Influence of Baseline Itch Severity on Treatment Outcomes With Difelikefalin in Adults With Moderate-to-Severe Pruritus Receiving Maintenance Haemodialysis: An Exploratory Analysis.
Kieran McCafferty, Thilo Schaufler, Pablo Molina and 3 others
PMID 40327387WHAT IT FOUND
Difelikefalin after haemodialysis reduced itch, improved itch-related quality of life and sleep in adults with moderate or severe dialysis itch.
Severe itch started higher, and week 12 mean scores were 2.9 and 3.1. Adverse events were common in both groups.
Key findings
01Among adults with moderate baseline itch, 62.9% achieved a clinically relevant improvement of at least 3 points in itch intensity by week 12, and the mean change was -3.0.
02Among adults with severe baseline itch, 78.8% achieved a clinically relevant improvement of at least 3 points in itch intensity by week 12, and the mean change was -5.2.
03By week 12, mean itch scores were 2.9 in the moderate subgroup and 3.1 in the severe subgroup, indicating residual mild itch.
STILL TO COME
How it was doneWhat they foundWhat it means for RNs
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What it does not show
This was an exploratory secondary analysis of a single-arm, open-label trial, so there was no placebo or control group to compare difelikefalin against. The moderate subgroup was smaller (70 participants) than the severe subgroup (152 participants), and analyses excluded participants without complete data at the key timepoints, except for a conservative rule for complete responders. Participants were adults on in-centre haemodialysis who already had moderate-to-severe itch, so the results do not address milder itch, home dialysis, transplant candidates, or itch from another cause. Because all participants received difelikefalin, improvements cannot be separated from the effects of time or routine dialysis care.
The easy way to misread this
Do not read the larger mean itch score drops in the severe subgroup as proof that difelikefalin works better for severe itch. This was an open-label, single-arm subgroup analysis with no placebo control. The severe group started with worse baseline scores, and week 12 mean itch scores were 2.9 and 3.1.