30/2008) were included. Continuous enrollment required 6 mos pre-index and 12 mos post-index. A sub-group of newly treated patients, defined as MS patients free of DMT claims for 6 mos prior to initial MS diagnosis, were also analyzed for frequencies of relapses. Using a claims-based definition, severe relapses were defined as an inpatient hospitalization with a primary diagnosis of MS. Moderate relapses were defined as an outpatient visit with a diagnosis of MS in combination with a pharmacy or medical claim for a corticosteroid within 7 days following the outpatient visit. Additional data collected included relapse-related costs and length of inpatient stay. All variables were analyzed descriptively. RESULTS: Among the 23,503 MS patients identified, mean age was 47 years and 18,027 (77%) were female. Overall, 1,479 (6.3%) patients had a relapse. 940 patients (4.0%) had a severe relapse, with an average length of inpatient stay of 5.6 days. Among, the sub group of newly treated MS patients (NTMS) (Nϭ 15,059), 1,059 (7.0%) were classified as having a relapse, 710 (4.7%) were severe.
To assess efficacy and safety of dornase alfa in the treatment of cystic fibrosis (CF) in children and adults. METHODS: Systematic review of Medline, Em-Base, CENTRAL and clinicaltrials.gov databases was conducted. The references from relevant articles and abstracts from conferences were also examined to identify any additional studies. Each full-text article was critically appraised with use of the Jadad Scale. Clinical practice and CF treatment procedures in Poland were consulted with clinical experts. Placebo and treatment without dornase were identified as potential comparators. Changes in FEV 1 , FVC, and FEF 25%-75% , exacerbation of respiratory symptoms, body mass change, use of drugs, number of days spent at home due to CF, hospitalizations (number and length), ambulatory visits, quality of life, mortality rate, treatment acceptance by patient and safety were assessed and compared based on the review results. RESULTS: Among 294 reports found, 17 publications concerning 12 randomized clinical trials were included in the analysis. The meta-analysis of available data regarding changes in FEV 1 after 1, 3, 6 months and 1 and 2 years showed better results with dornase therapy. The use of dornase also improved pulmonary function measured in FVC. Exacerbations of respiratory symptoms were less frequent (by 20% when dornase alpha was administered once daily and by 34% when administered twice daily), which resulted in fewer hospitalizations. Patients treated with dornase required less frequent courses of intravenous antibiotics and spent fewer days at home due to CF. Safety analysis showed a higher risk of rash, voice alteration and pharyngitis with dornase. Mortality was similar among groups. CONCLUSIONS: Dornase alfa is an effective (improves respiratory function, reduces CF symptoms, dyspnea and respiratory system exacerbations) and safe therapeutic option.
retreatment regimens, which allows continuous or paused therapeutic schemes. This study aims to perform cost-effectiveness and cost-utility analyses of biologic alternatives for moderate to severe psoriasis in Venezuela, from a public payer=s perspective. METHODS: A decision-tree model simulates psoriasis evolution after treatment with etanercept continuous (50mg twice a week for 12 weeks, followed by 25mg twice a week) or paused (12-week treatment cycle and 12-week interruption), adalimumab (80mg at first week, followed by 40mg in the second week, then 40mg every 2 weeks), infliximab (5 mg/kg at weeks 0, 2 and 6, then every 8 weeks) or ustekinumab (45mg in weeks 0 and 4, then 45mg every 12 weeks) and their associated costs in a 96-week time horizon. Therapy continuation or switch was evaluated at week 24. Effectiveness measures were PASI 75 success rate and quality adjusted life years (QALY) gained. Costs included biologicals, medical follow-up and adverse events management, from Venezuela official databases (values represented 2010 USD). Probabilistic sensitivity analyses were performed through Monte Carlo simulation. A 5% discount rate was applied for costs and benefits. RESULTS: Effectiveness resulted in [
30/2008) were included. Continuous enrollment required 6 mos pre-index and 12 mos post-index. A sub-group of newly treated patients, defined as MS patients free of DMT claims for 6 mos prior to initial MS diagnosis, were also analyzed for frequencies of relapses. Using a claims-based definition, severe relapses were defined as an inpatient hospitalization with a primary diagnosis of MS. Moderate relapses were defined as an outpatient visit with a diagnosis of MS in combination with a pharmacy or medical claim for a corticosteroid within 7 days following the outpatient visit. Additional data collected included relapse-related costs and length of inpatient stay. All variables were analyzed descriptively. RESULTS: Among the 23,503 MS patients identified, mean age was 47 years and 18,027 (77%) were female. Overall, 1,479 (6.3%) patients had a relapse. 940 patients (4.0%) had a severe relapse, with an average length of inpatient stay of 5.6 days. Among, the sub group of newly treated MS patients (NTMS) (Nϭ 15,059), 1,059 (7.0%) were classified as having a relapse, 710 (4.7%) were severe.
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