Infliximab therapy in patients with ankylosing spondylitis: an open label 12 month study.

OBJECTIVE: To evaluate the efficacy and safety of long term infliximab therapy in patients with severe refractory ankylosing spondylitis (AS). PATIENTS AND METHODS: Twenty five patients (24 male, 1 female; mean (SD) age 36.0 (10.5); disease duration 13.8 (8.5) years) with AS fulfilling the modified New York criteria for AS were investigated. Twenty two (88%) patients were HLA-B27 positive. All patients had active axial disease (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >/=30/100) and C reactive protein (CRP) >/=10 mg/l, despite adequate treatment. Intravenous infliximab (5 mg/kg) was given at weeks 0, 2, 6, and every eight weeks thereafter for 12 months. The primary end point was the reduction of the patient's global assessment of pain (GAP) by >20% on a 100 mm visual analogue scale. RESULTS: GAP was reduced by >20% in 23 (92%) patients, by 50% in 21 (84%) patients, and by 70% in 13 (52%). The change in BASDAI and CRP from baseline was statistically significant. The treatment was well tolerated with minimal side effects. One patient dropped out owing to inefficacy and one stopped treatment owing to an allergic reaction. CONCLUSION: This longer length study confirms the efficacy of infliximab and the good safety profile in patients with AS.

Infliximab treatment in combination with cyclosporin A in patients with severe refractory rheumatoid arthritis.

OBJECTIVE: To investigate whether infliximab can be used in combination with cyclosporin A (CsA) in patients with refractory rheumatoid arthritis (RA) who cannot tolerate methotrexate (MTX). MATERIALS AND METHODS: Eighteen patients with refractory RA receiving low dose CsA (2 mg/kg/day) and prednisone (5 mg/day) were treated with intravenous infliximab. The patients were given infliximab (3 mg/kg weight) at 0, two, six, and every eight weeks thereafter for a total period of 12 months. Clinical improvement was evaluated according to the American College of Rheumatology (ACR) 20% response criteria. RESULTS: Eighty per cent of patients receiving the combination treatment with CsA and infliximab achieved the 20% ACR criteria for response to treatment, whereas 39% satisfied the 50% response criteria. In addition, a 76% reduction in swollen and tender joint count was found. Finally, a reduction in C reactive protein and erythrocyte sedimentation rate was maintained throughout the study. In general, treatment was well tolerated, with minimal adverse drug reactions. Two patients dropped out; one because of an immediate hypersensitivity reaction and the other because of the development of pulmonary tuberculosis. CONCLUSION: Multiple infusions of infliximab and low doses of CsA improve patients with refractory RA. It seems that CsA may be an alternative disease modifying drug to be used in combination with infliximab in patients with refractory RA who cannot tolerate MTX.

Clinical course and outcome of early rheumatoid arthritis.

We studied whether patients with seropositivity in early rheumatoid arthritis (RA) comprise a different clinical group than those with seronegativity. Four hundred seventeen patients with early RA according to the American College of Rheumatology criteria (disease duration less than 1 year) were retrospectively studied by analysis of demographic, clinical, laboratory, radiological, and therapeutic disease characteristics from the time of diagnosis until the end of the study period (1981 1999) using a data base. There were 248 seropositive patients and 169 seronegative patients with RA. No statistically significant differences were seen between the two groups before commencement of the study period in relation to age of disease onset, male:female ratio, and disease duration. However, seropositive patients showed longer medical follow-up. In addition, at disease onset, seropositive RA patients presented more frequently with symmetrical polyarthritis and small joint involvement than seronegative patients. The seropositive group also had more tender and swollen joints, weaker grip strength, and higher erythrocyte sedimentation and C-reactive protein rates during the follow-up period. In contrast, the seronegative group had less severe radiological findings and greater functional ability at the end of the study. In Greek patients with early RA, rheumatoid factor seems to be a predictor of more severe disease activity.