Acitretin (Ro 10-1670, Etretin): Overall Evaluation of Clinical Studies

Abstract

Acitretin (Ro 10-1670, etretin) is the free acid derivative of etretinate. This compound possesses a much shorter half-life of elimination than etretinate and was therefore proposed for clinical development. A total of 635 patients with various dermatoses were studied in 12 main clinical trials performed in Europe and in the United States. It was shown that acitretin is effective in the treatment of psoriasis and other diseases of keratinization. Doses between 25 and 35 mg per day are recommended to initiate treatment since marked improvement or clearing was obtained in the majority of patients within this range. Hypervitaminosis A signs and symptoms have been observed in patients treated with acitretin. It is concluded that the efficacy and safety profile of acitretin resembles that of etretinate.

British Association of Dermatologists guidelines on the efficacy and use of acitretin in dermatology

“…A 'retinoid dermatitis', which may resemble unstable psoriasis, can also develop in up to 25% of patients receiving high-dose oral acitretin. 13,94,95 The severity of mucocutaneous side-effects was found to be dose related in some studies, with a higher incidence at doses of 50-75 mg daily. 13,94,95 However, this was not found to be the case in other studies.…”

“…13,94,95 The severity of mucocutaneous side-effects was found to be dose related in some studies, with a higher incidence at doses of 50-75 mg daily. 13,94,95 However, this was not found to be the case in other studies. 9,14 If severe mucocutaneous reactions occur during effective therapy with acitretin, dose reduction should be attempted before discontinuing the drug.…”

“…20,94 Gradual dose escalation has been shown to be the most effective approach and allows gradual onset of 'tolerance' to side-effects. 94,132 The initial daily dose, 25 mg or 30 mg for 2-4 weeks, may give satisfactory therapeutic results. The maintenance dose must be based on clinical efficacy and tolerability.…”

Determination of Acitretin and 13<i>-cis-</i>Acitretin in Skin

“…Acitretin (Ro 10-1670) is the main and active metabolite of etretinate with compa rable clinical effects to those of etretinate [1], In contrast to etretinate, acitretin is not se questered into fatty tissue and as a conse quence is eliminated much more rapidly from the body [2,3]. Previous studies have described the plasma pharmacokinetics of acitretin and its 13-os metabolite (Ro 13-7652) [2][3][4][5].…”

Efficacy of Acitretin and Commercial Tanning Bed Therapy for Psoriasis

“…A meta-analysis of 12 studies of acitretin monotherapy reported that only 30.4% of patients with plaque-type psoriasis achieved clearance. 16 Also, studies of TBUV alone showed only a 6% to 37% decrease in PASI. 11,12 When reviewed with the results reported by other retinoid and UV light combination therapy studies, re-TBUV fairs well.…”