Validation of endoscopic activity scores in patients with Crohn's disease based on a post hoc analysis of data from SONIC

Marc Ferrante, Jean Frederic Colombel, William J. Sandborn, Walter Reinisch, Gerassimos J. Mantzaris, Asher Kornbluth, Daniel Rachmilewitz, Simon Lichtiger, Geert R. D'Haens, Christien J. Van Der Woude, Silvio Danese, Robert H. Diamond, Alessandra Faria Oortwijn, Kezhen L. Tang, Michael Miller, Freddy Cornillie, Paul J. Rutgeerts

Research output: Contribution to journalArticle

86 Citations (Scopus)

Abstract

Background & Aims Mucosal healing might alter midterm and long-term outcomes of patients with Crohn's disease (CD) and has become an important end point in clinical trials. However, the minimal degree of mucosal improvement (endoscopic response) required to alter midterm outcomes is not known. We aimed to determine the best definition of endoscopic response by evaluating data on the Simple Endoscopic Score for Crohn's Disease (SES-CD) and the Crohn's Disease Endoscopic Index of Severity (CDEIS) from the Study of Biologic and Immunomodulator Naive Patients in Crohn's Disease (SONIC trial). Methods We analyzed data from 172 patients who participated in the SONIC trial, were found to have endoscopic lesions at baseline, and underwent a second endoscopic examination at week 26 of treatment with infliximab, azathioprine, or both. Mucosal healing was defined as absence of ulcers. A central reader calculated SES-CD and CDEIS results. Different cutoff values were set for endoscopic response based on the SES-CD or CDEIS. The diagnostic ability of these different cutoff values was evaluated using receiver operating characteristic (ROC) curves, positive likelihood ratios (PLR), and negative likelihood ratios (NLR). Corticosteroid-free clinical remission (CFREM) at week 50 was used as a binary classifier. Results Based on analyses of ROC curves, PLR, and NLR, endoscopic response was defined as a decrease from baseline in SES-CD of at least 50%. At week 26, mucosal healing and endoscopic response were achieved in 48% and 65% of patients, respectively. Mucosal healing at week 26 was associated with CFREM at week 50, with 56% sensitivity, 65% specificity, a PLR of 1.60, and an NLR of 0.67. Endoscopic response at week 26 was associated with CFREM at week 50, with 74% sensitivity, 48% specificity, a PLR of 1.42, and an NLR of 0.54. Endoscopic response, defined as a decrease from baseline in CDEIS of at least 50%, yielded similar results. Conclusions In patients with CD, mucosal healing and endoscopic response (defined as a decrease from baseline in SES-CD or CDEIS of at least 50%) at week 26 of treatment identified those most likely to be in CFREM at week 50. The ability of the proposed endoscopic response cutoff value to predict midterm CFREM should be validated in an independent, prospective cohort. Its correlation with changes in long-term disease progression still needs to be demonstration. ClinicalTrials.gov, Number: NCT00094458.

Original languageEnglish
JournalGastroenterology
Volume145
Issue number5
DOIs
Publication statusPublished - Nov 2013

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Crohn Disease
Adrenal Cortex Hormones
ROC Curve
Sensitivity and Specificity
Azathioprine
Immunologic Factors
Ulcer
Disease Progression
Clinical Trials

Keywords

  • IBD
  • Mucosal Healing
  • Prognosis
  • Response to Therapy

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Ferrante, M., Colombel, J. F., Sandborn, W. J., Reinisch, W., Mantzaris, G. J., Kornbluth, A., ... Rutgeerts, P. J. (2013). Validation of endoscopic activity scores in patients with Crohn's disease based on a post hoc analysis of data from SONIC. Gastroenterology, 145(5). https://doi.org/10.1053/j.gastro.2013.08.010

Validation of endoscopic activity scores in patients with Crohn's disease based on a post hoc analysis of data from SONIC. / Ferrante, Marc; Colombel, Jean Frederic; Sandborn, William J.; Reinisch, Walter; Mantzaris, Gerassimos J.; Kornbluth, Asher; Rachmilewitz, Daniel; Lichtiger, Simon; D'Haens, Geert R.; Van Der Woude, Christien J.; Danese, Silvio; Diamond, Robert H.; Oortwijn, Alessandra Faria; Tang, Kezhen L.; Miller, Michael; Cornillie, Freddy; Rutgeerts, Paul J.

In: Gastroenterology, Vol. 145, No. 5, 11.2013.

Research output: Contribution to journalArticle

Ferrante, M, Colombel, JF, Sandborn, WJ, Reinisch, W, Mantzaris, GJ, Kornbluth, A, Rachmilewitz, D, Lichtiger, S, D'Haens, GR, Van Der Woude, CJ, Danese, S, Diamond, RH, Oortwijn, AF, Tang, KL, Miller, M, Cornillie, F & Rutgeerts, PJ 2013, 'Validation of endoscopic activity scores in patients with Crohn's disease based on a post hoc analysis of data from SONIC', Gastroenterology, vol. 145, no. 5. https://doi.org/10.1053/j.gastro.2013.08.010
Ferrante, Marc ; Colombel, Jean Frederic ; Sandborn, William J. ; Reinisch, Walter ; Mantzaris, Gerassimos J. ; Kornbluth, Asher ; Rachmilewitz, Daniel ; Lichtiger, Simon ; D'Haens, Geert R. ; Van Der Woude, Christien J. ; Danese, Silvio ; Diamond, Robert H. ; Oortwijn, Alessandra Faria ; Tang, Kezhen L. ; Miller, Michael ; Cornillie, Freddy ; Rutgeerts, Paul J. / Validation of endoscopic activity scores in patients with Crohn's disease based on a post hoc analysis of data from SONIC. In: Gastroenterology. 2013 ; Vol. 145, No. 5.
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abstract = "Background & Aims Mucosal healing might alter midterm and long-term outcomes of patients with Crohn's disease (CD) and has become an important end point in clinical trials. However, the minimal degree of mucosal improvement (endoscopic response) required to alter midterm outcomes is not known. We aimed to determine the best definition of endoscopic response by evaluating data on the Simple Endoscopic Score for Crohn's Disease (SES-CD) and the Crohn's Disease Endoscopic Index of Severity (CDEIS) from the Study of Biologic and Immunomodulator Naive Patients in Crohn's Disease (SONIC trial). Methods We analyzed data from 172 patients who participated in the SONIC trial, were found to have endoscopic lesions at baseline, and underwent a second endoscopic examination at week 26 of treatment with infliximab, azathioprine, or both. Mucosal healing was defined as absence of ulcers. A central reader calculated SES-CD and CDEIS results. Different cutoff values were set for endoscopic response based on the SES-CD or CDEIS. The diagnostic ability of these different cutoff values was evaluated using receiver operating characteristic (ROC) curves, positive likelihood ratios (PLR), and negative likelihood ratios (NLR). Corticosteroid-free clinical remission (CFREM) at week 50 was used as a binary classifier. Results Based on analyses of ROC curves, PLR, and NLR, endoscopic response was defined as a decrease from baseline in SES-CD of at least 50{\%}. At week 26, mucosal healing and endoscopic response were achieved in 48{\%} and 65{\%} of patients, respectively. Mucosal healing at week 26 was associated with CFREM at week 50, with 56{\%} sensitivity, 65{\%} specificity, a PLR of 1.60, and an NLR of 0.67. Endoscopic response at week 26 was associated with CFREM at week 50, with 74{\%} sensitivity, 48{\%} specificity, a PLR of 1.42, and an NLR of 0.54. Endoscopic response, defined as a decrease from baseline in CDEIS of at least 50{\%}, yielded similar results. Conclusions In patients with CD, mucosal healing and endoscopic response (defined as a decrease from baseline in SES-CD or CDEIS of at least 50{\%}) at week 26 of treatment identified those most likely to be in CFREM at week 50. The ability of the proposed endoscopic response cutoff value to predict midterm CFREM should be validated in an independent, prospective cohort. Its correlation with changes in long-term disease progression still needs to be demonstration. ClinicalTrials.gov, Number: NCT00094458.",
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T1 - Validation of endoscopic activity scores in patients with Crohn's disease based on a post hoc analysis of data from SONIC

AU - Ferrante, Marc

AU - Colombel, Jean Frederic

AU - Sandborn, William J.

AU - Reinisch, Walter

AU - Mantzaris, Gerassimos J.

AU - Kornbluth, Asher

AU - Rachmilewitz, Daniel

AU - Lichtiger, Simon

AU - D'Haens, Geert R.

AU - Van Der Woude, Christien J.

AU - Danese, Silvio

AU - Diamond, Robert H.

AU - Oortwijn, Alessandra Faria

AU - Tang, Kezhen L.

AU - Miller, Michael

AU - Cornillie, Freddy

AU - Rutgeerts, Paul J.

PY - 2013/11

Y1 - 2013/11

N2 - Background & Aims Mucosal healing might alter midterm and long-term outcomes of patients with Crohn's disease (CD) and has become an important end point in clinical trials. However, the minimal degree of mucosal improvement (endoscopic response) required to alter midterm outcomes is not known. We aimed to determine the best definition of endoscopic response by evaluating data on the Simple Endoscopic Score for Crohn's Disease (SES-CD) and the Crohn's Disease Endoscopic Index of Severity (CDEIS) from the Study of Biologic and Immunomodulator Naive Patients in Crohn's Disease (SONIC trial). Methods We analyzed data from 172 patients who participated in the SONIC trial, were found to have endoscopic lesions at baseline, and underwent a second endoscopic examination at week 26 of treatment with infliximab, azathioprine, or both. Mucosal healing was defined as absence of ulcers. A central reader calculated SES-CD and CDEIS results. Different cutoff values were set for endoscopic response based on the SES-CD or CDEIS. The diagnostic ability of these different cutoff values was evaluated using receiver operating characteristic (ROC) curves, positive likelihood ratios (PLR), and negative likelihood ratios (NLR). Corticosteroid-free clinical remission (CFREM) at week 50 was used as a binary classifier. Results Based on analyses of ROC curves, PLR, and NLR, endoscopic response was defined as a decrease from baseline in SES-CD of at least 50%. At week 26, mucosal healing and endoscopic response were achieved in 48% and 65% of patients, respectively. Mucosal healing at week 26 was associated with CFREM at week 50, with 56% sensitivity, 65% specificity, a PLR of 1.60, and an NLR of 0.67. Endoscopic response at week 26 was associated with CFREM at week 50, with 74% sensitivity, 48% specificity, a PLR of 1.42, and an NLR of 0.54. Endoscopic response, defined as a decrease from baseline in CDEIS of at least 50%, yielded similar results. Conclusions In patients with CD, mucosal healing and endoscopic response (defined as a decrease from baseline in SES-CD or CDEIS of at least 50%) at week 26 of treatment identified those most likely to be in CFREM at week 50. The ability of the proposed endoscopic response cutoff value to predict midterm CFREM should be validated in an independent, prospective cohort. Its correlation with changes in long-term disease progression still needs to be demonstration. ClinicalTrials.gov, Number: NCT00094458.

AB - Background & Aims Mucosal healing might alter midterm and long-term outcomes of patients with Crohn's disease (CD) and has become an important end point in clinical trials. However, the minimal degree of mucosal improvement (endoscopic response) required to alter midterm outcomes is not known. We aimed to determine the best definition of endoscopic response by evaluating data on the Simple Endoscopic Score for Crohn's Disease (SES-CD) and the Crohn's Disease Endoscopic Index of Severity (CDEIS) from the Study of Biologic and Immunomodulator Naive Patients in Crohn's Disease (SONIC trial). Methods We analyzed data from 172 patients who participated in the SONIC trial, were found to have endoscopic lesions at baseline, and underwent a second endoscopic examination at week 26 of treatment with infliximab, azathioprine, or both. Mucosal healing was defined as absence of ulcers. A central reader calculated SES-CD and CDEIS results. Different cutoff values were set for endoscopic response based on the SES-CD or CDEIS. The diagnostic ability of these different cutoff values was evaluated using receiver operating characteristic (ROC) curves, positive likelihood ratios (PLR), and negative likelihood ratios (NLR). Corticosteroid-free clinical remission (CFREM) at week 50 was used as a binary classifier. Results Based on analyses of ROC curves, PLR, and NLR, endoscopic response was defined as a decrease from baseline in SES-CD of at least 50%. At week 26, mucosal healing and endoscopic response were achieved in 48% and 65% of patients, respectively. Mucosal healing at week 26 was associated with CFREM at week 50, with 56% sensitivity, 65% specificity, a PLR of 1.60, and an NLR of 0.67. Endoscopic response at week 26 was associated with CFREM at week 50, with 74% sensitivity, 48% specificity, a PLR of 1.42, and an NLR of 0.54. Endoscopic response, defined as a decrease from baseline in CDEIS of at least 50%, yielded similar results. Conclusions In patients with CD, mucosal healing and endoscopic response (defined as a decrease from baseline in SES-CD or CDEIS of at least 50%) at week 26 of treatment identified those most likely to be in CFREM at week 50. The ability of the proposed endoscopic response cutoff value to predict midterm CFREM should be validated in an independent, prospective cohort. Its correlation with changes in long-term disease progression still needs to be demonstration. ClinicalTrials.gov, Number: NCT00094458.

KW - IBD

KW - Mucosal Healing

KW - Prognosis

KW - Response to Therapy

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