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The Journal of Dermatological Treatment 2016Alitretinoin is approved for the treatment of adults with severe chronic hand eczema (CHE) refractory to potent topical steroids. In the 6 years since launch,...
BACKGROUND
Alitretinoin is approved for the treatment of adults with severe chronic hand eczema (CHE) refractory to potent topical steroids. In the 6 years since launch, approximately 250 000 patients have been treated with alitretinoin.
OBJECTIVE
To compare the postmarketing safety surveillance experience of alitretinoin with data from clinical trials and key safety issues with other retinoids.
METHODS
An integrated safety analysis of the pivotal studies of alitretinoin and postmarketing adverse event (AE) reports received since approval for alitretinoin were analyzed.
RESULTS
In the pivotal trials, headache, erythema, nausea, increased blood triglycerides and increased blood creatinine phosphokinase were the most frequently reported AEs. Headache, hyperlipidemia and nausea were also frequently reported postmarketing AEs, but depression was relatively more frequently reported than in the pivotal trials. Inflammatory bowel disease and benign intracranial hypertension were rare, and very few cases have been reported in postmarketing surveillance. There have been no reports of teratogenicity in humans consequent to fetal exposure.
CONCLUSIONS
Safety data collected in pivotal trials and postmarketing surveillance suggest that alitretinoin is well tolerated by patients with CHE with a relatively low incidence of serious reactions. The adverse reaction profile is congruent with reported effects of other marketed oral retinoids.
Topics: Adult; Alitretinoin; Chronic Disease; Eczema; Female; Hand Dermatoses; Headache; Humans; Pregnancy; Tretinoin
PubMed: 25886084
DOI: 10.3109/09546634.2015.1034080 -
Journal Der Deutschen Dermatologischen... Dec 2013
Topics: Aged; Alitretinoin; Antineoplastic Agents; Hand; Humans; Male; Pagetoid Reticulosis; Skin Neoplasms; Treatment Outcome; Tretinoin
PubMed: 23879462
DOI: 10.1111/ddg.12166 -
Giornale Italiano Di Dermatologia E... Apr 2015Despite a better insight into its pathogenesis, hidradenitis suppurativa (HS) remains very frustrating to treat. Acitretin has been described as one of the agents with...
AIM
Despite a better insight into its pathogenesis, hidradenitis suppurativa (HS) remains very frustrating to treat. Acitretin has been described as one of the agents with the highest effective profile. Acitretin however, due to its teratogenicity and prolonged half-life (up to three years) is not an option in young women of fertile age who, unfortunately, are the target of this disease. Alitretinoin has a similar pharmacology action to acitretin, but much shorter half-life (only four weeks), making it a far much more attractive option compared to acitretin for women of child-bearing age. The aim of this paper was to evaluate the use of alitretinoin in treating recalcitrant cases of HS, which have not been responsive to standard treatments.
METHODS
Fourteen patients (all female, of child-bearing age), who persistently failed traditional treatments, were treated with alitretinoin 10 mg/day for 24 weeks. The disease trend was evaluated by using both Sartorius and Dermatology Life Quality Index scores at time 0, at week 12 and at week 24.
RESULTS
A significant improvement was recorded in 78.5% of the cases.
CONCLUSION
Although more studies are necessary, this preliminary study shows that alitretinoin may have a role in the treatment of HS specifically in women of fertile age.
Topics: Adult; Alitretinoin; Dermatologic Agents; Female; Hidradenitis Suppurativa; Humans; Middle Aged; Quality of Life; Treatment Outcome; Tretinoin; Young Adult
PubMed: 24927170
DOI: No ID Found -
The British Journal of Dermatology Jun 2016Palmoplantar pustulosis (PPP) is an inflammatory, debilitating skin disease. Topical drugs and systemic immunosuppressive agents are often ineffective. Previous... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Palmoplantar pustulosis (PPP) is an inflammatory, debilitating skin disease. Topical drugs and systemic immunosuppressive agents are often ineffective. Previous uncontrolled studies have suggested that alitretinoin could be a meaningful treatment option for PPP.
OBJECTIVES
The primary objective was to determine response to alitretinoin for the treatment of PPP based on the Palmoplantar Pustulosis Area and Severity Index (PPPASI) after 24 weeks of treatment.
METHODS
A phase II, randomized, double-blind, placebo-controlled, multicentre study. Adult patients with PPP (with or without psoriasis) refractory to topical therapy and standard skin care were randomized 2:1 to alitretinoin 30 mg once daily or placebo for up to 24 weeks. The primary end point was PPPASI at week 24 (or the last visit in case of early withdrawal). Secondary end points included: percentage change from baseline in the modified Psoriasis Area and Severity Index (mPASI); percentage of patients with ≥ 50% or 75% improvement in PPPASI or mPASI scores from baseline; change in pustule count on the palms and soles; change in the Nail Psoriasis Severity Index and safety and tolerability assessments.
RESULTS
Thirty-three patients were randomized: 24 patients to alitretinoin 30 mg and nine to placebo. Overall, there were no significant differences between alitretinoin 30 mg and placebo for any end point. The safety profile was consistent with that seen in patients with chronic severe hand eczema refractory to potent topical corticosteroids.
CONCLUSIONS
Although the results were unexpected based on previous studies of alitretinoin in the treatment of PPP, this study provided no evidence to support further exploration of alitretinoin in the treatment of severe PPP.
Topics: Administration, Cutaneous; Administration, Oral; Alitretinoin; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Female; Foot Dermatoses; Hand Dermatoses; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index; Treatment Outcome; Tretinoin
PubMed: 26800106
DOI: 10.1111/bjd.14401 -
Dermatologic Therapy Nov 2020
Topics: Acitretin; Alitretinoin; Humans; Keratolytic Agents; Lichen Planus; Lichen Planus, Oral
PubMed: 33084184
DOI: 10.1111/dth.14441 -
Dermatology (Basel, Switzerland) 2015Chronic itch with secondary scratch lesions such as prurigo has a major impact on quality of life. Due to its relapsing nature and often unknown origin, its treatment is...
BACKGROUND
Chronic itch with secondary scratch lesions such as prurigo has a major impact on quality of life. Due to its relapsing nature and often unknown origin, its treatment is challenging.
OBJECTIVE
We sought to demonstrate that alitretinoin can be an efficacious and well-tolerated treatment in a patient suffering from chronic itch with concomitant prurigo and psoriatic lesions.
METHODS
Case report.
RESULTS
After 1 month of alitretinoin treatment (30 mg daily), itch as well as prurigo and psoriasis lesions decreased markedly. Three cycles of alitretinoin were administered, as each cessation of treatment led to relapse of the symptoms after 6-8 weeks. Tapering of the alitretinoin dose (30 mg every second day) after the third cycle allowed to maintain the effects for over 18 months.
CONCLUSION
Treatment of refractory prurigo with alitretinoin might be an efficacious alternative to standard therapies. In case of relapse, retreatment with alitretinoin reinduces a further long-lasting response.
Topics: Alitretinoin; Antineoplastic Agents; Female; Humans; Middle Aged; Prurigo; Pruritus; Psoriasis; Retreatment; Tretinoin
PubMed: 26304762
DOI: 10.1159/000435911 -
The New England Journal of Medicine Aug 2000
Topics: Alitretinoin; Gels; Humans; Sarcoma, Kaposi; Tretinoin
PubMed: 10979788
DOI: No ID Found -
Journal of the American Academy of... Aug 2014
Topics: Adult; Alitretinoin; Antineoplastic Agents; Female; Humans; Keratoderma, Palmoplantar; Tretinoin
PubMed: 25037811
DOI: 10.1016/j.jaad.2014.01.909 -
Der Hautarzt; Zeitschrift Fur... Oct 2019The treatment of hand eczema represents a great challenge in the daily clinical practice for dermatologists. There are various forms of local, physical and systemic... (Review)
Review
The treatment of hand eczema represents a great challenge in the daily clinical practice for dermatologists. There are various forms of local, physical and systemic treatment, such as alitretinoin which is the only registered systemic treatment option for severe chronic hand eczema. In 2017 dupilumab was approved for the treatment of moderate to severe atopic dermatitis and can theoretically also be applied for atopic hand eczema. The first and most important step in treatment is to identify the underlying etiology of the hand eczema with the appropriate diagnostic measures, ranging from skin biopsy to allergy testing including occupational products. An important component of treatment is the basic treatment in the form of consistent and stage-adapted skin care. Treatment of hand eczema should follow a step by step procedure whereby the basic treatment should be maintained and, depending on the etiology and clinical type, should be supplemented by topical, systemic and physical treatment forms, also often used in parallel. Mild to moderate forms of hand eczema are usually treated with the basic treatment, emollients and topical glucocorticoids according to various guidelines. In moderate to severe forms of hand eczema UV phototherapy and systemic treatment should be implemented. This article summarizes the most important treatment modalities based on case reports and series, clinical studies, guidelines and expert recommendations.
Topics: Alitretinoin; Dermatitis, Atopic; Dermatologic Agents; Disease Management; Eczema; Emollients; Hand Dermatoses; Humans; Treatment Outcome; Ultraviolet Therapy
PubMed: 31515578
DOI: 10.1007/s00105-019-04475-4 -
Bioorganic & Medicinal Chemistry Letters Mar 2017In silico screening of DrugBank database to detect liver X receptor (LXR) agonism of marketed drugs using a self-organizing map and successive LXR-Gal4 hybrid reporter...
In silico screening of DrugBank database to detect liver X receptor (LXR) agonism of marketed drugs using a self-organizing map and successive LXR-Gal4 hybrid reporter gene assay evaluation in vitro discovered alitretinoin and bexarotene as partial liver X receptor agonists. Dose-response curves demonstrated that plasma concentrations observed in clinical trials are sufficient for LXR activation and thus could account for LXR-mediated side-effects such as hypercholesterolemia and hyperlipidemia. The discovered drugs are the first reported dual LXR/RXR agonists and can serve as lead structures for LXR and dual LXR/RXR modulator development.
Topics: Alitretinoin; Animals; Bexarotene; Drug Evaluation, Preclinical; HEK293 Cells; Humans; Liver X Receptors; Mice; Tetrahydronaphthalenes; Tretinoin
PubMed: 28169169
DOI: 10.1016/j.bmcl.2017.01.066