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Patient with active or incompletely controlled pre-existing autoimmune or inflammatory di...

Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.

IDRF-ACTIVE-AUTOIMMUNE-DISEASE-ICI-RISK
TypeRed flag
Statusreviewed 2026-05-04 | pending_clinical_signoff
DiseasesDIS-BREAST DIS-CERVICAL DIS-CHL DIS-CRC DIS-ENDOMETRIAL DIS-ESOPHAGEAL DIS-GASTRIC DIS-HCC DIS-HNSCC DIS-MELANOMA DIS-MESOTHELIOMA DIS-NSCLC DIS-PMBCL DIS-RCC DIS-UROTHELIAL
SourcesSRC-ESMO-ICI-TOXICITY-2022 SRC-SITC-ICI-IRAEMANAGEMENT-2021

Red Flag Origin

DefinitionPatient with active or incompletely controlled pre-existing autoimmune or inflammatory disease (sarcoidosis, rheumatoid arthritis, IBD, SLE, autoimmune hepatitis, inflammatory myopathy, myasthenia gravis, or similar) is considered for immune checkpoint inhibitor (ICI) therapy — elevated risk of immune-related adverse events (irAE) flare or de-novo grade 3-4 irAE. Requires specialist (rheumatology / pulmonology / gastroenterology) pre-treatment review; prefer lower-irAE-burden backbone when options exist (pembrolizumab mono > ipilimumab+nivolumab).
Clinical directionde-escalate
Categoryfitness-eligibility

Trigger Logic

{
  "any_of": [
    {
      "finding": "active_autoimmune_disease",
      "value": true
    },
    {
      "finding": "autoimmune_disease_active",
      "value": true
    },
    {
      "finding": "active_sarcoidosis",
      "value": true
    },
    {
      "finding": "pulmonary_sarcoidosis_active",
      "value": true
    },
    {
      "finding": "active_rheumatoid_arthritis",
      "value": true
    },
    {
      "finding": "active_inflammatory_bowel_disease",
      "value": true
    },
    {
      "finding": "active_crohn_disease",
      "value": true
    },
    {
      "finding": "active_ulcerative_colitis",
      "value": true
    },
    {
      "finding": "active_autoimmune_hepatitis",
      "value": true
    },
    {
      "finding": "active_lupus",
      "value": true
    },
    {
      "finding": "active_sle",
      "value": true
    },
    {
      "finding": "active_inflammatory_myopathy",
      "value": true
    },
    {
      "finding": "active_myasthenia_gravis",
      "value": true
    },
    {
      "finding": "active_multiple_sclerosis",
      "value": true
    },
    {
      "finding": "active_psoriasis_systemic",
      "value": true
    }
  ],
  "type": "composite_clinical"
}

Notes

Pre-existing autoimmune disease is present in ~10-15% of patients eligible for ICI therapy; historically excluded from pivotal trials. Real-world data (Abdel-Wahab 2018, 3557 pts) shows 55% experienced irAE flare and ~29% required systemic immunosuppression beyond steroids. Risk stratification by SITC 2021: - **Low risk** (generally safe to proceed with monitoring): thyroiditis, vitiligo, stable psoriasis, type 1 diabetes — irAE flare mild, manageable. - **Moderate risk** (proceed with specialist input): RA, IBD (Crohn/UC), sarcoidosis, sicca syndrome, psoriatic arthritis — flare rate ~50%; baseline DMARDs often OK to continue (methotrexate, HCQ but NOT high-dose steroids or anti-TNF at start). - **High risk** (strongest caution; consider alternative if available): active autoimmune hepatitis, myasthenia gravis, inflammatory myopathy, neuromyelitis optica — flare can be life-threatening; benefit-risk discussion mandatory. Pulmonary sarcoidosis specifically: ICI-induced sarcoid-like reactions are well-documented (5-7% of patients on ICI), often mimicking disease progression on imaging. Active pulmonary sarcoidosis + ICI raises risk of severe pulmonary irAE (gr 3 pneumonitis). Pre-I...

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