Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 568-579 |
| Number of pages | 12 |
| Journal | Inflammatory Bowel Diseases |
| Volume | 25 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - 2019 |
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. et al.
In: Inflammatory Bowel Diseases, Vol. 25, No. 3, 2019, p. 568-579.Research output: Contribution to journal › Article › peer-review
}
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. 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(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? 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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 -