1. More patients in the delgocitinib cream group reported clear or almost clear skin at week 16 in both the DELTA 1 and 2 trials compared to control.
2. Majority of adverse events were mild-to-moderate and similar between groups.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Chronic hand eczema is an inflammatory condition significantly affecting patients’ quality of life. Existing treatments often fail to provide adequate relief. This randomized controlled trial evaluated the efficacy and safety of twice-daily applications of delgocitinib cream, a pan-Janus kinase inhibitor, compared to a vehicle control cream in adults with moderate to severe chronic hand eczema. The primary outcome of this study was achieving treatment success as measured by the Investigator’s Global Assessment for Chronic Hand Eczema (IGA-CHE) at week 16, while the key secondary outcome was the frequency of adverse events. According to study results, delgocitinib cream was more effective than the vehicle control, with a higher proportion of patients achieving treatment success. Although this study was well done, it was limited by its relatively short duration, affecting long-term efficacy and safety.
Click to read the study in The Lancet
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In-depth [randomized controlled trial]: Between May 10, 2021, and Oct 31, 2022, 566 and 557 patients were screened for eligibility across the DELTA 1 and DELTA 2 trials, respectively. Included were patients ≥ 18 years old with moderate to severe chronic hand eczema that significantly impacted their quality of life. Altogether, 960 patients were included in the final analysis, with 487 enrolled in DELTA 1 (325 to delgocitinib and 162 to standard) and 473 in DELTA 2 (314 to delgocitinib and 159 to standard). The primary outcome of treatment success at week 16, defined as clear or almost clear skin on the Investigator’s Global Assessment for Chronic Hand Eczema (IGA-CHE), was significantly greater in the delgocitinib cream group compared to standard therapy (20% vs. 10% in DELTA 1 and 29% vs. 7% in DELTA 2; both p<0.0055). Moreover, the secondary outcome of occurrence of adverse events was similar between the delgocitinib and placebo groups (45% vs. 51% in DELTA 1 and 46% vs. 45% in DELTA 2), with the most frequent events being COVID-19 and nasopharyngitis. Findings from this study suggest that delgocitinib cream is effective for patients with moderate to severe chronic hand eczema.
Image: PD
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