Canakinumab relieves symptoms of acute flares and improves health-related quality of life in patients with difficult-to-treat Gouty Arthritis by suppressing inflammation: results of a randomized, dose-ranging study

INTRODUCTION: We report the impact of canakinumab, a fully human anti-interleukin-1β monoclonal antibody, on inflammation and health-related quality of life (HRQoL) in patients with difficult-to-treat Gouty Arthritis. METHODS: In this eight-week, single-blind, double-dummy, dose-ranging study, patients with acute Gouty Arthritis flares who were unresponsive or intolerant to--or had contraindications for--non-steroidal anti-inflammatory drugs and/or colchicine were randomized to receive a single subcutaneous dose of canakinumab (10, 25, 50, 90, or 150 mg) (N = 143) or an intramuscular dose of triamcinolone acetonide 40 mg (N = 57). Patients assessed pain using a Likert scale, physicians assessed clinical signs of joint inflammation, and HRQoL was measured using the 36-item Short-Form Health Survey (SF-36) (acute version). RESULTS: At baseline, 98% of patients were suffering from moderate-to-extreme pain. The percentage of patients with no or mild pain was numerically greater in most canakinumab groups compared with triamcinolone acetonide from 24 to 72 hours post-dose; the difference was statistically significant for canakinumab 150 mg at these time points (P < 0.05). Treatment with canakinumab 150 mg was associated with statistically significant lower Likert scores for tenderness (odds ratio (OR), 3.2; 95% confidence interval (CI), 1.27 to 7.89; P = 0.014) and swelling (OR, 2.7; 95% CI, 1.09 to 6.50, P = 0.032) at 72 hours compared with triamcinolone acetonide. Median C-reactive protein and serum amyloid A levels were normalized by seven days post-dose in most canakinumab groups, but remained elevated in the triamcinolone acetonide group. Improvements in physical health were observed at seven days post-dose in all treatment groups; increases in scores were highest for canakinumab 150 mg. In this group, the mean SF-36 physical component summary score increased by 12.0 points from baseline to 48.3 at seven days post-dose. SF-36 scores for physical functioning and bodily pain for the canakinumab 150 mg group approached those for the US general population by seven days post-dose and reached norm values by eight weeks post-dose. CONCLUSIONS: Canakinumab 150 mg provided significantly greater and more rapid reduction in pain and signs and symptoms of inflammation compared with triamcinolone acetonide 40 mg. Improvements in HRQoL were seen in both treatment groups with a faster onset with canakinumab 150 mg compared with triamcinolone acetonide 40 mg. TRIAL REGISTRATION: clinicaltrials.gov: NCT00798369

GEMAS: Spatial distribution of the pH of European agricultural and grazing land soil

During 2008 the GEochemical Mapping of Agricultural Soils (GEMAS) project collected 2108 agricultural (ploughed soil, Ap horizon, 0–20 cm) and 2023 grazing land soil samples (Gr, 0–10 cm) evenly spread over 33 European countries and covering an area of 5.6 million km2. The pH of all samples was determined by one single laboratory applying a 0.01 M CaCl2 extraction, and following a strict quality-control procedure. The resulting pH-value distributions for European Ap and Gr soil are both bimodal. Broad acidic modes, with pH between 4 and 6, and sharp alkaline modes, with pH between 7 and 8 due to the Ca2+ buffer system, are clearly separated. The European median pH is 5.8 for the GEMAS Ap soil samples and 5.5 for the GEMAS Gr soil samples. According to the pH distribution maps, Europe is separated into two main zones: northern Europe with generally lower pH values (Ap: 5.2, Gr: 4.8), dominated by acidic soils occurring in Fennoscandia, and southern Europe with higher pH values (Ap: 6.3, Gr: 5.9), dominated by carbonate rich soils. The separation line coincides with the southern border of the sediments of the last glaciation. The dominant factors controlling pH at the European scale are thus geology (crystalline bedrock) in combination with climate (temperature and precipitation). The GEMAS pH maps mainly reflect the natural site conditions on the European scale, whilst anthropogenic impact is hardly detectable. The GEMAS results provide a unique set of homogenous and spatially representative soil pH data for the continent. The data set defines a dependable continental-scale background, and offers the possibility to calibrate studies on more detailed scales