Off-label use of rituximab in 196 patients with severe, refractory systemic autoimmune diseases.

OBJECTIVES: To analyse the safety and efficacy of the off-label use of rituximab in patients with severe, refractory systemic autoimmune diseases. METHODS: In 2006, the Study Group on Autoimmune Diseases of the Spanish Society of Internal Medicine created the BIOGEAS project, a multicenter study devoted to collecting data on the use of biological agents in adult patients with systemic autoimmune diseases refractory to standard therapies (failure of at least two immunosuppressive agents). RESULTS: One hundred and ninety-six patients with systemic autoimmune diseases treated with rituximab have been included in the Registry (158 women and 38 men, mean age 43 years). Systemic autoimmune diseases included systemic lupus erythematosus (107 cases), inflammatory myopathies (20 cases), ANCA-related vasculitides (19 cases), Sjögren's syndrome (15 cases) and other diseases (35 cases). A therapeutic response was evaluable in 194 cases: 99 (51%) achieved a complete response, 51 (26%) a partial response and 44 (23%) were classified as non-responders. After a mean follow-up of 27.56+/-1.32 months, 44 (29%) out of the 150 responders patients relapsed. There were 40 adverse events reported in 33 (16%) of the 196 patients. The most frequent adverse events were infections, with 24 episodes being described in 19 patients. Thirteen (7%) patients died, mainly due to disease progression (7 cases) and infection (3 cases). CONCLUSIONS: Although not yet licensed for this use, rituximab is currently used to treat severe, refractory systemic autoimmune diseases, with the most favourable results being observed in Sjögren's syndrome, inflammatory myopathies, systemic lupus erythematosus and cryoglobulinemia.

[Intermediate care units. Health care consequences in a reference hospital]. / Unidades de Cuidados Intermedios. Consecuencias asistenciales en un hospital de referencia.

INTRODUCTION: Intermediate Care Units are forms to provide health care services to potentially critical patients that allow for improved cost-benefit ratio of the care offered by Intensive Medicine Departments. OBJECTIVE: Analyze heart care repercussion that the permanent opening of this type of unit had in a reference teaching center. DESIGN: Prospective. PERIOD: From the beginning of 2003 to the end of 2005. SCOPE: Intensive Medicine Department (IMD), with teaching accreditation, which has 15 conventional ICU beds and 4 intermediate care beds. PATIENTS AND METHODS: Analysis of demographic data (gender and age, type of patient, and origin or admission), of severity (SAPS 2), prognosis (MPM II 0 and SAPS2) and health care burden (NEMS) in 3,392 consecutive admissions to IMD. Specific analysis of the stay and mortality (intra- and post ICU). RESULTS: Permanent opening of an intermediate care unit is associated with an increase of patients seen by the IMD and makes it possible to clearly identify two different types of patients according to the site linked to the cause of the admission. The patients seen in the Intermediate Care Unit have a shorter stay, less seriousness, greater survival prognosis and less care burden. However, the initiation of this service does not decrease the interval of total mortality (intra+post- ICU). CONCLUSION: Initiating an intermediate care unit depending on an IMD increases its health care capacity and that of the center it gives service to without affecting global mortality.