Improvements in cholestatic pruritus were seen as early as 2 weeks and continued throughout treatment with LIVMARLI.
IMPROVEMENTS IN
CHOLESTATIC PRURITUS (ITCH)
CHOLESTATIC PRURITUS (ITCH)
Results With
LIVMARLI
The goal of LIVMARLI is to provide fast and lasting relief from cholestatic pruritus for patients with progressive familial intrahepatic cholestasis (PFIC) who are 12 months of age and older.
LIVMARLI provides meaningful, long-lasting improvements in cholestatic pruritus for patients with PFIC.
Will LIVMARLI work right away?
What was the clinical study for LIVMARLI?
Patients with PFIC were treated with either LIVMARLI or placebo in a 6-month clinical study.
- Placebo looked and tasted like a “real” treatment, but did not have any active medicine
Patients in the study were split into multiple cohorts, or groups:
Only included patients with PFIC2
Included patients with PFIC2 as well as patients with PFIC1, PFIC3, PFIC4, or PFIC6
Other patients with less common or more variable forms of PFIC were also studied. Patients also had the option to continue taking LIVMARLI for up to 2 years as part of a long-term study.
How well does LIVMARLI work?
During the study, many patients taking LIVMARLI experienced significantly less itchiness.
During the first 6 months of treatment, patients taking LIVMARLI in the PFIC2 group saw significant improvements in cholestatic pruritus compared with those who took placebo.
During the 6-month clinical study, patients experienced improvements with LIVMARLI:
64%
Saw improvements in cholestatic pruritus
During the first 6 months of treatment with LIVMARLI, 64% of those in the All-PFIC group experienced noticeable improvements in cholestatic pruritus, vs 29% of those who received placebo.
62%
Had little or no cholestatic pruritus
In the first 6 months of treatment, 62% of patients treated with LIVMARLI had significantly more days with little to no cholestatic pruritus (had an Itch Reported Outcome [ItchRO] score of 0 or 1) compared with 28% of patients who received placebo.
50%
Saw improvements
in sBA levels
in sBA levels
Those taking LIVMARLI in the All-PFIC group also saw significantly greater improvements in serum bile acid (sBA) levels than those who took placebo.
50% of patients taking LIVMARLI had their sBA levels reduced by more than 75% or had their sBA decrease to below 102 µmol/L, compared with 7% of patients taking placebo.
LASTING RESULTS
Those who stayed on LIVMARLI in the long-term study saw relief from cholestatic pruritus through 2 years.
How did you monitor a patient’s cholestatic pruritus?
In the clinical study, patients kept an ongoing log of their cholestatic pruritus using the ItchRO tool. This tool was used to measure cholestatic pruritus severity over time based on a 5-point scale:
0
Not itchy at all
1
A little bit itchy
2
Somewhat itchy
3
Very itchy
4
Extremely itchy
What was considered to be an improvement in cholestatic pruritus?
3
Very itchy
2
A little bit itchy
Changes in ItchRO score by 1 point or more represent noticeable differences in cholestatic pruritus; for example, a change from 3 to 2 means that a patient went from feeling very itchy to feeling somewhat itchy.
Lower Costs Within Reach
Mirum Access Plus works closely with your doctor and insurance plan to help facilitate coverage for LIVMARLI.
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