Abstract
IntroductionTo elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR.MethodsTwenty newly diagnosed, glucocorticoid (GC) naïve 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.ResultsAt 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.ConclusionsEtanercept monotherapy ameliorates disease activity in GC naïve patients with PMR. However, the effect is modest, indicating a minor role of TNF-α in PMR.Trial registrationClinicalTrials.gov (NCT00524381).
Highlights
To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) a and the therapeutic potential of blockade with soluble TNF-a receptor, we carried out the first randomized controlled trial with etanercept in PMR
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 positive effect of etanercept is evident from the 24% reduction of PMR activity score (PMR-AS) in patients treated with the drug, as well as the insignificant changes in PMR-AS observed in placebo-treated patients (Figure 2)
Summary
To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) a and the therapeutic potential of blockade with soluble TNF-a receptor, we carried out the first randomized controlled trial with etanercept in PMR. Polymyalgia rheumatica (PMR) is the most common chronic inflammatory disease in the elderly [1]. 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 prevailing view is that PMR reflects inflammatory processes in synovial membranes in joints, The only effective treatment is medium-dose glucocorticoids (GC), which abolish symptoms within a few days [10]. Because long-term treatment is necessary, serious adverse effects, including type 2 diabetes, hypertension, and osteoporosis, are frequent [11]
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