IQIRVO ELATIVE trial
Efficacy
Adapted from Kowdley et al. 2024.
Biochemical response was analysed across patient subgroups3
The biochemical response of IQIRVO + UDCA was observed across subgroups irrespective of age, pruritus symptoms, ALP level and advanced disease stage*†3
Adapted from Kowdley et al. 2024.
SECONDARY ENDPOINT:
ALP reduction¶1,2
ALP reduction from baseline in just 4 weeks –sustained through to 52 weeks†1,2
Adapted from Kowdley et al. 2024.
SECONDARY ENDPOINT:
ALP normalisation¶1,2
ALP normalisation was achieved with 15% of patients treated with IQIRVO + UDCA vs Placebo + UDCA†1,2
Mean reduction to achieve ALP normalisation with IQIRVO + UDCA was 218 U/L1,2
Adapted from Kowdley et al. 2024.
Mean baseline ALP: 322 U/L1,2
ULN definition: 104 U/L for women 154/161 (96%)# participants1
IQIRVO: Impact of pruritus on patients’ quality of life¶1,2
IQRIVO + UDCA demonstrated an observed mean change in pruritus from baseline through Week 52 and Week 24 as measured by PBC WI-NRS in those with moderate-to-severe pruritus at baseline when compared to placebo + UDCA (this result was non-significant)†**1,2
Adapted from Kowdley et al. 2024.
IQIRVO + UDCA reduced the impact of pruritus on QoL vs placebo + UDCA as measured by the PBC-40 itch domain and 5-D itch scale†**1,2
The PBC-40 is a patient-derived, disease specific QoL measure developed and validated for use in PBC4
The 5-D Itch scale is a measure of itching that has been validated in patients with chronic pruritus5
Adapted from Kowdley et al. 2024.
BASELINE ALP SUBGROUP ANALYSIS
Biochemical response was achieved in 71% of patients with ALP ≤3 x ULN and 21% of patients with ALP >3x ULN at baseline*6
Adapted from Ipsen Data on File
Footnotes
*Biochemical response is defined in the trial as ALP <1.67 x ULN, and ALP decrease ≥15% and TB ≤ULN at 52 weeks.1
†Patients either received IQIRVO on a background of UDCA (102/108, 94%) or received UDCA plus a placebo (51/53, 96%).1
‡Defined as liver stiffness at baseline >10.0 kPa and/or bridging fibrosis or cirrhosis on histology.3
§Risk difference corresponds to difference (%) in response (IQIRVO + UDCA vs placebo + UDCA). If the subgroup at baseline included fewer than 20 patients across treatment groups or fewer than 5 patients for a treatment group, the subgroup was omitted.3
¶Key secondary endpoints (normalisation of ALP at Week 52, and the change from baseline in the WI-NRS score through Week 52 and through Week 24) were assessed with the use of a pre-specified fixed sequence testing approach, at a two-sided alpha of 0.05, until a non-significant result was encountered. Other secondary endpoints are reported as point estimates and 95% confidence intervals, which were not adjusted for multiple testing.1
#Percent of the study population.1
**In patients with moderate-to-severe pruritus (defined as PBC WI-NRS Score ≥4).1
Abbreviations
ALP, alkaline phosphatase; CI, confidence interval; kPa, kilopascals; LLN, lower limit of normal; mg, milligram; PBC WI-NRS, primary biliary cholangitis worst itch numeric rating scale; QoL, quality of life; TB, total bilirubin; UDCA, ursodeoxycholic acid; ULN, upper limit of normal; U/L, units per litre.
References
- Kowdley KV et al. N Engl J Med. 2024;390(9):795–805.
- IQIRVO® (elafibranor) Summary of product characteristics (SmPC). 2024.
- Kowdley KV et al. Supplement to: N Engl J Med. 2024;390(9):795–805.
- Jacoby A et al. Gut. 2005;54(11):1622–1629.
- Elmen S et al. Br J Dermatol 2010;162:587–59.
- Ipsen Data on File ELA-ALL-000985.
Resources
- PBC
- IQIRVO MoA
- The ELATIVE trial: Study design & baseline characteristics
- The ELATIVE trial: Efficacy
- The ELATIVE trial: Safety data
- IQIRVO Safety Data
- Dosing
- Resources
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