What tests and vaccinations are required before starting Tofacitinib (Janus kinase inhibitor) or Upadacitinib (Janus kinase inhibitor)?

Pre-Treatment Testing and Vaccinations for Tofacitinib and Upadacitinib

Before initiating tofacitinib or upadacitinib, you must complete tuberculosis screening, hepatitis B/C testing, baseline laboratory monitoring (CBC with differential, liver enzymes, renal function, lipid panel), and administer the recombinant zoster vaccine (Shingrix) along with other indicated non-live vaccines. 1, 2, 3

Mandatory Baseline Laboratory Testing

Complete Blood Count Requirements

• Obtain CBC with differential at baseline to ensure safe initiation thresholds are met 1, 3
• Do not initiate tofacitinib if: 4, 3
  • Lymphocyte count <500 cells/mm³
  • Absolute neutrophil count (ANC) <1000 cells/mm³
  • Hemoglobin <9 g/dL
• Do not initiate upadacitinib if: 5
  • Similar hematologic thresholds apply per FDA guidance

Metabolic and Hepatic Monitoring

• Obtain comprehensive metabolic panel (CMP) at baseline including liver enzymes (transaminases), renal function tests (creatinine, BUN) 1, 2
• Check lipid profile at baseline (total cholesterol, LDL, HDL, triglycerides) as JAK inhibitors cause dose-dependent lipid elevations 1, 3
• Avoid initiation in severe hepatic impairment for both agents 4, 3

Infectious Disease Screening

Tuberculosis Testing

• Screen all patients for latent tuberculosis before initiation using interferon-gamma release assay (IGRA) or tuberculin skin test 1, 2, 6
• Obtain chest X-ray if not recently performed, particularly in high-risk patients 2
• Complete treatment for latent TB before starting JAK inhibitors if positive 2

Viral Hepatitis Screening

• Test for hepatitis B virus (HBV): HBsAg, anti-HBs, and anti-HBc antibodies 1, 2
• If HBsAg positive (chronic HBV): Avoid JAK inhibitors if possible; if unavoidable, initiate antiviral prophylaxis (entecavir, tenofovir) with hepatology consultation 2
• If anti-HBc positive only: Check baseline HBV DNA to exclude occult infection; monitor for reactivation during treatment 2
• Test for hepatitis C virus (HCV) antibody and RNA if indicated 1

HIV Testing

• Consider HIV screening in patients with risk factors 1

Required Vaccinations Before Treatment

Herpes Zoster Vaccination (Priority)

• Administer recombinant zoster vaccine (Shingrix) before initiating JAK inhibitors - this is the single most important vaccination 4, 5, 7, 6
• Give 2-dose series separated by 2-6 months for patients ≥18 years old 7
• If recombinant vaccine unavailable: Live zoster vaccine must be given at least 3-4 weeks before starting treatment 7, 6
• Rationale: Herpes zoster risk increases 2-fold with JAK inhibitors, particularly with concomitant glucocorticoids 8

Other Recommended Vaccinations

• Inactivated pneumococcal vaccine for patients ≥18 years 7
• Annual influenza vaccine (inactivated) 7
• Complete all indicated non-live vaccines before treatment initiation, as JAK inhibitors impair vaccine responses 7, 6
• Update all routine immunizations per current guidelines 3

Critical Vaccination Timing

• Never administer live vaccines concurrently with JAK inhibitors 4, 3
• Wait at least 4 weeks after live vaccination before starting tofacitinib 3
• Consider 1-week pause after COVID-19 vaccination to ensure adequate immune response 6

Additional Baseline Assessments

Pregnancy and Contraception

• Obtain pregnancy test in all patients of childbearing potential 2
• Counsel on contraception requirements during treatment 2

Cardiovascular Risk Assessment

• Document history of venous thromboembolism (VTE) - JAK inhibitors carry increased VTE risk 2, 6
• Assess cardiovascular risk factors: age >65 years, smoking, obesity, inherited thrombophilias, exogenous estrogen use, recent surgery, immobility 6
• Use caution in patients >65 years due to increased infection and cardiovascular risks 2, 6

Dermatologic Screening

• Perform baseline skin examination for non-melanoma skin cancer in at-risk patients 2

Post-Initiation Monitoring Schedule

Early Monitoring (4-12 Weeks)

• Repeat CBC with differential at 4-8 weeks after starting treatment 1, 7, 3
• Recheck liver enzymes at 4 weeks (abrocitinib) or per routine (upadacitinib) 5
• Measure lipids at 4 weeks (abrocitinib) or 12 weeks (upadacitinib) 5

Ongoing Monitoring (Every 3 Months)

• CBC with differential every 3 months 1, 3
• CMP every 3 months 1
• Lipid panel annually after initial post-treatment check 1, 7

Common Pitfalls to Avoid

• Do not skip zoster vaccination - this is the most preventable serious adverse event with JAK inhibitors 4, 5
• Do not initiate with active serious infection including localized infections 3
• Do not combine with other potent immunosuppressants (azathioprine, cyclosporine, tacrolimus) or biologics 4
• Do not overlook HBV reactivation risk in anti-HBc positive patients 2
• Do not use standard tofacitinib dosing in moderate-severe renal or hepatic impairment - reduce to 5 mg once daily 4, 3