A phase II, double-blind, randomised, placebo-controlled study of BMS945429 (ALD518) in patients with rheumatoid arthritis with an inadequate response to methotrexate.

BACKGROUND: Interleukin 6 (IL-6) plays a key role in the inflammatory cascade in rheumatoid arthritis. BMS945429 is a humanised, monoclonal antibody that potently binds IL-6. OBJECTIVE: To conduct aphase II study to determine the efficacy and safety of BMS945429 in patients with active rheumatoid arthritis and an inadequate response to methotrexate. METHODS: Patients were randomised 1:1:1:1 to BMS945429 (80, 160 or 320 mg; administered intravenously) or placebo plus methotrexate during this 16-week, double-blind trial. The primary efficacy end point was the proportion of patients with a 20% improvement in American College of Rheumatology responses (ACR20) at week 12. Additional end points included ACR50 and ACR70 responses and 28-joint Disease Activity Scores (DAS28). RESULTS: Of 127 randomised and treated patients, 116 completed the trial. ACR20 responders at week 12 were 81% (80 mg; p<0.0001 vs placebo), 71% (160 mg; p=0.0005 vs placebo), 82% (320 mg; p<0.0001 vs placebo) and 27% (placebo), respectively. By week 16, 14% (80 mg), 28% (160 mg) and 44% (320 mg) of BMS945429 patients were in DAS28 remission (DAS28 score <2.6). Statistically significant and clinically meaningful improvements in health-related quality of life (HRQoL) were reported in all active treatment groups. Administration of BMS945429 was associated with increases in liver enzymes and in serum cholesterol. There were no serious infections, infusion reactions or apparent immunogenicity. CONCLUSIONS: In this phase II study, BMS945429 was associated with rapid and significant improvements in disease activity and HRQoL in patients with active rheumatoid arthritis and an inadequate response to methotrexate.

The Georgian version of the Childhood Health Assessment Questionnaire (CHAQ) and the Child Health Questionnaire (CHQ).

We report herein the results of the cross-cultural adaptation and validation into the Georgian language of the parent's version of two health related quality of life instruments. The Childhood Health Assessment Questionnaire (CHAQ) is a disease specific health instrument that measures functional ability in daily living activities in children with juvenile idiopathic arthritis (JIA). The Child Health Questionnaire (CHQ) is a generic health instrument designed to capture the physical and psychosocial well-being of children independently from the underlying disease. The Georgian CHAQ CHQ were fully validated with 3 forward and 3 backward translation. A total of 115 subjects were enrolled: 54 patients with JIA (44% systemic onset, 28% polyarticular onset, 7.5% extended oligoarticular subtype, and 20.5% persistent oligoarticular subtype) and 61 healthy children. The CHAQ clinically discriminated between healthy subjects and JIA patients, with the systemic, polyarticular and extended oligoarticular subtypes having a higher degree of disability, pain, and a lower overall well-being when compared to their healthy peers. Also the CHQ clinically discriminated between healthy subjects and JIA patients, with the systemic onset, polyarticular onset and extended oligoarticular subtypes having a lower physical and psychosocial well-being when compared to their healthy peers. In conclusion the Georgian version of the CHAQ-CHQ is a reliable, and valid tool for the functional, physical and psychosocial assessment of children with JIA.

[The comparative effectiveness of using basic preparations in the combined therapy of rheumatoid arthritis]. / Sravnitel'naia éffektivnost' primeneniia nekotorykh bazisnykh preparatov v kompleksnoi terapii revmatoidnogo artrita.

Comparison of the time-course of changes in the clinico-laboratory, x-ray and immunological findings in RA patients under the influence of the treatment with azathioprine (50 patients) sulfasalazine (42 patients) and their combination (48 patients) has demonstrated that the best effect (64.6%) may be provided by the use of combined therapy. Azathioprine and sulfasalazine should be administered in combination to patients with seropositive RA, systemic disease manifestations and a high laboratory activity as well as to patients with hormonal dependence. To reduce the number of untoward effects the indicated basic drugs should be applied in moderate doses.

[Incidence and various risk factors for gout in the Georgian SSR]. / Rasprostranennost' i nekotorye faktory riska podagry v Gruzinskoi SSR.

The results of simultaneous epidemiological surveys of the adult population (7000 persons) in the city of Tbilisi and workers at 7 enterprises of the machine-building and mining industries (9189) have shown that 0.29% of the population, mainly men aged over 40 with hereditary predisposition, obesity, carbohydrate metabolic derangement, consuming food rich in purine bases, national flavorings and spices, suffer from gout. A high prevalence of gout among workers of the mining industry and early age at the onset of disease suggest probable association of gout with some industrial factors (manganese, tungsten, molybdenum, bismuth).