Revestive delivered reductions in parenteral nutrition/IV fluids
with some patients achieving complete freedom from parenteral
Adults with short bowel syndrome-intestinal failure
Revestive has been studied in two, 24 week, phase III trials in adults.1
In STEPS/STEP-2, in adults with Short Bowel Syndrome-IF Revestive delivered sustained reductions in parenteral nutrition/IV fluids2,3
A randomised, double-blind, placebo-controlled Phase III trial including 86 adult patients with short bowel syndrome-intestinal failure (SBS-IF), who were dependent on parenteral nutrition/IV fluids (PN/IV) for at least 12 months prior to start of the study.
The primary efficacy endpoint was the proportion of patients who achieved a ≥20% reduction from baseline in weekly PN/IV volume at both Week 20 and Week 24
Secondary endpoints included the proportion and absolute change in PN/IV and the number of patients who stopped PN/IV and their time of discontinuation
Exploratory endpoints included reduction in days on PN/IV
A 2-year, open-label, multicentre extension study of STEPS. The primary objective was to study long-term safety and efficacy of Revestive.
Safety variables included adverse events, laboratory data, vital signs, body weight, and colonoscopy
Efficacy endpoints included the proportion of patients achieving a response (≥20% reduction from baseline weekly PN/IV), duration of response, reduction in days of PN/IV per week, and number of patients who achieved independence from PN/IV
WITH LONGER TERM TREATMENT, REVESTIVE GAVE PATIENTS FREEDOM FROM PARENTERAL NUTRITION/IV FLUIDS (PN/IV )**3
In a post-hoc analysis of completers, in patients completing 30 months of treatment***3
33% (10/30) achieved complete independence from PN/IV
60% (18/30) of Revestive treated patients achieved at least 3 day each week off PN/IV
70% (21/30) of Revestive treated patients achieved at least 1 day each week off PN/IV
Days off PN/IV may allow adult patients more independence and freedom7-9
Children with short bowel syndrome-intestinal failure
IN A 24-WEEK STUDY IN CHILDREN WITH SBS-IF, REVESTIVE DELIVERED REDUCTIONS IN PARENTERAL NUTRITION/IV FLUIDS6
A 24-week Phase III trial in children aged 1–17 years-old, who were dependent on PN/IV for at least 3 months, including 50 patients treated with Revestive (n=26 at the approved dose 0.05 mg/kg/day) and 9 who were treated with standard of care.
The primary efficacy endpoint was the proportion of patients who achieved a ≥20% reduction from baseline in weekly PN/IV volume at Week 24
Secondary endpoints included the change in PN/IV and the number of patients who stopped PN/IV at Week 24
As early as Week 24, 3/26 children treated with Revestive were independent from PN/IV‡6 – vs. 0 with standard of care
IN AN ADDITIONAL 12-WEEK PHASE III STUDY IN CHILDREN WITH SBS-IF, REVESTIVE DELIVERED REDUCTIONS IN PARENTERAL NUTRITION/IV FLUIDS1
At 12 weeks, with Revestive (0.05 mg/kg/day, n=15).1
Reduced PN/IV volume by 39% vs. baseline – vs. 7% increase with standard of care
Reduced the mean number of days/week on PN/IV by 1.36 days – vs. no change with standard of care
Gave patients an additional 4.18 hours per day free of PN/IV – vs. no change with standard of care
Gave complete freedom from PN/IV to 3/15 patients
The primary efficacy endpoint was based on clinical response, defined as subject achieving at least 20% reduction in weekly PN/IV volume from baseline (immediately before randomisation) at both weeks 20 and 24. Please note that in the Revestive clinical trials, the mean absolute reduction of PN/IV volume from baseline was significantly higher in the teduglutide group vs placebo at 8 weeks following initiation of treatment. However, individual response may vary as it depends on distinct patient characteristics (eg, remnant bowel anatomy).
** Post-hoc analysis of study completers. Please note that efficacy in this study was based on the intent-to-treat population. Further randomised, controlled clinical trials are necessary to corroborate these findings.
*** Of the 37 Revestive subjects in STEPS, 30 completed 24 months of further treatment with Revestive in STEPS-2 (the Revestive/Revestive group). Of the 39 placebo subjects in STEPS, 29 completed 24 months of treatment with Revestive. At the end of study, 14 (48.3%), 7 (24.1%), and 5 (17.2%) patients achieved a reduction of 1, 2 or 3 days per week in PN/IV, respectively. Two subjects were weaned off their PN/IV while on Revestive. Of the 12 subjects not randomised in the pivotal study, 6 completed 24 months of treatment with Revestive. At the end of study, 3 (50%), 2 (33%), and 2 (33%) achieved a reduction of 1, 2, or 3 days per week in PN/IV, respectively. Two subjects were weaned off their PN/IV while on Revestive.
† All patients were unable to reduce their PN/IV dependence for at least 3 months prior to study entry; weight normalised reduction.
‡ Patients treated with Revestive 0.05 mg/kg/day.
§ All patients were unable to reduce their dependence on PN/IV for at least 3 months prior to the study. Standard deviation for Revestive: -1.3±2. 6.6 days/week baseline PN/IV requirement for Revestive study population, 6.6 days/week baseline PN/IV requirement for SOC study population.
§§ All patients were unable to reduce their dependence on PN/IV for at least 3 months prior to the study. Standard deviation for Revestive: -41.6±28.90; SOC: -10.2±13.59.
Revestive (teduglutide) Summary of Product Characteristics. Shire Pharmaceuticals Ireland Limited, Dublin, Ireland. November 2017.
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