Ipsen: Iqirvo Confirms Its Efficacy on Fatigue and ALP
The French laboratory Ipsen strengthens the clinical profile of Iqirvo, its second-line treatment for primary biliary cholangitis (PBC). The data announced on Thursday at the European Association for the Study of the Liver (EASL) congress includes three analyses: a reanalysis of the pivotal Elative trial, a real-world retrospective study on the normalization of alkaline phosphatases (ALP), and interim results at 3 months from the Elfinity trial, conducted in routine clinical practice. These results demonstrate stable efficacy on debilitating symptoms (moderate to severe fatigue, pruritus) and favorable tolerance, reinforcing Iqirvo's position as a treatment offering both biochemical control and symptomatic relief. For Ipsen, this expanded file could open up product access beyond patients with inadequate response to standard therapy.
Iqirvo Demonstrates Clinically Significant Impact on Moderate to Severe Fatigue
In a post hoc analysis of the Elative trial, 67% of patients treated with Iqirvo who had moderate to severe fatigue initially achieved a clinically significant improvement at week 52, compared to 31% on placebo (p=0.020). Improvements were evident as early as week 4. The benefits of Iqirvo extended to multiple dimensions of fatigue: extreme exhaustion (62% vs 31% under placebo), inability to think clearly (57% vs 31%), and inability to wash or shower (55% vs 25%). This multi-dimensional scope suggests a systematic effect on various areas of physical and mental fatigue, a symptom identified as one of the most debilitating of PBC. Concurrently, the real-world retrospective analysis (Health Verity database) showed that among treatment-naive second-line patients, 72% achieved an ALP reduction of at least 15% over 6 months, with an average ALP decrease from 174 U/L to 131 U/L and 59% of patients normalizing their ALP.
Routine Clinical Practice Confirms Tolerance and Rapid Efficacy
The 3-month interim results from the Elfinity trial, conducted in routine clinical settings globally, show that Iqirvo brought about rapid and sustained reductions in ALP, with a biochemical response achieved in 55% of patients. More than half of the patients with moderate to severe fatigue initially experienced clinically significant improvements at 3 months, as well as clinically important improvements in pruritus. The tolerance profile proved favorable, with no serious or severe treatment-related adverse events reported. These data consolidate the profile observed in controlled trials and extend validation to routine practice.
