Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program

Autores da FMUP
Participantes de fora da FMUP
- Dubinsky, Marla C.
- Steinwurz, Flavio
- Hudesman, David P.
- Kinnucan, Jami A.
- Ungaro, Ryan C.
- Neurath, Markus F.
- Kulisek, Nicole
- Paulissen, Jerome
- Su, Chinyu
- de Leon, Dario Ponce
- Regueiro, Miguel
Unidades de investigação
Abstract
Background Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). These post hoc analyses assessed associations between C-reactive protein (CRP), partial Mayo score (PMS), and efficacy outcomes during tofacitinib induction in UC. Methods Patients received tofacitinib 10 mg twice daily (BID) in an 8-week, phase 2 induction study and 2 identical, 8-week, phase 3 induction studies (OCTAVE Induction 1 & 2); induction nonresponders (IndNR) received an additional 8 weeks of tofacitinib 10 mg BID in an open-label, long-term extension study. Associations between CRP and PMS, and efficacy outcomes (clinical response, clinical remission, endoscopic improvement, and endoscopic remission) were analyzed using univariate and multivariable logistic regression and receiver operating characteristic curves. Results Changes from baseline in the logarithm of CRP ([log]CRP) and PMS at week 4 were associated with clinical response at week 8 (univariate: per unit, odds ratio [OR], 0.55 [95% confidence interval (CI), 0.48-0.62]; and 0.42 [0.37-0.47], respectively). Among IndNR, change from baseline in PMS at week 8 was associated with clinical response at week 16 (univariate: per unit, OR, 0.59; 95% CI, 0.46-0.75). C-reactive protein at week 4 (area under the curve [AUC] > 0.6) and PMS at weeks 2 and 4 (AUC, > 0.7) generally exhibited predictive value for week 8 efficacy outcomes. Conclusions Patients who achieved clinical response at week 8 had larger decreases in CRP and PMS at week 4 than patients who did not. IndNR who achieved clinical response at week 16 with extended tofacitinib induction had a larger decrease in PMS at week 8 vs those who did not. ClinicalTrials.gov:NCT00787202;NCT01465763;NCT01458951;NCT01470612.
Dados da publicação
- ISSN/ISSNe:
- 1078-0998, 1536-4844
- Tipo:
- Article
- Páginas:
- 51-61
- DOI:
- 10.1093/ibd/izac061
- Link para outro recurso:
- www.scopus.com
Inflammatory Bowel Diseases Oxford University Press
Citações Recebidas na Web of Science: 8
Citações Recebidas na Scopus: 6
Documentos
- Não há documentos
Filiações
Keywords
- C-reactive protein; inflammatory bowel disease; partial Mayo score
Campos de estudo
Proyectos asociados
Gut microbiome and IBD therapy: an interplay?
Investigador Principal: Fernando José Magro Dias
Estudo Observacional Académico (GutIBD) . 2021
Iron deficiency and inflammatory bowel disease. Correlation with inflammation and Vitamin D status.
Investigador Principal: Fernando José Magro Dias
Estudo Observacional Académico (IronIBD) . 2021
Looking 4WARD: The role of dipeptidyl peptidase 4 (DPP-4) in inflammatory bowel disease (IBD) as a novel biomarker for predicting disease activity and monitoring response to therapy in IBD patients.
Investigador Principal: Fernando José Magro Dias
Estudo Observacional Académico (4WARD) . 2021
Isolated Ulceration of Crohn’s Anastomosis
Investigador Principal: Fernando José Magro Dias
Estudo Clínico Académico . 2021
Therapeutic Drug Monitoring: An Emergent Approach in Inflammatory Bowel Disease
Investigador Principal: Fernando José Magro Dias
Estudo Clínico Académico . 2021
Contributo da endoscopia, biomarcadores e imagiologia na evolução clinica dos doentes com doença inflamatória intestinal
Investigador Principal: Fernando José Magro Dias
Estudo Clínico Académico . 2019
Citar a publicação
Dubinsky MC,Magro F,Steinwurz F,Hudesman DP,Kinnucan JA,Ungaro RC,Neurath MF,Kulisek N,Paulissen J,Su C,de Leon DP,Regueiro M. Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program. Inflammatory Bowel Dis. 2023. 29. (1):p. 51-61. IF:4,900. (2).