Assessing vaccination status in patients taking immunomodulatory drugs
Australian Technical Advisory Group on Immunisation (ATAGI), 2022Bastidas, 2019Friedman, 2016Furer, 2020GSK, 2022Hirzel, 2021Rubin, 2014Soy, 2021van Assen, 2011Wong, 2017
The optimal approach to vaccinating patients treated with immunomodulatory therapy for autoimmune or autoinflammatory disorders is not known; the following recommendations offer a practical approach based on expert consensusAustralian Technical Advisory Group on Immunisation (ATAGI), 2022.
Assess the patient’s vaccination history and serology. In particular, perform hepatitis B and C virus serology in all patients1; perform HIV serology if the patient’s history suggests they are at risk of HIV infection; and consider varicella zoster serology, particularly in patients planned for treatment with Janus kinase (JAK) inhibitors.
To minimise the risk of vaccine-preventable infections, ensure all patients with autoimmune or autoinflammatory disorders are kept up to date with recommended vaccines (including COVID-19, influenza and pneumococcal vaccines)23. If vaccination is recommended, it is ideally performed before starting immunomodulatory therapy because live vaccines may be contraindicated and the immunological response to both live and inactivated vaccines may be reduced in immunosuppressed patients. However, if immediate treatment of an autoimmune or autoinflammatory disorder is required, immunomodulatory therapy should not be delayed so that vaccination can be completed. Nor should inactivated vaccines be withheld after immunomodulatory therapy is started, even though immunological response may be reduced. If there is uncertainty about the degree of immunosuppression or when vaccine administration may be safe, seek specialist advice.
The patient’s risk of exposure to vaccine-preventable infections can be further reduced by ensuring their household contacts are kept up to date with recommended vaccines.
Live vaccines should not be given to patients already taking an immunomodulatory drug; they should be given at least 4 weeks before starting therapy to minimise the risk of adverse effects and vaccine-related disease. For a list of live vaccines, see the Australian Immunisation Handbook. It can be difficult to determine the degree of immunosuppression, especially in patients taking combination therapy; consult a person with expertise if there is any uncertainty. The consideration to administer live vaccines with immunomodulatory treatment interruption requires consultation with the relevant experts.
The exceptions are varicella vaccines, which can be given to patients treated with low-level immunosuppression but should not be administered to highly immunosuppressed patients4. The choice to administer these vaccines to patients with low-level immunosuppression should be based on shared decision making between the patient and clinician; in particular the balance of likely benefits and harms should be consideredStadtmauer, 2014.
Inactivated vaccines should ideally be given at least 2 weeks before starting immunomodulatory therapy for maximal immunogenicity; however, some vaccines require earlier administration (eg at least 4 weeks before immunomodulatory therapy)Hall, 2018. For patients who are receiving a B cell–depleting drug or tumour necrosis factor (TNF) inhibitor, larger or additional doses of hepatitis B vaccine may be required to achieve protective antibody titres–specialist advice is recommended.
COVID-19 vaccination is recommended for people taking immunomodulatory drugs. Despite immunosuppressed patients not being assessed in initial clinical trials, there is increasing evidence of safety and effectiveness in this populationBaden, 2021Furer, 2021Machado, 2022Polack, 2020. It is not usually necessary to withhold immunomodulatory drug therapy at the time of COVID-19 vaccination; However, consideration must be given to the timing of vaccination in relation to treatment with some drugs (eg abatacept, rituximab). The following resources provide up-to-date recommendations on COVID-19 vaccination for immunocompromised patients; see:
- ATAGI – COVID-19 vaccination – Shared decision making guide for people with immunocompromise
- An Australian Living Guideline for the Pharmacological Management of Inflammatory Arthritis
- Australian clinician guide for the use of immunomodulatory drugs in autoimmune rheumatic diseases at the time of COVID-19 vaccination—a companion to the living guideline.