[Efficacy, tolerability and safety of cyclosporine for microemulsion in the treatment of active rheumatoid arthritis. Open study]. / Eficacia, tolerabilidad y seguridad de la ciclosporina para microemulsión en el tratamiento de la artritis reumatoidea activa. Estudio abierto.

Cyclosporine for microemulsion has been widely used in the treatment of rheumatoid arthritis (RA) with remarkably good results over progression of joint damage, as reported by the GRISAR Study. A local group in Argentina, performed a prospective, open label study (Neo-Ra-02), consisting of 12 centres which recruited 50 RA patients, who were followed during 6 months in order to assess efficacy, tolerability and safety of cyclosporine microemulsion in the treatment of RA. Efficacy parameters were: morning stiffness, functional evaluation (HAQ, Lee and Ritchie index) and laboratory and radiological (Larsen score) assessments. Safety parameters were: blood pressure and renal, liver and hematological laboratory data. Patients criteria for participation were: presence of active RA (as defined by the ACR), Steinbrocker anatomic and functional grade I to III, disease evolution no longer than 5 years, no previous history of hypertension, renal or liver disease and absence of DMARDs use during the previous 2 months. There was a statistically significant decrease in morning stiffness and in pain evolution. Improvement became evident after 4 weeks of treatment. Reduction of Ritchie index was significant also at 4 weeks and the same observation was made with tenderness and swollen joint scores. Regarding evolution of CRP and RF, a statistically significant reduction was observed only in positive RF. Safety parameters showed no significant increase in serum creatinine or uric acid: 6/50 patients developed mild hypertension with only a significant increase in systolic blood pressure in comparison with baseline. Cyclosporine microemulsion demonstrated efficacy with minimal adverse events (12% mild hypertension) when appropriately monitored and administered in low doses (3 mg/kg/day).

Eficacia, tolerabilidad y seguridad de la ciclosporina para microemulsión en el tratamiento de la artritis reumatoidea activa. Estudio abierto. / [Efficacy, tolerability and safety of cyclosporine for microemulsion in the treatment of active rheumatoid arthritis. Open study]

Cyclosporine for microemulsion has been widely used in the treatment of rheumatoid arthritis (RA) with remarkably good results over progression of joint damage, as reported by the GRISAR Study. A local group in Argentina, performed a prospective, open label study (Neo-Ra-02), consisting of 12 centres which recruited 50 RA patients, who were followed during 6 months in order to assess efficacy, tolerability and safety of cyclosporine microemulsion in the treatment of RA. Efficacy parameters were: morning stiffness, functional evaluation (HAQ, Lee and Ritchie index) and laboratory and radiological (Larsen score) assessments. Safety parameters were: blood pressure and renal, liver and hematological laboratory data. Patients criteria for participation were: presence of active RA (as defined by the ACR), Steinbrocker anatomic and functional grade I to III, disease evolution no longer than 5 years, no previous history of hypertension, renal or liver disease and absence of DMARDs use during the previous 2 months. There was a statistically significant decrease in morning stiffness and in pain evolution. Improvement became evident after 4 weeks of treatment. Reduction of Ritchie index was significant also at 4 weeks and the same observation was made with tenderness and swollen joint scores. Regarding evolution of CRP and RF, a statistically significant reduction was observed only in positive RF. Safety parameters showed no significant increase in serum creatinine or uric acid: 6/50 patients developed mild hypertension with only a significant increase in systolic blood pressure in comparison with baseline. Cyclosporine microemulsion demonstrated efficacy with minimal adverse events (12

mild hypertension) when appropriately monitored and administered in low doses (3 mg/kg/day).

Aluminum-containing particles in synovial fluid of a patient with normal renal function and chondrocalcinosis.

A 48-year-old Caucasian woman presented a tender effusion of small volume, with a mild increase in skin temperature in her right knee and wide spread chondrocalcinosis found radiologically. She had normal renal function, had undergone a gastrectomy, and was receiving therapeutic doses of aluminum hydroxide antacids. Synovial fluid analysis showed small, irregular, nonbirefringent particles that stained intensely positive with the alizarin red stain. Scanning electron microscopy, energy dispersive X-ray analysis, and microprobe analysis showed aluminum and variable concentrations of chlorine and/or oxygen in isolated small spherical particles (average diameter about 15 micro). Neither phosphorus nor calcium was ever detected in the aluminum containing particles. These findings strongly suggest the presence of a mixture of aluminum hydroxide and some form of aluminum hydroxide chloride; neither was previously reported in synovial fluid of patients with normal renal function. Aluminum-containing particles should be considered an explanation for unexplained particles in joint fluid and may be a factor in some arthritis.