ObjectivesEvaluation of rituximab and glucocorticoids as therapy to induce remission after relapse in ANCA-associated vasculitis (AAV) in a prospective observational cohort of patients enrolled into the induction phase of the RITAZAREM trial.MethodsPatients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis were prospectively enrolled and received remission-induction therapy with rituximab (4×375 mg/m2) and a higher or lower dose glucocorticoid regimen, depending on physician choice: reducing from either 1 mg/kg/day or 0.5 mg/kg/day to 10 mg/day by 4 months. Patients in this cohort achieving remission were subsequently randomised to receive one of two regimens to prevent relapse.Results188 patients were studied: 95/188 (51%) men, median age 59 years (range 19–89), prior disease duration 5.0 years (range 0.4–34.5). 149/188 (79%) had previously received cyclophosphamide and 67/188 (36%) rituximab. 119/188 (63%) of relapses had at least one major disease activity item, and 54/188 (29%) received the higher dose glucocorticoid regimen. 171/188 (90%) patients achieved remission by 4 months. Only six patients (3.2% of the study population) did not achieve disease control at month 4. Four patients died in the induction phase due to pneumonia (2), cerebrovascular accident (1), and active vasculitis (1). 41 severe adverse events occurred in 27 patients, including 13 severe infections.ConclusionsThis large prospective cohort of patients with relapsing AAV treated with rituximab in conjunction with glucocorticoids demonstrated a high level of efficacy for the reinduction of remission in patients with AAV who have relapsed, with a similar safety profile to previous studies.
Background. The evidence base regarding the safety of intravenous (IV) iron therapy in patients with chronic kidney disease (CKD) is incomplete and largely based on small studies of relatively short duration. Methods. FIND-CKD (ClinicalTrials.gov number NCT00994318) was a 1-year, open-label, multicenter, prospective study of patients with nondialysis-dependent CKD, anemia and iron deficiency randomized (1:1:2) to IV ferric carboxymaltose (FCM), targeting higher (400–600 µg/L) or lower (100–200 µg/L) ferritin, or oral iron. A post hoc analysis of adverse event rates per 100 patient-years was performed to assess the safety of FCM versus oral iron over an extended period. Results. The safety population included 616 patients. The incidence of one or more adverse events was 91.0, 100.0 and 105.0 per 100 patient-years in the high ferritin FCM, low ferritin FCM and oral iron groups, respectively. The incidence of adverse events with a suspected relation to study drug was 15.9, 17.8 and 36.7 per 100 patient-years in the three groups; for serious adverse events, the incidence was 28.2, 27.9 and 24.3 per 100 patient-years. The incidence of cardiac disorders and infections was similar between groups. At least one ferritin level ≥800 µg/L occurred in 26.6% of high ferritin FCM patients, with no associated increase in adverse events. No patient with ferritin ≥800 µg/L discontinued the study drug due to adverse events. Estimated glomerular filtration rate remained the stable in all groups. Conclusions. These results further support the conclusion that correction of iron deficiency anemia with IV FCM is safe in patients with nondialysis-dependent CKD.
Background:Repetitive loading and shear stress across the proximal femur account for the high prevalence of cam deformity in athletes.Purpose:To systematically review the literature to identify the reported number, age, mean alpha angle measurements, and differences between male and female athletes with radiographic cam deformity based on sport.Study Design:Systematic review; Level of evidence, 4.Methods:A systematic review was conducted of studies in the literature between January 1990 and March 2018 that reported on athletes with radiographic cam deformity based on sport. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed, and PubMed, Biosis Previews, SPORTDiscus, PEDro, and EMBASE databases were used. Inclusion criteria included studies documenting radiographic cam deformity based on alpha angle measurements categorized according to the athlete’s primary sport and according to sex. Exclusion criteria were (1) studies not documenting primary sport, (2) studies not reporting total number of athletes with radiographic cam deformity, and (3) studies not separating cam deformity based on sex or using alpha angle measurements. Statistical analysis was used to compare mean reported age and alpha angle measurements between males and females.Results:A total of 28 studies consisting of 1160 male and 53 female athletes with radiographic cam deformity were identified. Cam lesions were most commonly reported in soccer athletes among both males and females, followed by hockey and American football. Male athletes had significantly higher mean alpha angle measurements (59.9° ± 5.5°) compared with female athletes (48.3° ± 6.9°) (P = .001). No significant difference in age was appreciated between males (21.1 ± 4.0 years) and females (21.7 ± 3.0 years) (P = .62).Conclusion:Radiographic cam deformity is most commonly reported in athletes participating in soccer and hockey. Males possessed significantly greater mean alpha angle measurements compared with females, whereas no significant difference in mean age at the time of diagnosis was appreciated between sexes.
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