Efficacy and safety of rituximab with and without methotrexate in the treatment of rheumatoid arthritis patients: results from the GISEA register.

INTRODUCTION: Rituximab (RTX) is a monoclonal anti-CD20 antibody approved for the treatment of rheumatoid arthritis (RA) in association with methotrexate (MTX). OBJECTIVES: To evaluate the efficacy and safety of RTX-MTX combination therapy compared with RTX alone in the treatment of RA. METHODS: We analyzed data from a prospective cohort study, the Italian biologic register GISEA, to investigate the efficacy and safety of rituximab. Moreover, the adverse events (AE) and the causes of discontinuation therapy were analyzed. RESULTS: We identified 338 RA patients, 162 treated with RTX and 176 with RTX-MTX. After 52 and 104 weeks of therapy the disease activity score in 28 joints and the Health Assessment Questionnaire Score were available in 168 patients (78 with RTX-MTX and 60 with RTX alone), showing significant reduction without differences among the two groups. AE were reported in 142 patients (42%), for a total of 368 recorded side effects. The majority (90.5%) of AE were mild to moderate in severity. Comparable percentages of severe AE were reported in the 2 groups (9.9% for RTX alone and 9.3% for RTX+MTX). A poor disease control was observed in 14.2% and 13.5% of patients treated with RTX+MTX and RTX, respectively; while 12 patients (4.5% in RTX+MTX, and 2.5% in RTX group) suspended therapy for AE. CONCLUSIONS: RTX showed a good efficacy and safety profile in the real-life management of RA patients regardless of the association with MTX.

Osteonecrosis in systemic lupus erythematosus: an early, frequent, and not always symptomatic complication.

Osteonecrosis may complicate the course of systemic lupus erythematosus and may contemporaneously affect multiple joints. The major risk factor associated with the development of osteonecrosis is the use of glucocorticoid at high doses. Recent studies using serial MRI, which represents the "gold standard" for the early detection of osteonecrosis, yielded some interesting findings about the natural history of this clinical entity. Osteonecrosis in the majority of the cases is asymptomatic and occurs early in the course of the disease. Its later occurrence is associated with lupus flare that requires the increase of corticosteroid dose. The optimal treatment of osteonecrosis is controversial. In case of silent osteonecrosis involving a small area conservative strategy is usually adequate. When lesions are symptomatic surgical treatment as core decompression or free vascularized fibular grafting is required; extracorporeal shockwave treatment may represent an alternative therapeutic approach. When the lesion has a medium-large dimension or involves a weight-bearing area bone collapse is a common complication requiring total joint replacement. Coadministration of bisphosphonate or warfarin with high doses of corticosteroid might be a promising preventive strategy of osteonecrosis.