CLINICALLY PROVEN RESULTS IN
CHILDREN 1 YEAR AND OLDER
REID AND HIS MOM, JODI
Treating her son's SBS with GATTEX
For people 1 year of age and older with SHORT BOWEL SYNDROME (SBS) who are dependent on parenteral support (PS).
For children with SBS, GATTEX may reduce parenteral support (PS)
How effective is GATTEX in children?
GATTEX was evaluated in a clinical trial
-
In a 6-month study of 59 children (ages 1-17) with SBS who needed PS, the main goal was to determine the ability of GATTEX to reduce weekly PS volume by at least 20% from baseline to week 24. The study also evaluated the average reduction of weekly PS volume from baseline, number of people who reduced PS administration by at least 1 day per week, the average change in hours dedicated to daily PS administration, the number of people who completely stopped PS, and safety.
GATTEX was clinically proven to reduce volume of and time on PS; for some children, GATTEX resulted in complete freedom from PS.
Most children achieved less volume of PS with GATTEX*
of children reduced their weekly PS volume by 20% or more 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.
These kids are amazing and so resilient. We may have to do things a little differently than others, but we figure it out.”
Treating her son Reid's SBS with GATTEX
Individual results may vary.
GATTEX helped children achieve more time off PS‡
of children achieved at least
1 or more days off PS per week§
‡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.
Freedom from PS may be possible
Some children were able to wean off parenteral support (PS) after 6 months of treatment with GATTEX.¶
At 6 months with GATTEX
12% of children (3/26)
no longer needed PS and were able to wean off completely
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.
By her second birthday, GATTEX was a part of Penelope’s daily regimen. Over time, we gradually reduced her weekly PS volume.”
Treating her daughter Penelope's SBS with GATTEX
Individual results may vary.
When can you and your child expect to see results?
It may take time for GATTEX to work.
For the majority of children, GATTEX started to work at 6 months. It may take longer for some children, or they may not respond at all. It’s important to keep in mind that the time it takes for a reduction in weekly PS volume can vary from child to child.
GATTEX was evaluated in a 6-month pediatric clinical study
In a 6-month study, 59 children aged 1 through 17 chose whether to receive GATTEX or standard of care (SOC).**
- 50 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)
- The remaining 9 children received SOC
- Randomization to the GATTEX groups was stratified by age
- Prior to the study all the children were dependent on PS
The goal of the trial: 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.
Characteristics of children in the beginning of the study
| 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 |
Read more about how GATTEX may help children with SBS
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