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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.
RESUMO
In recent years, the use of vertebral cementing techniques for vertebroplasty and kyphoplasty has spread for the treatment of pain associated with osteoporotic vertebral compression fractures. This is also associated with the increased incidence of complications related with these procedures, the most frequent being originated by leakage of cementation material. Cement can escape into the vertebral venous system and reach the pulmonary circulation through the azygous system and cava vein, producing a cement embolism. This is a frequent complication, occurring in up to 26% of patients undergoing vertebroplasty but, since most patients have no clinical or hemodynamical repercussion, this event usually goes unnoticed. However, some serious, and even fatal cases, have been reported. We report the case of a 74-year-old male patient who underwent vertebroplasty for persistent pain associated with osteoporotic L3 vertebral fracture and who developed a cement leak into the cava vein and right pulmonary artery during the procedure. Although he developed a pulmonary cement embolism, the patient remained asymptomatic and did not present complications during follow-up.