A multidisciplinary group of Canadian clinicians has developed evidence-based clinical guidelines for the vaccination of patients receiving immunosuppressive and immunomodulatory agents for the treatment of immune-mediated diseases. The recommendations have been published in The Journal of Rheumatology.

At this time, immunization rates among patients with immune-mediated diseases are suboptimal, which is partly because of uncertainty about their safety and efficacy in this population.

A multidisciplinary team consisting of clinicians with expertise in gastroenterology, dermatology, rheumatology, and infectious diseases used literature searchers to identify relevant clinical trials, meta-analyses, systematic reviews, observational studies, case series, and existing guidelines published from 2009 to 2017. They used selected evidence to develop their initial guidelines statements, which then underwent 2 rounds of revisions based on author feedback. The strength of the recommendations and the quality of evidence were rated according to GRADE methodology.

A summary of the recommendations is as follows:

General vaccination recommendations

  • For patients who have been newly diagnosed with immune-mediated diseases, clinicians should assess their immunization status and administer age- and condition-appropriate vaccines before initiating immunosuppressive treatment (strong recommendation; moderate-level evidence).

Recommendations for inactivated vaccine

  • Clinicians should give immunizations at least 2 weeks before initiating patients on immunosuppressive therapy to optimize the immunogenicity of inactivated vaccines in treatment-naive patients with immune-related conditions (conditional recommendation; moderate-level evidence).
  • Clinicians should not interrupt immunosuppressive treatment to administer inactivated vaccines in patients with immune-mediated diseases who are currently receiving immunosuppressive therapy (strong recommendation, moderate-level evidence).
  •  Among patients with immune-mediated diseases who are being treated with rituximab and require optimal vaccine immunogenicity, clinicians should defer immunizations to ≥5 months after the last dose and at least 4 weeks before the next dose of rituximab (strong recommendation; low-level evidence).

Recommendations for live attenuated herpes zoster vaccine

  • Immunization should be performed at least 2 to 4 weeks before initiating immunosuppressive therapy to optimize the immunogenicity of the live attenuated herpes zoster vaccine in treatment-naive patients with immune-mediated conditions (conditional recommendation; moderate-level evidence).
  • For patients with immunization-mediated diseases receiving immunosuppressive drugs, the subunit herpes zoster vaccine is the preferred alternative, although the live attenuated vaccine can be safely administered with some risk. If the live vaccine is being considered, clinicians should assess individual situations for patients who are being treated with a combination of immunosuppressive drugs (strong recommendation; moderate-level evidence).

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Recommendations for other live attenuated vaccines

  • For treatment-naive patients with immune-mediated diseases who have been vaccinated with live attenuated vaccines, clinicians should consider the duration of viremia after immunization to determine the best time to initiate immunosuppressive therapy (strong recommendation; very low level evidence).
  • For patients with immune-mediated diseases who have interrupted immunosuppressive treatment before vaccination, clinicians should consider the duration of viremia after immunization to determine the best time to re-initiate immunosuppressive therapy (strong recommendation; very low level evidence).
  • For patients with immune-mediated disease who are receiving immunosuppressive agents, clinicians should administer live attenuated vaccines when individual benefits outweigh the perceived risks (conditional recommendation; low-level evidence).
  • Immunosuppressive treatment should be interrupted for a duration based on drug pharmacokinetics before immunization with live vaccines in situations where patient safety is a top concern and the clinical situation allows for it (conditional recommendation; low-level evidence).

Recommendations for vaccination of infants with early exposure to immunosuppressive agents

  • If an infant is exposed to immunosuppressive agents in utero during the third trimester, clinicians should administer inactivated vaccines according to the local immunization schedule (strong recommendation; very low level evidence).
  • If an infant is exposed to immunosuppressive agents in utero during the third trimester, clinicians should administer the measles, mumps, and rubella and varicella vaccines according to the local immunization schedule (strong recommendation; low-level evidence).
  • For infants breast-fed by mothers who are receiving immunosuppressive regiments, clinicians should administer inactivated and live attenuated vaccines to the infants, according to local immunization schedule, without delay (strong recommendation; very low level evidence).

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Reference

Papp KA, Haraoui B, Kumar D, et al. Vaccination guidelines for patients with immune-mediated disorders taking immunosuppressive therapies: executive summary [published online February 1, 2019]. J Rheumatol. doi: 10.3899/jrheum.180784