GATTEX may mean less weekly PS volume in your SBS patients’ lives1

Mean Range
50 years Age 18 to 82 years
77.3 cm Estimated small bowel length 5 to 343 cm
6 years Length of time on PS 1 to 26 years
5.73 days Prescribed days per week on PS 3 to 7 days
13 L/week Infusion volume 0.9 to 35 L/week

Study patients had varying types of bowel resection1,2:

  • 44% of patients did not have a colon-in-continuity (37/85)
    • In these patients, an average of 37% of the colon had been removed
  • 54% of patients with an intact distal/terminal ileum had an ileocecal valve (13/24)
  • Stoma was present in 45% (38/85) of patients (most commonly jejunostomy/​ileostomy)

Most common reasons for intestinal resection1:

  • Vascular disease: 34% (29/85)
  • Crohn’s disease: 21% (18/85)
  • Other: 21% (18/85)

GATTEX significantly reduced weekly PS volume (STEPS)1

Steps

STEPS was a 6-month, randomized, double-blind, placebo-controlled, multicenter clinical trial of adult patients with Short Bowel Syndrome dependent on PS ≥3 times/week for ≥12 months.1

The primary endpoint was based on a clinical response, defined as a subject achieving at least 20% reduction in weekly PS volume from baseline (immediately before randomization) to both Weeks 20 and 24.1

In STEPS, efficacy analysis was calculated as compared to the intent-to-treat population in the treatment group and placebo group, respectively. PS volume adjustments (up to 30% decrease) and clinical assessments were made at 2, 4, 8, 12, 20, and 24 weeks.1

Image of 63% (n=43) (P=0.002) graphic

of GATTEX-treated patients achieved at least a 20% reduction from baseline in weekly PS volume vs 30% with placebo (n=43) at 6 months1


Long-term response to GATTEX (STEPS-2)1

Steps-2

STEPS-2 was a 24-month, open-label extension study. 97% (76/78) of patients who completed STEPS elected to enroll in STEPS-2 (n=37, GATTEX; n=39, placebo). All patients (N=88), including 12 who were never in STEPS, received GATTEX in STEPS-2.1

Clinical response was defined as a ≥20% reduction in weekly PS volume from baseline.4

Efficacy analysis was calculated in patients who completed 24 months of GATTEX treatment in the placebo/GATTEX group, and 30 months of GATTEX treatment in the GATTEX/GATTEX group.4

Of the 88 patients enrolled in STEPS-2, 65 (74%) completed the study (n=30/37) GATTEX/GATTEX; (n=29/39) placebo/GATTEX; (n=6/12) not treated/GATTEX.4

In patients completing 30 months of treatment with GATTEX:

Image of 93% (n=30) graphic

of GATTEX/GATTEX-treated patients achieved at least a 20% reduction in weekly PS volume from baseline at 30 months1

Of the 37 GATTEX patients from STEPS who entered STEPS-2, 30 of them completed a total duration of 30 months (STEPS followed by STEPS-2).

Image of 55% (n=29) graphic

of placebo/GATTEX-treated patients achieved at least a 20% reduction in weekly PS volume from baseline at 24 months1

Of the 39 placebo patients who entered STEPS-2, 29 completed 24 months of treatment with GATTEX.


GATTEX may give patients daily freedom from PS1,3

Selected exploratory endpoint

In patients completing 6 months of treatment (STEPS):

Image of 54% (n=39) graphic

of GATTEX-treated patients achieved at least a 1-day reduction in PS per week vs 23% with placebo (n=39) at 6 months1,3

After randomization of the intent-to-treat population (N=86), 4 patients in the GATTEX arm and 4 patients in the placebo arm discontinued treatment, leaving 78 evaluable patients in the 6-month study.

GATTEX may give patients complete freedom from PS1,4

The timing of the complete wean ranged from 7 months to 30 months (mean ~20 months).5 In patients completing 30 months of treatment with GATTEX (STEPS-2):

Image of  33% (10/30) graphic

achieved complete independence from PS1,4

Image of 60% (18/30) graphic

achieved 3 or more days/week off PS1

Image of 70% (21/30) graphic

achieved 1 or more day(s)/week off PS1

Characteristics associated with patients who achieved complete independence in STEPS-25

Of the 33% (10/30) of patients who achieved complete independence from PS while on GATTEX treatment for 30 months4,5:

Image of 3 of 10 patients graphic
  • Had SBS due to inflammatory bowel disease
  • Did not have colon-in-continuity
Image of 7 of 10 patients graphic
  • Had SBS due to vascular and other causes
  • Had colon-in-continuity

No patients were completely independent of the need for PS at 6 months in STEPS.5

During the trial, patients were maintained on GATTEX after weaning off PS. Prior to GATTEX, these 10 patients required PS for 1.2 to 15.5 years and required 3.5 to 13.4 L/week of PS.1

Days off PS may allow patients more freedom for pastimes, sleep and rest, work, or social interaction.6,7

GATTEX safety profile in clinical studies1

Adverse reactions in ≥5% of GATTEX-treated short bowel syndrome patients and more frequent than placebo in Studies 1 and 31

  • If patients have a stoma, advise them that while they may experience abdominal pain and swelling of their stoma, especially when starting therapy with GATTEX, if they experience symptoms of intestinal obstruction, they should contact their physician
  • Many of these adverse reactions have been reported in association with the underlying disease and/or parenteral nutrition
Most common adverse reactions GATTEX 0.05 mg/kg/day
once daily
(N=77)
(%)
Placebo (N=59)
(%)
Abdominal pain1 30 22
Nausea 23 20
Upper respiratory tract infection2 21 12
Abdominal distension 20 2
Injection site reaction3 13 12
Vomiting 12 10
Fluid overload4 12 7
Hypersensitivity5 10 7
Flatulence 9 7
Decreased appetite 7 3
Influenza6 7 2
Skin hemorrhage7 5 2
Cough 5 0
Sleep disturbances8 5 0

* Reported at a rate of at least 5% in the GATTEX group, and greater than the placebo group.

1 Includes: Abdominal pain, upper abdominal pain, lower abdominal pain

2 Includes: Upper respiratory tract infection, nasopharyngitis, pharyngitis, sinusitis, laryngitis, rhinitis, viral upper respiratory tract infection

3 Includes: Injection site hematoma, injection site erythema, injection site pain, injection site swelling injection site hemorrhage, injection site discoloration, injection site reaction, injection site rash

4 Includes: Fluid overload, peripheral edema, edema, generalized edema, fluid retention and jugular vein distension

5 Includes: Erythema, rash, dermatitis allergic, pruritus, rash macular, drug eruption, eyelid edema, flushing

6 Includes: Influenza, influenza-like illness

7 Includes: Hematoma, abdominal wall hematoma, post procedural hematoma, umbilical hematoma, blood blister

8 Includes: Insomnia (3 patients) and hypersomnia (1 patient)

Among the 53 patients with a stoma in the placebo-controlled studies (Study 1 and Study 3), the percentage of patients with gastrointestinal stoma complication was 42% (13/31) for patients receiving GATTEX 0.05 mg/kg/day and 14% (3/22) for patients receiving placebo.

Image of actor portrayal of GATTEX patient

Not actual patient

How long may it take for patients to respond to GATTEX?

Time to Response

Indication:
GATTEX® (teduglutide) for injection is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

Important Safety Information:

Warnings and Precautions:
GATTEX has been associated with possible acceleration of neoplastic growth, intestinal obstruction, biliary and pancreatic disease, fluid imbalance and fluid overload, and increased absorption of concomitant oral medication. Click here for additional Important Safety Information.

Click here for additional Important Safety Information.

Indication

GATTEX® (teduglutide) for injection is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

Important Safety Information

Warnings and Precautions

Acceleration of neoplastic growth

Colorectal polyps were identified during clinical trials. There is a risk for acceleration of neoplastic growth. Within 6 months prior to starting treatment with GATTEX, colonoscopy (or alternate imaging) of the entire colon with removal of polyps should be performed and follow-up colonoscopy (or alternate imaging) is recommended at the end of 1 year of GATTEX. Subsequent colonoscopies should be performed every 5 years or more often as needed. In case of intestinal malignancy (GI tract, hepatobiliary, pancreatic), discontinue GATTEX. The clinical decision to continue GATTEX in patients with non-gastrointestinal malignancy should be made based on benefit-risk considerations.

Intestinal obstruction

Intestinal obstruction has been reported in clinical trials and postmarketing. In patients who develop intestinal or stomal obstruction, GATTEX should be temporarily discontinued pending further clinical evaluation and management.

Biliary and pancreatic disease

Cholecystitis, cholangitis, cholelithiasis, and pancreatitis have been reported in clinical trials and postmarketing. Laboratory assessment (bilirubin, alkaline phosphatase, lipase, amylase) should be obtained within 6 months prior to starting GATTEX. Subsequent laboratory tests should be done every 6 months or more often as needed. If clinically meaningful changes are seen, further evaluation is recommended including imaging, and continued treatment with GATTEX should be reassessed.

Fluid imbalance and fluid overload

Fluid overload and congestive heart failure have been observed in clinical trials. If fluid overload occurs, especially in patients with underlying cardiovascular disease, parenteral support should be adjusted and GATTEX treatment reassessed. If significant cardiac deterioration develops while on GATTEX, continued GATTEX treatment should be reassessed.

Discontinuation of treatment with GATTEX may also result in fluid and electrolyte imbalance. Fluid and electrolyte status should be monitored in patients who discontinue treatment with GATTEX.

Increased absorption of concomitant oral medication

In clinical trials, one patient receiving prazepam concomitantly with GATTEX experienced dramatic deterioration in mental status progressing to coma during first week of GATTEX therapy. Patients receiving concomitant oral drugs requiring titration or with a narrow therapeutic index should be monitored for adverse reactions due to potential increased absorption of the concomitant drug. The concomitant drug may require a reduction in dosage.

Adverse Reactions

The most common adverse reactions (≥10%) with GATTEX are abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity.

Use in Specific Populations

Breastfeeding is not recommended during treatment with GATTEX.

Please click here for full Prescribing Information.

References:
  1. GATTEX (teduglutide) for injection [package insert]. Lexington, MA: Shire-NPS Pharmaceuticals, Inc; 2018.
  2. Thampi S. Clinical study report CL0600-020: Teduglutide (rDNA origin). NPS Pharmaceuticals, Inc; July 12,2011.
  3. Jeppesen PB, Pertklewicz M, Messing B, et al. Gastroenterology. 2012;143(6):1473-1481.
  4. Schwartz LK, O’Keefe SJD, Fujioka K, Gabe SM, et al. Clin Transl Gastroenterol. 2016;7 e142. doi:10.1038/ctg.2015.69.
  5. Data on file. Shire Pharmaceuticals, Inc.
  6. Hofstetter S, Stern L, Willet J. Curr Med Res Opin. 2013;29(5):495-504.
  7. Vipperla K, O'Keefe SJ. Expert Rev Gastroenterol Hepatol. 2011;5(6):665-678.