Managing expectations with patients is an important component of Revestive treatment.1-3
A post-hoc analysis|| of STEPS and STEPS-2 identified factors associated with early versus late response
Early responders to treatment (n=27)
Late responders to treatment (n=7)
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.
§ 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
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