Patient-reported outcomes in polymyalgia rheumatica.
Matteson EL., Maradit-Kremers H., Cimmino MA., Schmidt WA., Schirmer M., Salvarani C., Bachta A., Dejaco C., Duftner C., Slott Jensen H., Poór G., Kaposi NP., Mandl P., Balint PV., Schmidt Z., Iagnocco A., Cantini F., Nannini C., Macchioni P., Pipitone N., Del Amo M., Espígol-Frigolé G., Cid MC., Martínez-Taboada VM., Nordborg E., Direskeneli H., Aydin SZ., Ahmed K., Hazelman B., Pease C., Wakefield RJ., Luqmani R., Abril A., Marcus R., Gonter NJ., Maz M., Crowson CS., Dasgupta B.
OBJECTIVE: To prospectively evaluate the disease course and the performance of clinical, patient-reported outcome (PRO) and musculoskeletal ultrasound measures in patients with polymyalgia rheumatica (PMR). METHODS: The study population included 85 patients with new-onset PMR who were initially treated with prednisone equivalent dose of 15 mg daily tapered gradually, and followed for 26 weeks. Data collection included physical examination findings, laboratory measures of acute-phase reactants, and PRO measures. Ultrasound evaluation was performed at baseline and Week 26 to assess for features previously reported to be associated with PMR. Response to corticosteroid treatment was defined as 70% improvement in PMR on visual analog scale (VAS). RESULTS: At baseline, 77% had hip pain in addition to shoulder pain and 100% had abnormal C-reactive protein or erythrocyte sedimentation rate. On ultrasound, 84% had shoulder findings and 32% had both shoulder and hip findings. Response to corticosteroid treatment occurred in 73% of patients by Week 4 and was highly correlated with percentage improvement in other VAS measures. Presence of ultrasound findings at baseline predicted response to corticosteroids at 4 weeks. Factor analysis revealed 6 domains that sufficiently represented all the outcome measures: PMR-related pain and physical function, an elevated inflammatory marker, hip pain, global pain, mental function, and morning stiffness. CONCLUSION: PRO measures and inflammatory markers performed well in assessing disease activity in patients with PMR. A minimum set of outcome measures consisting of PRO measures of pain and function and an inflammatory marker should be used in practice and in clinical trials in PMR.