An IL-31 antibody fails the endpoint it was designed around in dialysis itch

The edition in brief

NIKAIA-1 randomised 258 haemodialysis patients with chronic kidney disease-associated pruritus to nemolizumab 30 mg, 60 mg or placebo every four weeks for twelve weeks. The primary endpoint, a four-point or greater improvement in worst itch, was not met at either dose: 47.7% on 60 mg and 38.5% on 30 mg against 32.4% on placebo. At week 4 the separation was much wider, and itch-related quality of life improved on the higher dose at a nominal significance level, but the trial as designed was negative. The FDA has classified as Class II an ongoing Lupin Pharmaceuticals recall of clobetasol propionate cream 0.05% in 60 g tubes for failing content uniformity specifications, meaning drug content varies within or between tubes. Laboratory and mouse work reports that narrowband UVB drives dermal fibroblast senescence through MAPK and p53 signalling, with low-dose exposure reducing CD8 T cells and increasing pigmentation in vitiligo mice while high-dose exposure produced a senescent, pro-inflammatory microenvironment and worsened disease; this is research-stage and does not define a human dose. A review of keloid biology summarises multiomic findings implicating adipocyte lipolysis, microRNA regulation and disrupted vitamin D signalling, without offering new clinical data. A phase 4 randomised placebo-controlled trial in 327 Chinese adults found guselkumab reached PASI 90 in 82.4% at week 16 against 2.0% on placebo, with responses maintained at week 48 and a comparable early adverse event rate.