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Clinical and Experimental Dermatology Oct 2012In a previous large trial (Benefit of Alitretinoin in Chronic Hand Eczema; BACH), 47.7% of patients with severe chronic hand eczema (CHE) who received alitretinoin...
BACKGROUND
In a previous large trial (Benefit of Alitretinoin in Chronic Hand Eczema; BACH), 47.7% of patients with severe chronic hand eczema (CHE) who received alitretinoin 30 mg achieved 'clear' or 'almost clear' hands during the initial 24-week treatment course.
OBJECTIVES
The current open-label trial was designed to study extended treatment with a further 12- to 24-week course of oral alitretinoin 30 mg in patients who did not fully respond to initial treatment in the BACH study.
METHODS
At the end of the BACH study, patients whose eczema was rated 'mild', 'moderate' or 'severe' according to the Physician's Global Assessment (PGA) were eligible for a 24-week, open-label, multicentre study. Patients (n=243) received 30 mg of alitretinoin once daily, irrespective of previous treatment in BACH; either alitretinoin 30 mg, alitretinoin 10 mg or placebo.
RESULTS
By the end of the follow-on study, the PGA response rate to the subsequent course of alitretinoin 30 mg was 50% and 39% in patients treated previously in BACH with 10 or 30 mg per day, respectively, and 51% in patients who previously received placebo in BACH. Alitretinoin was well tolerated, and no significant late-arising toxicities were seen.
CONCLUSIONS
For a considerable number of patients with CHE who did not fully respond after an initial 24-week treatment period, a switch from either placebo to the active compound at 30 mg or from the lower to the higher dose, or treatment prolongation at the higher dose could be beneficial. Alitretinoin remains well tolerated for overall treatment durations of up to 48 weeks.
Topics: Administration, Oral; Adult; Alitretinoin; Canada; Chronic Disease; Dermatologic Agents; Eczema; Europe; Female; Hand Dermatoses; Humans; Male; Middle Aged; Retreatment; Tretinoin
PubMed: 22731739
DOI: 10.1111/j.1365-2230.2012.04396.x -
Dermatologic Therapy May 2021Alitretinoin is the only systemic agent approved to treat moderate-severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids. No nationwide Italian...
Alitretinoin is the only systemic agent approved to treat moderate-severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids. No nationwide Italian data regarding real-life efficacy, safety, and tolerability of treatment are available. The DECISA project (DErmatology Clinics in Italy: Survey on Alitretinoin) retrospectively examined data from a registry including 15 Dermatology Clinics authorized to prescription of alitretinoin for CHE patients. Disease severity was assessed at baseline, and after 3 and 6 months of treatment, using the 5-point Physician Global Assessment (PGA) and the modified Total Lesion-Symptoms-Severity (mTLSS) scores. Between November 2010 and July 2018, data of 248 male and 190 female patients (mean age 49.71 ± 13.20 years) treated with alitretinoin were collected. Of them, 43.2% had irritant contact dermatitis, 22.2% allergic contact dermatitis, 18.0% atopic dermatitis, 16.7% mixed (irritant/allergic) type of eczema. At 3 months, the 420 re-evaluated patients showed significantly reduced mTLSS and PGA (P < .0000001 vs baseline for both); PGA was clear/almost clear in 35.6% of cases. At 6 months, the 341 re-evaluated patients showed significant (P < .0000001) improvement of mTLSS and PGA vs baseline and 3 months (PGA clear/almost clear: 41.4%). Relapses occurred in 125 patients; 58 underwent an additional course of alitretinoin, with similarly good results. No relevant safety issues were reported; 86 patients experienced adverse effects, which forced 40 to prematurely stop treatment. The DECISA project results confirm the real-life efficacy, safety and tolerability of alitretinoin in the treatment of moderate to severe CHE refractory to standard topical therapies.
Topics: Adult; Alitretinoin; Chronic Disease; Dermatologic Agents; Dermatology; Eczema; Female; Hand Dermatoses; Humans; Italy; Male; Middle Aged; Retrospective Studies; Treatment Outcome; Tretinoin
PubMed: 33619833
DOI: 10.1111/dth.14911 -
Journal of the European Academy of... May 2020Alitretinoin is a systemic retinoid licensed for use in adult patients suffering from chronic hand eczema recalcitrant to potent topical steroids. Experience with its...
BACKGROUND
Alitretinoin is a systemic retinoid licensed for use in adult patients suffering from chronic hand eczema recalcitrant to potent topical steroids. Experience with its use in childhood is lacking.
OBJECTIVES
To report on the efficacy and safety of alitretinoin treatment in a cohort of children and adolescents with chronic hand eczema (CHE) and other inflammatory skin diseases.
METHODS
We performed a retrospective chart review of all consecutive patients under the age of 18 years treated with alitretinoin at our paediatric skin centre. Physician's Global Assessment (PGA) was used as the primary outcome measure.
RESULTS
Thirteen children (9 girls and 4 boys) were enrolled in this study. The median age at start of treatment with alitretinoin was 11.5 years (range 5.8-15.8 years). Nine children were diagnosed with CHE, two with severe atopic dermatitis (AD), and two with inherited ichthyosis [netherton syndrome (NS), autosomal recessive congenital ichthyosis (ARCI)]. Moderate to excellent response (PGA decrease of ≥1 point) was observed in 7 (78%) of the nine patients with CHE, one of the two patients with extensive AD and in the one patient with ARCI. In the remaining four subjects, no convincing effect was documented. Tolerability was overall very good. The most common adverse event was headache in 10 patients (77%) during the initiation of treatment, leading to interruption of therapy in one subject.
CONCLUSIONS
Alitretinoin seems to be highly effective and safe for the treatment of paediatric CHE and should thus be considered in children with refractory disease under topical therapy. Larger studies are required to corroborate these findings.
Topics: Adolescent; Adult; Alitretinoin; Child; Child, Preschool; Chronic Disease; Dermatologic Agents; Eczema; Female; Hand Dermatoses; Humans; Male; Retrospective Studies; Treatment Outcome; Tretinoin
PubMed: 31742759
DOI: 10.1111/jdv.16088 -
Lymphatic Research and Biology Feb 2019
Topics: Alitretinoin; Animals; Biological Assay; Cell Movement; Cell Proliferation; Endothelial Cells; Gene Expression Regulation; Humans; Lymphangiogenesis; Lymphedema; Mice; Peptides; Receptor, Fibroblast Growth Factor, Type 3; Signal Transduction; Trachea
PubMed: 30763178
DOI: 10.1089/lrb.2019.29058.sr -
Dermatitis : Contact, Atopic,... 2024Systemic remedies such as cyclosporine, methotrexate, and retinoids are off-license treatment options that are considered for severe chronic hand eczema (CHE) that is... (Comparative Study)
Comparative Study
Systemic remedies such as cyclosporine, methotrexate, and retinoids are off-license treatment options that are considered for severe chronic hand eczema (CHE) that is resistant to first-line treatment. The objective of this study was to determine the optimal treatment of CHE patients, including those with atopic Dermatitis®, and to compare the efficacy between cyclosporine and alitretinoin. This study was retrospective and included CHE patients who visited the Department of Dermatology at Hanyang University Seoul Hospital in Korea between March 2013 and February 2020. A total of 95 CHE patients was included in this study. In the cyclosporine treatment group, there were more patients with severe baseline Investigator Global Assessment (IGA) ( = 0.033) and higher immunoglobulin E (IgE) level ( = 0.019). The mean recurrence duration was 15.9 weeks in the alitretinoin group and 22.9 weeks in the cyclosporine group, the difference between which was not statistically significant. In a subgroup analysis according to treatment drug, only the low IgE group showed a better recurrence profile for alitretinoin treatment compared to cyclosporine treatment ( = 0.039). When comparing the cumulative recurrence rate during the treatment period and subsequent follow-up periods, the cyclosporine group showed a greater incidence of recurrence than the alitretinoin group in all follow-up periods. The results of our study are consistent with the previously reported efficacy of alitretinoin. Despite the rapid response in the cyclosporine group, 12 weeks of CHE treatment with alitretinoin showed superior efficacy compared to cyclosporine treatment. Both alitretinoin and cyclosporine groups showed efficacy in patients with CHE. Cyclosporine is an alternative treatment of CHE that is refractory to alitretinoin or relapses after its use, especially in the presence of atopic Dermatitis®.
Topics: Humans; Cyclosporine; Alitretinoin; Female; Male; Retrospective Studies; Hand Dermatoses; Eczema; Dermatologic Agents; Adult; Middle Aged; Chronic Disease; Dermatitis, Atopic; Recurrence; Tretinoin
PubMed: 37870578
DOI: 10.1089/derm.2023.0113 -
Acta Dermato-venereologica Sep 2010
Topics: Administration, Oral; Alitretinoin; Anti-Inflammatory Agents; Drug Therapy, Combination; Female; Humans; Lichen Planus; Male; Middle Aged; Skin; Time Factors; Treatment Outcome; Tretinoin
PubMed: 20814633
DOI: 10.2340/00015555-0781 -
Journal of Clinical Psychopharmacology Oct 2015
Topics: Adult; Alitretinoin; Dermatologic Agents; Eczema; Female; Humans; Psychoses, Substance-Induced; Tretinoin
PubMed: 26252440
DOI: 10.1097/JCP.0000000000000377 -
Journal of Cutaneous Medicine and... Oct 2014The treatment of moderate to severe chronic hand dermatitis (CHD) has been advanced with the introduction of alitretinoin (9-cis-retinoic acid). Although clinical trial...
BACKGROUND
The treatment of moderate to severe chronic hand dermatitis (CHD) has been advanced with the introduction of alitretinoin (9-cis-retinoic acid). Although clinical trial data demonstrated the efficacy and safety of alitretinoin, real-world experience is lacking in a more generalized patient population.
OBJECTIVE
Patients with CHD often, and unsuccessfully, attempt several therapeutic options before seeing a dermatologist. This chart review study aimed to examine the experience of using alitretinoin for CHD in a dermatology office setting.
METHODS
A retrospective chart review of electronic medical records was conducted of all patients prescribed alitretinoin in a community dermatology practice.
RESULTS
Alitretinoin was well tolerated in this patient population of 53 patients and showed a clinically significant reduction in disease symptoms.
CONCLUSION
Alitretinoin was a safe and well-tolerated treatment with significant clinical improvement in our patient population. Few clinically significant laboratory abnormalities were identified, and only one patient discontinued therapy due to adverse events.
Topics: Adult; Aged; Alitretinoin; Chronic Disease; Community Health Services; Dermatologic Agents; Dermatology; Female; Hand Dermatoses; Humans; Male; Middle Aged; Retreatment; Retrospective Studies; Treatment Outcome; Tretinoin
PubMed: 25186994
DOI: 10.2310/7750.2014.13195 -
Clinical and Experimental Dermatology Apr 2011Previous studies have shown that concomitant administration of food may enhance the bioavailability of oral retinoids. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Previous studies have shown that concomitant administration of food may enhance the bioavailability of oral retinoids.
AIM
To assess the influence of food on the pharmacokinetics (PK) of alitretinoin after a single oral dose.
METHODS
This was a single-dose, open-label, randomized, crossover study, which enrolled 30 healthy men, aged 18-44 years. Subjects received sequential doses of alitretinoin 40 mg either after fasting (treatment A) or 5 min after completion of a standard breakfast (treatment B), with the dosing sequence randomized (A/B or B/A). The washout period between the two doses was 1 week. Plasma concentrations over time were plotted and standard PK variables [area under the curve (AUC) of plasma concentration vs. time, maximum plasma concentration (C(max)), time to maximum plasma concentration (t(max)) and elimination half-life (t(1/2)] were determined.
RESULTS
Drug exposure was markedly increased when alitretinoin was taken with food compared with fasting, and there were significant increases in mean C(max) (82.8 vs.25.4 ng/mL, respectively) and AUC (220.2 vs. 55.7 ng · h/mL). The delaying effect of food on t(max) was less marked (median of 3.0 vs. 2.0 h). Administration with food also increased exposure to drug metabolites. Variability in exposure was markedly reduced if alitretinoin was taken with vs. without food (percentage coefficient of variation 40% vs. 74% for AUC; 49% vs. 85% for C(max)). Alitretinoin was generally well tolerated, with typical retinoid adverse reactions, mostly comprising headache.
CONCLUSIONS
Intake of alitretinoin with food substantially increased the bioavailability of alitretinoin, but variability in exposure was reduced. Consequently, oral alitretinoin should be taken with food as outlined in the manufacturer's summary of product characteristics.
Topics: Administration, Oral; Adolescent; Adult; Alitretinoin; Biological Availability; Cross-Over Studies; Dermatologic Agents; Fasting; Female; Food-Drug Interactions; Humans; Male; Middle Aged; Tretinoin; Young Adult
PubMed: 21443600
DOI: 10.1111/j.1365-2230.2011.04033.x -
Annales de Dermatologie Et de... Jun 2014The management of hand eczema, more readily called chronic hand dermatitis, is complex. This heaviness is related not only to the disease itself by its different... (Review)
Review
The management of hand eczema, more readily called chronic hand dermatitis, is complex. This heaviness is related not only to the disease itself by its different clinical forms but also the multiplicity and diversity of etiological factors, triggering / maintaining or aggravating factors. The repeated therapeutic failures are ransom of incorrect information about the disease and its environment, a lack of clarity in the prescription and duration of treatment in general too short. The reference treatment is high potency topical steroids with or without occlusion for 4-8 weeks followed by alitretinoin 30 mg / day for at least 3-6 months with a monthly lipid and liver monitoring and mandatory monthly pregnancy test in women of childbearing. Associated measures and patient education are the cornerstones of successful treatment. Other alternative treatments such as phototherapy, methotrexate, cyclosporin, mycophenolate mofetil etc. can be considered in case of resistance or for clearing followed by topical treatments.
Topics: Adrenal Cortex Hormones; Algorithms; Alitretinoin; Anti-Bacterial Agents; Chronic Disease; Dermatologic Agents; Disease Management; Drug Monitoring; Drug Therapy, Combination; Eczema; Emollients; Female; Hand Dermatoses; Histamine Antagonists; Humans; Immunosuppressive Agents; Male; Patient Education as Topic; Phototherapy; Pregnancy; Pregnancy Complications; Pregnancy Tests; Salicylic Acid; Tretinoin; Tumor Necrosis Factor-alpha
PubMed: 24953623
DOI: 10.1016/S0151-9638(14)70151-6