Guideline statements*.
| Statement | Recommendation | Evidence Level/Recommendation Strength |
|---|---|---|
| Statement 1 | In patients newly diagnosed with immune-mediated diseases, we recommend that immunization status be assessed, and age- and condition-appropriate vaccines be administered prior to initiation of immunosuppressive treatment. | Strong recommendation, moderate-level evidence |
| Inactivated vaccines | ||
| Statement 2a | To optimize the immunogenicity of inactivated vaccines in treatment- naive patients with immune-mediated conditions, we suggest that immunization be performed at least 2 weeks prior to initiation of immunosuppressive therapy, whenever possible. | Conditional recommendation, moderate-level evidence |
| Statement 2b | Among patients with immune-mediated diseases currently receiving immunosuppression, we recommend that immunosuppressive treatment not be interrupted for administration of inactivated vaccines. | Strong recommendation, moderate-level evidence |
| Statement 2c | In patients with immune-mediated diseases treated with RTX who require optimal vaccine immunogenicity, we recommend that immunization be deferred to ≥ 5 mos after the last dose and at least 4 weeks prior to the subsequent dose of RTX. | Strong recommendation, low-level evidence |
| Live attenuated herpes zoster vaccine | ||
| Statement 3a | To optimize the immunogenicity of the live attenuated herpes zoster vaccine in treatment-naive patients with immune-mediated conditions, we suggest immunization be performed at least 2–4 weeks prior to initiation of immunosuppressive therapy. | Conditional recommendation, moderate-level evidence |
| Statement 3b | In patients with immune-mediated diseases receiving immunosuppressive agents, the live attenuated herpes zoster vaccine can be safely administered to patients at risk, but the subunit vaccine is the preferred alternative. Individual situations should be assessed for patients treated with a combination of immunosuppressive drugs, if the live vaccine is being considered. | Strong recommendation, moderate-level evidence |
| Other live attenuated vaccines | ||
| Statement 4a | In treatment-naive patients with immune-mediated diseases who are vaccinated with live attenuated vaccines, we recommend that the duration of viremia following immunization be considered when determining the optimal time to initiate immunosuppressive therapy. | Strong recommendation, very low-level evidence |
| Statement 4b | In patients with immune-mediated diseases who interrupt immunosuppressive treatment prior to vaccination, we recommend that the duration of viremia following immunization be considered when determining the optimal time to re-initiate immunosuppressive therapy. | Strong recommendation, very low-level evidence |
| Statement 4c | In patients with immune-mediated diseases receiving immunosuppressive agents, we suggest that live attenuated vaccines be administered when individual benefits outweigh the perceived risks. | Conditional recommendation, low-level evidence |
| Statement 4d | In situations where patient safety is a paramount concern and the clinical situation allows, we suggest that immunosuppressive treatment be interrupted for a duration based on drug pharmacokinetics prior to immunization with live vaccines. | Conditional recommendation, low-level evidence |
| Vaccination of infants with early exposure to immunosuppressive agents | ||
| Statement 5a | In infants exposed to immunosuppressive agents in utero during the third trimester, we recommend that inactivated vaccines be administered according to the local immunization schedule. | Strong recommendation, very low-level evidence |
| Statement 5b | In infants exposed to immunosuppressive agents in utero during the third trimester, we recommend that the MMR and varicella vaccines be administered according to the local immunization schedule. | Strong recommendation, low-level evidence |
| Statement 5c | In infants breast-fed by mothers receiving immunosuppressive regimens, we recommend that inactivated and live attenuated vaccines be administered according to the local immunization schedule without delay. | Strong recommendation, very low-level evidence |
↵* Further information is available in the full guidelines11. RTX: rituximab; MMR: measles, mumps, rubella.