New late-breaking data reinforces IQIRVO®’s impact on ALP, fatigue and pruritus in PBC

Ipsen announced the presentation of new late-breaking results from the ELATIVE® Phase III trial and two real-world studies at the European Association for the Study of the Liver (EASL) congress. Together, these data further strengthen the growing body of evidence establishing IQIRVO® as the only second-line primary biliary cholangitis (PBC) treatment providing rapid and robust alkaline phosphatase (ALP) reduction with fatigue improvement (in patients with moderate-to-severe fatigue at baseline) and pruritus relief.

In a post hoc analysis of the pivotal ELATIVE study, shared in a late-breaking presentation, patients with moderate-to-severe fatigue at baseline experienced greater fatigue reductions with IQIRVO compared to placebo across 52 weeks. A clinically meaningful improvement in fatigue was achieved in 67% of patients on IQIRVO vs 31% on placebo (p=0.020) at Week 52, with improvements observed as early as Week 4. The benefits of IQIRVO vs placebo were observed across multiple dimensions of physical and mental fatigue, including extreme exhaustion (62% vs 31%), too tired to think clearly (57% vs 31%) and too tired to bath or shower (55% vs 25%), highlighting the breadth of improvement across several symptom domains.

“Fatigue is one of the most debilitating symptoms of PBC and has long represented a significant unmet need for patients and clinicians,” said David Jones, Professor of Liver Immunology for the Faculty of Medical Science at Newcastle University. “These data are particularly encouraging, showing that IQIRVO led to clinically meaningful improvements in fatigue compared with placebo. Importantly, improvements were seen across multiple dimensions of fatigue, including outcomes that matter most to patients.”

In a second late-breaking presentation, a U.S. real-world analysis using the Health Verity database, evaluated outcomes in patients with ALP elevated between 1-1.67 times the upper limit of normal (ULN). These data showed that improvements were observed through to month 6 in patients who were naïve to second-line treatment with 72% of patients having a ≥15% ALP reduction, a decline in mean ALP from 174 U/L to 131 U/L and 59% of patients achieving ALP normalization. Normalization of ALP is recognized as a key treatment goal for improved long-term prognosis and slowing disease progression in PBC. These data are the first real-world evidence establishing the benefit of IQIRVO on ALP normalization within this patient population.

In a third late-breaker, interim month 3 findings from the global Phase IV ELFINITY® study, conducted in routine clinical practice, showed IQIRVO delivered rapid and sustained reductions in ALP for three months, with biochemical response achieved in 55% of patients. More than half of patients with baseline moderate-to-severe fatigue experienced clinically meaningful improvements by month 3 as well as clinically important improvements in pruritus. IQIRVO demonstrated a favorable tolerability profile consistent with previous studies, with no serious or severe treatment-emergent adverse events reported.

“The growing evidence from both controlled trials and real-world practice highlights the meaningful difference IQIRVO can make for people living with PBC,” said Sandra Silvestri, MD, PhD, Chief Medical Officer, Ipsen. “Across multiple studies, we see consistent improvements in both biochemical control, a key marker of disease progression, and in the debilitating symptoms of fatigue and pruritus, which are independent of each other. These data further reinforce IQIRVO’s potential to address both disease biology and symptom burden in a meaningful and clinically relevant way.”