Intervention: Initial therapy with oral prednisone tapered from 15 mg/d to 0 mg/d over 16 weeks according to a standard protocol, plus infusions of placebo or infliximab, 3 mg/kg of body weight, at Weeks 0, 2, 6, 14, and 22.
Measurements: The primary efficacy end point was the proportion of patients without relapse or recurrence through Week 52. Secondary outcomes were the proportion of patients no longer taking prednisone, the number of relapses and recurrences, the duration of prednisone therapy, and the cumulative prednisone dose.
Results: Four patients (three in the infliximab group and one in the placebo group) did not complete the trial. The proportion of patients who were free of relapse and recurrence at 52 weeks did not differ between groups (six of 20 patients [30%] in the infliximab group versus 10 of 27 patients [37%] in the placebo group; adjusted risk difference, -3 percentage points [95% CI, -31 to 24 percentage points]; p=0.80). In a sensitivity analysis that included dropouts, the best-case scenario yielded a difference of 5 percentage points (CI, -21 to 31 percentage points) between the groups. The secondary outcomes at Weeks 22 and 52 did not differ between the groups.
Limitations: The study had a small sample and a short follow-up. A low dosage of infliximab was used, and the prednisone dosage was rapidly tapered.
Conclusions: Although too small to be definitive, the trial provides evidence that adding infliximab to prednisone for treating newly diagnosed PMR is of no benefit and may be harmful. If there is benefit, it is unlikely to be large.
Commentary
The need for meaningful alternatives to GCCs in treating GCA and PMR is painfully obvious to rheumatologists. Eighty percent of patients with GCA will experience at least one adverse event due to GCCs and overall morbidity of this therapy is high, especially in an older population. Unfortunately, studies to find safer treatments, such as methotrexate, to reduce the dose or duration of GCC therapy and lead to prolonged remissions have been disappointing to date.1,2
Growing knowledge of the role cytokine mediators in the vessels affected by GCA, including TNF, raises the possibility that the TNF-a inhibitors might be effective steroid-sparing agents. Several case reports suggested that infliximab could produce remissions in patients with GCA and PMR.3,4 Case studies are often encouraging—although sometimes misleading because of the bias in publishing positive results. Randomized trials are always important in determining the true value of a therapy, often dashing the hopes provided by the preliminary reports.
