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Efficacy and safety of acitretin in three fixed doses of 25, 35 and 50 mg in adult patients with severe plaque type psoriasis: a randomized, double blind, parallel group, dose ranging study.
J Eur Acad Dermatol Venereol. 2013 Mar; 27(3):e305-11.JE

Abstract

BACKGROUND

Acitretin is available for use in psoriasis since the late 1980s; however, there is no consensus on its optimum effective dose with acceptable side-effects.

OBJECTIVE

To evaluate the efficacy and safety of acitretin in three fixed doses in adult patients with severe plaque type psoriasis.

METHODS

This was a randomized, double blind, parallel group, dose ranging study. The study included patients of either gender (age range, 18-65 years) with severe chronic plaque type psoriasis. Of the 80 patients screened, 61 were randomly assigned to three groups: group A - 20 patients (acitretin 25 mg/day), group B - 20 patients (acitretin 35 mg/day) and group C - 21 patients (acitretin 50 mg/day) for 12 weeks. Forty-eight patients completed the study. The main outcome measure was change in Psoriasis Area Severity Index (PASI) score between the three groups from baseline to 12 weeks.

RESULTS

After 12 weeks of therapy, the percentage reduction in the PASI score was 54%, 76% and 54% in acitretin 25, 35 and 50 mg/day group respectively. PASI 75 was achieved in 47%, 69% and 53% patients in acitretin 25, 35 and 50 mg/day groups respectively. The majority of adverse events were mucocutaneous, mild-to-moderate severity and dose dependent.

CONCLUSIONS

Acitretin 35 mg/day was observed to be more efficacious compared to 25 mg/day and 50 mg/day dosing, whereas its safety profile is better than 50 mg/day dosing in the management of severe plaque type psoriasis in adult patients.

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Authors+Show Affiliations

Dogra S
Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Jain A
No affiliation info available
Kanwar AJ
No affiliation info available

MeSH

AcitretinAdultDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansKeratolytic AgentsMaleMiddle AgedPsoriasisYoung Adult

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

22816881

Citation

Dogra, S, et al. "Efficacy and Safety of Acitretin in Three Fixed Doses of 25, 35 and 50 Mg in Adult Patients With Severe Plaque Type Psoriasis: a Randomized, Double Blind, Parallel Group, Dose Ranging Study." Journal of the European Academy of Dermatology and Venereology : JEADV, vol. 27, no. 3, 2013, pp. e305-11.
Dogra S, Jain A, Kanwar AJ. Efficacy and safety of acitretin in three fixed doses of 25, 35 and 50 mg in adult patients with severe plaque type psoriasis: a randomized, double blind, parallel group, dose ranging study. J Eur Acad Dermatol Venereol. 2013;27(3):e305-11.
Dogra, S., Jain, A., & Kanwar, A. J. (2013). Efficacy and safety of acitretin in three fixed doses of 25, 35 and 50 mg in adult patients with severe plaque type psoriasis: a randomized, double blind, parallel group, dose ranging study. Journal of the European Academy of Dermatology and Venereology : JEADV, 27(3), e305-11. https://doi.org/10.1111/j.1468-3083.2012.04644.x
Dogra S, Jain A, Kanwar AJ. Efficacy and Safety of Acitretin in Three Fixed Doses of 25, 35 and 50 Mg in Adult Patients With Severe Plaque Type Psoriasis: a Randomized, Double Blind, Parallel Group, Dose Ranging Study. J Eur Acad Dermatol Venereol. 2013;27(3):e305-11. PubMed PMID: 22816881.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of acitretin in three fixed doses of 25, 35 and 50 mg in adult patients with severe plaque type psoriasis: a randomized, double blind, parallel group, dose ranging study. AU - Dogra,S, AU - Jain,A, AU - Kanwar,A J, Y1 - 2012/07/23/ PY - 2012/7/24/entrez PY - 2012/7/24/pubmed PY - 2014/9/24/medline SP - e305 EP - 11 JF - Journal of the European Academy of Dermatology and Venereology : JEADV JO - J Eur Acad Dermatol Venereol VL - 27 IS - 3 N2 - BACKGROUND: Acitretin is available for use in psoriasis since the late 1980s; however, there is no consensus on its optimum effective dose with acceptable side-effects. OBJECTIVE: To evaluate the efficacy and safety of acitretin in three fixed doses in adult patients with severe plaque type psoriasis. METHODS: This was a randomized, double blind, parallel group, dose ranging study. The study included patients of either gender (age range, 18-65 years) with severe chronic plaque type psoriasis. Of the 80 patients screened, 61 were randomly assigned to three groups: group A - 20 patients (acitretin 25 mg/day), group B - 20 patients (acitretin 35 mg/day) and group C - 21 patients (acitretin 50 mg/day) for 12 weeks. Forty-eight patients completed the study. The main outcome measure was change in Psoriasis Area Severity Index (PASI) score between the three groups from baseline to 12 weeks. RESULTS: After 12 weeks of therapy, the percentage reduction in the PASI score was 54%, 76% and 54% in acitretin 25, 35 and 50 mg/day group respectively. PASI 75 was achieved in 47%, 69% and 53% patients in acitretin 25, 35 and 50 mg/day groups respectively. The majority of adverse events were mucocutaneous, mild-to-moderate severity and dose dependent. CONCLUSIONS: Acitretin 35 mg/day was observed to be more efficacious compared to 25 mg/day and 50 mg/day dosing, whereas its safety profile is better than 50 mg/day dosing in the management of severe plaque type psoriasis in adult patients. SN - 1468-3083 UR - https://www.unboundmedicine.com/medline/citation/22816881/Efficacy_and_safety_of_acitretin_in_three_fixed_doses_of_25_35_and_50_mg_in_adult_patients_with_severe_plaque_type_psoriasis:_a_randomized_double_blind_parallel_group_dose_ranging_study_ L2 - https://doi.org/10.1111/j.1468-3083.2012.04644.x DB - PRIME DP - Unbound Medicine ER -