CLINICALLY PROVEN RESULTS IN ADULTS
MARRIKA
Treating her SBS with GATTEX
For people 1 year of age and older with SHORT BOWEL SYNDROME (SBS) who are dependent on parenteral support (PS).
For adults with SBS, GATTEX may reduce the need for parenteral support (PS)
How effective is GATTEX?
GATTEX was evaluated in 2 trials, STEPS (Study 1) and STEPS-2 (Study 2).
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STEPS: In this 6-month study of 86 adults (aged 18 and over) with SBS who needed PS, 43 received GATTEX and 43 received placebo. The study's main goal was to evaluate the ability of GATTEX to reduce patients' weekly PS volume by at least 20% from baseline to both weeks 20 and 24. The study also evaluated the average reduction of weekly PS volume from baseline, the number of people who reduced PS administration by at least 1 day per week, and safety.
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STEPS-2: In this 24-month study of 88 adults (aged 18 and over) with SBS who needed PS, 76 had participated in STEPS (Study 1). The study's main goal was to evaluate the average reduction of weekly PS volume since the beginning of the study. The study also looked at the percentage of people who achieved at least a 20% reduction in weekly PS volume, the number of people who reduced their PS administration by at least 3 days per week, the number of people who completely stopped PS, and safety.
GATTEX was clinically proven to reduce volume of and time on PS;
for some adults, GATTEX resulted in complete freedom from PS.
Most adults achieved less volume of PS with GATTEX
of adults reduced their PS volume
by 20% or more
of adults reduced their PS volume by 20% or more
Most adults achieved more time off PS with GATTEX
of adults achieved
1 or more days off PS per week
of adults achieved
3 or more days off PS per week
After starting GATTEX, I was able to reduce my PS volume and time from 7 days to 5 days. This time off PS gave me freedom to do more activities with my family.”
Treating her SBS with GATTEX
Individual results may vary.
Freedom from PS may be possible
At 30 months with GATTEX
10 out of 30 people
no longer needed PS*
Achieving complete freedom from parenteral support (PS) took 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.
Over time with GATTEX, my doctors started slowly reducing my weekly PS volume. A year later, my PS had been stopped altogether.”
Treating her SBS with GATTEX
Individual results may vary.
How long does it take to see results while taking GATTEX?
The time it takes to reduce weekly PS volume can vary. In adult clinical studies, some people experienced improved results the longer they stayed on GATTEX.
How long it took to reduce weekly PS volume by at least 20%:
~1 month
Some adults were able to reduce their weekly PS volume after about 1 month of treatment with GATTEX
≥12 months
Others being treated with GATTEX took 12 months or longer. Some people did not respond at all.
43 patients in STEPS study received GATTEX.
~1 month
Some adults were able to reduce their weekly PS volume after about 1 month of treatment with GATTEX
≥12 months
Others being treated with GATTEX took 12 months or longer. Some people did not respond at all.
43 patients in STEPS study received GATTEX.
How long it took to achieve freedom from PS:
~7 months
Some people were able to fully wean off of PS after 7 months of treatment with GATTEX
~30 months
Some people needed up to 30 months of treatment with GATTEX to fully wean off of PS.
88 people in STEPS-2 study received GATTEX, including 30 who received GATTEX for 30 months. Not everyone who takes GATTEX will fully wean off of PS. No one receiving GATTEX during the 6-month STEPS study achieved PS independence.
~7 months
Some people were able to fully wean off of PS after 7 months of treatment with GATTEX
~30 months
Some people needed up to 30 months of treatment with GATTEX to fully wean off of PS.
88 people in STEPS-2 study received GATTEX, including 30 who received GATTEX for 30 months. Not everyone who takes GATTEX will fully wean off of PS. No one receiving GATTEX during the 6-month STEPS study achieved PS independence.
After starting treatment with GATTEX, I was able to eventually wean completely off PS.† I like having my freedom from PS.”
Treating her SBS with GATTEX
Individual results may vary.
†In a 6-month study, 27 out of 43 adults treated with GATTEX reduced weekly PS volume by 20% or more versus 13 out of 43 on placebo. In a 24-month extension study, 10 out of 30 adults previously on GATTEX no longer needed PS after 30 months of treatment.
GATTEX was evaluated in 2 clinical trials
In the 6-month STEPS study
- 86 adults with SBS were studied
- Adults with SBS needed PS at least 3 times a week for at least a year
- Of the 86 participants, 43 received GATTEX and 43 received placebo once a day
In the 24-month STEPS-2 study
- 88 adults with SBS were studied
- 76 adults had participated in STEPS (37 received GATTEX, 39 received placebo) and were enrolled in STEPS-2 after STEPS ended
- 12 of the 88 adults had not participated in STEPS and had never been treated with GATTEX before
- In STEPS-2, all participants were treated with GATTEX once a day and were told that they were being treated with GATTEX
GATTEX was studied in a range of adults
Characteristics of participants 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 |
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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, and some did not.
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The most common reasons for intestinal resection included vascular disease, Crohn’s disease, or “other.”
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