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New Guideline: Vaccinations OK With Few Tweaks for Rheum Patients

Nearly all available vaccines can be given to people with rheumatologic diseases, according to a new, detailed guideline from the American College of Rheumatology (ACR), though the timing for their administration and dosing of antirheumatic drugs may need adjustment in some cases.

Only live attenuated-virus vaccines were considered inappropriate for certain patients, namely those taking immunosuppressive drugs that would be risky to withhold, concluded an ACR panel led by Anne R. Bass, MD, of the Hospital for Special Surgery in New York City.

The January 4 publication represents the ACR's first attempt to craft recommendations covering all the major types of vaccinations. It follows the August 2022 release of a three-page summary that hit the high points, but necessarily skipped over the nuances now described in the full 13-page, small-type guideline, and backed by a nearly 1,000-page evidence report.

The guideline covers vaccines against influenza, pneumococcal infection, varicella-zoster virus (VZV), human papillomavirus (HPV), and more than a dozen other product types. It cannot be called comprehensive, however, because COVID-19 vaccines were excluded. The writing committee explained that "the fast-changing nature of the pandemic and the COVID-19-related literature" made it impossible to provide recommendations that would not quickly be overtaken by new discoveries.

"COVID-19 vaccinations will be incorporated into a future guideline update once the pertinent literature has stabilized," the panel wrote. In the meantime, they suggested that clinicians refer to CDC recommendations as they evolve. The guideline also doesn't address vaccinations for patients taking medications such as avacopan (Tavneos) that first gained approval while the guideline was nearing completion.

Highlights of the new guideline include:

  • Flu vaccines may be given to all rheumatology patients, although high-dose or adjuvanted non-live virus products are recommended for patients 65 and over and for those taking immunosuppressive medications. Also, methotrexate should be stopped for 2 weeks after influenza vaccination. Other antirheumatic drugs including rituximab (Rituxan) and immunosuppressants may be continued normally.
  • Patients on rituximab should generally have non-live vaccines administered on the day their next rituximab dose is due, with that dose then deferred for 2 weeks.
  • Use of immunosuppressants should not preclude the generally recommended administration of HPV or recombinant VZV vaccines in adults.
  • Patients on corticosteroid doses of 20 mg/day or more in prednisone equivalents should have most vaccinations deferred until the steroid doses are brought below 20 mg. Flu vaccines, however, can be given even with steroids at ≥20 mg/day.
  • Patients with high disease activity can still receive vaccinations normally.
  • When live-virus vaccines are considered (e.g., the intranasal flu vaccine, non-recombinant VZV vaccines, and products for rotavirus, typhoid, yellow fever, and measles-mumps-rubella) for patients on immunosuppressants, these drugs should either be stopped prior to vaccination and for 4 weeks afterward, or else the vaccination should be deferred.
  • The live rotavirus vaccine is OK for infants younger than 6 months with fetal exposure to tumor necrosis factor inhibitors, but should be delayed till after 6 months for those exposed in utero to rituximab.
  • Multiple vaccinations can be given on the same day for all rheumatology patients without exception.

Most of these recommendations were graded as conditional ("uncertainty" about the balance of benefits vs risks) because high-quality evidence was lacking. That was true as well for those graded as strong ("very confident" of positive benefit-risk balance) because, despite the paucity of data, more than 70% of panel members were convinced of their correctness. Conditional recommendations, the panel added, mean that patient preference should have more weight in decision-making.

Bass and colleagues noted that this lack of hard evidence should prompt further research. They offered four suggestions: development of standardized trial designs to assess vaccination outcomes "across all age groups"; focused studies of live-virus vaccines in children on methotrexate and biologic antirheumatic drugs; trials for high-dose and adjuvanted flu vaccines, recombinant VZV products, and COVID-19 vaccinations specifically in rheumatologic disease patients; and studies to examine risks and benefits of antirheumatic drug holidays around the time of vaccinations.


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The author has no conflicts of interest to disclose related to this subject