Prediction of Short- and Medium-term Efficacy of Biosimilar Infliximab Therapy. Do Trough Levels and Antidrug Antibody Levels or Clinical And Biochemical Markers Play the More Important Role?

Lorant Gonczi, Zsuzsanna Vegh, Petra Anna Golovics, Mariann Rutka, Krisztina Barbara Gecse, Renata Bor, Klaudia Farkas, T. Szamosi, L. Bene, B. Gasztonyi, Tünde Kristóf, L. Lakatos, P. Miheller, K. Palatka, M. Papp, Árpád Patai, Ágnes Salamon, Gábor Tamás Tóth, A. Vincze, Edina BiroBarbara Dorottya Lovasz, Zsuzsanna Kurti, Zoltan Szepes, T. Molnár, P. Lakatos

Research output: Article

21 Citations (Scopus)

Abstract

Methods: Demographic data were collected and a harmonised monitoring strategy was applied. Clinical and biochemical activities were evaluated at Weeks 14, 30, and 54. Trough level [TL] and anti-drug antibody [ADA] concentrations were measured by enzyme-linked immunosorbent assay [ELISA] [LT-005, Theradiag, France] at baseline at 14, 30 and 54 weeks and in two centres at Weeks 2 and 6.

Results: A total of 291 consecutive IBD patients (184 Crohn's disease [CD] and 107 ulcerative colitis [UC]) were included. In UC, TLs at Week 2 predicted both clinical response and remission at Weeks 14 and 30 (clinical response/remission at Week 14: area under the curve [AUC] = 0.81, p < 0.001, cut-off: 11.5 μg/ml/AUC = 0.79, p < 0.001, cut-off: 15.3μg/ml; clinical response/remission at Week 30: AUC = 0.79, p = 0.002, cut-off: 11.5 μg/ml/AUC = 0.74, p = 0.006, cut-off: 14.5 μg/ml), whereas ADA positivity at Week 14 was inversely associated with clinical response at Week 30 [58.3% vs 84.8% ,p = 0.04]. Previous anti-tumour necrosis factor [TNF] exposure was inversely associated with short-term clinical remission [Week 2: 18.8% vs 47.8%, p = 0.03, at Week 6: 38.9% vs 69.7%, p = 0.013, at Week 14: 37.5% vs 2.5%, p = 0.06]. In CD, TLs at Week 2 predicted short-term [Week 14 response/remission, AUCTLweek2 = 0.715-0.721, p = 0.05/0.005] but not medium-term clinical efficacy. In addition, early ADA status by Week 14 [p = 0.04-0.05 for Weeks 14 and 30], early clinical response [p < 0.001 for Weeks 30/54] and normal C-reactive protein [CRP] at Week 14 [p = 0.005-0.0001] and previous anti-TNF exposure [p = 0.03-0.0001 for Weeks 14, 30, and 54] were associated with short-and medium-term clinical response and remission.

Conclusions: In UC, early TLs were predictive for short- and medium-term clinical efficacy, whereas in CD, Week 2 TLs were associated only with short-term clinical outcomes.

Background and Aims: Biosimilar infliximab CT-P13 received European Medicines Agency [EMA] approval in June 2013 for all indications of the originator product. In the present study, we aimed to evaluate the predictors of short- and medium-term clinical outcome in patients treated with the biosimilar infliximab at the participating inflammatory bowel disease [IBD] centres in Hungary.

Original languageEnglish
Pages (from-to)697-705
Number of pages9
JournalJournal of Crohn's & colitis
Volume11
Issue number6
DOIs
Publication statusPublished - jún. 1 2017

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Biosimilar Pharmaceuticals
Area Under Curve
Biomarkers
Ulcerative Colitis
Crohn Disease
Anti-Idiotypic Antibodies
Antibodies
Inflammatory Bowel Diseases
Tumor Necrosis Factor-alpha
Pharmaceutical Preparations
Hungary
Therapeutics
C-Reactive Protein
France
Enzyme-Linked Immunosorbent Assay
Demography
Infliximab

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Prediction of Short- and Medium-term Efficacy of Biosimilar Infliximab Therapy. Do Trough Levels and Antidrug Antibody Levels or Clinical And Biochemical Markers Play the More Important Role? / Gonczi, Lorant; Vegh, Zsuzsanna; Golovics, Petra Anna; Rutka, Mariann; Gecse, Krisztina Barbara; Bor, Renata; Farkas, Klaudia; Szamosi, T.; Bene, L.; Gasztonyi, B.; Kristóf, Tünde; Lakatos, L.; Miheller, P.; Palatka, K.; Papp, M.; Patai, Árpád; Salamon, Ágnes; Tóth, Gábor Tamás; Vincze, A.; Biro, Edina; Lovasz, Barbara Dorottya; Kurti, Zsuzsanna; Szepes, Zoltan; Molnár, T.; Lakatos, P.

In: Journal of Crohn's & colitis, Vol. 11, No. 6, 01.06.2017, p. 697-705.

Research output: Article

Gonczi, Lorant ; Vegh, Zsuzsanna ; Golovics, Petra Anna ; Rutka, Mariann ; Gecse, Krisztina Barbara ; Bor, Renata ; Farkas, Klaudia ; Szamosi, T. ; Bene, L. ; Gasztonyi, B. ; Kristóf, Tünde ; Lakatos, L. ; Miheller, P. ; Palatka, K. ; Papp, M. ; Patai, Árpád ; Salamon, Ágnes ; Tóth, Gábor Tamás ; Vincze, A. ; Biro, Edina ; Lovasz, Barbara Dorottya ; Kurti, Zsuzsanna ; Szepes, Zoltan ; Molnár, T. ; Lakatos, P. / Prediction of Short- and Medium-term Efficacy of Biosimilar Infliximab Therapy. Do Trough Levels and Antidrug Antibody Levels or Clinical And Biochemical Markers Play the More Important Role?. In: Journal of Crohn's & colitis. 2017 ; Vol. 11, No. 6. pp. 697-705.
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title = "Prediction of Short- and Medium-term Efficacy of Biosimilar Infliximab Therapy. Do Trough Levels and Antidrug Antibody Levels or Clinical And Biochemical Markers Play the More Important Role?",
abstract = "Methods: Demographic data were collected and a harmonised monitoring strategy was applied. Clinical and biochemical activities were evaluated at Weeks 14, 30, and 54. Trough level [TL] and anti-drug antibody [ADA] concentrations were measured by enzyme-linked immunosorbent assay [ELISA] [LT-005, Theradiag, France] at baseline at 14, 30 and 54 weeks and in two centres at Weeks 2 and 6.Results: A total of 291 consecutive IBD patients (184 Crohn's disease [CD] and 107 ulcerative colitis [UC]) were included. In UC, TLs at Week 2 predicted both clinical response and remission at Weeks 14 and 30 (clinical response/remission at Week 14: area under the curve [AUC] = 0.81, p < 0.001, cut-off: 11.5 μg/ml/AUC = 0.79, p < 0.001, cut-off: 15.3μg/ml; clinical response/remission at Week 30: AUC = 0.79, p = 0.002, cut-off: 11.5 μg/ml/AUC = 0.74, p = 0.006, cut-off: 14.5 μg/ml), whereas ADA positivity at Week 14 was inversely associated with clinical response at Week 30 [58.3{\%} vs 84.8{\%} ,p = 0.04]. Previous anti-tumour necrosis factor [TNF] exposure was inversely associated with short-term clinical remission [Week 2: 18.8{\%} vs 47.8{\%}, p = 0.03, at Week 6: 38.9{\%} vs 69.7{\%}, p = 0.013, at Week 14: 37.5{\%} vs 2.5{\%}, p = 0.06]. In CD, TLs at Week 2 predicted short-term [Week 14 response/remission, AUCTLweek2 = 0.715-0.721, p = 0.05/0.005] but not medium-term clinical efficacy. In addition, early ADA status by Week 14 [p = 0.04-0.05 for Weeks 14 and 30], early clinical response [p < 0.001 for Weeks 30/54] and normal C-reactive protein [CRP] at Week 14 [p = 0.005-0.0001] and previous anti-TNF exposure [p = 0.03-0.0001 for Weeks 14, 30, and 54] were associated with short-and medium-term clinical response and remission.Conclusions: In UC, early TLs were predictive for short- and medium-term clinical efficacy, whereas in CD, Week 2 TLs were associated only with short-term clinical outcomes.Background and Aims: Biosimilar infliximab CT-P13 received European Medicines Agency [EMA] approval in June 2013 for all indications of the originator product. In the present study, we aimed to evaluate the predictors of short- and medium-term clinical outcome in patients treated with the biosimilar infliximab at the participating inflammatory bowel disease [IBD] centres in Hungary.",
keywords = "Biosimilar infliximab, inflammatory bowel diseases",
author = "Lorant Gonczi and Zsuzsanna Vegh and Golovics, {Petra Anna} and Mariann Rutka and Gecse, {Krisztina Barbara} and Renata Bor and Klaudia Farkas and T. Szamosi and L. Bene and B. Gasztonyi and T{\"u}nde Krist{\'o}f and L. Lakatos and P. Miheller and K. Palatka and M. Papp and {\'A}rp{\'a}d Patai and {\'A}gnes Salamon and T{\'o}th, {G{\'a}bor Tam{\'a}s} and A. Vincze and Edina Biro and Lovasz, {Barbara Dorottya} and Zsuzsanna Kurti and Zoltan Szepes and T. Moln{\'a}r and P. Lakatos",
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month = "6",
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doi = "10.1093/ecco-jcc/jjw203",
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pages = "697--705",
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TY - JOUR

T1 - Prediction of Short- and Medium-term Efficacy of Biosimilar Infliximab Therapy. Do Trough Levels and Antidrug Antibody Levels or Clinical And Biochemical Markers Play the More Important Role?

AU - Gonczi, Lorant

AU - Vegh, Zsuzsanna

AU - Golovics, Petra Anna

AU - Rutka, Mariann

AU - Gecse, Krisztina Barbara

AU - Bor, Renata

AU - Farkas, Klaudia

AU - Szamosi, T.

AU - Bene, L.

AU - Gasztonyi, B.

AU - Kristóf, Tünde

AU - Lakatos, L.

AU - Miheller, P.

AU - Palatka, K.

AU - Papp, M.

AU - Patai, Árpád

AU - Salamon, Ágnes

AU - Tóth, Gábor Tamás

AU - Vincze, A.

AU - Biro, Edina

AU - Lovasz, Barbara Dorottya

AU - Kurti, Zsuzsanna

AU - Szepes, Zoltan

AU - Molnár, T.

AU - Lakatos, P.

PY - 2017/6/1

Y1 - 2017/6/1

N2 - Methods: Demographic data were collected and a harmonised monitoring strategy was applied. Clinical and biochemical activities were evaluated at Weeks 14, 30, and 54. Trough level [TL] and anti-drug antibody [ADA] concentrations were measured by enzyme-linked immunosorbent assay [ELISA] [LT-005, Theradiag, France] at baseline at 14, 30 and 54 weeks and in two centres at Weeks 2 and 6.Results: A total of 291 consecutive IBD patients (184 Crohn's disease [CD] and 107 ulcerative colitis [UC]) were included. In UC, TLs at Week 2 predicted both clinical response and remission at Weeks 14 and 30 (clinical response/remission at Week 14: area under the curve [AUC] = 0.81, p < 0.001, cut-off: 11.5 μg/ml/AUC = 0.79, p < 0.001, cut-off: 15.3μg/ml; clinical response/remission at Week 30: AUC = 0.79, p = 0.002, cut-off: 11.5 μg/ml/AUC = 0.74, p = 0.006, cut-off: 14.5 μg/ml), whereas ADA positivity at Week 14 was inversely associated with clinical response at Week 30 [58.3% vs 84.8% ,p = 0.04]. Previous anti-tumour necrosis factor [TNF] exposure was inversely associated with short-term clinical remission [Week 2: 18.8% vs 47.8%, p = 0.03, at Week 6: 38.9% vs 69.7%, p = 0.013, at Week 14: 37.5% vs 2.5%, p = 0.06]. In CD, TLs at Week 2 predicted short-term [Week 14 response/remission, AUCTLweek2 = 0.715-0.721, p = 0.05/0.005] but not medium-term clinical efficacy. In addition, early ADA status by Week 14 [p = 0.04-0.05 for Weeks 14 and 30], early clinical response [p < 0.001 for Weeks 30/54] and normal C-reactive protein [CRP] at Week 14 [p = 0.005-0.0001] and previous anti-TNF exposure [p = 0.03-0.0001 for Weeks 14, 30, and 54] were associated with short-and medium-term clinical response and remission.Conclusions: In UC, early TLs were predictive for short- and medium-term clinical efficacy, whereas in CD, Week 2 TLs were associated only with short-term clinical outcomes.Background and Aims: Biosimilar infliximab CT-P13 received European Medicines Agency [EMA] approval in June 2013 for all indications of the originator product. In the present study, we aimed to evaluate the predictors of short- and medium-term clinical outcome in patients treated with the biosimilar infliximab at the participating inflammatory bowel disease [IBD] centres in Hungary.

AB - Methods: Demographic data were collected and a harmonised monitoring strategy was applied. Clinical and biochemical activities were evaluated at Weeks 14, 30, and 54. Trough level [TL] and anti-drug antibody [ADA] concentrations were measured by enzyme-linked immunosorbent assay [ELISA] [LT-005, Theradiag, France] at baseline at 14, 30 and 54 weeks and in two centres at Weeks 2 and 6.Results: A total of 291 consecutive IBD patients (184 Crohn's disease [CD] and 107 ulcerative colitis [UC]) were included. In UC, TLs at Week 2 predicted both clinical response and remission at Weeks 14 and 30 (clinical response/remission at Week 14: area under the curve [AUC] = 0.81, p < 0.001, cut-off: 11.5 μg/ml/AUC = 0.79, p < 0.001, cut-off: 15.3μg/ml; clinical response/remission at Week 30: AUC = 0.79, p = 0.002, cut-off: 11.5 μg/ml/AUC = 0.74, p = 0.006, cut-off: 14.5 μg/ml), whereas ADA positivity at Week 14 was inversely associated with clinical response at Week 30 [58.3% vs 84.8% ,p = 0.04]. Previous anti-tumour necrosis factor [TNF] exposure was inversely associated with short-term clinical remission [Week 2: 18.8% vs 47.8%, p = 0.03, at Week 6: 38.9% vs 69.7%, p = 0.013, at Week 14: 37.5% vs 2.5%, p = 0.06]. In CD, TLs at Week 2 predicted short-term [Week 14 response/remission, AUCTLweek2 = 0.715-0.721, p = 0.05/0.005] but not medium-term clinical efficacy. In addition, early ADA status by Week 14 [p = 0.04-0.05 for Weeks 14 and 30], early clinical response [p < 0.001 for Weeks 30/54] and normal C-reactive protein [CRP] at Week 14 [p = 0.005-0.0001] and previous anti-TNF exposure [p = 0.03-0.0001 for Weeks 14, 30, and 54] were associated with short-and medium-term clinical response and remission.Conclusions: In UC, early TLs were predictive for short- and medium-term clinical efficacy, whereas in CD, Week 2 TLs were associated only with short-term clinical outcomes.Background and Aims: Biosimilar infliximab CT-P13 received European Medicines Agency [EMA] approval in June 2013 for all indications of the originator product. In the present study, we aimed to evaluate the predictors of short- and medium-term clinical outcome in patients treated with the biosimilar infliximab at the participating inflammatory bowel disease [IBD] centres in Hungary.

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KW - inflammatory bowel diseases

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