Early clinical remission and normalisation of CRP are the strongest predictors of efficacy, mucosal healing and dose escalation during the first year of adalimumab therapy in Crohn's disease

L. S. Kiss, T. Szamosi, T. Molnár, P. Miheller, L. Lakatos, A. Vincze, K. Palatka, Z. Barta, B. Gasztonyi, A. Salamon, G. Horvath, G. T. Tõth, K. Farkas, J. Banai, Z. Tulassay, F. Nagy, M. Szenes, G. Verès, B. D. Lovasz, Z. VeghP. A. Golovics, M. Szathmári, M. Papp, P. Lakatos

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Abstract

Background Adalimumab is a fully human monoclonal antibody targeting tumour necrosis factor with proven efficacy in the treatment of Crohn's disease (CD). Aim To investigate the predictors of medium-term clinical efficacy and mucosal healing during adalimumab therapy, in patients with CD, in specialised centres approved for biological therapy in Hungary. Methods Data capture of the 201 CD patients was standardised and prospective (male/female: 112/89, median age: 33.0 years, duration: 8 years). Previous infliximab therapy had been administered in 48% of patients, concomitant steroids in 41%, azathioprine in 69% and combined therapy in 27% of patients. Results Overall clinical response and remission rates at 24 weeks were 78% and 52%, respectively; at 52 weeks were 69% and 44%, respectively. Endoscopic improvement and healing were achieved in 43% and 24% of patients. In a logistic regression model, clinical efficacy and CRP at week 12, need for combined immunosuppression at induction, shorter disease duration and smoking were identified as independent predictors for 12-month clinical outcome, whereas CRP at week 12, clinical remission at week 24, inflammatory parameters and nonsmoking were associated to endoscopic improvement/healing. Intensification to weekly dosing was needed in 16% of patients. Parallel azathioprine therapy and clinical remission at week 12 were inversely associated with dose escalation. Conclusions Clinical efficacy and normalised CRP at week 12 (early deep clinical remission) are associated with medium-term clinical efficacy and mucosal healing during adalimumab therapy, whereas need for combined immunosuppression at induction and smoking status are predictors for non-response. Parallel azathioprine therapy may decrease the probability for dose escalation.

Original languageEnglish
Pages (from-to)911-922
Number of pages12
JournalAlimentary Pharmacology and Therapeutics
Volume34
Issue number8
DOIs
Publication statusPublished - okt. 2011

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Crohn Disease
Azathioprine
Immunosuppression
Therapeutics
Logistic Models
Smoking
Biological Therapy
Hungary
Adalimumab
Tumor Necrosis Factor-alpha
Steroids
Monoclonal Antibodies

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

@article{7264269ce9ff4b5982bceaeb7c7bccb4,
title = "Early clinical remission and normalisation of CRP are the strongest predictors of efficacy, mucosal healing and dose escalation during the first year of adalimumab therapy in Crohn's disease",
abstract = "Background Adalimumab is a fully human monoclonal antibody targeting tumour necrosis factor with proven efficacy in the treatment of Crohn's disease (CD). Aim To investigate the predictors of medium-term clinical efficacy and mucosal healing during adalimumab therapy, in patients with CD, in specialised centres approved for biological therapy in Hungary. Methods Data capture of the 201 CD patients was standardised and prospective (male/female: 112/89, median age: 33.0 years, duration: 8 years). Previous infliximab therapy had been administered in 48{\%} of patients, concomitant steroids in 41{\%}, azathioprine in 69{\%} and combined therapy in 27{\%} of patients. Results Overall clinical response and remission rates at 24 weeks were 78{\%} and 52{\%}, respectively; at 52 weeks were 69{\%} and 44{\%}, respectively. Endoscopic improvement and healing were achieved in 43{\%} and 24{\%} of patients. In a logistic regression model, clinical efficacy and CRP at week 12, need for combined immunosuppression at induction, shorter disease duration and smoking were identified as independent predictors for 12-month clinical outcome, whereas CRP at week 12, clinical remission at week 24, inflammatory parameters and nonsmoking were associated to endoscopic improvement/healing. Intensification to weekly dosing was needed in 16{\%} of patients. Parallel azathioprine therapy and clinical remission at week 12 were inversely associated with dose escalation. Conclusions Clinical efficacy and normalised CRP at week 12 (early deep clinical remission) are associated with medium-term clinical efficacy and mucosal healing during adalimumab therapy, whereas need for combined immunosuppression at induction and smoking status are predictors for non-response. Parallel azathioprine therapy may decrease the probability for dose escalation.",
author = "Kiss, {L. S.} and T. Szamosi and T. Moln{\'a}r and P. Miheller and L. Lakatos and A. Vincze and K. Palatka and Z. Barta and B. Gasztonyi and A. Salamon and G. Horvath and T{\~o}th, {G. T.} and K. Farkas and J. Banai and Z. Tulassay and F. Nagy and M. Szenes and G. Ver{\`e}s and Lovasz, {B. D.} and Z. Vegh and Golovics, {P. A.} and M. Szathm{\'a}ri and M. Papp and P. Lakatos",
year = "2011",
month = "10",
doi = "10.1111/j.1365-2036.2011.04827.x",
language = "English",
volume = "34",
pages = "911--922",
journal = "Alimentary Pharmacology and Therapeutics",
issn = "0269-2813",
publisher = "Wiley-Blackwell",
number = "8",

}

TY - JOUR

T1 - Early clinical remission and normalisation of CRP are the strongest predictors of efficacy, mucosal healing and dose escalation during the first year of adalimumab therapy in Crohn's disease

AU - Kiss, L. S.

AU - Szamosi, T.

AU - Molnár, T.

AU - Miheller, P.

AU - Lakatos, L.

AU - Vincze, A.

AU - Palatka, K.

AU - Barta, Z.

AU - Gasztonyi, B.

AU - Salamon, A.

AU - Horvath, G.

AU - Tõth, G. T.

AU - Farkas, K.

AU - Banai, J.

AU - Tulassay, Z.

AU - Nagy, F.

AU - Szenes, M.

AU - Verès, G.

AU - Lovasz, B. D.

AU - Vegh, Z.

AU - Golovics, P. A.

AU - Szathmári, M.

AU - Papp, M.

AU - Lakatos, P.

PY - 2011/10

Y1 - 2011/10

N2 - Background Adalimumab is a fully human monoclonal antibody targeting tumour necrosis factor with proven efficacy in the treatment of Crohn's disease (CD). Aim To investigate the predictors of medium-term clinical efficacy and mucosal healing during adalimumab therapy, in patients with CD, in specialised centres approved for biological therapy in Hungary. Methods Data capture of the 201 CD patients was standardised and prospective (male/female: 112/89, median age: 33.0 years, duration: 8 years). Previous infliximab therapy had been administered in 48% of patients, concomitant steroids in 41%, azathioprine in 69% and combined therapy in 27% of patients. Results Overall clinical response and remission rates at 24 weeks were 78% and 52%, respectively; at 52 weeks were 69% and 44%, respectively. Endoscopic improvement and healing were achieved in 43% and 24% of patients. In a logistic regression model, clinical efficacy and CRP at week 12, need for combined immunosuppression at induction, shorter disease duration and smoking were identified as independent predictors for 12-month clinical outcome, whereas CRP at week 12, clinical remission at week 24, inflammatory parameters and nonsmoking were associated to endoscopic improvement/healing. Intensification to weekly dosing was needed in 16% of patients. Parallel azathioprine therapy and clinical remission at week 12 were inversely associated with dose escalation. Conclusions Clinical efficacy and normalised CRP at week 12 (early deep clinical remission) are associated with medium-term clinical efficacy and mucosal healing during adalimumab therapy, whereas need for combined immunosuppression at induction and smoking status are predictors for non-response. Parallel azathioprine therapy may decrease the probability for dose escalation.

AB - Background Adalimumab is a fully human monoclonal antibody targeting tumour necrosis factor with proven efficacy in the treatment of Crohn's disease (CD). Aim To investigate the predictors of medium-term clinical efficacy and mucosal healing during adalimumab therapy, in patients with CD, in specialised centres approved for biological therapy in Hungary. Methods Data capture of the 201 CD patients was standardised and prospective (male/female: 112/89, median age: 33.0 years, duration: 8 years). Previous infliximab therapy had been administered in 48% of patients, concomitant steroids in 41%, azathioprine in 69% and combined therapy in 27% of patients. Results Overall clinical response and remission rates at 24 weeks were 78% and 52%, respectively; at 52 weeks were 69% and 44%, respectively. Endoscopic improvement and healing were achieved in 43% and 24% of patients. In a logistic regression model, clinical efficacy and CRP at week 12, need for combined immunosuppression at induction, shorter disease duration and smoking were identified as independent predictors for 12-month clinical outcome, whereas CRP at week 12, clinical remission at week 24, inflammatory parameters and nonsmoking were associated to endoscopic improvement/healing. Intensification to weekly dosing was needed in 16% of patients. Parallel azathioprine therapy and clinical remission at week 12 were inversely associated with dose escalation. Conclusions Clinical efficacy and normalised CRP at week 12 (early deep clinical remission) are associated with medium-term clinical efficacy and mucosal healing during adalimumab therapy, whereas need for combined immunosuppression at induction and smoking status are predictors for non-response. Parallel azathioprine therapy may decrease the probability for dose escalation.

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U2 - 10.1111/j.1365-2036.2011.04827.x

DO - 10.1111/j.1365-2036.2011.04827.x

M3 - Article

C2 - 21883326

AN - SCOPUS:80053182153

VL - 34

SP - 911

EP - 922

JO - Alimentary Pharmacology and Therapeutics

JF - Alimentary Pharmacology and Therapeutics

SN - 0269-2813

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