What is the risk of rheumatic complications associated with Immune Checkpoint Inhibitors (ICIs)?

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Last updated: March 26, 2025View editorial policy

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From the Guidelines

Immune checkpoint inhibitors (ICIs) are associated with a significant risk of rheumatic complications, including inflammatory arthritis, polymyalgia rheumatica-like syndromes, myositis, vasculitis, sicca syndrome, and lupus-like conditions, affecting approximately 10% of patients receiving these therapies 1.

Key Considerations

  • The risk of rheumatic complications varies by medication, with CTLA-4 inhibitors generally causing more severe reactions than PD-1/PD-L1 inhibitors 1.
  • These complications can occur at any time during treatment, even after discontinuation, and typically develop within 3-6 months of starting therapy 1.
  • Management depends on severity, ranging from symptomatic treatment with NSAIDs and low-dose corticorticoids for mild cases to higher-dose corticorticoids for moderate cases, and may require temporary or permanent ICI discontinuation and immunosuppressive therapy for severe cases 1.

Rheumatic Complications

  • Inflammatory arthritis: resembling rheumatoid arthritis or spondyloarthritis, with symptoms including joint pain and swelling 1.
  • Polymyalgia rheumatica-like syndromes: characterized by severe myalgia in the proximal upper and lower extremities, with severe fatigue 1.
  • Myositis: a rare but potentially severe complication, with symptoms including weakness, primarily in the proximal extremities, and myalgia 1.

Management

  • Symptomatic treatment with NSAIDs and low-dose corticorticoids is recommended for mild cases, while higher-dose corticorticoids and immunosuppressive therapy may be necessary for moderate to severe cases 1.
  • Temporary or permanent ICI discontinuation may be required for severe cases, and the decision to hold or continue cancer immunotherapy should be based on the severity of rheumatic immune-related adverse events, tumor response, and future oncology treatment plan 1.

Patient Monitoring

  • Regular assessment for joint pain, muscle weakness, dry eyes/mouth, and other rheumatic symptoms is essential during ICI therapy 1.
  • Patients with pre-existing autoimmune conditions have a higher risk of rheumatic complications and require careful monitoring 1.

From the Research

Risk of Rheumatic Complications

The use of Immune Checkpoint Inhibitors (ICIs) has been associated with significant immune-related adverse events (irAEs), including rheumatic complications.

  • Rheumatic irAEs can be categorized into de novo toxicity and flares of pre-existing rheumatic conditions 2.
  • The onset of de novo toxicity often occurs late into treatment, while flares of pre-existing rheumatic conditions occur shortly after ICI initiation 2.
  • Management of rheumatic irAEs often requires systemic or intra-articular steroids, as well as disease-modifying anti-rheumatic drug (DMARD) therapy in some cases 2, 3.

Prevalence of Rheumatic irAEs

  • The prevalence of arthralgia and myalgia in patients treated with ICIs has been reported to be common, ranging from 1-43% and 2-20%, respectively 4.
  • The prevalence of rheumatic irAEs such as inflammatory arthritis, vasculitis, and sicca syndrome is less clear from current evidence 4.
  • A study found that 32% of patients with rheumatoid arthritis (RA) developed immune-related adverse events (irAEs) after initiating ICI treatment, with 9% developing grade 3 (severe) irAEs 5.

Management and Treatment

  • The management of ICI-induced rheumatic irAEs includes the use of glucocorticoids, disease-modifying antirheumatic drugs (DMARDs), and biological agents 3.
  • A personalized approach to optimized combined therapy may be necessary to manage ICI-induced rheumatic irAEs, including the use of an ex vivo diagnostic assay to select the most effective ICI and antirheumatic drug combinations 3.
  • Close collaboration between oncologists and rheumatologists is advisable when considering ICIs in patients with pre-existing rheumatic conditions, such as RA 5.

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.

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