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A randomized controlled trial showed that adding infliximab to steroids provided no measurable benefit in the management of newly diagnosed GCA(17, 19). Although the primary end point of the AHRQ-5d study (GCA) was established, the results of the 6-month treatment and outcome of the AHRQ-5d study have been largely questioned. A secondary end point of the HUS-HIPLE trial showed no benefit from infliximab treatment (20). These findings led the AHRQ to update its guidelines on infliximab as a treatment for GCA (2). Although results from randomized controlled trials are encouraging, the risk of side effects in patients receiving infliximab are not well understood. In the AHRQ GCA trial (which was initiated in 2009 and ended in 2014), patients experienced more than 50% of adverse effects during treatment (5). Although some of these reported adverse events were mild or transient, others were severe, chronic, and life-threatening. In the AHRQ study of patients receiving infliximab alone, more than 50% of adverse events and at least 8% of major depression symptoms occurred during the first 6 months of treatment (9). Patients treated with infliximab had more severe adverse events compared with those receiving the combination of infliximab, fluconazole, and risperidone (6). A meta-analysis of placebo-controlled trials of infliximab found that the overall risk of serious adverse events was 1% per 1000 person-years (2). A recent article in JAMA Internal Medicine examined the impact of infliximab on GCA in patients diagnosed with a non-Hodgkin's lymphoma (23). The investigators reported that there was no reduction in the annualized incidence of new cancer reported for patients who were receiving infliximab from 5 years to 14 years of follow-up in studies of older patients (≥65 years) (23). Because the incidence of new GCA in the elderly population is approximately 8% (4, 22, 39), a small reduction in GCA in the elderly population would result in a small impact on the overall incidence of GCA. However, there was a small reduction in the rates of new GCA for patients over age 65 in these studies (13, 23, 39). If the data from these studies can also be generalized to younger and older patients with GCA, combined with previous experience among young patients receiving infliximab, any modest impact on incidence of GCA would be substantial. The AHRQ guidelines for Related Article:
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