Managing the Revestive Journey

Setting expectations and managing the patient experience

Managing expectations with patients is an important component of Revestive treatment.1-3

Educate patients about Revestive:

  • How it works
  • Results of clinical studies

Manage what patients can potentially expect from treatment2-4

  • Reduction in volume or the number of PN/IV days
  • Independence from PN/IV and potential timescale
  • Potential adverse reactions, for example fluid overload or increased absorption of concomitant medications

Emphasise the importance of persistency2,3

  • Results occur over time and may vary by patient
  • Bowel anatomy can impact time to response
    – In a post-hoc analysis of STEPS and STEPS-2 late responders more frequently had colon-in-continuity and a higher mean proportion of colon remaining (vs. early responders)5

Bowel anatomy may impact time to response§ to Revestive5

A post-hoc analysis|| of STEPS and STEPS-2 identified factors associated with early versus late response

3.6 months (1.1 SD)

Early responders to treatment (n=27)

  • / 51.9% had colon-in-continuity
  • / 24.6% of colon remaining
  • / 0% had ileocecal valve

10.0 months (6.1 SD)

Late responders to treatment (n=7)

  • / All patients had colon-in-continuity
  • / 57.1% of colon remaining
  • / 28.6% had ileocecal valve

A post-hoc analysis* of patients receiving Revestive (n=43) in the STEPS trial, a 24-week, placebo-controlled study of Revestive 0.05 mg/kg/day in patients with Short Bowel Syndrome, who could continue to receive Revestive for up to 24 months in the open-label extension trial STEPS-2, evaluating factors associated with sustained PN/IV volume reduction and early vs late response. PN/IV volume reduction was defined as 2 consecutive visits with PN/IV volume reduction ≥20%.

Kaplan-Meier analysis was conducted for time to sustained PN/IV volume reduction; Multivariable Cox proportional hazard model was used for predictors of sustained PN/IV volume reduction. Time to sustained PN/IV volume reduction was described for early and late responders. Patient characteristics were described and compared between early vs late responders using chi-square tests for categorical variables and Wilcoxon rank sum tests for continuous variables.

Explain the importance of monitoring during Revestive treatment1:

  • Treatment effect should be evaluated after 6 months of therapy
    – Limited data from clinical studies have shown that some patients may take longer to respond to treatment
  • If no overall improvement is achieved after 12 months, the need to continue treatment should be reconsidered
  • Continued treatment is recommended for patients who have weaned off parenteral nutrition/IV fluids

§ Early responders were defined as patients with PN/IV volume reduction ≥20% change from baseline at both Weeks 20 and 24 in STEPS. Late responders were defined as patients with sustained PN/IV volume reduction ≥20% change from baseline at any 2 consecutive visits during the
extension, or at both the Week 24 visit during STEPS and the Month 1 visit in STEPS-2 extension trial.

| | Please note that the presented predictors of response have been evaluated in separate post hoc analyses. The listed predictors of response denote probabilities and are not absolute predictors of response. Further randomised, controlled clinical trials are necessary to corroborate these findings.

*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.

PN/IV=parenteral nutrition/intravenous fluids; SBS-IF=short bowel syndrome – intestinal failure; SD=standard deviation


References

  1. Revestive (teduglutide) Summary of Product Characteristics. Shire Pharmaceuticals Ireland Limited, Dublin, Ireland. November 2017.
  2. Jeppesen PB, Pertkiewicz M, Messing B, et al. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gastroenterology. 2012;143:1473-1481.
  3. Schwartz LK, O’Keefe SJD, Fujioka K, et al. Long-term safety and efficacy of teduglutide for the treatment of intestinal failure associated with short bowel syndrome. Clin Transl Gastroenterol. 2016;7:e142.
  4. Kocoshis SA, Merritt RJ, Hill S, et al. Safety and Efficacy of Teduglutide in Pediatric patients With Intestinal Failure due to Short Bowel Syndrome: A 24-Week, Phase III Study. JPEN J Parenter Enteral Nutr. 2019. Epub ahead of print.
  5. Joly F, Gabe S, Seidner DL, et al. Oral presentation presented at: XV International Congress of the Intestinal Rehabilitation & Transplant Association. June 28-July 1, 2017; New York, NY
 
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