The PROSit cohort of infliximab biosimilar in IBD: A prolonged follow-up on the effectiveness and safety across Italy

التفاصيل البيبلوغرافية
العنوان:	The PROSit cohort of infliximab biosimilar in IBD: A prolonged follow-up on the effectiveness and safety across Italy
المؤلفون:	Armuzzi A., Guidi L., Pugliese D.
المساهمون:	Armuzzi, Alessandro, Fiorino, G., Variola, A., Manetti, N., Fries, W., Orlando, A., Maconi, G., Bossa, F., Cappello, M., Biancone, L., Cantoro, L., Costa, F., D'Inca, R., Lionetti, P., Principi, M., Castiglione, F., Annunziata, M. L., Di Sabatino, A., Di Girolamo, M., Terpin, M. M., Cortelezzi, C. C., Saibeni, S., Amato, A., Ardizzone, S., Guidi, Luisa, Danese, S., Massella, A., Ventra, A., Rizzuto, G., Massari, A., Perri, F., Annese, V., Saettone, S., Tari, R., Petruzzellis, C., Meucci, G., Imperiali, G., Guglielmi, F. W., Mazzuoli, S., Caserta, L., Parodi, M. C., Colli, A., Ronchetti, A., Pugliese, Daniela, Geccherle, A., Rogai, F., Milani, S., Renna, S., Cassinotti, A., Andriulli, A., Martino, G., Scrivo, B., Troncone, E., Kohn, A., Bertani, L., Lorenzon, G., Ghione, S., Nardone, O., Vecchi, M., Bertani, A., Bosani, M. A., Bezzio, C., Salerno, R.
بيانات النشر:	Oxford University Press
سنة النشر:	2019
المجموعة:	Università Cattolica del Sacro Cuore: PubliCatt
مصطلحات موضوعية:	Biosimilar, Crohn's disease, CT-P13, Inflammatory bowel disease, Inflectra, Infliximab, Remsima, Ulcerative coliti, Adolescent, Adult, Antibodies, Monoclonal, Female, Follow-Up Studie, Gastrointestinal Agent, Human, Italy, Male, Prognosi, Prospective Studie, Young Adult, Settore MED/09 - MEDICINA INTERNA, Settore MED/12 - GASTROENTEROLOGIA
الوصف:	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.
نوع الوثيقة:	article in journal/newspaper
اللغة:	English
العلاقة:	info:eu-repo/semantics/altIdentifier/pmid/30137352; info:eu-repo/semantics/altIdentifier/wos/WOS:000460620200026; volume:25; issue:3; firstpage:568; lastpage:579; numberofpages:12; issueyear:2019; journal:INFLAMMATORY BOWEL DISEASES; http://hdl.handle.net/10807/155054Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85059254975
DOI:	10.1093/ibd/izy264
الإتاحة:	https://doi.org/10.1093/ibd/izy264Test http://hdl.handle.net/10807/155054Test
حقوق:	info:eu-repo/semantics/closedAccess
رقم الانضمام:	edsbas.382A56DA
قاعدة البيانات:	BASE

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الوصف
DOI:	10.1093/ibd/izy264