In a hepatitis B‑naïve patient with psoriasis who is about to start adalimumab, how should hepatitis B vaccination be managed (schedule, timing of doses, and need for protective anti‑HBs titers)?

Management of Hepatitis B Vaccination in HBV-Naïve Psoriasis Patients Starting Adalimumab

In a hepatitis B-naïve patient with psoriasis starting adalimumab, complete the standard 3-dose hepatitis B vaccine series (0,1, and 6 months) and verify protective anti-HBs titers (≥10 mIU/mL) 1–2 months after the final dose before initiating adalimumab. 1

Pre-Treatment Screening Requirements

Before starting adalimumab, all psoriasis patients must undergo hepatitis B screening with triple serology: 2

• Hepatitis B surface antigen (HBsAg)
• Hepatitis B core antibody (anti-HBc)
• Hepatitis B surface antibody (anti-HBs)
• Liver function tests

This screening is essential because TNF-α inhibitors like adalimumab carry risk of hepatitis B reactivation, with documented cases of subfulminant liver failure and fatalities reported. 3, 4

Vaccination Schedule for HBV-Naïve Patients

For patients who test negative for all hepatitis B markers (truly naïve), administer the hepatitis B vaccine series: 1

• Dose 1: At baseline (week 0)
• Dose 2: 1 month after first dose
• Dose 3: 6 months after first dose

The first and second doses must be separated by at least 1 month, and the first and third doses by at least 4 months. 1 Administer intramuscularly in the deltoid muscle, not the buttock. 1

Post-Vaccination Testing Requirements

Mandatory postvaccination testing is required 1–2 months after completing the vaccine series to confirm protective immunity before starting adalimumab. 1, 5 This testing should measure anti-HBs using a method that detects the protective threshold of ≥10 mIU/mL. 1

Interpretation of Post-Vaccination Results:

If anti-HBs ≥10 mIU/mL: 1, 5

• Patient is considered immune and protected
• Safe to proceed with adalimumab therapy
• No further routine booster doses needed (immunocompetent persons maintain long-term protection through immune memory)

If anti-HBs <10 mIU/mL (non-responder): 5

• Administer one additional standard dose of hepatitis B vaccine
• Recheck anti-HBs 1–2 months after the booster dose
• If still <10 mIU/mL, proceed with a complete second 3-dose series (0,1,6 months)
• Among initial non-responders, 60–97% achieve protective levels after a booster dose, and 44–100% respond to a complete second series 5

Timing of Adalimumab Initiation

Delay adalimumab initiation until protective anti-HBs titers (≥10 mIU/mL) are documented. 1, 5 This typically means:

• Minimum 7–8 months from starting vaccination (if responsive after primary series)
• Longer if additional doses or second series required for non-responders

The risk of hepatitis B reactivation with TNF-α inhibitors is well-documented, with infliximab showing the highest reactivation rate among TNF-α inhibitors, though adalimumab also carries this risk. 3 Starting immunosuppression without confirmed protective immunity exposes patients to potentially fatal hepatitis B infection.

Ongoing Monitoring After Starting Adalimumab

Once adalimumab is initiated in a vaccinated patient with protective titers: 5

• No routine booster doses are needed for immunocompetent patients (immune memory persists even when antibody levels decline)
• No periodic anti-HBs retesting is required for immunocompetent individuals
• Continue standard adalimumab monitoring including periodic liver function tests 6

Common Pitfalls to Avoid

Do not start adalimumab before confirming protective anti-HBs titers. 1 The 7–8 month delay for vaccination may seem burdensome, but reactivation of hepatitis B during TNF-α inhibitor therapy can result in severe hepatitis, liver failure, and death. 3, 4

Do not rely on patient recall of prior vaccination. 5 Only accept dated vaccination records as evidence. If documentation is unavailable, perform serologic testing and vaccinate if non-immune.

Do not assume vaccination alone is sufficient without post-vaccination testing. 1 Approximately 10–15% of immunocompetent adults fail to respond to the primary vaccine series, and these non-responders remain at risk. 5

Do not confuse HBV-naïve patients with those who have isolated anti-HBc positivity (occult carriers). 1, 3 The latter group requires different management with potential antiviral prophylaxis and closer monitoring, not just vaccination.