Table 7.
Summary of recommendations*
| Recommendations | Level of evidence† | PICO | Evidence table page numbers |
|---|---|---|---|
| Expanded indications for specific vaccines in patients with RMDs receiving immunosuppression | |||
| Influenza vaccination | |||
| For patients with RMD age ≥65 years and patients with RMD age >18 and <65 years who are taking immunosuppressive medication, giving high‐dose or adjuvanted influenza vaccination is conditionally recommended over giving regular‐dose influenza vaccination. | PICO 9. Very low (indirect evidence only)‡ | PICO 9. In patients with RMD age ≥65 years, is high‐dose influenza vaccine more effective than seasonal regular‐dose influenza vaccine? | 728 |
| PICO 10. Very low (indirect evidence only)‡ | PICO 10. In patients with RMD age ≥65 years, is adjuvanted influenza vaccine more effective than seasonal regular‐dose influenza vaccine? | 728 | |
| PICO 11. Moderate | PICO 11. In patients with RMD <65 years of age, is high‐ dose vaccine more effective than seasonal regular‐dose influenza vaccine? | 728–737 | |
| PICO 12. Very low (indirect evidence only)‡ | PICO 12. In patients with RMD <65 years of age, is adjuvanted influenza vaccine more effective than seasonal regular‐dose influenza vaccine? | 737 | |
| Pneumococcal vaccination | |||
| For patients with RMD age <65 years who are taking immunosuppressive medication, pneumococcal vaccination is strongly recommended. | PICO 20. Low | PICO 20. Should patients with RMD receive vaccination against pneumococcus at age <65 years? | 933–952 |
| Recombinant VZV vaccination | |||
| For patients with RMD age >18 years who are taking immunosuppressive medication, administering the recombinant VZV vaccine is strongly recommended. | PICO 21. Very low (indirect evidence only)‡ | PICO 21. Should patients with RMD receive VZV vaccination at age <50 years? | 952 |
| HPV vaccination | |||
| For patients with RMD age >26 and <45 years who are taking immunosuppressive medication and are not previously vaccinated, vaccination against HPV is conditionally recommended. | PICO 19. Very low | PICO 19. Should patients with RMD be vaccinated against HPV at age >26 years? | 931–933 |
| Whether to hold immunosuppressive medication at the time of non–live attenuated vaccination to maximize vaccine immunogenicity, although holding medications could be associated with disease flare | |||
| For patients with RMD, holding methotrexate for 2 weeks after influenza vaccination is conditionally recommended, assuming disease activity allows. | PICO 3. Very low for most comparisons, moderate for a few | PICO 3. In patients with [RMD disease X], what is the effect of [drug Y/drug class] on immunization responses to [vaccine Z, vaccine type] in comparison with [general population, or drug Y]? | 7–550 |
| PICO 15. TNFi: low; tocilizumab: very low; secukinumab: very low; tofacitinib: moderate; glucocorticoids: very low; abatacept: very low | PICO 15. In patients with RMD, does the immunogenicity or efficacy of influenza vaccine differ in patients taking drug Y as compared to those not taking drug Y at the time of vaccination? | 754–898 | |
| PICO 16. MTX: moderate; tofacitinib: low; other medications: indirect evidence only | PICO 16. Should patients with RMD taking drug Y hold their drug Y for a period of time prior to or after receiving (not live attenuated) vaccines? | 898–927 | |
| For patients with RMD, continuing immunosuppressive medications other than methotrexate around the time of influenza vaccination is conditionally recommended. | PICO 3. Very low for most comparisons, moderate for a few | PICO 3. In patients with [RMD disease X], what is the effect of [drug Y/drug class] on immunization responses to [vaccine Z, vaccine type] in comparison with [general population, or drug Y]? | 7–550 |
| PICO 15. TNFi: low; tocilizumab: very low; secukinumab: very low; tofacitinib: moderate; glucocorticoids: very low; abatacept: very low | PICO 15. In patients with RMD, does the immunogenicity or efficacy of influenza vaccine differ in patients taking drug Y as compared to those not taking drug Y at the time of vaccination? | 754–898 | |
| PICO 16. MTX: moderate; tofacitinib: low; other medications: indirect evidence only | PICO 16. Should patients with RMD taking drug Y hold their drug Y for a period of time prior to or after receiving (not live attenuated) vaccines? | 898–927 | |
| For patients with RMD, continuing immunosuppressive medications around the time of other (non‐influenza) non–live attenuated vaccinations is conditionally recommended. | PICO 3. Very low for most comparisons, moderate for a few | PICO 3. In patients with [RMD disease X], what is the effect of [drug Y/drug class] on immunization responses to [vaccine Z, vaccine type] in comparison with [general population, or drug Y]? | 7–550 |
| PICO 16. MTX: moderate; tofacitinib: low; other medications: indirect evidence only | PICO 16. Should patients with RMD taking drug Y hold their drug Y for a period of time prior to or after receiving (not live attenuated) vaccines? | 898–927 | |
| Timing vaccinations in patients receiving rituximab to maximize vaccine efficacy | |||
| For patients with RMD receiving rituximab, administering influenza vaccination on schedule is conditionally recommended rather than deferring vaccination until the next rituximab administration is due. | PICO 17. Low | PICO 17. Should patients with RMD who are taking rituximab time non–live attenuated vaccine administration relative to the next dose of medication? | 927–930 |
| For patients with RMD receiving rituximab, deferring non–live attenuated vaccinations, other than influenza vaccination, until the next rituximab administration is due, and delaying rituximab for 2 weeks after vaccination, is conditionally recommended. | |||
| Whether to administer non–live attenuated vaccinations to patients receiving glucocorticoids or defer vaccination to a later time point to maximize vaccine immunogenicity | |||
| For patients with RMD who are taking the equivalent of prednisone ≤10 mg daily, administering any non–live attenuated vaccinations is strongly recommended. | PICO 4. Low for pneumococcal vaccines, very low for other vaccines | PICO 4. In patients with RMD, does the immunogenicity or efficacy of vaccine Z differ in patients taking high‐dose teroids as compared to those taking lower doses of steroids or those not taking steroids? | 551–579 |
| PICO 14. Very low | PICO 14. In patients with RMD, does the immunogenicity or efficacy of influenza vaccine differ in patients taking high‐dose steroids as compared to those taking lower doses of steroids or those not taking steroids? | 739–754 | |
| For patients with RMD who are taking the equivalent of prednisone >10 mg daily but <20 mg daily, administering any non–live attenuated vaccinations is conditionally recommended. | PICO 4. Low for pneumococcal vaccines, very low for other vaccines | PICO 4. In patients with RMD, does the immunogenicity or efficacy of vaccine Z differ in patients taking high‐dose steroids as compared to those taking lower doses of steroids or those not taking steroids? | 551–579 |
| PICO 14. Very low | PICO 14. In patients with RMD, does the immunogenicity or efficacy of influenza vaccine differ in patients taking high‐dose steroids as compared to those taking lower doses of steroids or those not taking steroids? | 739–754 | |
| For patients with RMD taking the equivalent of prednisone ≥20 mg daily, administering influenza vaccination is conditionally recommended. | PICO 14. Very low | PICO 14. In patients with RMD, does the immunogenicity or efficacy of influenza vaccine differ in patients taking high‐dose steroids as compared to those taking lower doses of steroids or those not taking steroids? | 739–754 |
| For patients with RMD who are taking the equivalent of prednisone ≥20 mg daily, deferring non–live attenuated vaccinations, other than the influenza vaccine, until glucocorticoids are tapered to the equivalent of prednisone <20 mg daily is conditionally recommended. | PICO 4. Low for pneumococcal vaccines, very low for other vaccines | PICO 4. In patients with RMD, does the immunogenicity or efficacy of vaccine Z differ in patients taking high‐dose steroids as compared to those taking lower doses of steroids or those not taking steroids? | 551–579 |
| Whether to defer vaccination in patients with high disease activity to maximize vaccine immunogenicity and/or avoid worsening disease activity | |||
| For patients with RMD, giving non–live attenuated vaccinations is conditionally recommended regardless of patients’ disease activity. | PICO 13. Very low | PICO 13. In patients with RMD, does the immunogenicity or efficacy of influenza vaccine differ in patients who have moderate to severely active underlying disease as compared to those in low disease activity or remission? | 737–739 |
| PICO 18. Very low | PICO 18. Should moderately to severely ill patients with RMD with disease X defer vaccination (not live attenuated) until the disease is better controlled? | 930–931 | |
| Managing immunosuppressive therapy at the time of live attenuated vaccination to avoid vaccine‐associated illness | |||
| For patients with RMD who are taking immunosuppressive medication, deferring live attenuated vaccines is conditionally recommended. | PICO 23. Very low | PICO 23. Should patients with RMD taking drug Y receive live attenuated vaccines? | 952–960 |
| For patients with RMD, holding immunosuppressive medication for an appropriate period before and 4 weeks after live attenuated virus vaccination is conditionally recommended. | PICO 24. Very low | PICO 24. Should patients with RMD taking drug Y hold the drug for a period of time prior to or after receiving live attenuated vaccines? | 960–964 |
| When to administer rotavirus vaccine to infants with second‐ and/or third‐trimester antenatal exposure to biologic DMARDs in utero | |||
| For neonates/infants with second‐ and/or third‐trimester antenatal exposure to TNFi, giving live attenuated rotavirus vaccine within the first 6 months of life is conditionally recommended. | PICO 25. Very low | PICO 25. Should neonates/infants with second‐ and third‐ trimester antenatal exposure to TNFi or rituximab receive live attenuated rotavirus vaccine in their first 6 months of life? | 964–966 |
| For neonates/infants with second‐ and/or third‐trimester antenatal exposure to rituximab, delaying live attenuated rotavirus vaccine until >6 months of age is conditionally recommended. | PICO 25. Very low | PICO 25. Should neonates/infants with second‐ and third‐ trimester antenatal exposure to TNFi or rituximab receive live attenuated rotavirus vaccine in their first 6 months of life? | 964–966 |
| Whether to give multiple vaccinations to patients with RMD on the same day | |||
| For patients with RMD, giving multiple vaccinations on the same day rather than giving each individual vaccination on a different day is conditionally recommended. | PICO 22. Very low (indirect evidence only)‡ | PICO 22. Should patients with RMD receive standardized regimens of vaccine combinations? | 952 |
= Strong recommendation.
= Conditional recommendation.
*
PICO = population, intervention, comparator, outcomes; RMD = rheumatic and musculoskeletal disease; VZV = varicella‐zoster virus; HPV = human papillomavirus; MTX = methotrexate; TNFi = tumor necrosis factor inhibitors; DMARDs = disease‐modifying antirheumatic drugs.
†
The terms ‘moderate’, ‘low’, and ‘very low’ are based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) definitions for quality of evidence. Moderate quality means that “further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.” Low quality means that “further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.” Very low quality means that “we are very uncertain about the estimate.” In the systematic review for this guideline, a judgment of moderate quality required at least some evidence from randomized controlled trials, and a judgment of low quality required at least some evidence from well‐designed observational studies with appropriate comparator groups.
‡
Indirect evidence indicates that there is evidence from other populations with RMD or other health conditions, or evidence that does not fully address the comparison specified in a PICO question.