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?
| Autor: | Beáta Gasztonyi, Ágnes Salamon, Tamas Szamosi, Zsuzsanna Vegh, Petra A. Golovics, Zsuzsanna Kurti, Edina Bíró, Zoltán Szepes, Mariann Rutka, Áron Vincze, Laszlo Lakatos, Károly Palatka, Árpád V. Patai, Pál Miheller, Gábor Tamás Tóth, László Bene, Lorant Gonczi, Klaudia Farkas, Krisztina Gecse, Mária Papp, Tunde Kristof, Tamás Molnár, Renáta Bor, Peter L. Lakatos, Barbara D. Lovasz |
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| Přispěvatelé: | Gastroenterology and Hepatology, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Inflammatory bowel diseases Inflammatory bowel disease Gastroenterology Antibodies 03 medical and health sciences Young Adult 0302 clinical medicine Crohn Disease Gastrointestinal Agents Internal medicine Biosimilar infliximab medicine Humans Prospective Studies Biosimilar Pharmaceuticals Crohn's disease biology business.industry C-reactive protein Area under the curve Antibodies Monoclonal Biosimilar General Medicine medicine.disease Ulcerative colitis Infliximab Surgery C-Reactive Protein 030220 oncology & carcinogenesis Area Under Curve biology.protein Trough level 030211 gastroenterology & hepatology Colitis Ulcerative Female business Biomarkers medicine.drug |
| Zdroj: | Journal of Crohn's and Colitis, 11(6), 697-705. Elsevier |
| ISSN: | 1873-9946 |
| Popis: | 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. 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. |
| Databáze: | OpenAIRE |
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