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Poster presentations: Clinical: Therapy and Observation 2020

P438 Real-life effectiveness and safety of ABP501, an adalimumab biosimilar, in inflammatory bowel disease: a multicentre Italian study

B. Barberio1, F. Zingone1, A. Ferronato2, A. Buda3, P. Melatti1, A. Gubbiotti1, D. Massimi1, C. Casadei1, L. Cingolani4, E.V. Savarino1

1Department of Surgery- Oncology- Gastroenterology, University of Padua, Padua, Italy, 2Pedemontana- Santorso, Digestive Endoscopy Unit, Santorso, Italy, 3Gastroenterology Unit, Feltre Hospital, Santorso, Italy, 4Department of Surgery- Oncology- Gastroenterology, University of Padua, Paduaita, Italy

Background

Recently, various adalimumab (ADA) biosimilars have been approved by the EMA with the same indications of the reference product (Humira), despite the lack of data in terms of efficacy and safety in patients with inflammatory bowel disease (IBD). The aim of our study was to verify the effectiveness and tolerability of ABP501, an ADA Biosimilar, in IBD in the short-term.

Methods

All consecutive moderate-to-severe IBD patients who completed induction with ABP501 at three Italian IBD Units (Padua, Santorso, Feltre) were included. We collected data on partial Mayo (p-Mayo) Score, Harvey–Bradshaw Index (HBI), C reactive protein (CRP), faecal calprotectin (FC), concomitant steroid and azathioprine therapy at baseline (T0), after induction (T1) and at six months (T2). Information on the need for optimisation and adverse events (AEs) were also collected. Continuous and categorical variables were expressed as mean with standard deviation and frequency with percentages, respectively. Comparisons between variables were conducted using a t-test and chi-square test. Data were analysed using STATA11.1 software.

Results

Thirty-three IBD patients [17 with ulcerative colitis (CU), 18 with Crohn’s disease (CD)] that completed induction (T1) were considered, with 18 of them who completed at least six months of therapy (T2). Clinical remission was achieved by 14/33 (45.5%) and 8/18 (44.4) patients at T1 and T2, respectively. Steroid-free clinical remission was obtained by 14/33 (42.4%) and 8/18 (44.4) patients at T1 and T2, respectively. After induction FC tended to decrease from baseline to T2, without reaching statistical significance (p = 0.1). However, a significant decrease in CRP levels (p < 0.02) was observed. After induction, AEs occurred in 11 (33.3%) patients: 2 had an infection, 8 reported headache or myalgia or arthralgia, and one experienced a local infusion reaction. Moreover, AEs were observed in 6/18 (33.3%) at T2: 5 had arthralgia and 1 had a local infusion reaction. After induction 4/33 (12.12%) stopped therapy for lack of response, whereas the dropout occurred in 6/12 (33.3%) at six months (4 for loss of response and 2 for adverse events). Finally, 7/33 (21.2%) and 5/18 (27.7%) patients needed therapeutic optimisation at T1 and T2, respectively.

Conclusion

ABP501 seemed to be successful in achieving clinical remission and steroid-free clinical remission, but further data are required. Overall the therapy was well tolerated.