About Gattex
Penelope, GATTEX patientwith her mom, Kelsey
GATTEX® (teduglutide) is a prescription medicine used in adults and children 1 year of age and older with short bowel syndrome (SBS) who are dependent on parenteral support (PS)
GATTEX works like a natural GLP-2.
In a study of adults, GATTEX was proven to help the remaining intestine absorb more fluid.*†
Increased absorption of fluid by the intestines by ~750 to 1000 mL/day
Increased
villus height
increased depth
between villi
The image above is for illustrative purpose only.
The ability of GATTEX to improve the amount of fluid absorbed by the intestines was studied in 17 adults with SBS. Participants in the study received GATTEX for 21 days. All the participants in this study knew they were taking GATTEX. They each took daily doses of either 0.03, 0.10, or 0.15 mg/kg by injection (0.6 to 3 times the recommended dose). The recommended dose is 0.05 mg/kg/day. The injections were administered under the skin in the stomach area (abdomen). All of the doses studied, except for the 0.03 mg/kg once-daily dose, resulted in enhanced absorption of fluid by the intestines—approximately 750 to 1000 mL per day—and increased the surface area of the intestines.
The ability of GATTEX to improve intestinal absorption in children has not been investigated.
Understanding How GATTEX Works
Watch this video to gain a better understanding of short bowel syndrome and the GATTEX mechanism of action.
Gattex is the first and only medicine that works like the
glp-2 the body
normally makes on its own
GATTEX Adult Clinical Trials
GATTEX was evaluated in 2 clinical studies (STEPS and STEPS-2).
STEPS: This was a 6-month study of 86 adults with short bowel syndrome (SBS) who needed PS at least 3 times per week for at least 1 year. Of the 86 participants, 43 received GATTEX and 43 received placebo once a day. The goal was to see if significantly more people treated with GATTEX compared with those who received placebo achieved a reduction in weekly PS volume of at least 20% at Weeks 20 and 24. The study also evaluated safety.
STEPS-2: This was a 24-month study of 88 adults with SBS. Seventy-six people had participated in STEPS (37 received GATTEX, 39 received placebo) and were enrolled in STEPS-2 after STEPS ended. Twelve people had not participated in STEPS and had never been treated with GATTEX before. In STEPS-2, all participants were treated with GATTEX once daily and were told that they were being treated with GATTEX.
In STEPS, GATTEX was studied in a range of adult patients.
Patient characteristics at the beginning of the STEPS study
Average
Range
Age
50 years
18-82 years
Estimated small bowel length
77.3 cm
5-343 cm
Length of time on PS
6 years
1-26 years
Prescribed days per week on PS
5.73 days
3-7 days
Infusion volume
13 L/week
0.9-35 L/week
Study patients had varying types of intestinal resection, for example, some kept an intact large intestine and/or lower small intestine, some required a stoma, but some did not.
The most common reasons for intestinal resection included vascular disease, Crohn’s disease, or “other.”
Most adults needed less volume of parenteral support (PS)
with GATTEX
In clinical studies, GATTEX reduced the weekly volume of parenteral support
(PS) by 20% or more.
At 6 months with GATTEX
In people who completed 30 months
of treatment with GATTEX
At 6 months
with GATTEX
More than half
63% (27/43)
reduced their weekly PS
volume
by 20% or
more
with GATTEX
vs
30% (13/43) of people who
received placebo
In people
who completed
30 months of
treatment with
GATTEX
Almost all
93% (28/30)
reduced their weekly
PS
volume by
20% or more
with GATTEX
Many adults spent less time on parenteral support (PS) with GATTEX
In clinical studies, some people treated with GATTEX achieved more time off of PS each week
At 6 months with GATTEX
In people who completed 30 months
of treatment with GATTEX
At 6 months
with GATTEX
54% (21/39) achieved
at least 1 day off
of PS
per week
with GATTEX
vs
23% (9/39) of people who
received placebo
In people
who completed
30 months of
treatment with
GATTEX
60% (18/30) achieved
at least 3 days
off of PS
per
week with
GATTEX
More information about the GATTEX clinical trials in adults can be found on the Clinical Studies tab.
Freedom from parenteral support (PS) may be possible
Some people taking GATTEX achieved complete freedom from parenteral
support (PS) after 30 months of treatment.§
10 out of 30 people
no longer needed PS
The time it took to achieve complete freedom ranged from about 7 to 30 months, with the average at
approximately 20 months.
Not everyone who takes GATTEX will fully wean off of PS.
§In STEPS-2, participants were maintained on GATTEX even if they no longer required PS.
More information about the GATTEX clinical trials in adults can be found on the Clinical Studies tab.
It may take time for GATTEX to work
The time it takes for a reduction in weekly PS volume can vary.
In adult clinical studies, some people experienced improved results the longer they stayed on GATTEX.
Time to reduction in weekly PS volume by at least 20%:
For some adults, they were able to reduce weekly PS volume after about 1 month of treatment with GATTEX.
For others, it took 12 months or longer of treatment with GATTEX. Some patients did not respond at all.
43 patients in STEPS study received GATTEX.
Time to freedom from PS*:
Some patients were able to fully wean off of PS after 7 months of treatment with GATTEX.
Some patients required up to 30 months of treatment with GATTEX to fully wean off of PS. Remember, not everyone who takes GATTEX will fully wean off of PS.
88 patients in STEPS-2 study received GATTEX, including 30 who received GATTEX for 30 months.
*No patients receiving GATTEX during the 6-month STEPS study achieved PS independence
GATTEX (teduglutide) Pediatric Clinical Trial
GATTEX was evaluated in a clinical study
STUDY DESIGN: In a 6-month study, 59 children aged 1 through 17 chose whether to receive GATTEX or standard of care (SOC).|| Children who were treated with GATTEX were subsequently randomized in a double-blind manner to receive either 0.025 mg/kg/day (n=24) or 0.05 mg/kg/day (n=26), while 9 children received SOC. Randomization to the GATTEX groups was stratified by age. All children were dependent on PS prior to the study. The goal was to see if children treated with GATTEX achieved a reduction in weekly PS volume of at least 20% from baseline. The study also evaluated safety.
||In this clinical trial, SOC primarily referred to parenteral nutrition, and for many patients, it also included enteral nutrition.
Patient baseline characteristics:
| Demographics |
People treated with GATTEX 0.05 mg/kg/day |
|---|---|
| Age | |
| 1-11 years | 92% |
| 12-17 years | 8% |
| Male | 73% |
| Primary causes of SBS | |
| Gastroschisis | 54% |
| Midgut volvulus | 23% |
| Necrotizing enterocolitis | 12% |
| Intestinal atresia | 4% |
| Hirschsprung’s disease | 4% |
| Baseline characteristics | |
| Mean remaining small intestine length | 47% |
| Mean PS infusion volumes | 60 mL/kg/day |
| Mean PS infusion time | 7 days/week |
Most children needed less volume of parenteral support (PS) with GATTEX
In a clinical study, children treated with GATTEX reduced parenteral support (PS) volume over time¶
At 6 months with GATTEX
More than half
69% (18/26)
reduced their weekly
volume of PS by 20% or
more
from baseline#
42% average
reduction
(-23/mL/kg/day) in daily
PS volume from baseline
Results are based on participant diary data.
Results are presented for the 0.05 mg/kg/day dosage, which is the recommended dosage of GATTEX.
Baseline average PS volume was 60 mL/kg/day.
Children spent less time on parenteral support (PS) with GATTEX
In a clinical study, GATTEX helped children achieve less time and fewer days on
parenteral support (PS) each week**
At 6 months with GATTEX
38% (10/26) achieved
at least 1 day off
or more off of PS††
3 fewer hours
on average,
of PS per day‡‡
** Results are presented for the 0.05 mg/kg/day dosage, which is the recommended dosage of GATTEX.
†† 7 days/week average baseline PS requirement for GATTEX 0.05 mg/kg/day dosage group.
‡‡ 11 hours/day average baseline PS requirement for GATTEX 0.05 mg/kg/day dosage group.
More information about the GATTEX clinical trials in children can be found on the Clinical Studies tab.
Freedom from parenteral support (PS) may be possible
Some children taking GATTEX achieved complete freedom from parenteral support (PS) after 6 months of treatment§§
12% of children
(3/26) no longer needed PS
Not all children will fully wean off of PS.
§§Results are presented for the 0.05 mg/kg/day dosage, which is the recommended dosage of GATTEX.
More information about the GATTEX clinical trials in children can be found on the Clinical Studies tab.
It may take time for GATTEX to work
The time it takes for a reduction in weekly PS volume can vary.
For the majority of children, GATTEX started to work within 6 months. For some children, it may
take longer,
or they may not respond at all.
Common Side Effects of GATTEX
In clinical studies of adults, the most common (≥10%) side effects were:
Stomach area (abdomen) pain or swelling
Vomiting
Nausea
Swelling of the hands or feet
Cold or flu symptoms
Allergic reactions
Skin reaction where the injection was given
The safety of GATTEX has been studied in 41 children with short bowel syndrome (SBS) across 2 clinical studies‡
The side effects seen in children and adolescents (aged 1 to 17 years) were similar to those seen in adults. Be sure to talk to your or your child’s doctor about any side effects that are bothersome or that do not go away.
This includes pediatric patients from an additional 3-month study that was conducted with GATTEX.
Gattex has been approved for use in children since 2019 And has been prescribed for adults with sbs since 2012
I knew GATTEX wasn't a cure,
but something that might help
reduce the volume and number
of days I was infusing PS.
Roy,
Gattex Patient
Roy,
Gattex Patient
Betsy,
Gattex Patient
I knew GATTEX wasn't a cure,
but something that might help
reduce the volume and number
of days I was infusing PS.
Roy,
Gattex Patient
Things to keep in mind during your or your loved one's
treatment journey
Track your or your child’s experiences and keep detailed notes that can be used in conversations with the doctor.
Check in with the doctor and talk openly about what you or your child are experiencing.
Take GATTEX as recommended by your or your child's doctor
Everyone with sbs is unique. Experiences with gattex will be, too.
Considering GATTEX?
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