Efficacy and Safety of Treatment with Methotrexate Versus a Combination of Low Dose of Methotrexate Plus Low Dose of Acitretin in Chronic Plaque Psoriasis: A Randomised Nonblinded Controlled Trial.

Authors

Satyendra K Singh, Sagnik De

Published in

Indian dermatology online journal. Oct 08, 2026. Epub Oct 08, 2026.

Abstract

Psoriasis is a chronic, inflammatory disease with no cure. Methotrexate (MTX) and acitretin (ACI) are well-established, FDA-approved systemic therapies for chronic plaque psoriasis. However, randomized trials evaluating their combination in fixed low doses are limited due to concerns of additive hepatotoxicity.
To assess and compare efficacy and safety of treatment with MTX (0.3 mg/kg/week) versus low-dose MTX (0.15 mg/kg/week) plus low-dose ACI (0.3 mg/kg/day) in patients with chronic plaque psoriasis.
This was a nonblinded randomized controlled trial. Patients with chronic plaque psoriasis having body surface area (BSA)>10% and psoriasis area severity index (PASI)>10 were randomized into two groups. One group received intramuscular MTX 0.3 mg/kg/week, and the other received intramuscular MTX 0.15 mg/kg/week plus oral ACI 0.3 mg/kg/day. Patients were followed every 2 weeks for first 4 weeks and monthly thereafter till 16 weeks.
A total of 134 patients (67 in each group) were analyzed. Baseline BSA and PASI were comparable between groups ( P = 0.54 and P = 0.82, respectively) and showed significant reduction at 16 weeks in both arms ( P = 0.01 and P = 0.04). PASI-75, 90, and 100 at 16 weeks were slightly higher in monotherapy group but not statistically significant on per-protocol or intention-to-treat analyses. Onset of action was significantly earlier in monotherapy group ( P = 0.001). Laboratory and clinical adverse effects between groups were mild and manageable.
Nonblinded, absence of ACI monotherapy arm, limited study duration, and lack of noninvasive hepatic fibrosis assessment.
Low-dose MTX plus ACI is a safe and effective alternative to standard-dose MTX in chronic plaque psoriasis, provided regular monitoring and follow-up are ensured.

PMID:
42849024
Bibliographic data and abstract were imported from PubMed on 09 Oct 2026.

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