Oral spleen tyrosine kinase/Janus Kinase inhibitor gusacitinib for the treatment of chronic hand eczema: Results of a randomized phase 2 study

J Am Acad Dermatol. 2023 Aug;89(2):235-242. doi: 10.1016/j.jaad.2023.04.027. Epub 2023 Apr 23.

Abstract

Background: Gusacitinib is an oral inhibitor of Janus and Spleen tyrosine kinases.

Methods: The efficacy and safety of gusacitinib were evaluated in a double-blind, placebo-controlled, multicenter, phase 2 study in 97 chronic hand eczema patients randomized (1:1:1) to placebo or gusacitinib (40 or 80 mg) for 12 weeks (part A). Then, in part B (through week 32), the patients received gusacitinib.

Results: At week 16, patients receiving 80 mg gusacitinib showed a 69.5% (P <.005) decrease in the modified total lesion-symptom score versus 49.0% for 40 mg (P =.132), and 33.5% for placebo. Considerable improvement in Physician's Global Assessment was seen in 31.3% of patients receiving 80 mg versus 6.3% of placebo (P <.05). A 73.3% decrease in the hand eczema severity index versus placebo (21.7%) occurred in patients receiving 80 mg (P <.001). Patients receiving 80 mg experienced a considerable decrease in hand pain (P <.05). As early as week 2, considerable reductions over placebo in modified total lesion-symptom score (P <.005), Physician's Global Assessment (P =.04), and hand eczema severity index (P <.01) were observed (80 mg gusacitinib). Adverse events included upper respiratory infection, headache, nausea, and nasopharyngitis.

Conclusions: Gusacitinib showed rapid improvement in chronic hand eczema patients and was well tolerated, warranting further investigations.

Keywords: Janus kinase inhibitor; chronic hand eczema; modified total lesion-symptom score; physician global assessment; spleen kinase inhibitor.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Double-Blind Method
  • Eczema* / chemically induced
  • Eczema* / drug therapy
  • Humans
  • Janus Kinase Inhibitors*
  • Severity of Illness Index
  • Syk Kinase / therapeutic use
  • Treatment Outcome

Substances

  • Janus Kinase Inhibitors
  • gusacitinib
  • Syk Kinase