The EULAR Study Group for Registers and Observational Drug Studies: comparability of the patient case mix in the European biologic disease modifying anti-rheumatic drug registers.

OBJECTIVE: Under the auspices of the European League Against Rheumatism (EULAR), a study group of investigators representing European biologic DMARD (bDMARD) registers was convened. The purpose of this initial assessment was to collect and compare a cross section of patient characteristics and collate information on the availability of potential confounders within these registers. METHODS: Baseline characteristics of patients starting their first bDMARD in an arbitrary year (2008) for the treatment of RA, including demographic and disease characteristics, bDMARD drug details and co-morbidities, were collected and compared across 14 European bDMARD registers. RESULTS: A total of 5320 patients were included. Half the registers had restricted recruitment to certain bDMARDs during the study year. All registers` collected data on age, gender, disease duration, seropositivity for IgM-RF and 28-joint DAS (DAS28). The mean DAS28 ranged from 4.2 to 6.6 and the mean HAQ from 0.8 to 1.9. Current smoking ranged from 9% to 34%. Nine registers reported co-morbidities with varying prevalence. CONCLUSION: In addition to demonstrating European-wide collaboration across rheumatology bDMARD registers, this assessment identified differences in prescribing patterns, recruitment strategies and data items collected. These differences need to be considered when applying strategies for combined analysis. The lack of a common data model across Europe calls for further work to harmonize data collection across registers.

The Way Forward: Practical Clinical Considerations for the Use of Canakinumab in Patients With Difficult-to-Treat Gouty Arthritis.

Canakinumab is indicated for patients with frequent gouty arthritis attacks who cannot be managed with standard-of-care medication, and should be used according to the labeled indication. Given its mechanism of action, physicians need to be aware of the potential contraindications and precautions with its use. When deciding as to whether a patient with gouty arthritis is an appropriate candidate for canakinumab treatment, several key clinical considerations should be kept in mind, which are discussed herein.

The Human and Economic Burden of Difficult-to-Treat Gouty Arthritis.

Gouty arthritis, one of the most painful and common forms of adult arthritis, is caused by monosodium urate crystal deposits in joints, most often in the lower extremities. Crystals trigger an inflammatory response leading to acute flares characterized by a rapid onset of pain, warmth, swelling, and redness in involved joints. Over time, continued monosodium urate crystal deposits and inflammation can lead to chronic tophaceous gout that result in bone erosion, progressing to joint destruction and significant disability. The goal of therapy in an acute gout flare is prompt and safe termination of pain and inflammation. Acute gouty arthritis is usually treated with nonsteroidal anti-inflammatory drugs, colchicine, or corticosteroids. However, for a growing number of patients, current standard treatments are ineffective or are contraindicated, largely due to the presence of comorbidities. Gouty arthritis can have a major negative impact of health-related quality of life, especially in patients with difficult-to-treat disease, as revealed by recent studies comparing health-related quality of life with that of the general population. Additionally, gouty arthritis also constitutes an important economic burden through absence from work and medical costs. This burden is even greater in patients with difficult-to-treat disease.