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Teduglutide

Phase III clinical studies have shown that treatment with teduglutide (TED) was associated with at least 20% reduction in intravenous supplementation (IVS) at 6 months in short bowel syndrome SBS adult patients. Due to the heterogeneity of patients in randomized studies and the cost of the drug, the ESPEN guidelines focused on the need to identify SBS patients who were candidates for growth factor treatment. Currently, the number of patients treated with these agents is still low. It is advised that these treatments should only be used under the guidance of a physician experienced in the management of SBS with an expectation that these patients need to be monitored closely during and potentially after their use. Since potential long term complications are unknown, careful long-term monitoring is required. In addition, careful ongoing evaluation of the clinical benefits has to be prudent.
To improve the quality of care, it seems urgent to achieve clinical practice consensus related to indication of Teduglutide, assessment before drug initiation, and to define modalities of follow up.

We propose a survey to centres with expertise on chronic intestinal failure to evaluate the different practices and considerations related to the treatment.

Answering to this survey will take you around 30 minutes. Thank you for your time.

For each question, several answers are possible. If in some cases, detailed specifications should be necessary, please be as succinct as possible. Please, give your opinion for each question, even in case you have never prescribed teduglutide.

mandatory answer

Question 1

Hospital/Name

mandatory answer

Question 2

About your activity:
A)Is Teduglutide available in your country: Yes/No
B)Is Teduglutide reimbursed in your country : Yes/No
C)Number of physicians in your centre:
D)Date of starting HPN activity:
E)Number (approximately) of patients on HPN at the date of filling out this questionnaire:
F)Percentage of patients with SBS on HPN at the date of filling out this questionnaire:

Please answer all sub questions and indicate the letter

mandatory answer

Question 3

If Teduglutide is available, do you know the cost of Teduglutide in your country (per patient per year in your currency, € or $) :

mandatory answer

Question 4

If teduglutide is available, do you have prescribed personally the drug:

Please specify

Yes (number of patient treated?)

No (specify the reason)

uncheck

Comments

mandatory answer

Question 5

Have you participated in randomized control studies evaluating the efficacy of others GLP2 analogs

Yes

uncheck

mandatory answer

Question 6

Do you believe that the drug can be used in SBS patients requiring IVS:

Please specify (answers 2 and 4)

in adults without consideration of age

in adults with consideration of age (specify the age)

In pediatric population without consideration of age

In pediatric population with consideration of age (specify the age)

without opinion

Comments

mandatory answer

Question 7

In which SBS etiology do you prescribe the drug (current practice)?Or in case of no experience with Teduglutide, in which SBS etiology could you propose Teduglutide ?

Please specify (answer 8)

Mesenteric infarction

Post radiation enteritis

Crohn disease

Motility disorder (CIPO)

Mucosal disease

Congenital disease (atresia)

Post – traumatic

other (specify)

you don’t consider the etiology of SBS

without opinion

Comments

Question 8

How long do you observe the patient after the last intestinal resection, before you prescribe the drug in terms of IVS at home duration? Or in case of no experience with Teduglutide, please indicate your opinion.

Please specify (answer 5)

< 6 months

6 months < x < 1 year

> 1 year

> 2 years

it depends of intestinal anatomy (specify)

without opinion

Comments

Question 9

Do You propose the drug to patients without IVS (current practice)?Or in case of no experience with Teduglutide, please give your opinion if you would propose the drug

Please specify

yes (specify in wich cases)

no (specify the reasons, ie. no indication, no reimbursement, other...)

without opinion

uncheck

Comments

Question 10

Concerning intestinal anatomy, have you considered teduglutide in the following cases? Or in case of no experience with Teduglutide, please indicate your opinion

Duodeno stoma

Jejuno stoma

Ileo stoma

Jejuno colonic anastomosis

Jejuno ileo colonic anastomosis

in all type of SBS (short bowel syndrom)

without opinion

Comments

Question 11

Is there a minimal length of small bowel (in addition to duodenum) to use Teduglutide ? Or in case of no experience with Teduglutide, please indicate your opinion.

Please specify

yes (indicate the length in cm)

no (specify the reasons, ie. no indication, no reimbursement, other...)

without opinion

uncheck

Comments

Question 12

Do you consider Teduglutide in SBS patients with colon (partially or totally) NOT in continuity with small bowel, without any possibility of intestinal continuity restoration ?

Please specify

yes

no (specify the reasons, ie. no indication, no reimbursement, other...)

without opinion

uncheck

Comments

Question 13

Do you consider Teduglutide in SBS patients with colon (partially or totally) NOT in continuity with small bowel, before a planned intestinal continuity restoration ?

yes

without opinion

uncheck

Question 14

In terms of Teduglutide indication, do you consider the characteristics of IVS ?

if yes, specify : minimal or maximal volume of IVS per week, minimum number of infusions per week and the type of IVS (only parenteral nutrition or also fluid and electrolyte alone ?)

yes

without opinion

uncheck

Comments

Question 15

In case of Crohn disease, which of the followings do you consider a contraindication for Teduglutide initiation ?:

presence of a structuring disease

presence of active inflammation

presence of an active fistula

ongoing treatment with biological agents (Infliximab, adalimumab, and certolizumab)

ongoing treatment with immunosuppressive drugs (azathioprine, methotrexate)

ongoing treatment with association immunosuppressive drugs and biological agent

ongoing treatment with steroïds

without opinion

Comments

Question 16

What are, in your opinion, the absolute contra indications to Teduglutide usage?

Please specify (answers 4, 6 and 13)

Heart failure (FeVG < 55%)

Patient under anticoagulant (oral form)

Patient under anticoagulant (sub cutaneous form)

Progressive non digestive cancer (specify if never authorize or authorize after a number of year after cured cancer)

Progressive digestive cancer

Patient history of non-digestive cancer (specify if never authorize or authorize after a number of year after cured cancer)

Colonic polyps adenomatous

cognitive impairment or difficulty understanding treatment and its follow-up prescription

Stricturing disease (because of Crohn’s disease, radiation… )

Premalignant disease

Chronic pancreatis

Primary cholangitis

Other (specify)

without opinion

Comments

Question 17

Before Teduglutide prescription, which exams do you prescribe? Or in case of no experience with Teduglutide, please indicate your opinion

Please specify (answer 9)

Abdominal CT

Lung and abdominal CT

abdominal ultrasoung

Colonoscopy

Upper digestive endoscopy

Biopsies during endoscopic exams

DXA (bone densitometry)

Oncological biomarkers (Ca 19.9, ACE)

Other (specify)

Without opinion

Comments

Question 18

Would you consider that in case of remnant colon but difficulties to perform a colonoscopy (patient refusal, not connected segment high risk of perforation), that :

Please specify (answer 4)

it is contraindicated to prescribe teduglutide

it is indicated to remove surgically the part of colon

it is indicated to monitor using imaging(CT scan or magnetic resonance imaging)

other (specify)

without opinion

Comments

Question 19

For a first injection of Teduglutide, please select the answer(s) relevant to your current practice, or in case of no experience with Teduglutide, please indicate your opinion :

The baseline medical assessment is performed in the hospital during an hospitalization

The medical assessment is performed during one or more outpatient visit(s)

The first injection must be performed in the hospital

The first injection could be performed at home by a nurse

The first injection could be performed at home by the patient or relatives

without opinion

Comments

Question 20

Do you use specific tools (apps, etc) to help you with data monitoring ? Or in case of no experience with Teduglutide, do you think you would need to use specific monitoring tools ?

Please specificy

yes (specify which tools and who is using the tools)

no (specify which kind of tools would you need)

without opinion

uncheck

Comments

Question 21

At which frequency do you perform the clinical follow up and what do you monitor?Or in case of no experience with Teduglutide, please indicate your opinion :

Questions 20,21,22 have the same items over a one year period. Q20 is for months 1 to 4, Q21 for months 5 to 8, Q22 for months 9 to 12
Please specify the monitoring frequency with a number (expressed in number / month). For example : if you monitor diuresis every week the first month please write 4.
Please specify if other item

	Month 1	Month 2	Month 3	Month 4
diuresis
stoma out pout/stool quantity
edema signs
cardiac auscultation
weight
oral intake
drinking evaluation
other
without opinion

Comments

Question 22

At which frequency do you perform the clinical follow up and what do you monitor?? Or in case of no experience with Teduglutide, please indicate your opinion :

	Month 5	Month 6	Month 7	Month 8
diuresis
stoma out pout/stool quantity
edema signs
cardiac auscultation
weight
oral intake
drinking evaluation
other
without opinion

Comments

Question 23

At which frequency do you perform the clinical follow up and what do you monitor?Or in case of no experience with Teduglutide, please indicate your opinion :

	Month 9	Month 10	Month 11	Month 12
diuresis
stoma out pout/stool quantity
edema signs
cardiac auscultation
weight
oral intake
drinking evaluation
other

Comments

Question 24

At which frequency do you perform blood/stool monitoring and what do you monitor? Or in case of no experience with Teduglutide, please indicate your opinion :

Questions 23, 24, 25 have the same items over a one year period. Q23 is for months 1 to 4, Q24 for months 5 to 8, Q25 for months 9 to 12
Please specify the monitoring frequency with a number (expressed in number / month). For example : if you monitor serum Na every week the first month please write 4.
Please specify if it depends to clinical status.
Please specify if other item.
Please specify which drug(s), in case you monitor serum concentration of drug(s)

	Month 1	Month 2	Month 3	Month 4
Serum Na, Cl K
Serum magnesium, calcium, phosphorus
urinary ionogram
urine analysis
serum creatinine
serum albumin
serum bicarbonate
serum amylase
serum lipase
liver function tests
CRP
Bain natriuretic peptide
vitamin A, vitamin E
Vitamin D
Trace elements (Se, Cu, Zn)
Vitamin B12, folates
Citrullin
D xylose absorption test
steatorrhea
fecal calorimetry
other (specify)
Without opinion

Comments

Question 25

At which frequency do you perform blood/stool monitoring and what do you monitor? Or in case of no experience with Teduglutide, please indicate your opinion :

	Month 5	Month 6	Month 7	Month 8
Serum Na, Cl K
Serum magnesium, calcium, phosphorus
urinary ionogram
urine analysis
serum creatinine
serum albumin
serum bicarbonate
serum amylase
serum lipase
liver function tests
CRP
Bain natriuretic peptide
vitamin A, vitamin E
Vitamin D
Trace elements (Se, Cu, Zn)
Vitamin B12, folates
Citrullin
D xylose absorption test
steatorrhea
fecal calorimetry
other (specify)
Without opinion

Comments

Question 26

At which frequency do you perform blood/stool monitoring and what do you monitor? Or in case of no experience with Teduglutide, please indicate your opinion :

	Month 9	Month 10	Month 11	Month 12
Serum Na, Cl K
Serum magnesium, calcium, phosphorus
urinary ionogram
urine analysis
serum creatinine
serum albumin
serum bicarbonate
serum amylase
serum lipase
liver function tests
CRP
Bain natriuretic peptide
vitamin A, vitamin E
Vitamin D
Trace elements (Se, Cu, Zn)
Vitamin B12, folates
Citrullin
D xylose absorption test
steatorrhea
fecal calorimetry
other (specify)
Without opinion

Comments

Question 27

At which frequency do you prescribe these morphological examinations? Or in case of no experience with Teduglutide, please give your opinion :

Questions 26, 27, 28 have the same items over a one year period. Q26 is for months 1 to 4, Q27 for months 5 to 8, Q28 for months 9 to 12
Please specify the monitoring frequency with a number (expressed in number / month). For example : if you monitor CT scan every week the first month please write 4.
Please specify if it depends on clinical status .
Please specify if other item.

	Month 1	Month 2	Month 3	Month 4
CT scan (chest and abdominal)
Full body scan (with brain)
PET scan
Colonoscopy
Upper digestive endoscopy
biopsy during colonoscopy
cardiac echography
DXA (bone densitometry)
Other
Without opinion

Comments

Question 28

At which frequency do you prescribe these morphological examinations? Or in case of no experience with Teduglutide, please indicate your opinion :

	Month 5	Month 6	Month 7	Month 8
CT scan (chest and abdominal)
Full body scan (with brain)
PET scan
Colonoscopy
Upper digestive endoscopy
biopsy during colonoscopy
cardiac echography
DXA (bone densitometry)
other
without opinion

Comments

Question 29

At which frequency do you prescribe these morphological examinations?Or in case of no experience with Teduglutide, please indicate your opinion:

	Month 9	Month 10	Month 11	Month 12
CT scan (chest and abdominal)
Full body scan (with brain)
PET scan
Colonoscopy
Upper digestive endoscopy
biopsy during colonoscopy
cardiac echography
DXA (bone densitometry)
other
without opinion

Comments

Question 30

Do you perform a stool evaluation for malabsorption assessment and hydration absorption? Or in case of no experience with Teduglutide, please indicate your opinion :

Please specify

yes, using the faecal fat output (specify the frequency)

yes, using the faecal ionogram (specify the frequency)

yes, using the energy output (specify the frequency)

using the other method (specify the method and frequency)

without opinion

Comments

Question 31

How do you modify the IVS ? Or in case of no experience with Teduglutide, please indicate your opinion :

Please specify (answer 6)

Decrease of PS if the patient has at least 10% of urine output increase and stable weight

Decrease of PS if the patient has at least 10% of urine output increase and weight increase

Decrease of PS if weight gain without consideration of urine output

Decrease of PS if decrease of stoma output or number/consistency of stools and a 10% increase of urine output

Decrease of PS if decrease of stoma output or number/consistency of stools without consideration of urine output

It depends of remnant intestinal anatomy (specify)

without opinion

Comments

Question 32

When you decide to decrease PS the first time (current practice), or in case of no experience with Teduglutide, please indicate your opinion :

Please specify (answer 5)

Decrease of 10% volume depending to increase of urine output or other parameters

Decrease of PS volume could be superior than 10%

Decrease on the same % the volume, energy and all components

Decrease of 10% only hydration without change of energy and micronutrients

other (specify)

without opinion

Comments

Question 33

How do you decide to withdraw one day of infusion per week? Or in case of no experience with Teduglutide, please give your opinion :

Please specify (answer 5)

it depends of intestinal anatomy

it depends of level of HPN dependency

it depends of faecal output

it depends of prior PS reduction

other

without opinion

Comments

Question 34

Do you consider Teduglutide discontinuation in some cases

Please specify (answers 3 and 4)

In case of insufficient response

In case of complication

After a period in all patients (specify the duration)

Other (specify)

Comments

Question 35

When do you change the Teduglutide dose regimen

never

if you increase the dose (specify why)

if you decrease the dose (specify why)

Comments

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