Gusacitinib shows promise as treatment for chronic hand eczema
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Key takeaways:
- At week 16, 73.3% of gusacitinib-treated patients achieved reduction in hand eczema severity vs. 21.7% of those treated with placebo.
- Physician Global Assessment improvements were seen as early as 2 weeks.
Gusacitinib significantly outperformed placebo, showing a tolerable safety profile and a rapid improvement in the treatment of patients with chronic hand eczema, according to a phase 2 study.
“Chronic hand eczema (CHE) current treatment options are limited and there is a high medical need for new options,” Pablo A. Jimenez, MD, FAPCR, chief medical officer and senior vice president of Asana BioSciences at the time of the study and current chief medical officer and senior vice president of Libertas Biosciences, told Healio. “Oral gusacitinib offers a potential effective treatment for moderate to severe chronic hand eczema.”
In this double-blind, placebo-controlled, multicenter, phase 2 study, Jimenez and colleagues evaluated the efficacy and safety of gusacitinib, an oral Janus kinase and spleen tyrosine kinase inhibitor, in the treatment of patients with CHE.
In part A, 97 adult patients were randomly assigned 1:1:1 to receive gusacitinib 40 mg, gusacitinib 80 mg or placebo once daily for 12 weeks; however, only 68 patients completed part A of the study. The main reason for discontinuation was withdrawal of informed consent with the exception of three placebo-treated patients that withdrew due to worsening CHE.
In part B, which continued through week 32, all patients received gusacitinib. A total of 39 patients completed part B of the study, with discontinuation predominantly due to the study’s early termination due to the COVID-19 pandemic.
Study results showed that at week 16, patients taking 80 mg and 40 mg of gusacitinib exhibited decreases of 69.5% and 49% in modified Total Lesion Symptom Score (mTLSS), respectively, compared with a decrease of 33.5% among placebo patients.
Further, of the patients treated with 80 mg and 40 mg of gusacitinib, 28.2% and 33.3% saw significant improvements in Patient Global Assessment as early as week 2 compared with 0% of those treated with placebo.
By week 16, 31.3% (95% CI, 0.01%-31.9%) of the 80 mg group and 21.2% (95% CI, 11%-45.3%) of the 40 mg group showed Physician Global Assessment (PGA) improvement vs. 6.3% of placebo.
Additionally, those taking 80 mg of gusacitinib achieved a greater reduction in hand eczema severity index (HECSI) at week 16 vs. placebo (73.3% vs. 21.7%; P < .001), whereas those taking 40 mg of the drug achieved a moderate reduction (51.6%; P = .033).
At week 16, patients in the 80 mg gusacitinib group also reported a significant reduction in hand pain (P < .05). These patients also reported significant reductions in mTLSS (P < .005), PGA (P < .04) and HECSI (P < .01) vs. placebo as early as week 2.
Gusacitinib was well tolerated, according to the researchers, with the most common adverse events occurring in at least 10% of patients being mild to moderate and short-term upper respiratory tract infections, headaches and nausea. Adverse events were most prevalent in the 80 mg gusacitinib group.
Jimenez told Healio that the drug exhibits promise.
“Gusacitinib has shown to be effective in all forms (irritant, allergic, atopic) of chronic hand eczema,” he said.
However, the authors add that larger and longer trials are needed to confirm the results of this study.