Extra-Articular Manifestations in Patients with Ankylosing Spondylitis: Baseline Characteristics from the RBSMR Study.

Objectives: To describe and analyse the prevalence of extra-articular manifestations (EAMs) including acute anterior uveitis (AAU), psoriasis and inflammatory bowel disease (IBD) in patients with ankylosing spondylitis (AS) in the Moroccan registry of biological therapies in rheumatic diseases RBSMR (Registre des Biothérapies de la Société Marocaine de Rhumatologie). Methods: A cross-sectional, multicentre and analytical study based on the RBSMR database, which included 170 AS. Incidence rates for the development of AAU, psoriasis and IBD were calculated, and risk factors were analysed. Results: Prevalence of EAMs in AS was 13.5%, 4.7% and 11.2% for AAU, psoriasis and IBD respectively. No significant differences were found while establishing a comparison of the prevalence of these EAMs between AS patients with and without peripheral arthritis. Interestingly, AAU was the most common EAM, and was positively associated in multivariable regression with family history of spondyloarthritis (OR= 7.21, CI 95%: 2.23-23.24). Conclusions: AAU was the leading EAM in patients with AS included in the Moroccan biotherapy registry (RBSMR) and it was associated with family history of spondyloarthritis.

Active tuberculosis infection in moroccan patients with rheumatic diseases under biologic therapy: A multicenter national study.

Background: The aim of this study was to evaluate the prevalence of active tuberculosis (TB) infection in Moroccan patients with rheumatic diseases under biologic therapy, and to describe the demographic characteristics of these patients as well as to explore potential risk factors. Methods: This 14-year nationally representative multicenter study enrolled Moroccan patients with rheumatic diseases who had been treated with biologic therapy. Patient medical records were reviewed retrospectively for demographic characteristics, underlying rheumatic diseases, associated comorbidities, and TB-related data. Results: In total, 1407 eligible patients were studied, detailed records were obtained for only 130 patients; 33 cases with active TB were identified at an estimated prevalence rate of 2.3%. The mean age was 42.9 ± 12 years and 75.8% were males. Ankylosing spondylitis accounted for 84.8% of active TB cases, and the majority of the cases (31/33) occurred among antitumor necrosis factor-alpha (TNF-α) users. A total of 8 out of 33 patients were positive at initial latent TB infection (LTBI) screening by tuberculin skin test and/or interferon-gamma release assay. Consumption of unpasteurized dairy products (odds ratio [OR], 34.841; 95% confidence interval [CI], 3.1-389.7; P = 0.04), diabetes (OR, 38.468; 95% CI, 1.6-878.3; P = 0,022), smoking (OR, 3.941; 95% CI, 1-159.9; P = 0.047), and long biologic therapy duration (OR, 1.991; 95% CI, 1.4-16.3; P = 0.001) were identified as risk factors for developing active TB. Conclusion: Moroccan patients with rheumatic diseases under anti-TNF-α agents are at an increased TB risk, especially when risk factors are present. Strict initial screening and regular monitoring of LTBI is recommended for patients living in high TB prevalence areas.

One-year direct costs of biological therapy in rheumatoid arthritis and its predictive factors: data from the Moroccan RBSMR registry.

The aim of the study was to estimate the annual direct costs of biological therapies in rheumatoid arthritis (RA), and to establish possible factors associated with those costs. The main data source was the Moroccan registry of biological therapies in rheumatic diseases (RBSMR Registry). We included patients with available 1-year data. Variables related to socio-economic status, disease and biological therapy were collected. Direct costs included prices of biologics, costs of infusions, and subcutaneous injections. Differences in costs across groups were tested by Mann-Whitney and Kruskal-Wallis tests. Correlations analysis was performed in search of factors associated with high costs. We included 197 rheumatoid arthritis patients. The mean age was 52.3 ± 11 years, with female predominance 86.8%. Receiving one of the following therapies: rituximab (n = 132), tocilizumab (n = 37), or TNF-blockers (n = 28). Median one-year direct costs per patient were €1665 [€1472-€9879]. The total annual direct costs were € 978,494. Rituximab, constituted 25.7% of the total annual budget. TNF-blockers and tocilizumab represented 27.3% and 47% of this overall budget, respectively. Although the costs were not significantly different in terms of gender or level of study, the insurance type significantly affected the cost estimation. A positive correlation was found between the annual direct cost and body mass index (r = 0.15, p = 0.04). In Morocco, a developing country, the annual direct costs of biological therapy are high. Our results may contribute to the development of strategies for better governance of these costs.

Safety of Symptomatic Slow-Acting Drugs for Osteoarthritis: Outcomes of a Systematic Review and Meta-Analysis.

BACKGROUND: Symptomatic slow-acting drugs for osteoarthritis (SYSADOAs) are an important drug class in the treatment armamentarium for osteoarthritis (OA). OBJECTIVE: We aimed to re-assess the safety of various SYSADOAs in a comprehensive meta-analysis of randomized placebo-controlled trials, using, as much as possible, data from full safety reports. METHODS: We performed a systematic review and random-effects meta-analyses of randomized, double-blind, placebo-controlled trials that assessed adverse events (AEs) with various SYSADOAs in patients with OA. The databases MEDLINE, Cochrane Central Register of Controlled Trials (Ovid CENTRAL) and Scopus were searched. The primary outcomes were overall severe and serious AEs, as well as AEs involving the following Medical Dictionary for Regulatory Activities (MedDRA) system organ classes (SOCs): gastrointestinal, cardiac, vascular, nervous system, skin and subcutaneous tissue, musculoskeletal and connective tissue, renal and urinary system. RESULTS: Database searches initially identified 3815 records. After exclusions according to the selection criteria, 25 studies on various SYSADOAs were included in the qualitative synthesis, and 13 studies with adequate data were included in the meta-analyses. Next, from the studies previously excluded according to the protocol, 37 with mainly oral nonsteroidal anti-inflammatory drugs (NSAIDs) permitted as concomitant medication were included in a parallel qualitative synthesis, from which 18 studies on various SYSADOAs were included in parallel meta-analyses. This post hoc parallel inclusion was conducted because of the high number of studies allowing concomitant anti-OA medications. Indeed, primarily excluding studies with concomitant anti-OA medications was crucial for a meta-analysis on safety. The decision for parallel inclusion was made for the purpose of comparative analyses. Glucosamine sulfate (GS), chondroitin sulfate (CS) and avocado soybean unsaponifiables (ASU; Piascledine®) were not associated with increased odds for any type of AEs compared with placebo. Overall, with/without concomitant OA medication, diacerein was associated with significantly increased odds of total AEs (odds ratio [OR] 2.22; 95% confidence interval [CI] 1.58-3.13; I2 = 52.8%), gastrointestinal disorders (OR 2.85; 95% CI 2.02-4.04; I2 = 62.8%) and renal and urinary disorders (OR 3.42; 95% CI 2.36-4.96; I2 = 17.0%) compared with placebo. In studies that allowed concomitant OA medications, diacerein was associated with significantly more dermatological disorders (OR 2.47; 95% CI 1.42-4.31; I2 = 0%) and more dropouts due to AEs (OR 3.18; 95% CI 1.85-5.47; I2 = 13.4%) than was placebo. No significant increase in serious or severe AEs was found with diacerein versus placebo. CONCLUSIONS: GS and CS can be considered safe treatments for patients with OA. All eligible studies on ASU included in our analysis used the proprietary product Piascledine® and allowed other anti-OA medications; thus, the safety of ASU must be confirmed in future studies without concomitant anti-OA medications. Given the safety concerns with diacerein, its usefulness in patients with OA should be assessed, taking into account individual patient characteristics.

A new decision tree for diagnosis of osteoarthritis in primary care: international consensus of experts.

BACKGROUND AND AIMS: Although osteoarthritis (OA) is managed mainly in primary care, general practitioners (GPs) are not always trained in its diagnosis, which leads to diagnostic delays, unnecessary resource utilization, and suboptimal patient outcomes. METHODS: To address this situation, an International Rheumatologic Board (IRB) of 8 experts from 3 continents developed guidelines for the diagnosis of OA in primary care. The focus was three major topologies: hip, knee, and hand/finger OA. The IRB used American College of Rheumatology diagnostic criteria. RESULTS: Care pathways based on clinical and radiological findings were developed to identify intervention thresholds for GPs/specialists. To optimize usefulness in the primary care setting, the guidelines were formatted as an uncomplicated, but comprehensive one-page decision tree for each topology, highlighting key aspects of the evaluation process and incorporating red flags. In a two-phase validation stage, the draft guidelines were evaluated by rheumatologists and GPs for project execution, content and perceived benefit. The strength of the guidelines lies in their user-friendly diagram and potential for broad application. Such guidelines will allow GPs to make an easy but definite diagnosis of OA and offer clear guidance about situations requiring an expert opinion. The guidelines have potential to improve patient outcomes and reduce the number of unnecessary procedures. DISCUSSION AND CONCLUSIONS: This project demonstrated the feasibility of developing easy-to-use and effective visual decision trees to facilitate the diagnosis and management of OA of the hip, knee and hand/finger in primary care. The next step should be to conduct a large impact study of implementation of these recommendations in the diagnostic management of OA in general practice in different areas.

Guidelines for the conduct of pharmacological clinical trials in hand osteoarthritis: Consensus of a Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).

OBJECTIVES: To gather expert opinion on the conduct of clinical trials that will facilitate regulatory review and approval of appropriate efficacious pharmacological treatments for hand osteoarthritis (OA), an area of high unmet clinical need. METHODS: The European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal diseases (ESCEO) organized a working group under the auspices of the International Osteoporosis Foundation (IOF) and the World Health Organization (WHO). RESULTS: This consensus guideline is intended to provide a reference tool for practice, and should allow for better standardization of the conduct of clinical trials in hand OA. Hand OA is a heterogeneous disease affecting different, and often multiple, joints of the thumb and fingers. It was recognized that the various phenotypes and limitations of diagnostic criteria may make the results of hand OA trials difficult to interpret. Nonetheless, practical recommendations for the conduct of clinical trials of both symptom and structure modifying drugs are outlined in this consensus statement, including guidance on study design, execution, and analysis. CONCLUSIONS: While the working group acknowledges that the methodology for performing clinical trials in hand OA will evolve as knowledge of the disease increases, it is hoped that this guidance will support the development of new pharmacological treatments targeting hand OA.

Aseptic necrosis of the femoral head after pregnancy: a case report.

A documented case of beginning aseptic necrosis of the femoral head associated with pregnancy together with a review of the literature about this rare complication of pregnancy is presented. The known risk factors of osteonecrosis are; steroid use, alcoholism, organ transplantation, especially after kidney transplant or bone marrow transplantation bone, systemic lupus erythematosus, dyslipidemia especially hypertriglyceridemia, dysbaric decompression sickness, drepanocytosis and Gaucher's disease. Among the less established factors, we mention procoagulations abnormalities, HIV infection, chemotherapy. We report a case of osteonecrosis of femoral head after pregnancy.

Gastroprotection et anti-inflammatoires non stéroïdiens : Enquête auprès des médecins généralistes de Casablanca

Introduction : Si les anti-inflammatoires non stéroïdiens (AINS) sont largement utilisés pour leurs effets anti-inflammatoires, analgésiques et antipyrétiques, ils sont pourvus d'effets secondaires graves essentiellement gastriques. La coprescription de gastroprotecteur connait certaines règles. Aussi avons-nous mené cette enquête, avec pour objectif d'étudier l'approche des médecins généralistes vis-à-vis de la prescription de gastroprotecteurs au cours d'un traitement par AINS.Matériels et méthodes : Enquête téléphonique auprès de 230 médecins généralistes. Données recueillies grâce à une fiche d'exploitation précisant les modalités, la fréquence ainsi que les moyens de surveillance d'une prescription d'AINS et identifiant les déterminants de la coprescription d'une gastroprotection. Résultats : Parmi les 300 médecins sollicités, 230 (77 %) ont répondu au questionnaire. 40% prescrivaient les AINS moins de 5 fois par jour, alors que la majorité plus de 5 fois. La durée de prescription ne dépassait pas 7 jours dans la majorité des cas (73%). Un gastroprotecteur type inhibiteur de la pompe à protons (94% des cas) était prescrit de façon systémique par 108 (47%) médecins. 90% des médecins ne connaissaient pas les effets secondaires d'un excès d'IPP. Les raisons de la prescription des IPP chez les autres médecins étaient: l'antécédent de problème gastrique (74%), le reflux gastro-œsophagien (0,5%), l'âge avancé (21%), la prescription prolongée d'AINS (9%), le tabagisme chronique (6%) ou la poly médication (6%). Conclusion : La prévention de la toxicité digestive des AINS impose leur bonne prescription et une évaluation appropriée des facteurs de risque chez certains patients, avant la coprescription de protecteurs gastriques, en premier lieu un inhibiteur de la pompe à proton, sans oublier les effets secondaires liés à un excès de ces derniers