The PROSIT Cohort of Infliximab Biosimilar in IBD: A Prolonged Follow-up on the Effectiveness and Safety Across Italy

Armuzzi A1, Fiorino G2, Variola A3, Manetti N4, Fries W5, Orlando A6, Maconi G7, Bossa F8, Cappello M9, Biancone L10, Cantoro L11, Costa F12, D'Incà R13, Lionetti P14, Principi M15, Castiglione F16, Annunziata ML17, Di Sabatino A18, Di Girolamo M19, Terpin MM20, Cortelezzi CC21, Saibeni S22, Amato A23, Ardizzone S24, Guidi L1, Danese S2, Massella A3, Ventra A5, Rizzuto G6, Massari A7, Perri F8, Annese V4; PROSIT Investigators. Inflamm Bowel Dis. 2018 Aug 18. doi: 10.1093/ibd/izy264. [Epub ahead of print]

Collaborators (31)

Author information

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.


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, inflammatorybiomarkers (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.

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