Should a patient with a severe infection on Rinvoq (upadacitinib) be admitted to the hospital?

Hospital Admission for Patients with Severe Infection on Rinvoq (Upadacitinib)

Yes, a patient with a severe infection while on Rinvoq (upadacitinib) should be admitted to the hospital for management and close monitoring.

Rationale for Hospitalization

Rinvoq carries a black box warning regarding serious infections that may lead to hospitalization or death 1. The FDA label explicitly states that patients on Rinvoq are at increased risk for developing serious infections, and if a serious infection develops, Rinvoq should be interrupted until the infection is controlled.

Key Factors Supporting Hospital Admission:

1. Immunosuppressive Risk Profile

   • Rinvoq is a JAK inhibitor that significantly impairs immune function
   • The FDA label specifically warns that "patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death" 1
   • Most patients who developed serious infections while on Rinvoq were taking concomitant immunosuppressants such as methotrexate or corticosteroids 1

2. Infection Severity Assessment

   • Severe infections while on immunosuppressive therapy require prompt evaluation and management
   • According to IDSA/ATS guidelines, patients with severe infections should be hospitalized 2
   • The BTS guidelines recommend hospital admission for severely ill patients with suspected pneumonia and those with elevated risk of complications 2

3. Medication Management

   • Rinvoq should be interrupted during serious infections 1
   • Intravenous antibiotics may be required for severe infections
   • Close monitoring of response to antimicrobial therapy is necessary

Clinical Decision Algorithm

Step 1: Assess Infection Severity

• Presence of systemic inflammatory response syndrome (SIRS) criteria:

  • Temperature >38°C or <36°C
  • Heart rate >90 beats/minute
  • Respiratory rate >20 breaths/minute
  • White blood cell count >12,000/mm³ or <4,000/mm³

• Additional severity markers:

  • Hypoxemia (SaO₂ <92% or PaO₂ <8 kPa)
  • Hypotension (systolic BP <90 mmHg)
  • Altered mental status
  • Bilateral or multilobar involvement on chest imaging
  • Rapid progression of symptoms

Step 2: Consider Comorbidities and Risk Factors

• Patient is on Rinvoq (major immunosuppressive risk)
• Any additional immunosuppressive medications
• Age and underlying conditions
• History of prior serious infections

Step 3: Decision for Admission

• Admit if ANY of the following are present:
  • Severe infection (any SIRS criteria or severity markers)
  • Moderate infection with comorbidities
  • Inability to tolerate oral medications
  • Need for close monitoring
  • Need for intravenous antibiotics

Management Considerations

1. Interrupt Rinvoq Treatment

   • The FDA label clearly states: "If a patient develops a serious infection, interrupt RINVOQ treatment until the infection is controlled" 1

2. Antimicrobial Therapy

   • Initiate empiric broad-spectrum antibiotics based on suspected source
   • Obtain appropriate cultures before starting antibiotics when possible
   • Consider coverage for opportunistic pathogens

3. Monitoring Requirements

   • Regular assessment of vital signs
   • Laboratory monitoring (CBC, inflammatory markers)
   • Evaluation of response to therapy

Special Considerations

• Opportunistic Infections: Patients on Rinvoq are at risk for opportunistic infections including tuberculosis, invasive fungal infections, and viral infections like herpes zoster 1

• Laboratory Abnormalities: Monitor for neutropenia, lymphopenia, and anemia which may be exacerbated by both the infection and Rinvoq 1

• Thrombosis Risk: Patients on JAK inhibitors have increased risk of thrombosis, which may be further elevated during acute infections 1

Conclusion

The decision to hospitalize a patient with severe infection on Rinvoq should not be taken lightly. Given the black box warning on the FDA label regarding serious infections and the recommendation to interrupt treatment until infection is controlled, hospital admission allows for appropriate monitoring, administration of intravenous antibiotics if needed, and careful management of both the infection and the patient's underlying condition.