory patients (4%) underwent surgery (for toxic megacolon and persistent activity of the disease).

Conclusion

These preliminary data showed that golimumab is effective and safe in most patients with UC, and it is comparable to the other anti-TNF alpha therapies (infliximab and adalimumab) in the daily clinical practice.