Patients who had ≥1-point ObsRO reduction (n=20)1†‡
76%
fewer days
needing help falling asleep
75%
fewer days
needing soothing from a caregiver
55%
fewer days
needing to sleep with a caregiver
37%
fewer days
of scratching with bleeding
*Limitations: Data are from a post hoc analysis from a secondary endpoint that was not adjusted for multiplicity. PEDFIC 2 is ongoing. Therefore, results should be interpreted with caution.1
†Mean improvements from baseline to weeks 61-72 were significant in the percentages of days seeing blood due to scratching, needing help falling asleep, needing soothing, and sleeping with caregivers (all P<0.001).1
‡Additional PEDFIC 2 sleep-related parameters in this post hoc analysis were number of awakenings, days needing to take medications to induce sleep, and daytime tiredness.2
†Mean improvements from baseline to weeks 61-72 were
significant in the percentages of days seeing blood due
to scratching, needing help falling asleep, needing
soothing, and sleeping with caregivers (all P<0.001).1
‡Additional PEDFIC 2 sleep-related parameters in this
post hoc analysis were number of awakenings, days
needing to take medications to induce sleep, and
daytime tiredness.2
Reported data. Using the PRUCISIONTM scale daily, caregivers answered yes or no to 4 questions about the effects that itch had on their child’s sleep and sleep-related parameters.1
Serum bile acid reductions were also seen in patients treated with Bylvay3
ObsRO=observer-reported outcome; PFIC=progressive familial intrahepatic cholestasis; sBA=serum bile acid.
References:
- Gupte G, Thompson RJ, D’Antiga L, et al. Analysis of quality of life, hepatic biochemical markers, and sleep in patients with progressive familial intrahepatic cholestasis who had a pruritus response with odevixibat treatment. Presented at: EASL International Liver Congress 2022; June 22-26, 2022; London, UK.
- Data on file A4250-005. Boston, MA: Albireo Pharma, Inc.
- Data on file PEDFIC 1 and 2 Figure Pru and sBA. 2022. Boston, MA: Albireo Pharma, Inc.
- Gupte G, Thompson RJ, D’Antiga L, et al. Analysis of
quality of life, hepatic biochemical markers, and
sleep in patients with progressive familial
intrahepatic cholestasis who had a pruritus response
with odevixibat treatment. Presented at: EASL
International Liver Congress 2022; June 22-26, 2022;
London, UK. - Data on file A4250-005. Boston, MA: Albireo Pharma, Inc.
- Data on file PEDFIC 1 and 2 Figure Pru and sBA. 2022. Boston, MA: Albireo Pharma, Inc.