Long-term Efficacy, Safety, and Immunogenicity of Biosimilar Infliximab after One Year in a Prospective Nationwide Cohort

Lorant Gonczi, Krisztina B. Gecse, Zsuzsanna Vegh, Zsuzsanna Kurti, Mariann Rutka, Klaudia Farkas, Petra A. Golovics, Barbara D. Lovasz, Janos Banai, Laszlo Bene, Bea Gasztonyi, Tunde Kristof, Laszlo Lakatos, Pal Miheller, Ferenc Nagy, Karoly Palatka, Maria Papp, Arpad Patai, Agnes Salamon, Tamas SzamosiZoltan Szepes, Gabor T. Toth, Aron Vincze, Balazs Szalay, Tamas Molnar, P. Lakatos

Research output: Article

16 Citations (Scopus)

Abstract

Background: It has been previously shown that biosimilar infliximab CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases. We report here the 1-year outcomes from a prospective nationwide inflammatory bowel disease cohort. Methods: A prospective, nationwide, multicenter, observational cohort was designed to examine the efficacy and safety of CT-P13 in the induction and maintenance treatment of Crohn's disease (CD) and ulcerative colitis (UC). Demographic data were collected and a harmonized monitoring strategy was applied. Clinical remission, response, and biochemical response were evaluated at weeks 14, 30, and 54, respectively. Safety data were registered. Results: Three hundred fifty-three consecutive inflammatory bowel disease (209 CD and 144 UC) patients were included, of which 229 patients reached the week 54 endpoint at final evaluation. Age at disease onset: 24/28 years (median, interquartile range: 19-34/22-39) in patients with CD/UC. Forty-nine, 53, 48% and 86, 81 and 65% of patients with CD reached clinical remission and response by weeks 14, 30, and 54, respectively. Clinical remission and response rates were 56, 41, 43% and 74, 66, 50% in patients with UC. Clinical efficacy was influenced by previous anti-tumor necrosis factor (TNF) exposure in patients with a drug holiday beyond 1 year. The mean C-reactive protein level decreased significantly in both CD and UC by week 14 and was maintained throughout the 1-year follow-up (both UC/CD: P < 0.001). Thirty-one (8.8%) patients had infusion reactions and 32 (9%) patients had infections. Antidrug antibody positivity rates were significantly higher throughout patients with previous anti-TNF exposure; concomitant azathioprine prevented antidrug antibody formation in anti-TNF-naive patients with CD. Conclusions: Results from this prospective nationwide cohort confirm that CT-P13 is effective and safe in inducing and maintaining long-term remission in both CD and UC. Efficacy was influenced by previous anti-TNF exposure; no new safety signals were detected.

Original languageEnglish
Pages (from-to)1908-1915
Number of pages8
JournalInflammatory bowel diseases
Volume23
Issue number11
DOIs
Publication statusPublished - nov. 1 2017

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Biosimilar Pharmaceuticals
Crohn Disease
Ulcerative Colitis
Safety
Tumor Necrosis Factor-alpha
Inflammatory Bowel Diseases
Infliximab
Holidays
Azathioprine

ASJC Scopus subject areas

  • Immunology and Allergy
  • Gastroenterology

Cite this

Long-term Efficacy, Safety, and Immunogenicity of Biosimilar Infliximab after One Year in a Prospective Nationwide Cohort. / Gonczi, Lorant; Gecse, Krisztina B.; Vegh, Zsuzsanna; Kurti, Zsuzsanna; Rutka, Mariann; Farkas, Klaudia; Golovics, Petra A.; Lovasz, Barbara D.; Banai, Janos; Bene, Laszlo; Gasztonyi, Bea; Kristof, Tunde; Lakatos, Laszlo; Miheller, Pal; Nagy, Ferenc; Palatka, Karoly; Papp, Maria; Patai, Arpad; Salamon, Agnes; Szamosi, Tamas; Szepes, Zoltan; Toth, Gabor T.; Vincze, Aron; Szalay, Balazs; Molnar, Tamas; Lakatos, P.

In: Inflammatory bowel diseases, Vol. 23, No. 11, 01.11.2017, p. 1908-1915.

Research output: Article

Gonczi, L, Gecse, KB, Vegh, Z, Kurti, Z, Rutka, M, Farkas, K, Golovics, PA, Lovasz, BD, Banai, J, Bene, L, Gasztonyi, B, Kristof, T, Lakatos, L, Miheller, P, Nagy, F, Palatka, K, Papp, M, Patai, A, Salamon, A, Szamosi, T, Szepes, Z, Toth, GT, Vincze, A, Szalay, B, Molnar, T & Lakatos, P 2017, 'Long-term Efficacy, Safety, and Immunogenicity of Biosimilar Infliximab after One Year in a Prospective Nationwide Cohort', Inflammatory bowel diseases, vol. 23, no. 11, pp. 1908-1915. https://doi.org/10.1097/MIB.0000000000001237
Gonczi, Lorant ; Gecse, Krisztina B. ; Vegh, Zsuzsanna ; Kurti, Zsuzsanna ; Rutka, Mariann ; Farkas, Klaudia ; Golovics, Petra A. ; Lovasz, Barbara D. ; Banai, Janos ; Bene, Laszlo ; Gasztonyi, Bea ; Kristof, Tunde ; Lakatos, Laszlo ; Miheller, Pal ; Nagy, Ferenc ; Palatka, Karoly ; Papp, Maria ; Patai, Arpad ; Salamon, Agnes ; Szamosi, Tamas ; Szepes, Zoltan ; Toth, Gabor T. ; Vincze, Aron ; Szalay, Balazs ; Molnar, Tamas ; Lakatos, P. / Long-term Efficacy, Safety, and Immunogenicity of Biosimilar Infliximab after One Year in a Prospective Nationwide Cohort. In: Inflammatory bowel diseases. 2017 ; Vol. 23, No. 11. pp. 1908-1915.
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abstract = "Background: It has been previously shown that biosimilar infliximab CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases. We report here the 1-year outcomes from a prospective nationwide inflammatory bowel disease cohort. Methods: A prospective, nationwide, multicenter, observational cohort was designed to examine the efficacy and safety of CT-P13 in the induction and maintenance treatment of Crohn's disease (CD) and ulcerative colitis (UC). Demographic data were collected and a harmonized monitoring strategy was applied. Clinical remission, response, and biochemical response were evaluated at weeks 14, 30, and 54, respectively. Safety data were registered. Results: Three hundred fifty-three consecutive inflammatory bowel disease (209 CD and 144 UC) patients were included, of which 229 patients reached the week 54 endpoint at final evaluation. Age at disease onset: 24/28 years (median, interquartile range: 19-34/22-39) in patients with CD/UC. Forty-nine, 53, 48{\%} and 86, 81 and 65{\%} of patients with CD reached clinical remission and response by weeks 14, 30, and 54, respectively. Clinical remission and response rates were 56, 41, 43{\%} and 74, 66, 50{\%} in patients with UC. Clinical efficacy was influenced by previous anti-tumor necrosis factor (TNF) exposure in patients with a drug holiday beyond 1 year. The mean C-reactive protein level decreased significantly in both CD and UC by week 14 and was maintained throughout the 1-year follow-up (both UC/CD: P < 0.001). Thirty-one (8.8{\%}) patients had infusion reactions and 32 (9{\%}) patients had infections. Antidrug antibody positivity rates were significantly higher throughout patients with previous anti-TNF exposure; concomitant azathioprine prevented antidrug antibody formation in anti-TNF-naive patients with CD. Conclusions: Results from this prospective nationwide cohort confirm that CT-P13 is effective and safe in inducing and maintaining long-term remission in both CD and UC. Efficacy was influenced by previous anti-TNF exposure; no new safety signals were detected.",
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TY - JOUR

T1 - Long-term Efficacy, Safety, and Immunogenicity of Biosimilar Infliximab after One Year in a Prospective Nationwide Cohort

AU - Gonczi, Lorant

AU - Gecse, Krisztina B.

AU - Vegh, Zsuzsanna

AU - Kurti, Zsuzsanna

AU - Rutka, Mariann

AU - Farkas, Klaudia

AU - Golovics, Petra A.

AU - Lovasz, Barbara D.

AU - Banai, Janos

AU - Bene, Laszlo

AU - Gasztonyi, Bea

AU - Kristof, Tunde

AU - Lakatos, Laszlo

AU - Miheller, Pal

AU - Nagy, Ferenc

AU - Palatka, Karoly

AU - Papp, Maria

AU - Patai, Arpad

AU - Salamon, Agnes

AU - Szamosi, Tamas

AU - Szepes, Zoltan

AU - Toth, Gabor T.

AU - Vincze, Aron

AU - Szalay, Balazs

AU - Molnar, Tamas

AU - Lakatos, P.

PY - 2017/11/1

Y1 - 2017/11/1

N2 - Background: It has been previously shown that biosimilar infliximab CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases. We report here the 1-year outcomes from a prospective nationwide inflammatory bowel disease cohort. Methods: A prospective, nationwide, multicenter, observational cohort was designed to examine the efficacy and safety of CT-P13 in the induction and maintenance treatment of Crohn's disease (CD) and ulcerative colitis (UC). Demographic data were collected and a harmonized monitoring strategy was applied. Clinical remission, response, and biochemical response were evaluated at weeks 14, 30, and 54, respectively. Safety data were registered. Results: Three hundred fifty-three consecutive inflammatory bowel disease (209 CD and 144 UC) patients were included, of which 229 patients reached the week 54 endpoint at final evaluation. Age at disease onset: 24/28 years (median, interquartile range: 19-34/22-39) in patients with CD/UC. Forty-nine, 53, 48% and 86, 81 and 65% of patients with CD reached clinical remission and response by weeks 14, 30, and 54, respectively. Clinical remission and response rates were 56, 41, 43% and 74, 66, 50% in patients with UC. Clinical efficacy was influenced by previous anti-tumor necrosis factor (TNF) exposure in patients with a drug holiday beyond 1 year. The mean C-reactive protein level decreased significantly in both CD and UC by week 14 and was maintained throughout the 1-year follow-up (both UC/CD: P < 0.001). Thirty-one (8.8%) patients had infusion reactions and 32 (9%) patients had infections. Antidrug antibody positivity rates were significantly higher throughout patients with previous anti-TNF exposure; concomitant azathioprine prevented antidrug antibody formation in anti-TNF-naive patients with CD. Conclusions: Results from this prospective nationwide cohort confirm that CT-P13 is effective and safe in inducing and maintaining long-term remission in both CD and UC. Efficacy was influenced by previous anti-TNF exposure; no new safety signals were detected.

AB - Background: It has been previously shown that biosimilar infliximab CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases. We report here the 1-year outcomes from a prospective nationwide inflammatory bowel disease cohort. Methods: A prospective, nationwide, multicenter, observational cohort was designed to examine the efficacy and safety of CT-P13 in the induction and maintenance treatment of Crohn's disease (CD) and ulcerative colitis (UC). Demographic data were collected and a harmonized monitoring strategy was applied. Clinical remission, response, and biochemical response were evaluated at weeks 14, 30, and 54, respectively. Safety data were registered. Results: Three hundred fifty-three consecutive inflammatory bowel disease (209 CD and 144 UC) patients were included, of which 229 patients reached the week 54 endpoint at final evaluation. Age at disease onset: 24/28 years (median, interquartile range: 19-34/22-39) in patients with CD/UC. Forty-nine, 53, 48% and 86, 81 and 65% of patients with CD reached clinical remission and response by weeks 14, 30, and 54, respectively. Clinical remission and response rates were 56, 41, 43% and 74, 66, 50% in patients with UC. Clinical efficacy was influenced by previous anti-tumor necrosis factor (TNF) exposure in patients with a drug holiday beyond 1 year. The mean C-reactive protein level decreased significantly in both CD and UC by week 14 and was maintained throughout the 1-year follow-up (both UC/CD: P < 0.001). Thirty-one (8.8%) patients had infusion reactions and 32 (9%) patients had infections. Antidrug antibody positivity rates were significantly higher throughout patients with previous anti-TNF exposure; concomitant azathioprine prevented antidrug antibody formation in anti-TNF-naive patients with CD. Conclusions: Results from this prospective nationwide cohort confirm that CT-P13 is effective and safe in inducing and maintaining long-term remission in both CD and UC. Efficacy was influenced by previous anti-TNF exposure; no new safety signals were detected.

KW - antidrug antibody

KW - biosimilar

KW - Crohn's disease

KW - efficacy

KW - infliximab

KW - side effects

KW - therapeutic drug monitoring

KW - trough level

KW - ulcerative colitis

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U2 - 10.1097/MIB.0000000000001237

DO - 10.1097/MIB.0000000000001237

M3 - Article

C2 - 28922253

AN - SCOPUS:85040732711

VL - 23

SP - 1908

EP - 1915

JO - Inflammatory Bowel Diseases

JF - Inflammatory Bowel Diseases

SN - 1078-0998

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