In the ASSERT trials, cholestatic pruritus was measured using the PRUCISION™ ObsRO scale1,2
- A validated 5-point scale from 0 (“No scratching”) to 4 (“Worst possible scratching”)
- Scratching scores were recorded twice daily by an observer
- All patients had medium to severe cholestatic pruritus at baseline (ObsRO score ≥2)
A reduction of ≥1 point is a meaningful score change in cholestatic pruritus1-3
Consider what even a small reduction in pruritus could mean for your patients with ALGS.
Primary endpoint: Change in cholestatic pruritus. Secondary endpoint: Change in serum bile acid levels.
ASSERT 2 is an ongoing open-label extension trial. Data shown are interim data.
Clinically meaningful reductions in cholestatic pruritus achieved by most patients with Bylvay4
At Week 124
More than
7 out of 10
patients experienced a ≥1-point improvement in pruritus
74% with Bylvay 120 mcg/kg/day (n=35)
vs 35% with placebo (n=17)*
*P=0.0038 vs placebo.
At Week 244
More than
8 out of 10
patients experienced a ≥1-point improvement in pruritus
80% with Bylvay 120 mcg/kg/day (n=35)
vs 35% with placebo (n=17)†
†P=0.0006 vs placebo.
90% of patients achieved a meaningful reduction in pruritus, defined as ≥1-point improvement at any time throughout the trial5
51% and 54% of patients had little or no scratching at weeks 12 and 24, respectively6
Bylvay reduced cholestatic pruritus early and over time1,6,7
Change in Scratching Score: ASSERT 1 Through ASSERT 2 Week 24
Change in Scratching Score: ASSERT 1 Through ASSERT 2 Week 24
Reductions in cholestatic pruritus were seen as early as week 4 and sustained through week 487,8
Primary endpoint: Change in cholestatic pruritus from baseline to month 6 (weeks 21-24).
ASSERT 2 is an ongoing open-label extension trial. Data shown are interim data.
Learn how Bylvay impacted sleep in patients with ALGS
ALGS=Alagille syndrome; ObsRO=observer-reported outcomes.
References:
- Bylvay Prescribing Information. Boston, MA: Albireo Pharma, Inc.; 2023.
- Gwaltney C, Ivanescu C, Karlsson L, Warholic N, Kjems L, Horn P. Validation of the PRUCISION instruments in pediatric patients with progressive familial intrahepatic cholestasis. Adv Ther. 2022;39:5105-5125.
- ClinicalTrials.gov. An open-label study to evaluate the long-term safety and efficacy of odevixibat (A4250) in patients with Alagille syndrome (ASSERT-EXT). NCT05035030. Updated October 18, 2022. Accessed April 24, 2023.
- Data on file A4250-012. November 10, 2022. Boston, MA: Albireo Pharma, Inc.
- Data on file A4250-012 2.7.3 Summary of Clinical Efficacy EMA. Boston, MA: Albireo Pharma, Inc.
- Data on file A4250-012 Pruritus Responders. Boston, MA: Albireo Pharma, Inc.
- Data on file A4250-012 Tables-Figures. Boston, MA: Albireo Pharma, Inc.
- Data on file A4250-015 Pruritus Change. Boston, MA: Albireo Pharma, Inc.