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

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.