Clinical value of CT-P13 trough levels, an infliximab biosimilar, in the management of inflammatory bowel disease
| Autor: | Leticia Ollero Domenche, Patricia Sanz Segura, Maria José Alcalá Escriche, Maria Teresa Arroyo Villarino, Santiago López García, Óscar Nantes Castillejo, Cristina Rodríguez Gutiérrez, Daniel Oyón Lara, Alfonso Elosua González |
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| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Disease Inflammatory bowel disease Gastroenterology 03 medical and health sciences 0302 clinical medicine Gastrointestinal Agents Internal medicine medicine Humans 030212 general & internal medicine Prospective Studies Prospective cohort study Biosimilar Pharmaceuticals biology business.industry Remission Induction Antibodies Monoclonal Biosimilar medicine.disease Inflammatory Bowel Diseases Ulcerative colitis Infliximab Treatment Outcome biology.protein Clinical value Colitis Ulcerative Antibody business medicine.drug |
| Zdroj: | Medicina clinica. 154(12) |
| ISSN: | 1578-8989 |
| Popis: | Introduction CT-P13 is a biosimilar drug of infliximab (IFX), effective in patients with inflammatory bowel disease (IBD). The monitoring of levels of IFX and anti-IFX antibodies is now considered part of the integral management. Objective To compare the clinical response according to a strictly clinical (CLN) or proactive (PRO) approach based on the monitoring of levels in week 14, in clinical practice. Methods We conducted a prospective study in IBD patients starting CT-P13. In the PRO group, levels of IFX and post-induction antibodies were systematically measured (week 14) and those with infraterapeutic levels ( Results We included 77 patients (23 ulcerative colitis and 54 Crohn's disease). Both PRO (n = 41) and CLN (n = 36) groups showed initial and long-term efficacy without significant differences. At week 14, 61% clinical remission (CR) (58.5% PRO, 63.9% CLN) and 80.5% at least partial response (PR) (80.5% PRO, 80.6% CLN). In week 54, 68.8% CR (61% PRO, 77.8% CLN) and 76.6% at least PR (73.2% PRO, 80.6% CLN). Of the patients in CR in week 14 (24 PRO, 23 CLN), 13 of the PRO group were intensified due to infra-therapeutic levels. In this subgroup no significant differences were observed in secondary loss of response (PRO 0%, CLN 8.7%). Conclusion Proactive management does not improve response or remission rates in the first year. The intensification of clinical remission patients with post-induction infratherapeutic levels does not seem to significantly prevent secondary loss of response in the first year. |
| Databáze: | OpenAIRE |
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