P477 Italian real-life study evaluating the long-term effectiveness of vedolizumab for the treatment of inflammatory bowel disease: the elderly cohort
D. Pugliese, G. Privitera, A. Armuzzi, LIVE IG-IBD study group (Ambrogio Orlando and Federica Crispino – AZ.Osp. Ospedali Riuniti ‘Villa Sofia-Cervello’ Palermo Nicolò Mezzina and Alessandro Massari – ASST Fatebenefratelli Sacco Department of Biochemical and Clinical Sciences University of Milan Milan Lucienne Pellegrini and Fabiana Castiglione – AOU ‘Federico II’ Napoli Lucrezia Laterza and Franco Scaldaferri – CEMAD Fondazione Policlinico Universitario A. Gemelli IRCCS Roma Anna Viola and Walter Fries – Policlinico Messina Pietro Soru and Flavio Caprioli – Fondazione IRCCS Cà Granda Ospedale Policlinico Milan Maria Cappello and Barbara Scrivo – Universita’ di Palermo Policlinico Paolo Giaccone Palermo Brigida Barberio and Edoardo Savarino – University of Padua - Azienza Ospedaliera di Padova Padova Chiara Ricci – Università degli Studi di Brescia Ospedali Civili Brescia Brescia Dario Pluchino – AOU Policlinico Vittorio Emanuele Catania Maria Lia Scribano – San Camillo-Forlanini Rome Lorenzo Bertani Azienda Ospedaliera Universitaria Pisana Pisa Renato Sablich – Azienda per l’Assistenza Sanitaria n. 5 ‘Friuli Occidentale’ Pordenone Luca Pastorelli – University of Milan IRCCS Policlinico San Donato Milan Francesco Manguso – AORN A. Cardarelli Napoli Angela Variola – IRCCS Sacro Cuore Don Calabria Negrar di Valpolicella (VR) Antonio Di Sario – Università Politecnica delle Marche Ospedali Riuniti - University Hospital Ancona Laurino Grossi – G d’Annunzio University Ospedale Spirito Santo Pescara Davide Giuseppe Ribaldone – University of Turin Turin Giuseppe Biscaglia – IRCCS Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo (FG) Pierenrico Lecis – Ospedale S.Maria del Prato - ULSS 1 Dolomiti Belluno Paola Balestrieri – Unviersità Campus Biomedico Roma Gianmarco Mocci – AOU G Brotzu Cagliari Angelo Viscido – University of L’Aquila L’Aquila Maria Carla Di Paolo Azienda Ospedaliera San Giovanni Addolorata Roma Sara Onali – University of Rome Tor Vergata Rome Stefano Rodinò – Azienda Ospedaliera ‘Pugliese-Ciaccio’ Catanzaro Marina Coletta – ASST Santi Paolo e Carlo-Ospedale San Paolo Polo Universitario Milano Mariabeatrice Principi – Azienda Ospedaliera Universitaria Policlinico di Bari Bari Agnese Miranda – Università della Campania Luigi Vanvitelli II Policlinico di Napoli Napoli Arnaldo Amato – Valduce hospital Como Cristina Bezzio – Rho Hospital ASST Rhodense Rho Carlo Petruzzellis – Istituto Ospedaliero Fondazione Poliambulanza Brescia Silvia Mazzuoli – Osp San Nicola Pellegrino ASL BT Trani Stefano Festa – San Filippo Neri Hospital Rome Alessandro Sartini – Azienda Ospedaliero-Universitaria Policlinico di Modena Modena Libera Frangiulo – Ospedale SS. Annunziata di Taranto Taranto Sara Gallina – Ospedale Belcolle Viterbo Giorgia Bodini – University of Genoa Genoa)
Fondazione Policlinico Universitario A Gemelli IRCCS- Università Cattolica del Sacro Cuore, IBD Unit Presidio Columbus, Rome, Italy
Background
Vedolizumab (VDZ) is the first biological therapy for Inflammatory Bowel Disease (IBD) tested, in pivotal trials, on patients up to 80 years old and has usually been presented as a safer choice in frail patients. However, real-world data on the effectiveness and safety of VDZ in elderly (≥ 65 years) are scarce. The aim of this study is to explore the effectiveness and safety of VDZ in a large real-life cohort of elderly IBD patients, with a 2 years follow-up.
Methods
The Long-term Italian Vedolizumab Effectiveness (LIVE) study included CD and UC patients started on VDZ from April 2016 to June 2017 at 40 centres of the Italian Group for the study of inflammatory bowel disease (IG-IBD). Patients were prospectively followed-up to June 2019. Co-primary endpoints were to evaluate cumulative VDZ treatment persistence and safety.
Results
Of 966 patients, 174 (18%; 81 CD, 93 UC) were ≥ 65 years old at enrolment. Mean disease duration at baseline was 10.9 years ± SD10 (CD 12.5 ± 11, UC 9.6 ± 9). VDZ was used as a first biologic therapy in 78 patients (44.8%). 25 patients (14.4%) had a history of previous cancer. The majority of CD patients had a stricturing behaviour (45, 55.6%) and had already undergone surgery (41, 49.4%). 48 UC patients (51.6%) had extensive colitis. Moderate-to-severe endoscopic activity was present in 80% of CD and in 92% of UC, according to SES-CD and endoscopic Mayo score, respectively. Cumulative VDZ treatment persistence at 12 and 24 months was 71.8% (71.6% CD and 72.0% UC) and 54% (54.2% CD and 53.8%% UC), respectively. 52.9% (40 CD; 52 UC), 4.0%, 3.5%% and 2.9% of patients were on concomitant steroids at baseline, 6, 12, and 24 months, respectively. Clinical remission at 12 and 24 months was achieved in 28.7% (31 CD and 29 UC) and in 31.6% (25 CD and 30 UC) of patients. Mean C-reactive protein was 15.6 mg/l ± SD 20 (CD 15.9 ± 21; UC 15.2 ± 19) at baseline and dropped to 8.4 mg/l ± 10 (CD 8.0 ± 8, UC 8.9 ± 11) at 12 months and to 5.9 mg/l ± 6 (CD 5.8 ± 5, UC 6 ± 7) at 24 months. Dose escalation was necessary for 20.3% and 24.7% of patients within the first 12 and 24 months. 44 adverse events were reported: 16 infections.,6 new diagnosis of cancer/dysplasia (2 colon, 1 kidney, 1 prostate, 1 lung, 1 melanoma), 4 arthritis, 3 skin rash, 2 drug-induced cholestasis,11 miscellaneous. 11 patients (6.3%) underwent VDZ withdrawal because of adverse events (6 new diagnosis of cancer/dysplasia; 4 infections; 1 cholestasis). One patient died for pneumonia complications.
Conclusion
In this preliminary analysis of the largest reported real-world cohorts of elderly IBD patients treated with VDZ, up to 55% of patients persisted on therapy after two years; an acceptable safety profile was observed throughout the entire follow-up period.