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Adverse events with disease modifying antirheumatic drugs (DMARD): a cohort study of leflunomide compared with other

Grant W Cannon1, William L Holden, Juhaeri Juhaeri

  • 1Veterans Affairs Salt Lake City Health Care System, Division of Rheumatology, University of Utah, Salt Lake City, Utah, USA. grant.cannon@med.va.gov

The Journal of Rheumatology
|October 7, 2004
PubMed
Abstract

Insights

Leflunomide (LEF) monotherapy for rheumatoid arthritis (RA) showed significantly lower adverse event (AE) rates compared to methotrexate (MTX) and other disease-modifying antirheumatic drugs (DMARDs). Combination therapy with LEF also demonstrated favorable AE profiles, highlighting its safety in RA treatment.

Area of Science:

  • Rheumatology
  • Clinical Pharmacology
  • Drug Safety

Background:

  • Rheumatoid arthritis (RA) management involves disease-modifying antirheumatic drugs (DMARDs).
  • Comparative safety data on specific DMARDs, particularly leflunomide (LEF), are crucial for clinical decision-making.
  • Understanding adverse event (AE) profiles is essential for optimizing RA treatment strategies.

Purpose of the Study:

  • To determine and compare the incidence of serious adverse events (AE) in rheumatoid arthritis (RA) patients treated with various disease-modifying antirheumatic drugs (DMARDs).
  • To specifically evaluate the safety profile of leflunomide (LEF) in comparison to other DMARDs and no-DMARD therapy.

Main Methods:

  • Retrospective cohort study utilizing a large US insurance claims database.
  • Patients with RA were classified by DMARD exposure: no-DMARD, single-agent DMARD (monotherapy), or combination-DMARD therapy.
  • Primary endpoints included hepatic, dermatologic, hematologic, infectious, respiratory, hypertension, and pancreatitis AEs.

Main Results:

  • Leflunomide (LEF) monotherapy demonstrated a significantly lower incidence rate of all AEs (94 events/1000 PY) compared to methotrexate (MTX) (145 events/1000 PY) and other DMARDs (143 events/1000 PY).
  • Combination therapy including LEF (LEF + MTX: 43/1000 PY; LEF + other DMARD: 59/1000 PY) showed lower AE rates than MTX-based combination therapy (70/1000 PY).
  • LEF monotherapy exhibited the lowest rate of hepatic events among DMARD monotherapy groups.

Conclusions:

  • Adverse event rates associated with leflunomide (LEF), both as monotherapy and in combination with methotrexate (MTX), were generally lower than or comparable to those observed with MTX and other agents.
  • Leflunomide presents a favorable safety profile for rheumatoid arthritis treatment.
  • These findings support the use of leflunomide in RA management, considering its comparative safety.

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