Rapid, substantial improvements seen with gusacitinib for chronic hand eczema

Gusacitinib produced significant and rapid improvement of severity and pain in patients with moderate to severe chronic hand eczema, according to a study presented at AAD VMX 2021.

Gusacitinib is an oral dual inhibitor of JAK1, JAK2, JAK3, TYK2 and SYK kinases.

“It is felt that chronic hand eczema (CHE) affects about 7 million people in the U.S., with no current approved treatments,” Howard Sofen, MD, said during the presentation.

The phase 2b randomized, double-blind, placebo-controlled study evaluated the efficacy, safety and tolerability of gusacitinib in 97 patients between the ages of 18 and 75 years who had CHE for at least 6 months. Patients had a Physician Global Assessment severity of 3 or 4 out of 5 and used topical or systemic corticosteroids in the past year. The majority of patients were female.

Sofen and colleagues conducted a two-part treatment of three randomized cohorts: a placebo arm, a 40 mg gusacitinib arm and an 80 mg gusacitinib arm. Treatment occurred for 16 weeks in the first part of the study. After efficacy assessments, the treatment continued for an additional 16 weeks with the placebo arm switched to 80 mg gusacitinib.

The researchers began to see efficacy starting at week 2 among the 80 mg group, which was sustained over the 32 weeks “with good separation from the 40 mg group and placebo,” Sofen said during the presentation. While the 80 mg treatment produced the best results, 40 mg gusacitinib showed superiority to placebo. By week 32, the modified total lesion symptom score decreased by 66.5% in the 80 mg group, 48.9% in the 40 mg group and 72.7% in the placebo group due to 80 mg gusacitinib treatment beginning at week 16.

Patient-reported outcomes included statistically significant improvements in pain with 80 mg gusacitinib. The treatment exhibited a similar safety profile to other JAK inhibitors and was well tolerated overall. The most common adverse events included upper respiratory tract infection, headache, nausea and nasopharyngitis. In addition to rapid and significant improvements, gusacitinib exhibited efficacy with chronic foot eczema and hyperkeratotic, pompholyx and fingertip forms of CHE.

“This molecule was well tolerated in patients with moderate to severe CHE,” Sofen said.