A total of 15,554 patients were analyzed. There were a total of 11,881 anti-TNF–treated patients and 3,673 nbDMARD-treated patients, a ratio of about 3:1. The incidence of shingles was approximately double in the anti-TNF–treated patients (1.6 per 100 patient-years) compared to the nbDMARD patients (0.8 per 100 patient-years). After adjusting for potential confounders (e.g., age, sex, disease severity, disease duration, comorbidities), the hazard ratio (HR) for shingles was 1.7 in RA patients on anti-TNF therapy. Among the 320 cases of shingles, 20 of 21 were severe and occurred in the anti-TNF–treated patients. The HR for developing shingles was 1.5 in the adalimumab-treated patients; 1.7 for the etanercept-treated patients; and 2.2 for infliximab-treated patients. In addition, 269 SSSIs were reported in the anti-TNF group and 39 in the nbDMARD-treated group. The SSSI incidence rate was 1.6 per 100 patient-years for the anti-TNF–treated patients and 0.7 per 100 patient-years for the nbDMARD-treated patients; this was not statistically significant. Most infections were staphylococcus cellulitis, but there were four cases of necrotizing fasciitis. The authors note that these study findings would support the use of zoster vaccination in this patient population.
In addition, in a recently published study Winthrop et al evaluated the herpes zoster risk in a large U.S. multiinstitutional collaboration in new TNF-α inhibitor–treated patients with RA, and other inflammatory diseases.10 A total of 33,324 TNF-α inhibitor–treated patients and 25,742 nbDMARD-treated patients were evaluated. Of TNF-α inhibitor–treated patients, there were 310 herpes zoster cases comprising 12.1 per 1,000 patient-years for RA, with baseline corticosteroid use of more than 10 mg daily associated with an increase zoster risk. It did not appear that these patients were at higher risk for zoster compared to those treated with nbDMARDs. Comorbidities and other factors were not known for these patients and they comprised a large number of Medicare and Medicaid recipients. Therefore, it seems that when different criteria and study design is used, it is still unclear whether patients taking anti-TNFs are at a higher risk for developing herpes zoster.
Peginesatide (Omontys), a synthetic erythropoiesis stimulating agent, was recalled in February due to severe hypersensitivity reactions, some fatal.11 The agent was approved by the Food and Drug Administration (FDA) in March 2012 to treat adults with anemia from chronic kidney disease receiving hemodialysis; more than 25,000 people have received it. Severe hypersensitivity reactions occurred in 0.2% of patients, with fatal anaphylactic reactions occurring in 0.02% of patients. During its FDA approval process, peginesatide was endorsed by a 15-to-1 vote, and at that time had no “safety signals.”
