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OP005 The PROSIT cohort of infliximab biosimilar in IBD: a prolonged follow-up on the efficacy and safety across Italy

Guidi L.1, Fiorino G.*2, Variola A.3, Manetti N.4, Fries W.5, Rizzuto G.6, Bossa F.7, Cappello M.8, Biancone L.9, D'Incà R.10, Cantoro L.11, Castiglione F.12, Principi M.13, Annunziata M.L.14, Di Girolamo M.15, Terpin M.M.16, Cortelezzi C.C.17, Costa F.18, Amato A.19, Di Sabatino A.20, Saibeni S.21, Meucci G.22, Petruzzellis C.23, Tari R.24, Gugliemi F.W.25, Armuzzi A.26, Danese S.2, Geccherle A.3, Rogai F.4, Ventra A.5, Orlando A.6, Andriulli A.7, Scrivo B.8, Troncone E.9, Caccaro R.10, Kohn A.11, Nardone O.12, Annese V.27

1Complesso Integrato Columbus, Fondazione Policlinico Gemelli Universita' Cattolica, Internal Medicine and Gastroenterology, Rome, Italy 2Humanitas Research Hospital and University, Gastroenterology and IBD Center, Rozzano, Italy 3Sacro Cuore Don Calabria Hospital, Gastroenterology and Hepatology, Negrar, Italy 4AOU Careggi, DEA, Gastroenterology, Florence, Italy 5University of Messina, Clinical Unit for Chronic Bowel Disorders, Messina, Italy 6Riuniti Villa Sofia - Cervello Hospital, Internal Medicine 2, Palermo, Italy 7IRCCS-CSS Hospital, Gastroenterology, San Giovanni Rotondo, Italy 8University Hospital, Gastroenterology, Palermo, Italy 9Tor Vergata, Gastroenterology, Roma, Italy 10University of Padova, Gastroenterology, Padova, Italy 11S. Camillo-Forlanini Hospital, Gastroenterology, Rome, Italy 12Federico II University, Gastroenterology, Naples, Italy 13University Bari, Gastroenterology, Bari, Italy 14IRCCS Policlinico, Gastroenterology & Digestive Endoscopy Unit, San Donato, Milano, Italy 15University Hospital, Gastroenterology, Modena, Italy 16AO Hospital, Gastroenterology and Endoscopy, Legnano, Italy 17AOU di Circolo Fondazione Macchi, Gastroenterology, Varese, Italy 18AOUP, Gastroenterology, Pisa, Italy 19Ospedale Valduce, Gastroenterology, Como, Italy 20S.Matteo Hospital Foundation, University of Pavia, First Department of Medicine, Pavia, Italy 21ASST Rhodense, Gastroenterology Unit, Rho, Italy 22S. Giuseppe Hospital, Gastroenterology, Milano, Italy 23Poliambulanza Hospital, Gastroenterology and Digestive Endoscopy, Brescia, Italy 24AOU Maggiore, Gastroenterology, Novara, Italy 25S. Pellegrino Hospital, Gastroenterology, Trani, Italy 26Complesso Integrato Columbus - Catholic University, Internal Medicine and Gastroenterology, Rome, Italy 27Valiant Clinic, Gastroenterology, Dubai, United Arab Emirates

Background

The Infliximab biosimilar CT-P13 has been used since March 2015 in Italy. We report here a prolonged follow-up of a prospective, nationwide, multicentre, observational cohort (PROSIT) evaluating the safety, and clinical/endoscopic efficacy.

Methods

A structured data base has been used to record relevant serious adverse events (SAEs), clinical efficacy (partial Mayo [PM] and Harvey-Bradshaw Index [HBI]), inflammatory markers (CRP and calprotectin [calpro]) and endoscopic findings (endoscopic Mayo [EM] and Simple Endoscopic Score for Crohn's Disease [SES-CD]).

Results

Results 680 consecutive patients (373 CD, 307 UC) have been included from academic (n=13) and non-academic (n=12) referral centers. Age at the disease onset was 30.5±13.9 years in CD and 33.7±13.3 years for UC. 400 patients were naïve to anti-TNFα (192 CD, 208 UC), 171 patients (115 CD, 56 UC) had a previous exposure to one or more biologics, whereas the remaining 109 patients (66 CD, 43 UC) were switched after a mean of 18±10 previous infusions of infliximab (range 3–72). All patients were included in the safety evaluation. A total number of over 4,000 infusions were recorded; 92 SAEs (13.5%) were reported, leading to stop biosimilar in 73 patients (10.7%). IRs were 46, leading to stop biosimilar in 38 subjects (5.6%), and were significantly more frequent in patients pre-exposed to anti-TNFα (p<0.02).

Primary failure was recorded in 55/680 patients (8.1%). The efficacy of therapy was calculated following the induction regimen or at least two infusions after switching in 601 patients with a mean follow-up of 32 weeks (range 8–83). As a whole 274 patients were in remission (45.6%), 186 were considered responders (30.9%) and 62 lost the response (10.3%). The remaining patients were failure or stopped the therapy. 377 patients (222 CD) and 150 patients (89 CD) completed the follow-up of 6 and 12 months, respectively. After 1 year of CT-P13 therapy, HBI, SES-CD, CRP, and Calpro significantly (p<0.01) dropped in CD patients (7.1±3.4 vs 3.2±2; 10.1±42 vs 3±2.6; 1.9±1.7 mg/dl vs 0.9±0.8; 565±485 mg/kg vs 126±133 respectively), compared to baseline. Similarly, in UC patients PM, EM, CRP, and Calpro (6.1±2.3 vs 1.9±1.8; 2.1±0.6 vs 1.3±0.8; 3±2 mg/dl vs 0.9±0.7; 759±516 mg/kg vs 72±65, respectively) were significantly reduced (p<0.001). A deep remission was achieved in 57% and 50% of CD and UC patients in whom all information were available, respectively.

Conclusion

This is one of the largest prospective cohort of patients with IBD treated with CT-P13. After a more prologed follow-up, no further signals of difference in safety and clinical efficacy has been observed.