DEVELOPMENT & VALIDATION

Watch Dr. Corey Siegel give a presentation on the development, validation, and limitations of the CDPATH model.

[On screen]

CDPATH logo
Personalized prognostic tool

Development, validation, and limitations of the CDPATH model with Dr. Corey Siegel

Photo of Dr. Corey Siegel

[On screen]

Development, validation, and limitations of the CDPATH model

Corey Siegel, M.D.

Co-Founder, MiTest Health
Initial Co-Creator, CDPATH
Co-Director of the IBD Center at the Dartmouth-Hitchcock Medical Center

Dr. Siegel is a paid consultant for Takeda

Photo of Dr. Corey Siegel

[On screen]

1. Defining the Model: Patient Population

A validated patient communication tool to display individualized Crohn’s disease predicted outcomes based on clinical, serologic and genetic variables

Corey A. Siegel, Henry Horton, Lori S. Siegel, Kimberly D. Thompson, Todd Mackenzie, Sabrina K. Stewart, Philip W. Rice, Joanne M. Stempak, Seper Dezfoli, Talin Haritunians, Alexander Levy, Michael Baek, Raquel Milgrom, Parambir S. Dulai, Stephan R. Targan, Mark S. Silverberg, Marla C. Dubinsky, Dermot P.B. McGovern

Siegel CA, Horton H, Siegel LS, Thompson KD, Mackenzie T, Stewart SK, et al. Aliment Pharmacol Ther. 2016;43(2):262-271.

CDPATH is only validated in, and can only be performed on, adult Crohn’s disease patients (≥ 18 years old) diagnosed within the past ten (10) years, who have not experienced a Crohn’s disease complication, defined as any fistulas or strictures in the bowels or non-perianal (area other than in or around the anus) surgery (removal of portions of small and/or large intestine or repair of strictures).

Due to the nature of clinical testing, there are limitations to consider for CDPATH. See CDPATH.com for more information.

[Audio]

This is how we designed the CDPATH model and used an independent clinical study.

[On screen]

1. Defining the Model in an Independent Clinical Study: Patient Population

CDPATH was designed using an independent well-characterized calibration cohort:

  • N=243
  • Adult CD patients (18 years and older)
  • Diagnosed within the last 10 years
  • No complication at time of diagnosis

A chart review and blood specimens were taken from the original cohorts at the time of entry.

CD=Crohn’s disease.
Siegel CA, Horton H, Siegel LS, Thompson KD, Mackenzie T, Stewart SK, et al. Aliment Pharmacol Ther. 2016;43(2):262-271.

CDPATH is only validated in, and can only be performed on, adult Crohn’s disease patients (≥ 18 years old) diagnosed within the past ten (10) years, who have not experienced a Crohn’s disease complication, defined as any fistulas or strictures in the bowels or non-perianal (area other than in or around the anus) surgery (removal of portions of small and/or large intestine or repair of strictures).

Due to the nature of clinical testing, there are limitations to consider for CDPATH. See CDPATH.com for more information.

[Audio]

So, we started with an independent clinical study and a calibration cohort.

  • The CDPATH model was defined using an independent well-characterized cohort of 243 adults (18 years or older) all with Crohn’s disease diagnosed within 10 years and who had no prior serious complications. Patients were excluded if they had a complication at the time of diagnosis.
  • For the purposes of the independent study and as it related to the balance of this discussion, serious complications were defined as bowel strictures, internal penetrating disease, or non-perianal surgery (bowel resection or stricturoplasty).
  • We did a chart review and took blood specimens from the original cohorts at the time of entry.
  • The patient characteristics of the independent calibration cohort are presented in the table you see here to the right.

[On screen]

1. Defining the Model in an Independent Clinical Study: Significant Variables

A multivariate Cox proportional model was created to predict the potential risk of developing a CD complication over 3 years.1

The model was developed using the independent calibration cohort by1:

  1. Using univariate Cox analysis to select statistically significant variables based on hazard ratios with a P value less than 0.1
  2. Running multivariate Cox proportional analysis to understand the association between the variables and the time to first complication
  3. Leveraging Harrell's Concordance statistic (C-statistic) to assess predictive accuracy

Univariate Analysis for the Risk of CD Complication in the Independent Calibration Cohort1,2

Table displays hazard ratios for developing Crohn’s disease complications over 3 years by various disease characteristics in the independent calibration cohort.

ANCA=anti-neutrophil cytoplasmic antibody; ASCA=anti-Saccharomyces cerevisiae antibody; CBir1=anti-flagellin; CD=Crohn’s disease; CI=confidence interval; Ln=natural log; NOD2=nucleotide-binding oligomerization domain-containing protein 2.

1. Siegel CA, Horton H, Siegel LS, Thompson KD, Mackenzie T, Stewart SK, et al. Aliment Pharmacol Ther. 2016;43(2):262-271. 2. Data on file. Takeda Pharmaceuticals USA, Inc.

CDPATH is only validated in, and can only be performed on, adult Crohn’s disease patients (≥ 18 years old) diagnosed within the past ten (10) years, who have not experienced a Crohn’s disease complication, defined as any fistulas or strictures in the bowels or non-perianal (area other than in or around the anus) surgery (removal of portions of small and/or large intestine or repair of strictures).

Due to the nature of clinical testing, there are limitations to consider for CDPATH. See CDPATH.com for more information.

[Audio]

Then to determine what variables were important, we used a multivariate Cox proportional analysis to design a model to predict the potential risk of developing a Crohn’s disease complication over a 3-year period. We leveraged the calibration cohort to run the analysis.1

  • With many potential variables to consider, we used univariate Cox analysis to select statistically significant variables to potentially be included in the CDPATH model.
  • The results of the univariate Cox analysis are shown here in the table on the right. We identified the variables that were statistically significant based on the hazard ratio values and then ran these in a multivariate Cox analysis to understand the association between identified variables and the time to first complication of Crohn’s disease.1,2
  • We used the Harrell’s Concordance statistic or C-statistic for assessing the predictive accuracy and to confirm the model’s CDPATH variables.1

[On screen]

2. Establishing Clinical Relevance in an Independent Clinical Study

The clinical relevance of CDPATH was established in an independent clinical study using a validation cohort.1

  • N=109
  • Adult cohort (18 years and older)
  • CD patients who were within 10 years of diagnosis and without a previous CD-related complication

Table displays patient characteristics for the independent validation cohort used in the development of the CDPATH model.

CD=Crohn's disease.

  1. Siegel CA, Horton H, Siegel LS, Thompson KD, Mackenzie T, Stewart SK, et al. Aliment Pharmacol Ther. 2016;43(2):262-271.
  2. Siegel CA, Horton H, Siegel LS, Thompson KD, Mackenzie T, Stewart SK, et al. Aliment Pharmacol Ther. 2016;43(2):262-271 [supplemental appendix].

The CDPATH risk assessment tool was developed and validated by Prometheus Laboratories Inc., a partner of Takeda. Test results are provided via Prometheus Laboratories Inc. to physicians.

[Audio]

Next, we validated that the model worked in our target population with an independent validation cohort of 109 adult patients, 18 years or older, who were diagnosed with Crohn’s disease within 10 years or less at the time of the study and also had not yet had serious complications.1 Very similar to the calibration cohort.

  • The table on the right outlines the patient characteristics of this independent validation cohort.2

[On screen]

3. Developing and Validating CDPATH as a Laboratory Developed Test

CDPATH is a laboratory developed test (LDT) designed, manufactured, and performed in a reference clinical laboratory

  • CDPATH performance derived from the calibration (N=106) and validation (N=32) cohorts in adult (18 years and older) CD patients within 10 years of diagnosis without serious complications verified it as an LDT

Patient Characteristics of the LDT Calibration and Validation Cohorts

Table displays patient characteristics of the laboratory-developed test calibration and validation cohorts used in the development of the CDPATH model.

CD=Crohn's disease; SEM=standard error of the mean; N/A= not available but not required for model validation.

Data on file. Takeda Pharmaceuticals USA, Inc.

The CDPATH risk assessment tool was developed and validated by Prometheus Laboratories Inc., a partner of Takeda. Test results are provided via Prometheus Laboratories Inc. to physicians.

[Audio]

To bring CDPATH to market, further work was done by Prometheus Laboratories to develop and validate CDPATH as a Laboratory Developed Test or LDT.

  • This work was done using a calibration cohort sample of 106 and a validation cohort sample of 32 adult patients with Crohn’s disease who were 18 years and older, within 10 years of their diagnosis, and who had not yet experienced a serious complication.
  • The table on the right outlines the patient characteristics of these 2 cohorts.

[On screen]

CDPATH Demonstrated Consistent Performance Results1

Harrell's Concordance Statistic (C-Statistic):
A measure to assess the accuracy of predictive models.2

  • Value of 0.5 = random chance3
  • Value of 1 = perfect prediction3

Used to evaluate the ability of the CDPATH model to predict the potential for developing CD-related complications.2

Cox Regression Analysis: Revealed statistically significant association between individualized risk assessment scores and CD complications at 3 years for all cohorts of the independent clinical study and laboratory developed test.1,2

Harrell's C-Statistic and P Values for the CDPATH Cohorts1,2

Table shows Harrell's C-statistic and P values for the independent clinical study and laboratory-developed test cohorts.

* The CDPATH risk assessment tool was developed and validated by Prometheus Laboratories Inc., a partner of Takeda. Test results are provided via Prometheus Laboratories Inc. to physicians.1

CD=Crohn’s disease.

1. Data on file. Takeda Pharmaceuticals USA, Inc. 2. Siegel CA, Horton H, Siegel LS, Thompson KD, Mackenzie T, Stewart SK, et al. Aliment Pharmacol Ther. 2016;43(2):262-271. 3. Schmid M, Wright MN, Ziegler A. Expert Syst Appl. 2016;63:450-459.

Healthcare Providers should not rely primarily on the risk predictions from CDPATH to make a clinical diagnosis or treatment decision regarding an individual patient. CDPATH should only be considered an additional piece of information in combination with a doctor’s evaluation of a patient’s CD.

[Audio]

Furthermore, CDPATH demonstrated consistent, statistically significant performance results1 across the work my team did in the independent clinical study to develop the CDPATH model and the LDT calibration and validation work.

  • We used the Harrell C-statistic2 to assess the predictive accuracy of the CDPATH model.
  • The C-statistic for the CDPATH calibration and validation cohorts in the independent study and the LDT were consistent across a range of 0.70-0.73.1
  • So, what does this mean? Well, a value of 0.5 means the prediction is the same as random chance3 and a value of 1 is a perfect prediction.3
  • We also looked at the Cox regression analysis which revealed a statistically significant association between individualized risk assessment scores and Crohn’s disease complications at 3 years for all cohorts of the independent clinical study and the LDT with P values ranging from <0.001 to 0.015.1

So overall, very consistent C-statistics and p-value results.

[On screen]

CDPATH Model Limitations to Consider

Due to the nature of clinical testing, there are limitations to consider for CDPATH1:

  • Testing was conducted only with patients from North America; the results for patients from other regions have not been established1
  • Patients were recruited from large referral centers and may not be representative of all CD patients1
  • The model was built and validated in CD patients with 15 years as the maximum duration of disease; as such, it is not understood whether the model is applicable to patients with long-standing CD beyond 15 years from diagnosis1
  • The validity of the model after the first complication* or surgery has not been tested or established; therefore, CDPATH may only be used one time for each patient1,2
  • CDPATH is intended to be used in combination with your clinical assessment and providers should not rely primarily on the risk predictions from CDPATH to make a clinical diagnosis or treatment decision regarding an individual patient

*For CDPATH, a serious CD complication was defined as bowel stricture, internal penetrating disease, or non-perianal surgery (bowel resection or stricturoplasty).

CD=Crohn's disease.

1. Siegel CA, Horton H, Siegel LS, Thompson KD, Mackenzie T, Stewart SK, et al. Aliment Pharmacol Ther. 2016;43(2):262-271., 2. Data on file. Takeda Pharmaceuticals USA, Inc.

Healthcare Providers should not rely primarily on the risk predictions from CDPATH to make a clinical diagnosis or treatment decision regarding an individual patient. CDPATH should only be considered an additional piece of information in combination with a doctor’s evaluation of a patient’s CD.

[Audio]

Due to the nature of the clinical testing, there are limitations to consider for CDPATH1:

  • First the testing was conducted only with patients from North America. So what does that mean – it means that results for patients from other regions have not yet been established.1
  • Also, patients were recruited from large referral centers, and as such, the cohorts from the independent clinical study may not be representative of all Crohn’s disease patients.1
  • We built the model and validated it in Crohn’s disease patients with 15 years as the maximum disease duration; as such, we are not able to infer whether the model is applicable to patients with long-standing Crohn’s disease beyond 15 years from diagnosis.1
  • We have not done any study in patients after their first complication or surgery, so this has not been tested or established. Therefore, CDPATH may only be used one time for each patient.1,2
  • Lastly, CDPATH is intended to be used in combination with your clinical assessment, and providers should not rely primarily on the risk predictions from CDPATH to make a clinical diagnosis or treatment decision regarding an individual patient.

[On screen]

CDPATH logo
Personalized prognostic tool

For more information, contact Client Services at 1-877-556-8766 or ask your CDPATH representatives.

Hours of Operation:
Monday-Friday
6:00 am-4:30 pm PST

[On screen]

TERMS AND CONDITIONS:   CDPATH is only validated in, and can only be run on, adult Crohn’s disease patients (≥18 years old) diagnosed within the past ten (10) years, who have not experienced a Crohn’s disease complication such as blockages, strictures, or fistulas. Beneficiaries of any state or federal health insurance program (including, but not limited to, Medicare, Medicaid, Department of Veterans Affairs, Coast Guard, Public Health Service, or Department of Defense) are excluded from participating in this program. No insurance claims should be collected or processed, and no charges should be billed to the patient for CDPATH and shipping. Takeda has made arrangements with the processing laboratory to directly cover these charges. Void where prohibited by law. Takeda reserves the right to change or end CDPATH at any time without notice, and other terms and conditions may apply. This test cannot be substituted for or combined with any other test and is only offered for a one-time use.

[On screen]

CDPATH logo
Personalized prognostic tool

Up Next
Interpreting the CDPATH Risk Profile

CDPATH is a trademark of Takeda Pharmaceuticals U.S.A., Inc.
©2022 Takeda Pharmaceuticals U.S.A., Inc.
All rights reserved. Contact CDPATH Client Services at 1-877-556-8766.
US-NON-6719v1.0 03/22
Takeda logo

CDPATH: A Validated Personalized Prognostic Tool
CDPATH model development and validation details
Independent Clinical Study

Defining the model through a calibration cohort in an independent clinical study1

The model was defined using a well-characterized calibration cohort of 243 adult patients (18 years and older) with Crohn's disease diagnosed within the last 10 years to identify statistically significant variables that predicted the potential of serious Crohn's disease-related complications within 3 years*

Establishing clinical relevance through a validation cohort in an independent clinical study1,2

A well-characterized adult cohort of 109 Crohn's disease patients who were within 10 years of diagnosis without a previous complication confirmed the clinical relevancy of the model*

Model Validation

Developing and validating the laboratory developed test (LDT)2

The model was developed and validated as an LDT using calibration (N=106) and validation (N=32) cohorts of adult Crohn's disease patients within 10 years of diagnosis without a previous complication

*Patients were excluded if they had a complication at the time of diagnosis.

Serious complications are defined as bowel strictures, internal penetrating disease, or non-perianal surgery (bowel resection or stricturoplasty).1,2

The CDPATH risk assessment tool was developed and validated by Prometheus Laboratories Inc., a partner of Takeda, and has received conditional approval from the New York State Department of Health (NYS DoH) as an LDT. Test results are provided via Prometheus Laboratories Inc. to physicians.2

The performance of CDPATH showed consistent results

Harrell's C-statistic and P Value for CDPATH Cohorts1,2
Patient Population
Harrell's
C-Statistic
P Value
Independent
Clinical Study
Model
Validation§
Calibration cohort
(N=243)
0.73
P<0.001
Validation cohort
(N=109)
0.73
P<0.001
Calibration cohort
(N=106)
0.73
P<0.001
Validation cohort
(N=32)
0.70
P=0.015

The ability of CDPATH to predict the potential risk of Crohn's disease-related complications was evaluated using the Harrell's Concordance statistic (C-statistic), a measure used to assess the accuracy of predictive risk models.1,2

  • A value of 0.5 means a prediction that is the same as random chance, and a value of 1 means a perfect prediction3

LIMITATIONS TO CONSIDER: Due to the nature of clinical testing, there are limitations to consider for CDPATH model1:

  1. Testing was conducted with only patients from North America; the results for patients from other regions have not been established.1
  2. Patients were recruited from large referral centers and may not be representative of all CD patients.1
  3. The model was built and validated in CD patients with 15 years as the maximum duration of disease; as such, it is not understood whether the model is applicable for patients with long-standing CD beyond 15 years from diagnosis.1
  4. The validity of the model after the first complication or surgery has not been tested or established; therefore, CDPATH may only be used one time for each patient.1,2

§The CDPATH risk assessment tool was developed and validated by Prometheus Laboratories Inc., a partner of Takeda, and has received conditional approval from the New York State Department of Health (NYS DoH) as an LDT. Test results are provided via Prometheus Laboratories, Inc. to physicians.2

Transforming CDPATH results into an individualized risk profile

Interpreting the Risk Profiles

[On screen]

CDPATH logo
Personalized prognostic tool

Interpreting the CDPATH Risk Profile with Dr. Corey Siegel

Photo of Dr. Corey Siegel

[On screen]

Interpreting the CDPATH Risk Profile

Corey Siegel, M.D.

Co-Founder, MiTest Health
Initial Co-Creator, CDPATH
Co-Director of the IBD Center at the Dartmouth-Hitchcock Medical Center

Dr. Siegel is a paid consultant for Takeda

Photo of Dr. Corey Siegel

[On screen]

Creating the Individual Potential Risk Profile

Using SDA, CDPATH results are transformed into a simple graphical display of the individual CD patient’s stratified risk profile1,2:

Line graphs display predicted risk of complications from Crohn’s disease over 3 years for hypothetical patients at low, medium, and high risk.

Complex clinical data → Easy to interpret1

CDPATH is only validated in, and can only be performed on, adult Crohn’s disease patients (≥18 years old) diagnosed within the past ten (10) years, who have not experienced a Crohn’s disease complication, defined as any fistulas or strictures in the bowels or non-perianal (area other than in or around the anus) surgery (removal of portions of small and/or large intestine or repair of strictures). 

Due to the nature of clinical testing, there are limitations to consider for CDPATH. See CDPATH.com for more information.

[Audio]

…We transformed the complex clinical results from CDPATH and converted it into an easy to interpret graphic. A graphical display that can also be used as a tool to show patients their individualized risk profile for the potential likelihood of developing serious complications within 3 years. Examples of low, medium, and high risk graphs are shown here.1,2

CD=Crohn's disease; SDA=system dynamics analysis.

1. Siegel CA, Horton H, Siegel LS, Thompson KD, Mackenzie T, Stewart SK, et al. Aliment Pharmacol Ther. 2016;43(2):262-271., 2. Data on file. Takeda Pharmaceuticals USA, Inc.

The CDPATH risk assessment tool was developed and validated by Prometheus Laboratories Inc., a partner of Takeda. Test results are provided via Prometheus Laboratories Inc. to physicians.

[Audio]

This visual was also developed based on a lot of qualitative work sitting with patients, listening to patients, and we did cognitive interviews and think aloud protocols meaning we asked patients what their interpretation of the graph was.

Healthcare Providers should not rely primarily on the risk predictions from CDPATH to make a clinical diagnosis or treatment decision regarding an individual patient. CDPATH should only be considered an additional piece of information in combination with a doctor’s evaluation of a patient’s CD.

[Audio]

For instance, patients told us that they’re not interested in the exact percentage they just wanted to know if they were high, medium, or low risk and over how much time might be expected for that complication.

[On screen]

CDPATH Model Limitations to Consider

  • Due to the nature of clinical testing, there are limitations to consider for CDPATH1:
  • Testing was conducted only with patients from North America; the results for patients from other regions have not been established1
  • Patients were recruited from large referral centers and may not be representative of all CD patients1
  • The model was built and validated in CD patients with 15 years as the maximum duration of disease; as such, it is not understood whether the model is applicable to patients with long-standing CD beyond 15 years from diagnosis1
  • The validity of the model after the first complication* or surgery has not been tested or established; therefore, CDPATH may only be used one time for each patient1,2
  • CDPATH is intended to be used in combination with your clinical assessment and providers should not rely primarily on the risk predictions from CDPATH to make a clinical diagnosis or treatment decision regarding an individual patient

*For CDPATH, a serious CD complication was defined as bowel stricture, internal penetrating disease, or non-perianal surgery (bowel resection or stricturoplasty).1,2

CD=Crohn's disease.

1. Siegel CA, Horton H, Siegel LS, Thompson KD, Mackenzie T, Stewart SK, et al. Aliment Pharmacol Ther. 2016;43(2):262-271., 2. Data on file. Takeda Pharmaceuticals USA, Inc.

Healthcare Providers should not rely primarily on the risk predictions from CDPATH to make a clinical diagnosis or treatment decision regarding an individual patient. CDPATH should only be considered an additional piece of information in combination with a doctor’s evaluation of a patient’s CD.

[Audio]

Due to the nature of clinical testing, there are limitations to consider for CDPATH1:

  • First the testing was conducted only with patients from North America. So what does that mean – that means the results for patients from other regions have not yet been established.1
  • Also, patients were recruited from large referral centers, and as such, the cohorts from the independent clinical study may not be representative of all Crohn’s disease patients.1
  • We built the model and validated it in Crohn’s disease patients with 15 years as the maximum disease duration; as such, we are not able to infer whether the model is applicable to patients with long-standing Crohn’s disease beyond 15 years from diagnosis.1
  • We have not done any study in patients after their first complication or surgery, so this has not been tested or established. Therefore, CDPATH may only be used one time for each patient.1,2
  • Lastly, CDPATH is intended to be used in combination with your clinical assessment, and providers should not rely primarily on the risk predictions from CDPATH to make a clinical diagnosis or treatment decision regarding an individual patient.

[On screen]

CDPATH logo
Personalized prognostic tool

For more information, contact Client Services at 1-877-556-8766 or ask your CDPATH representatives.

Hours of Operation:
Monday-Friday
6:00 am-4:30 pm PST

[On screen]

TERMS AND CONDITIONS:   CDPATH is only validated in, and can only be run on, adult Crohn’s disease patients (≥18 years old) diagnosed within the past ten (10) years, who have not experienced a Crohn’s disease complication such as blockages, strictures, or fistulas. Beneficiaries of any state or federal health insurance program (including, but not limited to, Medicare, Medicaid, Department of Veterans Affairs, Coast Guard, Public Health Service, or Department of Defense) are excluded from participating in this program. No insurance claims should be collected or processed, and no charges should be billed to the patient for CDPATH and shipping. Takeda has made arrangements with the processing laboratory to directly cover these charges. Void where prohibited by law. Takeda reserves the right to change or end CDPATH at any time without notice, and other terms and conditions may apply. This test cannot be substituted for or combined with any other test and is only offered for a one-time use.

[On screen]

CDPATH logo
Personalized prognostic tool

Up Next
Two Patient Case Examples

CDPATH is a trademark of Takeda Pharmaceuticals U.S.A., Inc.
©2022 Takeda Pharmaceuticals U.S.A., Inc.
All rights reserved. Contact CDPATH Client Services at 1-877-556-8766.
US-NON-6720v1.0 03/22
Takeda logo

Two Patient Case Examples

[On screen]

CDPATH logo
Personalized prognostic tool

Two Patient Case Examples with Dr. Corey Siegel

Photo of Dr. Corey Siegel

[On screen]

Two patient case examples

Corey Siegel, M.D.

Co-Founder, MiTest Health
Initial Co-Creator, CDPATH
Co-Director of the IBD Center at the Dartmouth-Hitchcock Medical Center

Dr. Siegel is a paid consultant for Takeda

Photo of Dr. Corey Siegel

[On screen]

Real Patient Case Example 1

Patients understanding their potential risk profile for serious CD-related complications:

Patient Background:

  • 28-year-old musician from Maine
  • Moderately active ileal CD
  • Patient was passive in managing his CD Follow-Up With the HCP
  • Patient expressed interest in proactively managing his CD
  • Follow-up colonoscopy 10 months after starting treatment showed improved clinical picture

CDPATH Result: HIGH Potential Risk

Line graph shows CDPATH test results for a patient with high potential risk of developing serious CD complications over 3 years.

CD=Crohn's disease; HCP=healthcare professional.
Data on file. Takeda Pharmaceuticals USA, Inc.

CDPATH is only validated in, and can only be performed on, adult Crohn’s disease patients (≥ 18 years old) diagnosed within the past ten (10) years, who have not experienced a Crohn’s disease complication, defined as any fistulas or strictures in the bowels or non-perianal (area other than in or around the anus) surgery (removal of portions of small and/or large intestine or repair of strictures).

Due to the nature of clinical testing, there are limitations to consider for CDPATH. See CDPATH.com for more information.

[Audio]

To give you an example of how the CDPATH results can be used to support shared discussions, I have a couple of patient examples to show you that I’ve used in clinical practice.

  • This is a patient of mine from the clinical trial.
  • He was a 28-year-old musician from Maine who had moderately active ileal Crohn’s disease.
  • As many patients I find, he was passively managing his Crohn’s disease, felt fine, but he was frustrated that he was referred to me and really wasn’t interested in treatment.
  • I talked to him about the study, and he agreed to give it a try.
  • We ran the CDPATH model, and we saw that he was actually at high risk of potential complications. When we discussed these results, his attitude changed, and he shifted from passively managing his Crohn’s to wanting to be more proactive in his care.
  • I was happy to see that after 10 months of therapy – we saw an improved clinical picture and also at the follow-up colonoscopy.

[On screen]

Real Patient Case Example 2

Patients understanding their potential risk profile for serious CD-related complications:

Patient Background:

  • 20-year-old soccer player from Vermont with a very active lifestyle
  • Mild to moderately active ileal and colonic CD Follow-Up With the HCP
  • Patient remained actively engaged in managing her CD
  • Patient and HCP decided to closely monitor any disease progression
  • Improved clinical presentation at follow-up colonoscopy 9 months after office visit

CDPATH Result: LOW Potential Risk

Line graph shows CDPATH test results for a patient with low potential risk of developing serious Crohn’s disease complications over 3 years.

CD=Crohn's disease; HCP=healthcare professional.
Data on file. Takeda Pharmaceuticals USA, Inc.

The CDPATH risk assessment tool was developed and validated by Prometheus Laboratories Inc., a partner of Takeda. Test results are provided via Prometheus Laboratories Inc. to physicians.

[Audio]

Just to show you a contrasting patient - This was an amazing young 20-year-old soccer player from Vermont with a very active lifestyle.

  • She had mild to moderately active ileal and colonic Crohn’s disease, and she was also frustrated as her doctor was pushing her to more advanced therapies, but she was questioning the need for this.
  • We ran her information through the model and found that she had a low potential risk of serious complications within 3 years as you can see here.
  • After discussing the results as part of my clinical assessment, we agreed there was no need for aggressive management plan, but rather she focused on soccer, modest lifestyle changes, and on-going monitoring.
  • She had an improved clinical presentation and follow-up colonoscopy 9 months after the office visit.

Healthcare Providers should not rely primarily on the risk predictions from CDPATH to make a clinical diagnosis or treatment decision regarding an individual patient. CDPATH should only be considered an additional piece of information in combination with a doctor’s evaluation of a patient’s CD.

[Audio]

As a result of the CDPATH test and my shared discussions with these patients, together we agreed on their Crohn’s disease management plan. My patients and I were more informed and the CDPATH report offered a tool to support shared discussions with my patients.

[On screen]

CDPATH logo
Personalized prognostic tool

For more information, contact Client Services at 1-877-556-8766 or ask your CDPATH representatives.

Hours of Operation:
Monday-Friday
6:00 am-4:30 pm PST

[On screen]

TERMS AND CONDITIONS:   CDPATH is only validated in, and can only be run on, adult Crohn’s disease patients (≥18 years old) diagnosed within the past ten (10) years, who have not experienced a Crohn’s disease complication such as blockages, strictures, or fistulas. Beneficiaries of any state or federal health insurance program (including, but not limited to, Medicare, Medicaid, Department of Veterans Affairs, Coast Guard, Public Health Service, or Department of Defense) are excluded from participating in this program. No insurance claims should be collected or processed, and no charges should be billed to the patient for CDPATH and shipping. Takeda has made arrangements with the processing laboratory to directly cover these charges. Void where prohibited by law. Takeda reserves the right to change or end CDPATH at any time without notice, and other terms and conditions may apply. This test cannot be substituted for or combined with any other test and is only offered for a one-time use.

[On screen]

CDPATH logo
Personalized prognostic tool

Up Next
What CDPATH Could Mean for Crohn’s Disease Patients

CDPATH is a trademark of Takeda Pharmaceuticals U.S.A., Inc.
©2022 Takeda Pharmaceuticals U.S.A., Inc.
All rights reserved. Contact CDPATH Client Services at 1-877-556-8766.
US-NON-6721v1.0 03/22
Takeda logo

Individual person icon.

Using a graphical display to show patients their individualized risk profile

Using system dynamics analysis (SDA), the results of the multivariate Cox proportional analyses were transformed into a tool to show patients their individualized risk profile for the potential likelihood of developing a complication over a 3-year period based on a stratification of low, medium, and high probable risk.1,2

The graphs below are examples of patient reports with low-, medium-, and high-risk profiles, respectively2:

Graphical example of low risk of serious Crohn's disease complications over 3 years. Graphical example of medium risk of serious Crohn's disease complications over 3 years. Graphical example of high risk of serious Crohn's disease complications over 3 years.
See a sample patient test report