Itch
Itch was measured using 3 questionnaires
IQIRVO was studied in people with primary biliary cholangitis (PBC) who had moderate-to-severe levels of itch.a Three different questionnaires were used to understand the impact of itch in people taking IQIRVO. The results of these questionnaires were observed after one year and are described below.
Though the impact of IQIRVO on itch was explored in this study, it is unclear if IQIRVO caused the results, or if they just happened by chance. Data should be reviewed with caution. If you have questions about this limitation, your doctor can help explain it further.
WI-NRS
The WI-NRS measures how people rate their worst itch experience over a specific period.
PBC-40 (itch domain)
The PBC-40 is the only test validated for PBC-specific measurements. One section of the test focuses on itch and its impact on people with PBC.
5-D itch
People were asked to rate their experience based on degree, duration, direction, disability, and distribution of itchiness using the 5-D itch scale.
WI-NRS
People taking IQIRVO reported an average reduction of
1.93 points
in the WI-NRS score, compared to people taking ursodiolb alone (average reduction of 1.15 points).
PBC-40 itch
People taking IQIRVO reported an average reduction of
2.5 points
in the PBC-40 itch score, compared to people taking ursodiolb alone (average reduction of 0.1 points).
5-D itch
People taking IQIRVO reported an average reduction of
4.2 points
in the 5-D itch total score, compared to people taking ursodiolb alone (average reduction of 1.2 points).
aModerate-to-severe levels of itch were defined as a Worst Itch Numeric Rating Scale (WI-NRS) score of at least 4 on a scale from 1-10.
bUrsodeoxycholic acid, or ursodiol, may also be referred to as UDCA.
People scored their itchiness by responding to questions and rating situations like:
- Itching disturbed my sleep
- I scratched so much I made my skin raw
- Please rate the intensity of your itching over the past 2 weeks
- Over the past 2 weeks has your itching gotten better or worse compared to the previous month?
Fatigue
Moderate-to-severe fatigue was measured using
2 questionnaires
Fatigue was measured in people at the beginning of the trial and then evaluated again 1 year later using 2 questionnaires. The information below focuses on people who had moderate-to-severe fatigue when the study began.c
Though the impact of IQIRVO on fatigue was explored in this study, it is unclear if IQIRVO caused the results, or if they just happened by chance. Data should be reviewed with caution. If you have questions about this limitation, your doctor can help explain it further.
PROMIS fatigue
PROMIS fatigue is a questionnaire that asks about the frequency of exhaustion and how fatigue limits daily activities.
PBC-40 (fatigue domain)
The PBC-40 is the only test validated for PBC-specific measurements. One section of the test focuses on fatigue and its impact on daily functioning.
PROMIS fatigue
After 1 year, the impact of moderate-to-severe fatigue on people with PBC was measured in people taking IQIRVO (42 people) and those taking ursodiol alone (16 people) using the PROMIS fatigue questionnaire.
67% of people treated with IQIRVO reported a reduction of 3 or more points on the PROMIS questionnaire
compared to 31% of peoplewho took ursodiold alone.
People with moderate-to-severe fatigue reported an average reduction of
6.5 points
in their PROMIS fatigue score, compared to 2.6 points with ursodiold alone.
PBC-40 fatigue
After 1 year, the impact of moderate-to-severe fatigue on people with PBC was measured in people taking IQIRVO (53 people) and those taking ursodiol alone (26 people) using the PBC-40 fatigue questionnaire.
40% of people treated with IQIRVO reported a reduction of 5 or more points on the PBC-40 questionnaire
compared to 27% of people who took ursodiold alone.
People with moderate-to-severe fatigue reported an average reduction of
3.6 points
in their PBC-40 (fatigue domain) score, compared to 2.1 points with ursodiold alone.
cModerate-to-severe fatigue was defined as a PROMIS fatigue total score of 60 or more or PBC-40 fatigue domain total score of 29 or more at baseline.
dUrsodeoxycholic acid, or ursodiol, may also be referred to as UDCA.
People scored their fatigue by responding to questions and rating situations like:
- How often do you feel tired?
- How often are you too tired to take a bath or shower?
- Fatigue interfered with my daily routine
- I felt so tired, I had to force myself to do things I needed to do
- PBC drained every ounce of energy out of me
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