Decrease in disruptive sleep parameters at week 24 in patients taking Bylvay vs placebo (n=35, n=17)1*
47%
fewer days
needing soothing from a caregiver
43%
fewer days
needing help falling asleep
35%
fewer days
needing to sleep with a caregiver
>1-point reduction in tiredness score from baseline at week 24 for Bylvay (-1.13) vs placebo (0.53)†
Additional sleep parameters were number of awakenings, as well as days seeing blood due to scratching and days needing to take medication to induce sleep, which were not statistically significant.
Reported data. Using the PRUCISION™ scale daily, caregivers answered yes or no to 7 questions about the effects that itch had on their child’s sleep and sleep-related parameters.
*Mean improvements from baseline to weeks 21-24 were significant vs placebo in the percentages of days needing soothing from a caregiver (P<0.0001), needing help falling asleep (P=0.0016), needing to sleep with a caregiver (P=0.0017).
†Tiredness score measured on a 5-point scale from 0=Not tired at all; 1=A little tired; 2=Medium tired; 3=Very tired; 4=Very, very tired (P=0.0062).
Consistent improvements in pruritus and sleep as observed by caregivers1
Improvements in Sleep as Early as Week 4 Were Consistent Over Time
In the open-label extension study, improvements in CaGIC were observed in patients at week 48, including those patients who switched from placebo to Bylvay starting at week 242
- Caregivers evaluated changes in global symptom relief (scratching/itching and sleep) from baseline at weeks 4, 12, 24, 48, and 72 using the GIC scale1,2
- Symptoms were assessed using a 7-point scale of “very much better” to “very much worse.” Patients with improvement were those assessed as “very much better,” “much better,” and “a little better”
Reducing sBA is possible in your ALGS patients
ALGS=Alagille syndrome; CaGIC=Caregiver Global Impression of Change; GIC=Global Impression of Change; sBA=serum bile acid.
References:
- Data on file A4250-012. November 10, 2022. Boston, MA: Albireo Pharma, Inc.
- Data on file A4250-015. November 11, 2022. Boston, MA: Albireo Pharma, Inc.