Abstract | BACKGROUND: A reliable alternative to steroids for treating polymyalgia rheumatica 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: DESIGN: Randomized, placebo-controlled trial. SETTING: 7 rheumatology clinics in Italy. PATIENTS: 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 (3 in the infliximab group and 1 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 (6 of 20 patients [30%] in the infliximab group vs. 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 polymyalgia rheumatica is of no benefit and may be harmful. If there is benefit, it is unlikely to be large. Australian Clinical Trials Registry number: ACTRN012606000205538.
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Authors | Carlo Salvarani, PierLuigi Macchioni, Carlo Manzini, Giuseppe Paolazzi, Aldo Trotta, Paolo Manganelli, Marco Cimmino, Roberto Gerli, Maria Grazia Catanoso, Luigi Boiardi, Fabrizio Cantini, Catherine Klersy, Gene G Hunder |
Journal | Annals of internal medicine
(Ann Intern Med)
Vol. 146
Issue 9
Pg. 631-9
(May 01 2007)
ISSN: 1539-3704 [Electronic] United States |
PMID | 17470831
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Antibodies, Monoclonal
- Antirheumatic Agents
- Glucocorticoids
- Placebos
- Tumor Necrosis Factor-alpha
- Infliximab
- Prednisone
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Topics |
- Aged
- Antibodies, Monoclonal
(adverse effects, therapeutic use)
- Antirheumatic Agents
(adverse effects, therapeutic use)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Glucocorticoids
(adverse effects, therapeutic use)
- Humans
- Infliximab
- Male
- Middle Aged
- Placebos
- Polymyalgia Rheumatica
(drug therapy)
- Prednisone
(adverse effects, therapeutic use)
- Recurrence
- Remission Induction
- Tumor Necrosis Factor-alpha
(antagonists & inhibitors)
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