74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis

The objective was to describe the prevalence, types, and predictors of adverse events (AEs) in rheumatoid arthritis (RA) patients treated with infliximab and methotrexate in a daily clinical setting.0Journal ArticleMulticenter StudyResearch Support, Non-U.S. Gov'tREMITRACT study groupinfo:eu-repo/semantics/publishe

Effect on bone turnover markers of once-yearly intravenous infusion of zoledronic acid versus daily oral risedronate in patients treated with glucocorticoids

Objective. Long-term glucocorticoid use is accompanied by rapid bone loss; however, early treatment with bisphosphonates prevents bone loss and reduces fracture risk. The aim of this study was to examine the effects of two bisphosphonates, i.v. zoledronic acid (ZOL) versus oral risedronate (RIS), on bone turnover markers (BTMs) in subjects with glucocorticoid-induced osteoporosis (GIO). Methods. Patients were randomly stratified according to the duration of pre-study glucocorticoid therapy [prevention subpopulation (ZOL, n = 144; RIS, n = 144) ≤3 months, treatment subpopulation (ZOL, n = 272; RIS, n = 273) >3 months]. Changes in β-C-terminal telopeptides of type 1 collagen (β-CTx), N-terminal telopeptide of type I collagen (NTx), procollagen type 1 N-terminal propeptide (P1NP) and bone-specific alkaline phosphatase (BSAP) from baseline were measured on day 10 and months 3, 6 and 12. Results. At most time points, there were significantly greater reductions (P < 0.05) in the concentrations of serum β-CTx, P1NP and BSAP and urine NTx in subjects on ZOL compared with RIS in both males and females of the treatment and prevention subpopulations. In pre- and post-menopausal women, there were significantly greater reductions in the concentrations of BTMs with ZOL compared with RIS. At 12 months, ZOL had significantly greater reductions compared with RIS (P < 0.05) for β-CTx, P1NP, BSAP and NTx levels, independent of glucocorticoid dose. Conclusions. Once-yearly i.v. infusion of ZOL 5 mg was well tolerated in different subgroups of GIO patients. ZOL was non-inferior to RIS and even superior to RIS in the response of BTMs in GIO patients. Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT0010062

A FRAX model for the assessment of fracture probability in Belgium

peer reviewedRESUME : Cette étude a pour but d’adapter à la population belge l’algorithme FRAX® récemment publié par l’Organisation Mondiale de la Santé (OMS) et permettant de calculer, dans les deux sexes, le risque absolu de fractures ostéoporotiques, à 10 ans. Nous nous sommes attachés à quantifier le risque fracturaire correspondant aux critères actuellement appliqués, en Belgique, pour le remboursement des médicaments de l’ostéoporose et à identifier les situations cliniques correspondant à une probabilité équivalente de fracture. Les probabilités fracturaires ont été calculées, à partir des incidences de fractures et de décès publiées, pour la population belge. Ces probabilités prennent en considération l’âge, le sexe, l’existence de facteurs cliniques de risque (FCR) et la densité minérale osseuse (DMO), mesurée au niveau de la zone propre du col fémoral. L’algorithme FRAX® permet d’identifier différents scénarios d’intervention, en Belgique, correspondant à un risque fracturaire identique ou supérieur à celui servant de base aux critères actuels de remboursement des médicaments. Il est donc possible de recommander une modification des attitudes actuelles, délaissant une stratégie basée sur une évaluation dichotomique de la DMO, au profit d’une intégration progressive des FCR qui permettra, in fine, une meilleure identification des patients à risque accru de fracture. Cette approche devra être substantiée par des analyses pharmaco-économiques appropriées

Ten Years’ Experience with Alendronate for Osteoporosis in Postmenopausal Women

Background Antiresorptive agents are widely used to treat osteoporosis. We report the results of a multinational randomized, double-blind study, in which postmenopausal women with osteoporosis were treated with alendronate for up to 10 years. Methods The initial three-year phase of the study compared three daily doses of alendronate with placebo. Women in the original placebo group received alendronate in years 4 and 5 and then were discharged. Women in the original active-treatment groups continued to receive alendronate during the initial extension (years 4 and 5). In two further extensions (years 6 and 7, and 8 through 10), women who had received 5 mg or 10 mg of alendronate daily continued on the same treatment. Women in the discontinuation group received 20 mg of alendronate daily for two years and 5 mg daily in years 3, 4, and 5, followed by five years of placebo. Randomized group assignments and blinding were maintained throughout the 10 years. We report results for the 247 women who participated in all four phases of the study. Results Treatment with 10 mg of alendronate daily for 10 years produced mean increases in bone mineral density of 13.7 percent at the lumbar spine (95 percent confidence interval, 12.0 to 15.5 percent), 10.3 percent at the trochanter (95 percent confidence interval, 8.1 to 12.4 percent), 5.4 percent at the femoral neck (95 percent confidence interval, 3.5 to 7.4 percent), and 6.7 percent at the total proximal femur (95 percent confidence interval, 4.4 to 9.1 percent) as compared with base-line values; smaller gains occurred in the group given 5 mg daily. The discontinuation of alendronate resulted in a gradual loss of effect, as measured by bone density and biochemical markers of bone remodeling. Safety data, including fractures and stature, did not suggest that prolonged treatment resulted in any loss of benefit. Conclusions The therapeutic effects of alendronate were sustained, and the drug was well tolerated over a 10-year period. The discontinuation of alendronate resulted in the gradual loss of its effects

Les complications neurologiques de la maladie de Paget

Les complications neurologiques de la maladie de Page