Patients: Forty-four patients with newly diagnosed GCA that was in glucocorticosteroid (GCC)-induced remission.
Intervention: Participants were randomly assigned in a two-to-one ratio to receive infliximab (5 mg/kg of body weight) or placebo. Sixteen patients were assigned to GCC plus placebo, and 28 patients to GCC plus infliximab.
Measurements: End points were measured through Week 22, when an interim analysis resulted in early stopping of the planned 54-week trial. Primary end points were the number of patients who remained free of relapse through Week 22 and adverse events. Secondary end points were time to first relapse, biomarkers, cumulative GCC dose, and the number of patients who remained relapse free while the GCC dosage was tapered to 10 mg/d.
Results: Infliximab therapy did not increase the proportion of patients without relapse at Week 22 compared with placebo (43% versus 50%, respectively; difference, -7 percentage points [95% CI, -38 to 23 percentage points]; p=0.65), nor did it increase the proportion of patients whose GCC dosages were tapered to 10 mg/d without relapse (61% versus 75%, respectively; difference, -14 percentage points [CI, -42 to 14 percentage points]; p=0.31). The incidence of infection was 71% with infliximab and 56% with placebo (difference, 15 percentage points [CI, -14 to 45 percentage points]).
Limitations: The sample was too small to rule out modest effects of infliximab and included only patients with a new diagnosis. Only one dose of infliximab was evaluated, and the study was terminated early.
Conclusions: This trial is too small to draw definitive conclusions, but it provides evidence that using infliximab as maintenance therapy in patients in GCC-induced remission of newly diagnosed GCA is of no benefit and may be harmful. If infliximab has benefit, it is unlikely to be great.
Salvarani C, Macchioni P, Manzini C, et al. Infliximab plus prednisone or placebo plus prednisone for the initial treatment of polymyalgia rheumatica. Ann Intern Med. 2007; 146: 631-639.
Background: A reliable alternative to steroids for treating polymyalgia rheumatica (PMR) has not yet been identified. Although infliximab has been used occasionally in steroid-resistant cases, its efficacy has not been demonstrated in a controlled study.
Objective: To compare the efficacy of prednisone plus infliximab with that of prednisone plus placebo in patients with newly diagnosed PMR.
Design: Randomized, placebo-controlled trial.
Setting: Seven rheumatology clinics in Italy.
Patients: Fifty-one patients with newly diagnosed PMR. Patients with associated GCA and those who had been previously treated with steroids or biological or immunosuppressive agents were excluded.