Systemic alitretinoin is safe and effective for patients with moderate to severe chronic hand eczema (CHE) that is refractory to standard therapy with potent topical corticosteroids, according to study findings published in Dermatologic Therapy.
The DECISA project (Dermatology Clinics in Italy: Survey on Alitretinoin), a retrospective cohort study conducted in 15 Italian dermatology clinics, sought to collect clinical data for patients with CHE unresponsive to potent or super-potent topical corticosteroids. All participants were treated with oral alitretinoin 30 mg daily for 6 consecutive months.
Investigators assessed patients’ disease severity at baseline and after 3 and 6 months of treatment with use of the 5-point Physician Global Assessment (PGA) and the modified Total Lesion Symptom Score (mTLSS).
A total of 438 patients (mean age, 49.71±13.20 years; 248 men, 56.6%) were enrolled from 2010 to 2018. Within the cohort, irritant contact dermatitis (ICD) was diagnosed in 189 cases (43.2%), allergic contact dermatitis (ACD) in 97 (22.2%), and atopic dermatitis in 79 (18.0%). Eczema was considered mixed type (ICD/ACD) in the other 73 patients (16.7%).
At baseline, 364 patients (83.1%) had a severe PGA score (4), and 74 (16.9%) had a moderate score (3). The mean mTLSS score was 12.86 (±2.76). After 3 months, 420 patients were re-evaluated, and the decrease in mTLSS score was significant compared with baseline (6.29±3.27, P <.0000001). The PGA score was clear (0) in 33 cases (7.5%), almost clear (1) in 123 (28.1%), mild (2) in 101 (23.1%), moderate (3) in 130 (29.7%), and severe (4) in 33 (7.5%), confirming the improvement (P <.0000001 vs baseline). There were 26 nonresponders (5.9%).
After the first follow-up, 350 patients continued alitretinoin treatment, and 341 (97.4%) were re-evaluated after 6 months, at which time the PGA score was clear in 85 cases (24.9%), almost clear in 117 (34.3%), mild in 56 (16.4%), moderate in 59 (17.3%), and severe in 24 (7.0%). The mTLSS score was not assessed in 23 cases, and in the remaining 318 cases, the average score was 4.32 (±3.29). The improvement of both scores was evident compared with scores at baseline and the 3-month visit (P <.0000001 in all comparisons), according to the study authors.
After 6 months of alitretinoin treatment, 125 patients had relapses and another course of treatment was prescribed for 58 of them.
Side effects during treatment were reported by 17.6% of patients (n=77), and 7.1% (n=31) discontinued treatment owing to these effects. After the study authors applied the “worst case scenario” criteria for the 9 patients lost at follow-up and assessed them as though they had experienced adverse effects that had forced them to discontinue treatment, the percentages were 19.6% and 9.1%, respectively.
In a majority of cases, the type of side effect was not reported in the database; headache was the most common side effect among those that were reported, occurring in 12 patients, followed by dyslipidemia in 4 patients.
“These statistical trends and significant associations deserve, in our opinion, further investigation in larger and different populations, and, if confirmed, could give an important contribution to the definition of the risk profile of patients who undergo treatment with alitretinoin for CHE,” the researchers commented.
Ferrucci S, Persichini P, Gola M, et al. DECISA Project (DErmatology Clinics in Italy: Survey on Alitretinoin): a real-life retrospective cohort multicenter study on 438 subjects with chronic hand eczema. Dermatol Ther. Published online February 22, 2021. doi:10.1111/dth.14911