Indian dermatology online journal
October 8, 2026 · via Europe PMC
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.
Singh SK, De S.
AI summary — for doctors, generated from the abstract only
Low-dose methotrexate plus acitretin gave improvements similar to standard methotrexate monotherapy in plaque psoriasis in an open-label trial, with earlier onset in the monotherapy arm.
What was studied
Nonblinded randomized trial of 134 patients (67 per group) with chronic plaque psoriasis (BSA >10%, PASI >10) comparing methotrexate alone with a reduced-dose methotrexate and acitretin combination over 16 weeks.
Key findings
- Both arms showed significant reductions in BSA and PASI at 16 weeks
- PASI-75, 90 and 100 were slightly higher with monotherapy but not significantly different on per-protocol or intention-to-treat analysis
- Onset of action was earlier with monotherapy (P = 0.001), and adverse effects were mild and manageable in both groups
Clinical relevance
Offers a possible alternative combination approach under monitoring; this summary gives no dosing guidance.
Who should care
Limitations
Nonblinded, no acitretin-only arm, short 16-week duration, and no noninvasive liver fibrosis assessment; the claim of equivalence is not directly tested.
Combination was similar overall, but slower to act.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
Abstract
Background
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.
Aim and objectives
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.
Patients and methods
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.
Results
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.
Limitations
Nonblinded, absence of ACI monotherapy arm, limited study duration, and lack of noninvasive hepatic fibrosis assessment.
Conclusion
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.
DOI
10.4103/idoj.idoj_1317_25
PMID
42849024
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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