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OBJECTIVE: To assess effectiveness and safety of certolizumab PEGol (CZP) in rheumatoid arthritis (RA) patients after 12 months of treatment and to detect predictors of response. METHODS: Observational longitudinal prospective study of RA patients from 35 sites in Spain. Variables (baseline, 3- and 12-month assessment): sociodemographics, previous Disease Modifying Anti-Rheumatic Drug (DMARD) and previous Biological Therapies (BT) use; TJC, SJC, ESR, CRP, DAS28, SDAI. Response variables: TJC, SJC, CRP, ESR, and steroids dose reductions, EULAR Moderate/Good Response, SDAI response and remission, DAS28 remission. Safety variables: discontinuation due to side-effects. Descriptive, comparative and Logistic regression analyses were performed. RESULTS: We included 168 patients: 79.2% women, mean age 54.5 years (±13.2 SD), mean disease duration 7.5 years (±7.3 SD). Mean number of prior DMARD: 1.4 (±1.2 SD), mean number of prior BT was 0.8 (±1.1). Mean time on CZP was 9.8 months (±3.4 SD). A total of 71.4% were receiving CZP at 12-month assessment. Baseline predictors of response: lower prior number DMARD; low number prior BT; higher CRP, ESR, TJC, SJC, DAS28 and SDAI (p < 0.05) scores. A 25/46.4% Moderate/Good Response, a 20% SDAI remission, and a 44% DAS28 remission were observed. We observed 48 discontinuations (28.6%), 31 due to partial or complete ineffectiveness, and 17 due to side-effects. CONCLUSIONS: CZP showed benefit in severe RA patients, with significant reduction of all effectiveness parameters, despite the high prevalence of previous BT exposure in our series. We found CRP, ESR, prior DMARD/BT number, TJC, SJC, DAS28, and SDAI as baseline predictors of response. CZP was mostly well tolerated.
RESUMEN
OBJECTIVES: To describe a series of patients with haematogenous vertebral osteomyelitis (HVO) in a primary care hospital. The results were compared with other Spanish and foreign series. PATIENTS AND METHODS: The files of patients with HVO diagnosed in the Viladecans hospital from 1993 through 2008, were retrospectively reviewed. Only patients with microbiological demonstration of infection were included. Patients with HVO after surgical procedures were excluded. RESULTS: Twenty six patients had inclusion criteria, 9 females and 17 males, with a mean age of 61 years (range 36-83). The most patients had any predisposing factor, generally diabetes mellitus. Pyogenic microorganisms were the most frequent aetiological agents (77%). Back pain was by far the most common presenting symptom (88,4%), followed by peripheral septic arthritis in two patients (7,6%), and acute abdominal pain in one. Fever was found in 22 cases (84,6%). None of our patients died, but the sequelae were non rare. CONCLUSION: We did not find difference between our series and others. It is noteworthy that the streptococcal species represents the most frequently isolated organism, followed by Staphylococcus aureus, more common in other series. Remarkably, none of our patients died. HVO is a infrequent disease. However, evidence suggest that the incidence is increasing. Early diagnosis can avoid potential serious sequelae.