ObjectiveThis study assessed the efficacy and safety of canakinumab, a fully human anti-interleukin 1β monoclonal antibody, for prophylaxis against acute gouty arthritis flares in patients initiating urate-lowering treatment.MethodsIn this double-blind, double-dummy, dose-ranging study, 432 patients with gouty arthritis initiating allopurinol treatment were randomised 1:1:1:1:1:1:2 to receive: a single dose of canakinumab, 25, 50, 100, 200, or 300 mg subcutaneously; 4×4-weekly doses of canakinumab (50+50+25+25 mg subcutaneously); or daily colchicine 0.5 mg orally for 16 weeks. Patients recorded details of flares in diaries. The study aimed to determine the canakinumab dose having equivalent efficacy to colchicine 0.5 mg at 16 weeks.ResultsA dose-response for canakinumab was not apparent with any of the four predefined dose-response models. The estimated canakinumab dose with equivalent efficacy to colchicine was below the range of doses tested. At 16 weeks, there was a 62% to 72% reduction in the mean number of flares per patient for canakinumab doses ≥50 mg versus colchicine based on a negative binomial model (rate ratio: 0.28–0.38, p≤0.0083), and the percentage of patients experiencing ≥1 flare was significantly lower for all canakinumab doses (15% to 27%) versus colchicine (44%, p<0.05). There was a 64% to 72% reduction in the risk of experiencing ≥1 flare for canakinumab doses ≥50 mg versus colchicine at 16 weeks (hazard ratio (HR): 0.28–0.36, p≤0.05). The incidence of adverse events was similar across treatment groups.ConclusionsSingle canakinumab doses ≥50 mg or four 4-weekly doses provided superior prophylaxis against flares compared with daily colchicine 0.5 mg.

Gout is an inflammatory disease manifested by the deposition of monosodium urate (MSU) crystals in joints, cartilage, synovial bursa, tendons or soft tissues. Gout is not a new disease, which was first documented nearly 5,000 years ago. The prevalence of gout has increased globally in recent years, imposing great disease burden worldwide. Moreover, gout or hyperuricemia is clearly associated with a variety of comorbidities, including cardiovascular diseases, chronic kidney disease, urolithiasis, metabolic syndrome, diabetes mellitus, thyroid dysfunction, and psoriasis. To prevent acute arthritis attacks and complications, earlier use of pharmacotherapeutic treatment should be considered, and patients with hyperuricemia and previous episodes of acute gouty arthritis should receive long-term urate-lowering treatment. Urate-lowering drugs should be used during the inter-critical and chronic stages to prevent recurrent gout attacks, which may elicit gradual resolution of tophi. The goal of urate-lowering therapy should aim to maintain serum uric acid (sUA) level <6.0 mg/dL. For patients with tophi, the initial goal can be set at lowering sUA to <5.0 mg/dL to promote tophi dissolution. The goal of this consensus paper was to improve gout and hyperuricemia management at a more comprehensive level. The content of this consensus paper was developed based on local epidemiology and current clinical practice, as well as consensuses from two multidisciplinary meetings and recommendations from Taiwan Guideline for the Management of Gout and Hyperuricemia.

Objective. To evaluate the efficacy and tolerability of dehydroepiandrosterone (DHEA) at a dosage of 200 mg/day in adult women with active systemic lupus erythematosus (SLE).Methods. In a multicenter randomized, doubleblind, placebo-controlled trial, 120 adult women with active SLE received oral DHEA (200 mg/day; n ‫؍‬ 61) or placebo (n ‫؍‬ 59) for 24 weeks. The primary end point was the mean change from baseline in the Systemic Lupus Activity Measure (SLAM) score at 24 weeks of therapy. Secondary end points included time to first flare, change in SLE Disease Activity Index (SLEDAI) score, and physician's and patient's global assessment scores at week 24.Results. The two groups were well balanced for baseline characteristics. Mean reductions in SLAM scores from baseline were similar and were not statistically significantly different between treatment groups (DHEA ؊2.6 ؎ 3.4 versus placebo ؊2.0 ؎ 3.8, mean ؎ SD). The number of patients with flares was decreased by 16% in the DHEA group (18.3% of DHEA-treated patients versus 33.9% of placebo-treated patients; P ‫؍‬ 0.044, based on time to first flare). The mean change in the patient's global assessment was statistically significant between the two groups (DHEA ؊5.5 versus placebo 5.4; P ‫؍‬ 0.005). The number of patients with serious adverse events, most of which were related to SLE flare, was significantly lower in DHEA-treated patients compared with placebo-treated patients (P ‫؍‬ 0.010). Expected hormonal effects, including increased testosterone levels and increased incidence of acne, were observed. No life-threatening reactions or serious safety issues were identified during this study.Conclusion. The overall results confirm that DHEA treatment was well-tolerated, significantly reduced the number of SLE flares, and improved patient's global assessment of disease activity.

BackgroundPolysomnography (PSG) is treated as the gold standard for diagnosing obstructive sleep apnea (OSA). However, it is labor-intensive, time-consuming, and expensive. This study evaluates validity of overnight pulse oximetry as a diagnostic tool for moderate to severe OSA patients.MethodsA total of 699 patients with possible OSA were recruited for overnight oximetry and PSG examination at the Sleep Center of a University Hospital from Jan. 2004 to Dec. 2005. By excluding 23 patients with poor oximetry recording, poor EEG signals, or respiratory artifacts resulting in a total recording time less than 3 hours; 12 patients with total sleeping time (TST) less than 1 hour, possibly because of insomnia; and 48 patients whose ages less than 20 or more than 85 years old, data of 616 patients were used for further study. By further considering 76 patients with TST < 4 h, a group of 540 patients with TST ≥ 4 h was used to study the effect of insufficient sleeping time. Alice 4 PSG recorder (Respironics Inc., USA) was used to monitor patients with suspected OSA and to record their PSG data. After statistical analysis and feature selection, models built based on support vector machine (SVM) were then used to diagnose moderate and moderate to severe OSA patients with a threshold of AHI = 30 and AHI = 15, respectively.ResultsThe SVM models designed based on the oxyhemoglobin desaturation index (ODI) derived from oximetry measurements provided an accuracy of 90.42-90.55%, a sensitivity of 89.36-89.87%, a specificity of 91.08-93.05%, and an area under ROC curve (AUC) of 0.953-0.957 for the diagnosis of severe OSA patients; as well as achieved an accuracy of 87.33-87.77%, a sensitivity of 87.71-88.53%, a specificity of 86.38-86.56%, and an AUC of 0.921-0.924 for the diagnosis of moderate to severe OSA patients. The predictive outcome of ODI to diagnose severe OSA patients is better than to diagnose moderate to severe OSA patients.ConclusionsOvernight pulse oximetry provides satisfactory diagnostic performance in detecting severe OSA patients. Home-styled oximetry may be a tool for severe OSA diagnosis.

AimTo assess the potential risk of tuberculosis (TB) in patients treated with anti-tumor necrosis factor-alpha (TNF-α) agents in Asia.MethodsAbsolute risk increase (ARI) of TB was estimated for three widely used anti-TNF-α therapies using published standardized incidence ratios (SIR) from the French Research Axed on Tolerance of bIOtherapies registry and incidence (absolute risk [AR]) of TB in Asia. Assuming an association of increased TB risk with anti-TNF-α therapy and country TB AR (incidence), the ARI of TB by country was calculated by multiplying the SIR of the anti-TNF-α therapy by the country's TB AR. The numbers needed to harm (NNH) for each anti-TNF-α agent and numbers needed to treat (NNT) to reduce one TB event using etanercept therapy instead of adalimumab or infliximab were also calculated for each country.ResultsThe ARI of TB with anti-TNF-α therapies in Asian countries is substantially higher than Western Europe and North America and the difference between etanercept versus the monoclonal antibodies becomes more evident. The NNH for Asian countries ranged from 8 to 163 for adalimumab, 126 to 2646 for etanercept and 12 to 256 for infliximab. The NNT to reduce one TB event using etanercept instead of adalimumab therapy ranged from 8 to 173, and using etanercept instead of infliximab therapy the NNT ranged from 13 to 283.ConclusionHigher numbers of patients are at risk of developing TB with anti-TNF-α therapy in Asia compared with Western Europe and North America. The relative lower risk of TB with etanercept may be particularly relevant for Asia, an endemic area for TB.