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* = Presenting author

P395 Real-life prospective experience with adalimumab in ulcerative colitis in Italy: preliminary results of a pilot study

M. Daperno*1, A. Armuzzi2, D. Pugliese2, A. Lavagna1, P. Gionchetti3, F. Rizzello3

1AO Ordine Mauriziano, Gastroenterology Unit, Torino, Italy, 2Complesso Integrato Columbus, Internal Medicine, Roma, Italy, 3AO S. Orsola-Malpighi & University, Internal Medicine, Bologna, Italy

Background

Moderate-to-severe active ulcerative colitis (UC) may be treated with anti-TNF agents. Since the marketing of adalimumab in Italy (May 2014), its use in UC patients follows rigid entry criteria and a standard schedule of evaluation of clinical outcomes.

Aims: the aim of this pilot study is to explore real-life effectiveness of adalimumab in UC.

Methods

All consecutive adult UC patients treated at 3 institutions were prospectively followed-up. For the purposes of this interim analysis, a few characteristics were evaluated: week 8 response, treatment intensification/discontinuation, and colectomy. Relationship with previous anti-TNF exposure and time-dependent analyses were carried out. Patients were admitted to the treatment if clinically moderate-to-severely active (partial Mayo score between 6 and 9), with negative screening for anti-TNF, endoscopic Mayo score of 2 or 3 and previous failure to any of the following: systemic steroids, immunomodulators, and/or previous infliximab.

Results

In total, 54 patients were available for analysis at the time of abstract submission; median age was 38.7 years; 33 patients had been previously exposed to anti-TNF treatment (61%). Median follow-up after inclusion was 35 weeks (95%CI 29–43); 38 (70%) patients were followed-up > 26 weeks.

Further, 49 patients presented wk 8 response according to predefined criteria (91%); dose intensification (weekly) was required in 27 (50%) patients, drug was stopped in 17 s (32%) because of lack of efficacy or adverse events, and colectomy before the end of the follow-up was required in 5 (9%). Time to intensification/discontinuation or to colectomy was not significantly affected by previous anti-TNF exposure (p = NS), and rates of clinical events were not significantly different according to previous anti-TNF exposure. Kaplan–Meier curves for drug intensification and for colectomy are reported in Figure 1 and 2.

Figure 1. Kaplan–Meier analysis of survival free from drug intensification.

Figure 2. Kaplan–Meier analysis of survival free from colectomy.

Conclusion

Real-life effectiveness of adalimumab in UC is promising, with 50% of patients still being in treatment at 1 year after inclusion (more than expected from pivotal trials), and colectomy-free survival at 1 year is >7 5%, even if almost 2/3 of patients had already been exposed to infliximab beforehand. Larger groups of patients and perspective design of the trial, with longer follow-up, are warranted to confirm such results.