Methotrexate monotherapy vs. methotrexate plus leflunomide combination therapy for PsA

By Scott Cunningham, MD, PhD
Published April 26, 2022

Key Takeaways

  • Although combination methotrexate (MTX) plus leflunomide (LFM) is more effective in treating psoriatic arthritis (PsA) than MTX alone, mild side effects were more common in patients receiving combination therapy.

Putting It Into Practice

PsA is a complex inflammatory disease with variable musculoskeletal and cutaneous components, quality-of-life disturbances, extra-articular manifestations, and co-morbidities. Thus, devising a robust, effective, and well-tolerated treatment strategy can be challenging.

Currently, PsA is treated with traditional and conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs), biologics, and targeted agents; however, a clearly superior treatment regimen has not been established.

Why this study matters

Conventional synthetic DMARDs are currently first-line treatment for patients with PsA; however, optimal dosing and combination therapies have not been established.

This study showed that MTX plus LFM combination therapy is superior to MTX alone in the treatment of PsA, but not without increased untoward effects.

Study design

Seventy-eight patients (median age = 55 y) with a psoriatic arthritis disease activity score (PASDAS) > 5.4 were randomly stratified to one of the following groups and treated for 16 w: MTX (15 mg/w x 4 w, then 25 mg/w) + placebo; or MTX (15 mg/w x 4 w, then 25 mg/w) + LFM (10 mg x 2 qd).

Results and conclusion

The PASDAS after 16 w of treatment was 3.1 and 3.7 in the MTX + LFM combination and MTX monotherapy groups, respectively. Adverse events, such as nausea and vomiting, were mild, but more frequent in the combination treatment group.

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