What are the potential complications of Disease-Modifying Antirheumatic Drug (DMARD) treatment?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: October 18, 2025View editorial policy

Personalize

Help us tailor your experience

Which best describes you? Your choice helps us use language that's most understandable for you.

Complications of Disease-Modifying Antirheumatic Drug (DMARD) Treatment

DMARDs carry significant risks of infections, malignancies, and organ toxicity that require careful monitoring and management throughout treatment. 1

Infection Risks

  • Biological DMARDs (bDMARDs) significantly increase the risk of serious infections compared to conventional synthetic DMARDs (csDMARDs), with TNF inhibitors showing a 3.1-fold increased risk and non-TNF biologics showing a 3.9-fold increased risk 1

  • Specific infection risks include:

    • Tuberculosis: Higher risk with monoclonal TNF antibodies compared to etanercept (adjusted odds ratio 2.49) 1
    • Herpes zoster: Increased risk with JAK inhibitors (tofacitinib) compared to abatacept (adjusted hazard ratio 2.01) 1
    • Opportunistic infections: Similar risk between tocilizumab and TNF inhibitors 1
  • Combination therapy with multiple biologics significantly increases infection risk without added benefit; therefore, combining TNF blockers with anakinra or abatacept is not recommended 2

Malignancy Risks

  • Long-term registry data have not confirmed initial fears of increased malignancy risk with most DMARDs, including TNF inhibitors 3

  • For patients with a history of cancer, the database is smaller but current evidence suggests no substantial increased risk of recurrence with DMARD therapy 3

  • JAK inhibitors require more surveillance as limited long-term data exists outside of clinical trials; one study showed increased malignancy risk with tofacitinib compared to TNF inhibitors in high-risk patients 3

Organ-Specific Toxicities

  • Liver toxicity: Methotrexate can cause hepatotoxicity ranging from transient elevation of liver enzymes to fibrosis and cirrhosis in rare cases 4

  • Retinal toxicity: (Hydroxy)chloroquine can cause irreversible retinopathy, one of the few non-reversible DMARD complications 4

  • Pulmonary complications: Interstitial lung disease and pulmonary fibrosis can occur with several DMARDs 2

  • Gastrointestinal perforations: Reported with some biologics, particularly in combination therapy 2

Hematological Complications

  • Blood dyscrasias: Various DMARDs can cause cytopenias, requiring regular blood count monitoring 4

  • Neutropenia: More common with certain biologics and can increase infection risk 1

Cardiovascular and Thrombotic Risks

  • Venous thromboembolism (VTE): Observed with JAK inhibitors in clinical trials 1

  • Major adverse cardiovascular events (MACE): Require monitoring, particularly in patients with pre-existing cardiovascular risk factors 1

Monitoring Recommendations

  • More intensive monitoring is required during the first few months of treatment when most adverse reactions occur 4

  • Standard monitoring includes:

    • Complete blood count
    • Liver function tests
    • Kidney function tests
    • Urinalysis
    • Ophthalmologic exams (for antimalarials) 4
  • Tuberculosis screening before initiating bDMARDs and monitoring during treatment 1

Management of Complications

  • Dose-dependent adverse effects may improve with dose reduction 4

  • Idiosyncratic reactions often require drug discontinuation 4

  • Most adverse reactions to DMARDs are reversible if detected early, with exceptions including hydroxychloroquine-induced retinopathy and methotrexate-induced liver cirrhosis 4

  • For difficult-to-treat patients, especially those with severe complications like macrophage activation syndrome, management in collaboration with expert centers is recommended 1

Special Considerations

  • Treatment adherence significantly impacts effectiveness and safety; non-adherence rates range from 30-80% in RA patients 1, 5

  • Patients with comorbidities have higher risk of adverse events and may require adjusted monitoring schedules 1

  • Glucocorticoids, while effective for controlling inflammation, have significant toxicity in intermediate to long-term use and should be used cautiously for short periods 1

  • Live vaccines should be avoided in patients on bDMARDs 2

By understanding and proactively monitoring for these potential complications, clinicians can optimize the benefit-risk ratio of DMARD therapy for patients with rheumatoid arthritis and other inflammatory conditions.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.