Live shingles vaccine shows safe, short-term efficacy for persons taking TNFis for inflammatory diseases

1. Live shingles vaccine shows safe, short-term efficacy for persons taking TNFis for inflammatory diseases

A randomized controlled trial found that the live shingles, or varicella-zoster, vaccine was safe and showed short-term efficacy for participants also taking tumor necrosis factor inhibitors (TNFis) for a broad range of inflammatory disorders.  These finding suggest that a live virus vaccine in immunosuppressed patients receiving biologic therapies may be a reasonable option, especially for the zoster vaccine, if no alternative vaccine is available. The findings are published in Annals of Internal Medicine. 

TNFis are increasingly used in the United States and worldwide to treat a range of chronic autoimmune and inflammatory diseases, including rheumatoid arthritis, psoriasis, and inflammatory bowel diseases, but their use may result in immunosuppression. Compared with the general population, patients with these conditions are at higher risk for varicella-zoster virus reactivation, or shingles, due to their underlying disease states and commonly used immunosuppressive treatments, such as glucocorticoids. The safety and effectiveness of live virus vaccines largely are unknown in this patient population.

Researchers from the University of Alabama at Birmingham (UAB) and Oregon Health Sciences University (OHSU) randomly assigned 617 participants receiving TNFIs to either the live varicella-zoster vaccine or placebo to determine its safety and efficacy for preventing shingles in these immunocompromised patients. Among those studied, the most common conditions were rheumatoid arthritis (57.6%) and psoriatic arthritis (24.1%); TNFi medications taken were adalimumab (32.7%), infliximab (31.3%), etanercept (21.2%), golimumab (9.1%), and certolizumab (5.7%); and concomitant therapies included methotrexate (48.0%) and oral glucocorticoids (10.5%). Through 6 weeks of observation, there were no cases of vaccine-associated shingles or varicella infection, and the vaccine was well tolerated. The authors noted that although vaccine-induced immunogenicity responses were robust, cell-mediated responses were variable and not sustained at 1 year after vaccination, suggesting that patients may need to be evaluated for a booster vaccination. The authors conclude that although historically contraindicated, the live varicella-zoster vaccine may be considered for those using TNFIs, particularly in healthcare settings where no alternative zoster vaccine is available.

Media contacts For an embargoed PDF, please contact Angela Collom at [email protected]. The corresponding author, Jeffrey R. Curtis, MD, MS, MPH, can be reached at [email protected].

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2. SGLT2 inhibitors associated with reduced risk for hospitalization for heart failure compared with GLP-1 RAs in patients with diabetes with or without CVD

A large population-based cohort study found that sodium–glucose cotransporter-2 (SGLT2) inhibitors were associated with a reduced risk for hospitalization for heart failure compared with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) when initiated for treatment of type 2 diabetes in patients with or without cardiovascular disease (CVD). The two medications did not largely differ with respect to the risk for hospitalization for myocardial infarction or stroke, regardless of whether the patient had established CVD. The findings are published in Annals of Internal Medicine.

CVD is the leading cause of morbidity and mortality in patients with type 2 diabetes, who are also at substantially elevated risk for heart failure. Recent meta-analyses found that both GLP-1 RAs and SGLT2 inhibitors reduced the risk for major adverse cardiovascular events (MACE) in these patients, with SGLT2s offering a more substantial reduction in the risk for hospitalization with heart failure. Current guidelines recommend both therapies for patients with diabetes and atherosclerotic CVD and recommend SGLT2 inhibitors for patients with a history of heart failure. However, there is a lack of randomized trials directly comparing the two therapies for cardiovascular event prevention.

Researchers from Brigham and Women’s Hospital and Harvard Medical School studied data from Medicare and 2 U.S. commercial claims databases for 370,000 patients with type 2 diabetes, including more than 100,000 with established CVD, to evaluate whether SGLT2 inhibitors and GLP-1 RAs are associated with differential cardiovascular benefit. They found that initiating SGLT2 inhibitor versus GLP-1 RA therapy was associated with no differences in the risk of hospitalization for myocardial infarction or stroke and rates of myocardial infarction and stroke were similar regardless of CVD history.  However, among patients with CVD at the time of drug initiation, there was a 10% decrease in risk of myocardial infarction and stroke for those who started SGLT2 inhibitor versus GLP-1 RA therapy. The researchers also found that initiation of SGLT2 inhibitor versus GLP-1 RA therapy was associated with an approximately 30% reduction in the risk for hospitalization for heart failure in all included patients. The absolute benefit in reducing the risk of heart failure hospitalization was substantially greater among patients with CVD compared with those without CVD. The data showed no meaningful differences in the risk for all-cause mortality in those who initiated SGLT2 inhibitor versus GLP-1 RA therapy.  However, among patients with CVD at the time of drug initiation, a decrease in the risk of all-cause mortality was seen among those who received SGLT2 inhibitors. According to the researchers, these data provide much needed understanding of the comparative cardiovascular effectiveness of SGLT2i vs. GLP-1RA in routine care patients with and without cardiovascular disease, and may help clinicians and patients choose which of the two classes to use.

Media contacts For an embargoed PDF, please contact Angela Collom at [email protected]. To speak with the corresponding author, Elisabetta Patorno, MD, DrPH, please contact Serena Bronda at [email protected].

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3. ACP Leaders call for strategies to support the well-being of the physician workforce in the COVID-19 environment

A group of American College of Physicians (ACP) leaders are calling on employers to provide tactical support to physicians and other clinicians to ensure they can safely care for patients and support one another during the COVID-19 pandemic. The commentary is published in Annals of Internal Medicine.

The authors say employers must move beyond suggesting stress reduction activities such as yoga and meditation. They call upon every health system, hospital, and clinical practice to adopt a variety of recommendations, considering recommendations in conjunction with their frontline clinicians to decide which would be most impactful and feasible in their current environments. Recommendations include:

• Ensuring physical safety by reducing clinician’s risk of contracting COVID through vaccination mandates, policies and practices that ensure universal masking and adequate ventilation in work areas, and access to personal protective equipment. 
• Providing professional development and training in the areas clinicians identify as causing emotional stress or moral injury.
• Providing sufficient time during clinical encounters for members of the care team to address COVID-19 and vaccine misinformation.
• Supporting clinicians who are parents by offering flexible work schedules, support groups, and supporting policies for reducing SARS-CoV-2 transmission in school settings.
• Reducing administrative tasks that are not mission critical.
• Adopting robust anti-discrimination and anti-harassment policies to acknowledge and mitigate harm particularly against minoritized people.
• Offering free and confidential resources to support clinicians’ mental health including the ACP IM Emotional Support Hub.
• Updating credentialing and employment applications to remove unnecessary questions about mental and physical health diagnoses.
• Actively encouraging clinicians to use vacation and professional development days available to nurture a mentally healthy workplace.
• Implementing suicide prevention strategies including “wellness check-ins” for clinicians in hard-hit areas.