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

A. Armuzzi, G. Fiorino, A. Variola, N. Manetti, W. Fries, A. Orlando, G. Maconi, F. Bossa, M. Cappello, L. Biancone, L. Cantoro, F. Costa, R. D'Incà, P. Lionetti, M. Principi, F. Castiglione, M.L. Annunziata, A. Di Sabatino, M. Di Girolamo, M.M. TerpinC.C. Cortelezzi, S. Saibeni, A. Amato, S. Ardizzone, L. Guidi, S. Danese, A. Massella, A. Ventra, G. Rizzuto, A. Massari, F. Perri, V. Annese, S. Saettone, R. Tari, C. Petruzzellis, G. Meucci, G. Imperiali, F.W. Guglielmi, S. Mazzuoli, L. Caserta, M.C. Parodi, A. Colli, A. Ronchetti, D. Pugliese, A. Geccherle, F. Rogai, S. Milani, S. Renna, A. Cassinotti, A. Andriulli, G. Martino, B. Scrivo, E. Troncone, A. Kohn, L. Bertani, G. Lorenzon, S. Ghione, O. Nardone, M. Vecchi, A. Bertani, M.A. Bosani, C. Bezzio, R. Salerno

Research output: Contribution to journalArticle

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. © 2018 Crohn's & Colitis Foundation. Published by Oxford University Press. All rights reserved.
Original languageEnglish
Pages (from-to)568-579
Number of pages12
JournalInflammatory Bowel Diseases
Volume25
Issue number3
DOIs
Publication statusPublished - 2019

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Biosimilar Pharmaceuticals
Inflammatory Bowel Diseases
Italy
Safety
Crohn Disease
Biomarkers
Leukocyte L1 Antigen Complex
Infliximab
Colitis

Keywords

  • Biosimilar
  • Crohn's disease
  • CT-P13
  • Inflammatory bowel disease
  • Inflectra
  • Infliximab
  • Remsima
  • Ulcerative colitis
  • adalimumab
  • biological marker
  • biosimilar agent
  • C reactive protein
  • calgranulin
  • ct p 13
  • golimumab
  • infliximab
  • tumor necrosis factor inhibitor
  • unclassified drug
  • adult
  • arthralgia
  • Article
  • clinical evaluation
  • clinical feature
  • clinical outcome
  • cohort analysis
  • controlled study
  • Crohn disease
  • disease duration
  • drug efficacy
  • drug exposure
  • drug safety
  • drug substitution
  • drug tolerability
  • drug withdrawal
  • female
  • follow up
  • gastroscopy
  • human
  • immunopathology
  • infection
  • inflammatory bowel disease
  • infusion related reaction
  • major clinical study
  • male
  • neurologic disease
  • observational study
  • patient safety
  • priority journal
  • prospective study
  • randomized controlled trial
  • remission
  • scoring system
  • skin manifestation
  • steroid therapy
  • ulcerative colitis

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The PROSit cohort of infliximab biosimilar in IBD: A prolonged follow-up on the effectiveness and safety across Italy. / Armuzzi, A.; Fiorino, G.; Variola, A.; Manetti, N.; Fries, W.; Orlando, A.; Maconi, G.; Bossa, F.; Cappello, M.; Biancone, L.; Cantoro, L.; Costa, F.; D'Incà, 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, L.; 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, D.; 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.

In: Inflammatory Bowel Diseases, Vol. 25, No. 3, 2019, p. 568-579.

Research output: Contribution to journalArticle

Armuzzi, A, Fiorino, G, Variola, A, Manetti, N, Fries, W, Orlando, A, Maconi, G, Bossa, F, Cappello, M, Biancone, L, Cantoro, L, Costa, F, D'Incà, R, Lionetti, P, Principi, M, Castiglione, F, Annunziata, ML, Di Sabatino, A, Di Girolamo, M, Terpin, MM, Cortelezzi, CC, Saibeni, S, Amato, A, Ardizzone, S, Guidi, L, 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, FW, Mazzuoli, S, Caserta, L, Parodi, MC, Colli, A, Ronchetti, A, Pugliese, D, 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, MA, Bezzio, C & Salerno, R 2019, 'The PROSit cohort of infliximab biosimilar in IBD: A prolonged follow-up on the effectiveness and safety across Italy', Inflammatory Bowel Diseases, vol. 25, no. 3, pp. 568-579. https://doi.org/10.1093/ibd/izy264
Armuzzi, A. ; Fiorino, G. ; Variola, A. ; Manetti, N. ; Fries, W. ; Orlando, A. ; Maconi, G. ; Bossa, F. ; Cappello, M. ; Biancone, L. ; Cantoro, L. ; Costa, F. ; D'Incà, 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, L. ; 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, D. ; 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. / The PROSit cohort of infliximab biosimilar in IBD: A prolonged follow-up on the effectiveness and safety across Italy. In: Inflammatory Bowel Diseases. 2019 ; Vol. 25, No. 3. pp. 568-579.
@article{7c17573ca7ff4477ac47945b4925dad5,
title = "The PROSit cohort of infliximab biosimilar in IBD: A prolonged follow-up on the effectiveness and safety across 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 na{\"i}ve 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. {\circledC} 2018 Crohn's & Colitis Foundation. Published by Oxford University Press. All rights reserved.",
keywords = "Biosimilar, Crohn's disease, CT-P13, Inflammatory bowel disease, Inflectra, Infliximab, Remsima, Ulcerative colitis, adalimumab, biological marker, biosimilar agent, C reactive protein, calgranulin, ct p 13, golimumab, infliximab, tumor necrosis factor inhibitor, unclassified drug, adult, arthralgia, Article, clinical evaluation, clinical feature, clinical outcome, cohort analysis, controlled study, Crohn disease, disease duration, drug efficacy, drug exposure, drug safety, drug substitution, drug tolerability, drug withdrawal, female, follow up, gastroscopy, human, immunopathology, infection, inflammatory bowel disease, infusion related reaction, major clinical study, male, neurologic disease, observational study, patient safety, priority journal, prospective study, randomized controlled trial, remission, scoring system, skin manifestation, steroid therapy, ulcerative colitis",
author = "A. Armuzzi and G. Fiorino and A. Variola and N. Manetti and W. Fries and A. Orlando and G. Maconi and F. Bossa and M. Cappello and L. Biancone and L. Cantoro and F. Costa and R. D'Inc{\`a} and P. Lionetti and M. Principi and F. Castiglione and M.L. Annunziata and {Di Sabatino}, A. and {Di Girolamo}, M. and M.M. Terpin and C.C. Cortelezzi and S. Saibeni and A. Amato and S. Ardizzone and L. Guidi and S. Danese and A. Massella and A. Ventra and G. Rizzuto and A. Massari and F. Perri and V. Annese and S. Saettone and R. Tari and C. Petruzzellis and G. Meucci and G. Imperiali and F.W. Guglielmi and S. Mazzuoli and L. Caserta and M.C. Parodi and A. Colli and A. Ronchetti and D. Pugliese and A. Geccherle and F. Rogai and S. Milani and S. Renna and A. Cassinotti and A. Andriulli and G. Martino and B. Scrivo and E. Troncone and A. Kohn and L. Bertani and G. Lorenzon and S. Ghione and O. Nardone and M. Vecchi and A. Bertani and M.A. Bosani and C. Bezzio and R. Salerno",
note = "Cited By :9 Export Date: 30 October 2019 CODEN: IBDNB Correspondence Address: Annese, V.; Gastroenterology Department, Valiant Clinic, 13th Street City Walk, United Arab Emirates; email: vito.annese@valiant.ae Chemicals/CAS: adalimumab, 331731-18-1, 1446410-95-2; C reactive protein, 9007-41-4; golimumab, 476181-74-5; infliximab, 170277-31-3 Tradenames: ct p 13 Funding details: AbbVie Funding details: Medtronic Funding details: Pfizer Funding details: Chiesi Farmaceutici, Chiesi Funding details: Samsung Funding details: Takeda Oncology Funding details: Food and Drug Administration, FDA Funding text 1: Conflicts of interest: AA served as consultant to Abbvie, Allergan, Amgen, Biogen, Celgene, Celltrion, Ferring, Hospira, Janssen, Lilly, MS&D, Mundipharma, Pfizer, Samsung Bioepis, Sofar, Takeda. He received lectures fees from Abbvie, Astra-Zeneca, Chiesi, Ferring, Hospira, Janssen, Medtronic, MS&D, Mitsubishi Tanabe, Mundipharma, Nikkiso, Otsuka, Pfizer, Samsung Bioepis, Takeda, Tigenix, Zambon, and research grant from MS&D. VA served as consultant to Abbvie, Hospira, Mundipharma, MS&D, Takeda, Janssen, Ferring. He received lecture fees from Abbvie, Ferring, Hospira, MS&D, Takeda, Medtronic, Menarini and unrestricted research grants from Giuliani, Ferring, Sofar, Roche, Gillead, MS&D, Abbvie, and Otsuka. MA served as advisory board member for MSD, Takeda, and AbbVie. SA received consulting and advisory board fees and/or research support from AbbVie, MSD, Abbvie, Ferring, MSD, Janssen, Takeda, Mundipahrma, Zambon, and Sofar. BA received speaker fees from Takeda and unrestricted research grant from Sofar. LB received lecture fees from: Takeda, Zambon, Abbvie, MSD, and Wassermann. BS served as consultant to Abbvie, Takeda, and MSD. LC received a speaker fee form MS&D. MC has received lecture fees from MSD, Abbvie, Takeda, and Chiesi and has served as advisory board member for MSD and Abbvie. FC has served as advisory board member for Abbvie, MSD, and Takeda and received speaker fees from Abbvie, MSD, Takeda, Zambon, Otsuka, Phadia, and Diasorin. SD has served as a speaker, consultant, and advisory board member for Schering-Plough, Abbott Laboratories, Merck, UCB-pharma, Ferring, Cellerix, Millenium Takeda, Nycomed, Pharmacosmos, Actelion, Danone, Alpha Wasserman, Genentech, Grunenthal, Pfizer, Astra Zeneca, Novo Nordisk, Cosmo Pharmaceuticals, Vifor, and Johnson & Johnson. MDG received speaker fees from Abbvie. GF has served as a consultant and advisory board member for MSD, Takeda, AbbVie, and Janssen. WF received speaker fees form Mundipharma, and Zambon, served on the advisory board for Abbvie, and received an unconditioned grant from MS&D. FWG has served as a speaker and advisory board member for Abbvie, MSD, Takeda, and MultiPharma. LG has served as speaker/consultant for AbbVie, Janssen, Mundipharma, MSD, Shire, Takeda, Vifor Pharma, and Zambon. SM has served as a speaker and advisory board member for Abbvie, MSD, Takeda, and MultiPharma. AK received unconditioned grants from Abbvie and Takeda. MP has served as a speaker and advisory board member for Abbvie, MSD, Takeda, and Chiesi. SR has received lecture fees from Abbvie. MV has received speaker fees, research support, or served as an advisory board member for Abbvie, MSD, Takeda, Mundipharma, Hospira, Otsuka, Pfizer, Amgen, Jannsen, Giuliani, Sofar, Chiesi, and Wasserman. All the other authors have no conflict of interest to declare. Address correspondence to: Vito Annese MD, Gastroenterology Department, Valiant Clinic, 13th Street City Walk, Dubai, UAE. E-mail: vito.annese@valiant.ae. {\circledC} 2018 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. doi: 10.1093/ibd/izy264 Published online 18 August 2018 Funding text 2: CT-P13 (Celltrion, Inc., Incheon, Republic of Korea) has been the first mAb biosimilar of infliximab evaluated and approved by the European Medicines Agency (EMA) and Food and Drug Administration (FDA). The program to demonstrate its biosimilarity consisted of a phase 1 pharmacokinetic study in patients with ankylosing spondylitis (AS)6 and a phase 3 study evaluating efficacy in patients with rheumatoid arthritis (RA).7 Both were randomized, double-blinded, multinational trials and provided data up to 30 weeks of treatment.6, 7 Subsequently, data up to 54 weeks8–10 with a following open-label 48-week extension, in which patients initially receiving reference infliximab were switched to CT-P13, have been published.11, 12 These studies have demonstrated pharmacokinetic equivalence and clinical efficacy in both AS and RA6, 7 up to 102 weeks and in patients switched from infliximab to CT-P1311, 12. 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Jani, R.H., Gupta, R., Bhatia, G., A prospective, randomized, double-blind, multicenter, parallel-group, active controlled study to compare efficacy and safety of biosimilar adalimumab (exemptia; ZRC-3197) and adalimumab (humira) in patients with rheumatoid arthritis (2016) Int J Rheum Dis, 19, pp. 1157-1168; Gecse, K.B., Lov{\'a}sz, B.D., Farkas, K., Efficacy and safety of the biosimilar infliximab CT-P13 treatment in inflammatory bowel diseases: A prospective, multicenter, nationwide cohort (2016) J Crohns Colitis, 10, pp. 133-140; Schmitz, E.M.H., Boekema, P.J., Straathof, J.W.A., Switching from infliximab innovator to biosimilar in patients with inflammatory bowel disease: A 12-month multicenter observational prospective cohort study (2018) Aliment Pharmacol Ther, 47, pp. 356-363; Richmond, L., Curtis, L., Garrick, V., Biosimilar infliximab use in pediatric IBD (2018) Arch Dis Child, 103, pp. 89-91; Eberl, A., Huoponen, S., Pahikkala, T., Switching maintenance infliximab therapy to biosimilar infliximab in inflammatory bowel disease patients (2017) Scand J Gastroenterol, 52, pp. 1348-1353; Farkas, K., Rutka, M., Ferenci, T., Infliximab biosimilar CT-P13 therapy is effective and safe in maintaining remission in Crohn's disease and ulcerative colitis - Experiences from a single center (2017) Expert Opin Biol Ther, 17, pp. 1325-1332; Smits, L.J.T., Grelack, A., Derikx, L.A.A.P., Long-term clinical outcomes after switching from remicade{\circledR} to biosimilar CT-P13 in inflammatory bowel disease (2017) Dig Dis Sci, 62, pp. 3117-3122; B{\'a}lint, A., Rutka, M., V{\'e}gh, Z., Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: Results from central European nationwide cohort (2017) Expert Opin Drug Saf, 16, pp. 885-890; Arg{\"u}elles-Arias, F., Guerra Veloz, M.F., Perea Amarillo, R., Effectiveness and safety of CT-P13 (biosimilar infliximab) in patients with inflammatory bowel disease in real life at 6 months (2017) Dig Dis Sci, 62, pp. 1305-1312; Razanskaite, V., Bettey, M., Downey, L., Biosimilar infliximab in inflammatory bowel disease: Outcomes of a managed switching programme (2017) J Crohns Colitis, 11, pp. 690-696; Kolar, M., Duricova, D., Bortlik, M., Infliximab biosimilar (remsima™) in therapy of inflammatory bowel diseases patients: Experience from one tertiary inflammatory bowel diseases center (2017) Dig Dis, 35, pp. 91-100; Buer, L.C., Moum, B.A., Cvancarova, M., Switching from remicade{\circledR} to remsima{\circledR} is well tolerated and feasible: A prospective, open-label study (2017) J Crohns Colitis, 11, pp. 297-304; Feagan, B., Benefits, concerns, and future directions of biosimilars in inflammatory bowel disease (2017) Gastroenterol Hepatol, 13, pp. 745-747; Fiorino, G., Correale, C., Radice, S., Letter: Immunogenicity of infliximab originator vs. CT-P13 in IBD patients (2017) Aliment Pharmacol Ther, 46, pp. 903-905; FLIXABI{\circledR}, Biogen's Infliximab Biosimilar Referencing Remicade{\circledR}, Approved in The European Union 2016, , http//media.biogen.com/press-release/biosimilars/flixabi-biogens-infliximab-biosimilar-referencing-remicade-ap-proved-europe, June 1, 2018, date last accessed; Choe, J.Y., Prodanovic, N., Niebrzydowski, J., A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy (2017) Ann Rheum Dis, 76, pp. 58-64; A study of PF-06438179 Infliximab-Pfizer) and Infliximab in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B537-02), , https://clinicaltrials.gov/ct2/show/NCT02222493, ClinicalTrials.gov2016; Rajan, C., Epirus' Biosimilar Arthritis Drug wins approval in India (2014) Bioprocess Online, , hhtp://www.bioprocessonline.com/doc/epirus-s-biosimilar-arthri-tis-drug-wins-approval-in-india-0001, June 1, 2018, date last accessed",
year = "2019",
doi = "10.1093/ibd/izy264",
language = "English",
volume = "25",
pages = "568--579",
journal = "Inflammatory Bowel Diseases",
issn = "1078-0998",
publisher = "Oxford University Press",
number = "3",

}

TY - JOUR

T1 - The PROSit cohort of infliximab biosimilar in IBD: A prolonged follow-up on the effectiveness and safety across Italy

AU - Armuzzi, A.

AU - Fiorino, G.

AU - Variola, A.

AU - Manetti, N.

AU - Fries, W.

AU - Orlando, A.

AU - Maconi, G.

AU - Bossa, F.

AU - Cappello, M.

AU - Biancone, L.

AU - Cantoro, L.

AU - Costa, F.

AU - D'Incà, R.

AU - Lionetti, P.

AU - Principi, M.

AU - Castiglione, F.

AU - Annunziata, M.L.

AU - Di Sabatino, A.

AU - Di Girolamo, M.

AU - Terpin, M.M.

AU - Cortelezzi, C.C.

AU - Saibeni, S.

AU - Amato, A.

AU - Ardizzone, S.

AU - Guidi, L.

AU - Danese, S.

AU - Massella, A.

AU - Ventra, A.

AU - Rizzuto, G.

AU - Massari, A.

AU - Perri, F.

AU - Annese, V.

AU - Saettone, S.

AU - Tari, R.

AU - Petruzzellis, C.

AU - Meucci, G.

AU - Imperiali, G.

AU - Guglielmi, F.W.

AU - Mazzuoli, S.

AU - Caserta, L.

AU - Parodi, M.C.

AU - Colli, A.

AU - Ronchetti, A.

AU - Pugliese, D.

AU - Geccherle, A.

AU - Rogai, F.

AU - Milani, S.

AU - Renna, S.

AU - Cassinotti, A.

AU - Andriulli, A.

AU - Martino, G.

AU - Scrivo, B.

AU - Troncone, E.

AU - Kohn, A.

AU - Bertani, L.

AU - Lorenzon, G.

AU - Ghione, S.

AU - Nardone, O.

AU - Vecchi, M.

AU - Bertani, A.

AU - Bosani, M.A.

AU - Bezzio, C.

AU - Salerno, R.

N1 - Cited By :9 Export Date: 30 October 2019 CODEN: IBDNB Correspondence Address: Annese, V.; Gastroenterology Department, Valiant Clinic, 13th Street City Walk, United Arab Emirates; email: vito.annese@valiant.ae Chemicals/CAS: adalimumab, 331731-18-1, 1446410-95-2; C reactive protein, 9007-41-4; golimumab, 476181-74-5; infliximab, 170277-31-3 Tradenames: ct p 13 Funding details: AbbVie Funding details: Medtronic Funding details: Pfizer Funding details: Chiesi Farmaceutici, Chiesi Funding details: Samsung Funding details: Takeda Oncology Funding details: Food and Drug Administration, FDA Funding text 1: Conflicts of interest: AA served as consultant to Abbvie, Allergan, Amgen, Biogen, Celgene, Celltrion, Ferring, Hospira, Janssen, Lilly, MS&D, Mundipharma, Pfizer, Samsung Bioepis, Sofar, Takeda. He received lectures fees from Abbvie, Astra-Zeneca, Chiesi, Ferring, Hospira, Janssen, Medtronic, MS&D, Mitsubishi Tanabe, Mundipharma, Nikkiso, Otsuka, Pfizer, Samsung Bioepis, Takeda, Tigenix, Zambon, and research grant from MS&D. VA served as consultant to Abbvie, Hospira, Mundipharma, MS&D, Takeda, Janssen, Ferring. He received lecture fees from Abbvie, Ferring, Hospira, MS&D, Takeda, Medtronic, Menarini and unrestricted research grants from Giuliani, Ferring, Sofar, Roche, Gillead, MS&D, Abbvie, and Otsuka. MA served as advisory board member for MSD, Takeda, and AbbVie. SA received consulting and advisory board fees and/or research support from AbbVie, MSD, Abbvie, Ferring, MSD, Janssen, Takeda, Mundipahrma, Zambon, and Sofar. BA received speaker fees from Takeda and unrestricted research grant from Sofar. LB received lecture fees from: Takeda, Zambon, Abbvie, MSD, and Wassermann. BS served as consultant to Abbvie, Takeda, and MSD. LC received a speaker fee form MS&D. MC has received lecture fees from MSD, Abbvie, Takeda, and Chiesi and has served as advisory board member for MSD and Abbvie. FC has served as advisory board member for Abbvie, MSD, and Takeda and received speaker fees from Abbvie, MSD, Takeda, Zambon, Otsuka, Phadia, and Diasorin. SD has served as a speaker, consultant, and advisory board member for Schering-Plough, Abbott Laboratories, Merck, UCB-pharma, Ferring, Cellerix, Millenium Takeda, Nycomed, Pharmacosmos, Actelion, Danone, Alpha Wasserman, Genentech, Grunenthal, Pfizer, Astra Zeneca, Novo Nordisk, Cosmo Pharmaceuticals, Vifor, and Johnson & Johnson. MDG received speaker fees from Abbvie. GF has served as a consultant and advisory board member for MSD, Takeda, AbbVie, and Janssen. WF received speaker fees form Mundipharma, and Zambon, served on the advisory board for Abbvie, and received an unconditioned grant from MS&D. FWG has served as a speaker and advisory board member for Abbvie, MSD, Takeda, and MultiPharma. LG has served as speaker/consultant for AbbVie, Janssen, Mundipharma, MSD, Shire, Takeda, Vifor Pharma, and Zambon. SM has served as a speaker and advisory board member for Abbvie, MSD, Takeda, and MultiPharma. AK received unconditioned grants from Abbvie and Takeda. MP has served as a speaker and advisory board member for Abbvie, MSD, Takeda, and Chiesi. SR has received lecture fees from Abbvie. MV has received speaker fees, research support, or served as an advisory board member for Abbvie, MSD, Takeda, Mundipharma, Hospira, Otsuka, Pfizer, Amgen, Jannsen, Giuliani, Sofar, Chiesi, and Wasserman. All the other authors have no conflict of interest to declare. Address correspondence to: Vito Annese MD, Gastroenterology Department, Valiant Clinic, 13th Street City Walk, Dubai, UAE. E-mail: vito.annese@valiant.ae. © 2018 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. doi: 10.1093/ibd/izy264 Published online 18 August 2018 Funding text 2: CT-P13 (Celltrion, Inc., Incheon, Republic of Korea) has been the first mAb biosimilar of infliximab evaluated and approved by the European Medicines Agency (EMA) and Food and Drug Administration (FDA). The program to demonstrate its biosimilarity consisted of a phase 1 pharmacokinetic study in patients with ankylosing spondylitis (AS)6 and a phase 3 study evaluating efficacy in patients with rheumatoid arthritis (RA).7 Both were randomized, double-blinded, multinational trials and provided data up to 30 weeks of treatment.6, 7 Subsequently, data up to 54 weeks8–10 with a following open-label 48-week extension, in which patients initially receiving reference infliximab were switched to CT-P13, have been published.11, 12 These studies have demonstrated pharmacokinetic equivalence and clinical efficacy in both AS and RA6, 7 up to 102 weeks and in patients switched from infliximab to CT-P1311, 12. The development of antidrug antibodies (ADA) was similar in CT-P13 and infliximab in both trials.7, 12 References: Danese, S., Vuitton, L., Peyrin-Biroulet, L., Biologic agents for IBD: Practical insights (2015) Nat Rev Gastroenterol Hepatol, 12, pp. 537-545; Annese, V., Duricova, D., Gower-Rousseau, C., Impact of new treatments on hospitalisation, surgery, infection, and mortality in IBD: A focus paper by the epidemiology committee of ECCO (2016) J Crohns Colitis, 10, pp. 216-225; Van Der Valk, M.E., Mangen, M.J., Leenders, M., Healthcare costs of inflammatory bowel disease have shifted from hospitalisation and surgery towards anti-tnfα therapy: Results from the COIN study (2014) Gut, 63, pp. 72-79; Cohen, R.D., Thomas, T., Economics of the use of biologics in the treatment of inflammatory bowel disease (2006) Gastroenterol Clin North Am, 35, pp. 867-882; Zheng, M.K., Shih, D.Q., Chen, G.C., Insights on the use of biosimilars in the treatment of inflammatory bowel disease (2017) World J Gastroenterol, 23, pp. 1932-1943; Park, W., Hrycaj, P., Jeka, S., A randomised, double-blind, multicenter, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: The PLANETAS study (2013) Ann Rheum Dis, 72, pp. 1605-1612; Yoo, D.H., Hrycaj, P., Miranda, P., A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: The PLANETRA study (2013) Ann Rheum Dis, 72, pp. 1613-1620; Park, W., Yoo, D.H., Miranda, P., Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study (2017) Ann Rheum Dis, 76, pp. 346-354. , pii: annrheumdis-2015-208783; Yoo, D.H., Racewicz, A., Brzezicki, J., A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study (2016) Arthritis Res Ther, 18, p. 82; Yoo, D., Yagensky, A., Toncheva, A., Impact of CT-P13 and originator infliximab treatment on quality of life derived from the Health Assessment Questionnaire (AQ) and Short-Form 36 (SF- 36) from a randomized, double-blind trial in patients with active RA (2013) ACR/ARHP Annual Meeting, , abstract 2392. In: San Diego; October 26-30; Park, W., Yoo, D.H., Miranda, P., Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study (2017) Ann Rheum Dis, 76, pp. 346-354; Yoo, D.H., Prodanovic, N., Jaworski, J., Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: Comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study (2017) Ann Rheum Dis, 76, pp. 355-363; McKeage, K., A review of CT-P13: An infliximab biosimilar (2014) Biodrugs, 28, pp. 313-321; Committee for medicinal products for human use (2013) Assessment Report: Remsima (Infliximab), , www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf, CHMP. June 1, 2018, date last accessed; (2015) Biosimilars Approved in South Korea, , http://gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea, initiative online. June 1, 2018, date last accessed; (2015) Biosimilars Approved in Japan, , http://gabionline.net/Biosimilars/General/Biosimilars-approved-in-Japan, initiative online; www.fda.gov/downloads/.../UCM484859.pdf, June 1, 2018, date last accessed; (2016) Summary Basis of Decision - Inflectra, , http://www.hc-sc.gc.ca/dhp-mps/prodpharma/rds-sdr/drug-med/rds-sdr-infectra-184564-eng.php, June 1, 2018, date last accessed; Jha, A., Upton, A., Dunlop, W.C., The budget impact of biosimilar infliximab (remsima®) for the treatment of autoimmune diseases in five European countries (2015) Adv Ther, 32, pp. 742-756; Danese, S., Fiorino, G., Michetti, P., Viewpoint: Knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn's and colitis organization (2014) J Crohns Colitis, 8, pp. 1548-1550; Feagan, B.G., Choquette, D., Ghosh, S., The challenge of indication extrapolation for infliximab biosimilars (2014) Biologicals, 42, pp. 177-183; Ben-Horin, S., Heap, G.A., Ahmad, T., The immunogenicity of biosimilar infliximab: Can we extrapolate the data across indications? (2015) Expert Rev Gastroenterol Hepatol, 9, pp. 27-34; Van Den Brande, J.M., Koehler, T.C., Zelinkova, Z., Prediction of antitumour necrosis factor clinical efficacy by real-time visualisation of apoptosis in patients with Crohn's disease (2007) Gut, 56, pp. 509-517; Tilg, H., Moschen, A., Kaser, A., Mode of function of biological anti-TNF agents in the treatment of inflammatory bowel diseases (2007) Expert Opin Biol Ther, 7, pp. 1051-1059; Komaki, Y., Yamada, A., Komaki, F., Systematic review with meta-analysis: The efficacy and safety of CT-P13, a biosimilar of anti-tumour necrosis factor-α agent (infliximab), in inflammatory bowel diseases (2017) Aliment Pharmacol Ther, 45, pp. 1043-1057; Jørgensen, K.K., Olsen, I.C., Goll, G.L., Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): A 52-week, randomised, double-blind, non-inferiority trial (2017) Lancet, 389, pp. 2304-2316; Fiorino, G., Manetti, N., Armuzzi, A., The PROSIT-BIO cohort: A prospective observational study of patients with inflammatory bowel disease treated with infliximab biosimilar (2017) Inflamm Bowel Dis, 23, pp. 233-243. , PROSIT-BIO Cohort; Lennard-Jones, J.E., Classification of inflammatory bowel disease (1989) Scand J Gastroenterol Suppl, 170, pp. 2-6. , discussion 16; Dignass, A., Eliakim, R., Magro, F., Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 1: Definitions and diagnosis (2012) J Crohns Colitis, 6, pp. 965-990; Van Assche, G., Dignass, A., Panes, J., The second European evidence-based consensus on the diagnosis and management of Crohn's disease: Definitions and diagnosis (2010) J Crohns Colitis, 4, pp. 7-27. , European Crohn's and Colitis Organisation ECCO; Rutgeerts, P., Sandborn, W.J., Feagan, B.G., Infliximab for induction and maintenance therapy for ulcerative colitis (2005) N Engl J Med, 353, pp. 2462-2476; Harvey, R.F., Bradshaw, J.M., A simple index of Crohn's-disease activity (1980) Lancet, 1, p. 514; D'Haens, G.R., Panaccione, R., Higgins, P.D., The London position statement of the world congress of gastroenterology on biological therapy for IBD with the European Crohn's and colitis organization: When to start, when to stop, which drug to choose, and how to predict response? (2011) Am J Gastroenterol, 106, pp. 199-212. , quiz 213; Ben-Horin, S., Chowers, Y., Review article: Loss of response to anti-TNF treatments in Crohn's disease (2011) Aliment Pharmacol Ther, 33, pp. 987-995; Ding, N.S., Hart, A., De Cruz, P., Systematic review: Predicting and optimising response to anti-TNF therapy in Crohn's disease - Algorithm for practical management (2016) Aliment Pharmacol Ther, 43, pp. 30-51; Lichtenstein, G.R., Introduction to biosimilar use in patients with inflammatory bowel disease (2017) Gastroenterol Hepatol, 13, pp. 612-614. , N Y; 2017 IMS Biosimilar Report - The Impact of Biosimilar Competition in Europe, , http://ec.europa.eu/growth/content/impact-biosimilar-competition-price-vol-ume-and-market-share-update-2017-0_en, February 27, 2007, date last accessed; (2018) 2017 IMS Biosimilar Report - The Impact of Biosimilar Competition in Europe, , June 1, date last accessed; Choe, J.Y., Prodanovic, N., Niebrzydowski, J., A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy (2017) Ann Rheum Dis, 76, pp. 58-64; Jani, R.H., Gupta, R., Bhatia, G., A prospective, randomized, double-blind, multicenter, parallel-group, active controlled study to compare efficacy and safety of biosimilar adalimumab (exemptia; ZRC-3197) and adalimumab (humira) in patients with rheumatoid arthritis (2016) Int J Rheum Dis, 19, pp. 1157-1168; Gecse, K.B., Lovász, B.D., Farkas, K., Efficacy and safety of the biosimilar infliximab CT-P13 treatment in inflammatory bowel diseases: A prospective, multicenter, nationwide cohort (2016) J Crohns Colitis, 10, pp. 133-140; Schmitz, E.M.H., Boekema, P.J., Straathof, J.W.A., Switching from infliximab innovator to biosimilar in patients with inflammatory bowel disease: A 12-month multicenter observational prospective cohort study (2018) Aliment Pharmacol Ther, 47, pp. 356-363; Richmond, L., Curtis, L., Garrick, V., Biosimilar infliximab use in pediatric IBD (2018) Arch Dis Child, 103, pp. 89-91; Eberl, A., Huoponen, S., Pahikkala, T., Switching maintenance infliximab therapy to biosimilar infliximab in inflammatory bowel disease patients (2017) Scand J Gastroenterol, 52, pp. 1348-1353; Farkas, K., Rutka, M., Ferenci, T., Infliximab biosimilar CT-P13 therapy is effective and safe in maintaining remission in Crohn's disease and ulcerative colitis - Experiences from a single center (2017) Expert Opin Biol Ther, 17, pp. 1325-1332; Smits, L.J.T., Grelack, A., Derikx, L.A.A.P., Long-term clinical outcomes after switching from remicade® to biosimilar CT-P13 in inflammatory bowel disease (2017) Dig Dis Sci, 62, pp. 3117-3122; Bálint, A., Rutka, M., Végh, Z., Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: Results from central European nationwide cohort (2017) Expert Opin Drug Saf, 16, pp. 885-890; Argüelles-Arias, F., Guerra Veloz, M.F., Perea Amarillo, R., Effectiveness and safety of CT-P13 (biosimilar infliximab) in patients with inflammatory bowel disease in real life at 6 months (2017) Dig Dis Sci, 62, pp. 1305-1312; Razanskaite, V., Bettey, M., Downey, L., Biosimilar infliximab in inflammatory bowel disease: Outcomes of a managed switching programme (2017) J Crohns Colitis, 11, pp. 690-696; Kolar, M., Duricova, D., Bortlik, M., Infliximab biosimilar (remsima™) in therapy of inflammatory bowel diseases patients: Experience from one tertiary inflammatory bowel diseases center (2017) Dig Dis, 35, pp. 91-100; Buer, L.C., Moum, B.A., Cvancarova, M., Switching from remicade® to remsima® is well tolerated and feasible: A prospective, open-label study (2017) J Crohns Colitis, 11, pp. 297-304; Feagan, B., Benefits, concerns, and future directions of biosimilars in inflammatory bowel disease (2017) Gastroenterol Hepatol, 13, pp. 745-747; Fiorino, G., Correale, C., Radice, S., Letter: Immunogenicity of infliximab originator vs. CT-P13 in IBD patients (2017) Aliment Pharmacol Ther, 46, pp. 903-905; FLIXABI®, Biogen's Infliximab Biosimilar Referencing Remicade®, Approved in The European Union 2016, , http//media.biogen.com/press-release/biosimilars/flixabi-biogens-infliximab-biosimilar-referencing-remicade-ap-proved-europe, June 1, 2018, date last accessed; Choe, J.Y., Prodanovic, N., Niebrzydowski, J., A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy (2017) Ann Rheum Dis, 76, pp. 58-64; A study of PF-06438179 Infliximab-Pfizer) and Infliximab in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B537-02), , https://clinicaltrials.gov/ct2/show/NCT02222493, ClinicalTrials.gov2016; Rajan, C., Epirus' Biosimilar Arthritis Drug wins approval in India (2014) Bioprocess Online, , hhtp://www.bioprocessonline.com/doc/epirus-s-biosimilar-arthri-tis-drug-wins-approval-in-india-0001, June 1, 2018, date last accessed

PY - 2019

Y1 - 2019

N2 - 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. © 2018 Crohn's & Colitis Foundation. Published by Oxford University Press. All rights reserved.

AB - 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. © 2018 Crohn's & Colitis Foundation. Published by Oxford University Press. All rights reserved.

KW - Biosimilar

KW - Crohn's disease

KW - CT-P13

KW - Inflammatory bowel disease

KW - Inflectra

KW - Infliximab

KW - Remsima

KW - Ulcerative colitis

KW - adalimumab

KW - biological marker

KW - biosimilar agent

KW - C reactive protein

KW - calgranulin

KW - ct p 13

KW - golimumab

KW - infliximab

KW - tumor necrosis factor inhibitor

KW - unclassified drug

KW - adult

KW - arthralgia

KW - Article

KW - clinical evaluation

KW - clinical feature

KW - clinical outcome

KW - cohort analysis

KW - controlled study

KW - Crohn disease

KW - disease duration

KW - drug efficacy

KW - drug exposure

KW - drug safety

KW - drug substitution

KW - drug tolerability

KW - drug withdrawal

KW - female

KW - follow up

KW - gastroscopy

KW - human

KW - immunopathology

KW - infection

KW - inflammatory bowel disease

KW - infusion related reaction

KW - major clinical study

KW - male

KW - neurologic disease

KW - observational study

KW - patient safety

KW - priority journal

KW - prospective study

KW - randomized controlled trial

KW - remission

KW - scoring system

KW - skin manifestation

KW - steroid therapy

KW - ulcerative colitis

U2 - 10.1093/ibd/izy264

DO - 10.1093/ibd/izy264

M3 - Article

VL - 25

SP - 568

EP - 579

JO - Inflammatory Bowel Diseases

JF - Inflammatory Bowel Diseases

SN - 1078-0998

IS - 3

ER -