Long‐term safety and drug survival of acitretin in psoriasis: a retrospective observational study

Abstract

Background This retrospective observational study aimed to investigate the long‐term safety, drug survival, and factors associated with the survival of acitretin in a real‐world setting. Methods Data of adult patients with psoriasis who attended Siriraj Hospital between 2012 and 2017 and were treated with acitretin were reviewed. Demographic data and clinical courses were recorded. The Kaplan–Meier curve and Cox regression were used to calculate drug survival and the factors associated with drug survival, respectively. Results Of 104 patients, 56 and 48 were male and female, respectively, with a mean treatment duration of 3.2 years. The mean cumulative dose per patient was 19.28 ± 7.84 mg/day. Acitretin was administered to 73, 39, 24, and six patients for more than 1, 3, 5, and 10 years, respectively. Most side effects were mild and tolerable; only nine patients withdrew acitretin due to side effects. No patients developed clinical features of cirrhosis or uncontrolled hyperlipidemia. The drug survival rates were 79%, 69.5%, 61.2%, 57.6%, and 53.5% at 1, 2, 3, 4, and 5 years, respectively, higher than those of previous studies. Patients without obesity, metabolic syndrome, and dyslipidemia did not have a significantly longer acitretin survival compared to patients with these comorbidities. Conclusions Long‐term, low‐dose acitretin in patients with psoriasis is unlikely to cause significant liver or lipid problems. In countries with difficulty accessing biological agents for psoriasis, acitretin may have a high drug survival rate due to its long‐term safety. This study has several limitations: its retrospective nature, single‐center study design, and small sample size.

Prevalence of non‐alcoholic fatty liver and liver fibrosis in patients with moderate–severe psoriasis: A cross‐sectional cohort study

“…Chularojanamontri L et al . showed that low doses of acitretin were not related to significant long‐term liver problems …”

New Treatment Addressing the Pathogenesis of Psoriasis

“…Retinoids are derivatives of vitamin A and bind to nuclear receptors, retinoic acid receptors, and retinoid X receptors, which regulate gene transcription such as IL6 [ 6 ]. Retinoids induce keratinocyte differentiation and reduce epidermal hyperplasia, leading to a slowing of cell reproduction [ 62 ]. Etretinate, which is a second-generation retinoid, is used in Japan, and acitretin, which is an active metabolite of etretinate, has a shorter half-life, and is eliminated more rapidly than etretinate, is used in many countries [ 62 ].…”

“…Retinoids induce keratinocyte differentiation and reduce epidermal hyperplasia, leading to a slowing of cell reproduction [ 62 ]. Etretinate, which is a second-generation retinoid, is used in Japan, and acitretin, which is an active metabolite of etretinate, has a shorter half-life, and is eliminated more rapidly than etretinate, is used in many countries [ 62 ]. The Psoriasis Area Severity Index 75 (PASI75) response to acitretin 25, 35, and 50 mg/day groups at week 12 were 47%, 69%, and 53%, respectively [ 63 ].…”

“…The Psoriasis Area Severity Index 75 (PASI75) response to acitretin 25, 35, and 50 mg/day groups at week 12 were 47%, 69%, and 53%, respectively [ 63 ]. The main adverse effects were dry mouth, cheilitis, pruritus, teratogenicity, and elevations in serum lipid and liver enzymes [ 62 , 63 ].…”

Practical recommendations for systemic treatment in psoriasis according to age, pregnancy, metabolic syndrome, mental health, psoriasis subtype and treatment history (BETA‐PSO: Belgian Evidence‐based Treatment Advice in Psoriasis; part 1)

“…61,62 Regarding acitretin, serum aminotransferase elevation has been noted, but is usually self-limiting. 63 Psoriasis subtypes Nail psoriasis. From an efficacy perspective, we recommend in psoriasis patients with nail disease the TNF antagonists: infliximab, adalimumab, certolizumab pegol and etanercept; the IL12/23 inhibitor: ustekinumab; the IL23/ p19 inhibitors: guselkumab and risankizumab; the IL17 receptor blocker: brodalumab; the IL17 inhibitors: ixekizumab and secukinumab; and the synthetic drug, apremilast.…”