Alessandro Armuzzi1, Gionata Fiorino2, Angela Variola3, Natalia Manetti4, Walter Fries5, Ambrogio Orlando6, Giovanni Maconi7, Fabrizio Bossa8, Maria Cappello9, Livia Biancone10, Laura Cantoro11, Francesco Costa12, Renata D'Incà13, Paolo Lionetti14, Mariabeatrice Principi15, Fabiana Castiglione16, Maria L Annunziata17, Antonio Di Sabatino18, Maria Di Girolamo19, Maria M Terpin20, Claudio C Cortelezzi21, Simone Saibeni22, Arnaldo Amato23, Sandro Ardizzone24, Luisa Guidi1, Silvio Danese2, Arianna Massella3, Agostino Ventra5, Giulia Rizzuto6, Alessandro Massari7, Francesco Perri8, Vito Annese4. 1. IBD Unit, Presidio Columbus, Fondazione Policlinico Gemelli Università Cattolica, Rome, Italy. 2. Humanitas Research Hospital and University, Gastroenterology and IBD Center, Rozzano, Italy. 3. Centro Malattie retto-intestinali, Sacro Cuore Don Calabria Hospital, Negrar, Italy. 4. AOU Careggi, Gastroenterology, Florence, Italy. 5. University of Messina, Clinical Unit for Chronic Bowel Disorders, Messina, Italy. 6. Riuniti Villa Sofia-Cervello Hospital, Internal Medicine 2, IBD Unit Palermo, Italy. 7. Luigi Sacco University Hospital, Gastroenterology and IBD Unit, Milan, Italy. 8. IRCCS-CSS Hospital, Gastroenterology, San Giovanni Rotondo, Italy. 9. Gastroenterology and Hepatology Section, DiBiMis, University of Palermo, Palermo, Italy. 10. University of Rome Tor Vergata, Department of Systems Medicine, Gastroenterology, Roma. 11. S. Camillo-Forlanini Hospital, Gastroenterology, Rome, Italy. 12. AOUP, Gastroenterology, Pisa, Italy. 13. University of Padova, Gastroenterology, Padova, Italy. 14. Meyer Children's Hospital, Gastroenterology and Nutrition, Florence, Italy. 15. University of Bari, Gastroenterology, Bari, Italy. 16. Federico II University, Gastroenterology, Naples, Italy. 17. IRCCS Policlinico, Gastroenterology, San Donato Milanese-Milano, Italy. 18. First Department of Medicine, S. Matteo Hospital Foundation, University of Pavia, Pavia, Italy. 19. University Hospital, Gastroenterology, Modena, Italy. 20. U.O.C. Gastroenterologia ed Endoscopia Digestiva ASST Ovest Milanese, Legnano, Italy. 21. SC Gastroenterology ASST Settelaghi Varese, Italy. 22. ASST Rhodense, Rho Hospital, Gastroenterology Unit, Rho, Italy. 23. Ospedale Valduce, Gastroenterology, Como, Italy. 24. Department of Biochemical and Clinical Science "L. Sacco" ASST Fatebenefratelli Sacco-University of Milan, Italy.
Abstract
BACKGROUND: We report a prospective, nationwide cohort evaluating the safety and effectiveness of CT-P13. METHODS: A structured database was used to record serious adverse events (SAEs), clinical remission/response, inflammatory biomarkers (CRP and calprotectin), and endoscopic findings. RESULTS: Eight hundred ten patients with inflammatory bowel disease (IBD) (452 Crohn's disease [CD]) were enrolled. Four hundred fifty-nine patients were naïve to anti-TNFα (group A), 196 had a previous exposure (group B), and the remaining 155 were switched to CT-P13 (group C). All patients were included in the safety evaluation with a mean follow-up of 345 ± 215 days and a total number of 6501 infusions. One hundred fifty-four SAEs were reported (19%), leading to cessation of the biosimilar in 103 subjects (12.7%). Infusion reactions were 71, leading to cessation of the biosimilar in 53 subjects (6.5%), being significantly more frequent in patients pre-exposed to anti-TNFα (P = 0.017). The efficacy of therapy was calculated in 754 IBD patients, with a mean follow-up of 329 ± 202 days. Forty-eight patients had a primary failure (6.4%), and 188 (25.6%) lost response during follow-up. Six hundred twenty-eight (364 CD) and 360 IBD patients (222 CD) completed the follow-up at 6 and 12 months, respectively. At 12 months, patients without loss of response were 71%, 64%. and 82% in groups A, B, and C, respectively (log rank P = 0.01). Clinical/endoscopic scores and inflammatory biomarkers dropped significantly in CD and UC patients (P = 0.01 and P < 0.0001) compared with baseline. CONCLUSIONS: In this large prospective cohort, no further signals of difference in safety and effectiveness of CT-P13 in IBD has been observed.
BACKGROUND: We report a prospective, nationwide cohort evaluating the safety and effectiveness of CT-P13. METHODS: A structured database was used to record serious adverse events (SAEs), clinical remission/response, inflammatory biomarkers (CRP and calprotectin), and endoscopic findings. RESULTS: Eight hundred ten patients with inflammatory bowel disease (IBD) (452 Crohn's disease [CD]) were enrolled. Four hundred fifty-nine patients were naïve to anti-TNFα (group A), 196 had a previous exposure (group B), and the remaining 155 were switched to CT-P13 (group C). All patients were included in the safety evaluation with a mean follow-up of 345 ± 215 days and a total number of 6501 infusions. One hundred fifty-four SAEs were reported (19%), leading to cessation of the biosimilar in 103 subjects (12.7%). Infusion reactions were 71, leading to cessation of the biosimilar in 53 subjects (6.5%), being significantly more frequent in patients pre-exposed to anti-TNFα (P = 0.017). The efficacy of therapy was calculated in 754 IBDpatients, with a mean follow-up of 329 ± 202 days. Forty-eight patients had a primary failure (6.4%), and 188 (25.6%) lost response during follow-up. Six hundred twenty-eight (364 CD) and 360 IBDpatients (222 CD) completed the follow-up at 6 and 12 months, respectively. At 12 months, patients without loss of response were 71%, 64%. and 82% in groups A, B, and C, respectively (log rank P = 0.01). Clinical/endoscopic scores and inflammatory biomarkers dropped significantly in CD and UC patients (P = 0.01 and P < 0.0001) compared with baseline. CONCLUSIONS: In this large prospective cohort, no further signals of difference in safety and effectiveness of CT-P13 in IBD has been observed.
Authors: Philipp Schreiner; Markus F Neurath; Siew C Ng; Emad M El-Omar; Ala I Sharara; Taku Kobayashi; Tadakazu Hisamatsu; Toshifumi Hibi; Gerhard Rogler Journal: Inflamm Intest Dis Date: 2019-07-09
Authors: Jan Marsal; Manuel Barreiro-de Acosta; Irina Blumenstein; Maria Cappello; Thomas Bazin; Shaji Sebastian Journal: Front Med (Lausanne) Date: 2022-06-15
Authors: Kristin K Jørgensen; Guro L Goll; Joe Sexton; Nils Bolstad; Inge C Olsen; Øivind Asak; Ingrid P Berset; Ingrid M Blomgren; Katrine Dvergsnes; Jon Florholmen; Svein O Frigstad; Magne Henriksen; Jon Hagfors; Gert Huppertz-Hauss; Espen A Haavardsholm; Rolf A Klaasen; Bjørn Moum; Geir Noraberg; Ulf Prestegård; Jan H Rydning; Liv Sagatun; Kathrine A Seeberg; Roald Torp; Cecilia Vold; David J Warren; Carl M Ystrøm; Knut E A Lundin; Tore Kvien; Jørgen Jahnsen Journal: BioDrugs Date: 2020-10 Impact factor: 5.807