alitretinoin (Alitoc / BAL 4079 / BAL4079)

A Multi-Center, Open-Label, Single-Arm, Prospective Investigator Initiated Trial to Evaluate the Efficacy and Safety of Alitretinoin in Patients With Chronic Hand Eczema in Real-World Practice (DWALG_P401) and Overview of Korean Studies.

Kwon Min Jung MJ, Yu Jin Woo JW, Han Byeol B, Ahn Jiyoung J et al.

Chronic hand eczema (CHE) is a debilitating dermatologic condition often refractory to topical corticosteroids (TCS). Although oral alitretinoin has demonstrated efficacy in CHE, real-world multicenter data in Korean populations remain limited. To evaluate the real-world efficacy and safety of oral alitretinoin in Korean patients with severe CHE with insufficient response to TCS. This multicenter, prospective, open-label study enrolled 146 patients with severe CHE at tertiary hospitals in Korea. Patients received oral alitretinoin (30 mg once daily, with dose reduction to 10 mg permitted) for up to 24 weeks, with observation up to 36 weeks. The primary endpoint was achievement of "clear" or "almost clear" on the Physician's Global Assessment (PGA) at treatment completion. Secondary endpoints included the modified total lesion symptom score (mTLSS) and Patient's Global Assessment (PaGA). Safety was evaluated by monitoring adverse events (AEs) and laboratory abnormalities. Efficacy analyses were performed on the full analysis set (n=129). At treatment completion, 55 patients (42.64%) achieved a PGA response. Improvement increased from week 4 (1.83%) to week 36 (60.87%). PaGA showed consistent improvement, with 17.32% reporting "clear or almost clear" and 28.35% reporting "marked improvement" at treatment completion. mTLSS scores improved by 62.3% at treatment completion and by 75.7% at week 36. In the safety analysis (n=134), 44.03% experienced AEs, most commonly headache (29.10%). Oral alitretinoin at daily doses of 10 mg or 30 mg demonstrated effective symptom improvement and an acceptable safety profile in Korean patients with CHE in a real-world setting.

Efficacy and Safety of Alitretinoin for Chronic Hand Eczema: A Meta-Analysis.

Lee Yu Jin YJ, Lee Jung Min JM, Choi Yun Jeong YJ, Han Tae Young TY et al.

Hand eczema is a common inflammatory dermatosis that can severely impair quality of life. Chronic or refractory cases often require systemic therapy. Alitretinoin, a vitamin A derivative, is approved for patients unresponsive to potent topical corticosteroids. This meta-analysis aimed to evaluate its efficacy and safety in chronic hand eczema. A PubMed search up to April 10, 2023, identified relevant studies. Outcomes included therapeutic response, adverse events, and laboratory changes. Efficacy was assessed using Physician Global Assessment (PGA), Patient Global Assessment (PaGA), and modified Total Lesion Symptom Score (mTLSS). Subgroup analyses by dosage and treatment duration, with meta-regression, were performed. Twenty-four studies were included. Overall improvement rates were 47.8% for PGA and 36.4% for PaGA, with greater benefit observed in PGA. Higher dosages produced superior efficacy in both PGA and PaGA, and meta-regression confirmed significant differences between 10 mg and 30 mg groups. Longer treatment in 30 mg subgroup was associated with better outcomes for PGA, PaGA, and mTLSS. Adverse events occurred in 48.3% of cases, most commonly headache, skin fissure, back pain, and dry eye. Triglyceride elevation was the most frequent laboratory abnormality. Alitretinoin showed favorable efficacy in chronic hand eczema. Consistent with previous studies, we observed a trend of increasing efficacy with higher dosages. Furthermore, at high dosage, greater efficacy was observed with longer durations of use. Adverse events were generally tolerable, supporting its role as a therapeutic option in refractory cases.

Evaluation of delgocitinib for the treatment of moderate to severe chronic hand eczema in adults.

Piaskowski Nicole N, Globig Philipp P, Worm Margitta M

Chronic hand eczema (CHE) is a frequent inflammatory skin disorder associated with a substantial psychosocial and economic burden. Its prevalence ranges from 4.7% up to 10%. The therapeutic management of CHE remains challenging. Long-term use of topical corticosteroids, which are used as first-line therapy, can be associated with local side effects and a negative impact on the skin barrier. Alitretinoin, a vitamin A derivate licensed as a systemic treatment option in Europe, has demonstrated efficacy but is accompanied by systemic adverse effects. Delgocitinib is a novel topical anti-inflammatory pan-janus kinase inhibitor with negligible systemic exposure and a reduced risk of side effects. It has shown clinical efficacy in double blind placebo-controlled trials and most recently superiority against alitretinoin in terms of both, efficacy and safety. This review summarizes the data on delgocitinib as a topical treatment for CHE including pharmacokinetics, pharmacodynamics, efficacy and safety. Delgocitinib is a topical pan-janus kinase (JAK) inhibitor and represents a novel treatment option for CHE with a favorable safety and tolerability profile. Further data on long-term use and real-world effectiveness are still needed.

Efficacy of oral alitretinoin for concomitant foot eczema in chronic hand eczema.

Cha Soobin S, Lee Jungsoo J, Shin Kihyuk K, Kim Hoon-Soo HS et al.