Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

Twenty newly diagnosed, glucocorticoid (GC) na？ve patients with PMR and 20 matched non-PMR control subjects completed the trial. Subjects were randomized in a 1:1 ratio to monotherapy with etanercept (25 mg s.c. biweekly) or placebo (saline) for 14 days. Study outcomes were assessed at baseline and after 14 days. The primary outcome was the change in PMR activity score (PMR-AS). Secondary outcomes were: changes in erythrocyte sedimentation rate (ESR) and plasma levels of TNF-α and interleukin (IL) 6; patients' functional status (health assessment questionnaire) and cumulative tramadol intake during the trial.At baseline, plasma TNF-α was higher in patients than in controls (P < 0.05). The concentration always increased with etanercept treatment (P < 0.05). In patients, etanercept decreased PMR-AS by 24% (P = 0.011), reflecting significant improvements in shoulder mobility, physician's global assessment and C-reactive protein, and insignificant (P > 0.05) improvements in duration of morning stiffness and patient's assessment of pain. In parallel, ESR and IL-6 were reduced (P < 0.05). Placebo treatment did not change PMR-AS, ESR and IL-6 (P > 0.05). Functional status did not change and tramadol intake did not differ between patient groups. In controls, no changes occurred in both groups.Etanercept monotherapy ameliorates disease activity in GC na？ve patients with PMR. However, the effect is modest, indicating a minor role of TNF-α in PMR.ClinicalTrials.gov (NCT00524381).Polymyalgia rheumatica (PMR) is the most common chronic inflammatory disease in the elderly [1]. Clinically, it is characterized by pain in the neck and lower back as well as proximal extremity complaints, including tender, aching, and stiff muscles. Patients feel fatigued and their level of physical activity is reduced [1]. These symptoms are accompanied by elevated erythrocyte sedimentation rate (ESR) and increased blood levels of C-reactive protein (CRP) [1].The knowledge of the etiology and pathoph