Incidence Rates of Interstitial Lung Disease Events in Tofacitinib-Treated Rheumatoid Arthritis Patients: Post Hoc Analysis From 21 Clinical Trials.

BACKGROUND/OBJECTIVE: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Interstitial lung disease (ILD) is an extra-articular manifestation of RA. We investigated incidence rates of ILD in patients with RA, receiving tofacitinib 5 or 10 mg twice daily, and identified potential risk factors for ILD. METHODS: This post hoc analysis comprised a pooled analysis of patients receiving tofacitinib 5 or 10 mg twice daily or placebo from 2 phase (P)1, 10 P2, 6 P3, 1 P3b/4, and 2 long-term extension studies. Interstitial lung disease events were adjudicated as "probable" (supportive clinical evidence) or "possible" (no supportive clinical evidence) compatible adverse events. Incidence rates (patients with events per 100 patient-years) were calculated for ILD events. RESULTS: Of 7061 patients (patient-years of exposure = 23,393.7), 42 (0.6%) had an ILD event; median time to ILD event was 1144 days. Incidence rates for ILD with both tofacitinib doses were 0.18 per 100 patient-years. Incidence rates generally remained stable over time. There were 17 of 42 serious adverse events (40.5%) of ILD; for all ILD events (serious and nonserious), 35 of 42 events (83.3%) were mild to moderate in severity. A multivariable Cox regression analysis identified age 65 years or older (hazard ratio 2.43 [95% confidence interval, 1.13-5.21]), current smokers (2.89 [1.33-6.26]), and Disease Activity Score in 28 joints-erythrocyte sedimentation rate score (1.30 [1.04-1.61]) as significant risk factors for ILD events. CONCLUSIONS: Across P1/2/3/4/long-term extension studies, incidence rates for ILD events were 0.18 following tofacitinib treatment, and ILD events were associated with known risk factors for ILD in RA.

Safety of Tofacitinib in the Treatment of Rheumatoid Arthritis in Latin America Compared With the Rest of the World Population.

OBJECTIVE: Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint destruction. Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. This post hoc analysis assessed the safety of tofacitinib in Latin American (LA) patients with RA versus the Rest of World (RoW) population. METHODS: Data were pooled from 14 clinical studies of tofacitinib: six Phase 2, six Phase 3 and two long-term extension studies. Incidence rates (IRs; patients with events/100 patient-years of treatment exposure) were calculated for safety events of special interest combined across tofacitinib doses. 95% confidence intervals (CI) for IRs were calculated using the maximum likelihood method. Descriptive comparisons were made between LA and RoW (excluding LA) populations. RESULTS: This analysis included data from 984 LA patients and 4687 RoW patients. IRs for safety events of special interest were generally similar between LA and RoW populations, with overlapping 95% CIs. IRs for discontinuation due to adverse events, serious infections, tuberculosis, all herpes zoster (HZ), serious HZ, malignancies (excluding non-melanoma skin cancer) and major adverse cardiovascular events were numerically lower for LA versus RoW patients; IR for mortality was numerically higher. No lymphoma was reported in the LA population versus eight cases in the RoW population. Exposure (extent and length) was lower in the LA population (2148.33 patient-years [mean = 2.18 years]) versus RoW (10515.68 patient-years [mean = 2.24 years]). CONCLUSION: This analysis of pooled data from clinical studies of tofacitinib in patients with RA demonstrates that tofacitinib has a consistent safety profile across LA and RoW patient populations.

PANLAR Consensus Recommendations for the Management in Osteoarthritis of Hand, Hip, and Knee.

OBJECTIVE: The objective of this consensus is to update the recommendations for the treatment of hand, hip, and knee osteoarthritis (OA) by agreeing on key propositions relating to the management of hand, hip, and knee OA, by identifying and critically appraising research evidence for the effectiveness of the treatments and by generating recommendations based on a combination of the available evidence and expert opinion of 18 countries of America. METHODS: Recommendations were developed by a group of 48 specialists of rheumatologists, members of other medical disciplines (orthopedics and physiatrists), and three patients, one for each location of OA. A systematic review of existing articles, meta-analyses, and guidelines for the management of hand, hip, and knee OA published between 2008 and January 2014 was undertaken. The scores for Level of Evidence and Grade of Recommendation were proposed and fully consented within the committee based on The American Heart Association Evidence-Based Scoring System. The level of agreement was established through a variation of Delphi technique. RESULTS: Both "strong" and "conditional" recommendations are given for management of hand, hip, and knee OA and nonpharmacological, pharmacological, and surgical modalities of treatment are presented according to the different levels of agreement. CONCLUSIONS: These recommendations are based on the consensus of clinical experts from a wide range of disciplines taking available evidence into account while balancing the benefits and risks of nonpharmacological, pharmacological, and surgical treatment modalities, and incorporating their preferences and values. Different backgrounds in terms of patient education or drug availability in different countries were not evaluated but will be important.

Osteoarthritis in Latin America: Study of Demographic and Clinical Characteristics in 3040 Patients.

BACKGROUND: Latin America is a heterogeneous region made up of different populations, cultures, latitudes, altitudes, and immigrants from different areas and ethnic groups. OBJECTIVE: The purpose of this study is to describe the clinical and demographic profile of patients with osteoarthritis (OA) evaluated by a selected group of rheumatologists in 13 Latin American countries. METHODS: A descriptive, observational, cross-sectional study was conducted in 13 Latin American countries of patients with symptomatic OA. Data were collected over a 3-month period using an ad hoc questionnaire to evaluate the clinical and demographic features of OA seen by rheumatologists. RESULTS: Among the 3040 patients, their average age was 62.5 years, and female-to-male ratio was 4.8:1. Patients with body mass index of greater than 30 kg/m or obesity was found in 38.2%. Approximately 88% had primary OA. Joints with OA were as follows: knee 31.2%, hand 9.5%, hand and knee 22.9%, proximal and distal interphalangeal joints (erosive OA) 6.5%, axial 6.6%, and hip 1.3%. Approximately 88.5% had radiographic severity of grade 2 or 3 on Kellgren-Lawrence scale (0-4). Nonsteroidal anti-inflammatory drugs were the predominant OA treatment included in combinations with glucosamine sulfate/chondroitin and viscosupplementation. Associated comorbidities included hypertension (39%), obesity (36.3%), diabetes mellitus (12%), and without comorbidity (12.7%). CONCLUSIONS: This is 1 of the largest population studies that evaluated the characteristics of OA in 3040 patients evaluated by rheumatologists in 13 Latin American countries. This study provides important data for each Latin American country to develop new health care planning in management of OA.

From the model of integral attention to the creation of centers of excellence in rheumatoid arthritis.

For the Pan American Health Organization (PAHO), the care of patients with chronic diseases currently experiences fragmentation in attention, generating poor performance of health services. Thus, comprehensive health care strategies arise to mitigate these problems; one of them are Centers of Excellence (CoEs), which aim to obtain high quality results in health from the adequate and minimum use of resources. The objective of this study was to describe the history and current context of the CoE in comprehensive care in patients with rheumatoid arthritis (RA). A systematic search of the literature terms (MeSH) was performed. The bases used were PubMed, Ebsco Host, Lilacs, Science Direct, Ovid, and Google (gray literature). The source of the information was evaluated to determine its quality. International standards focus the CoEs starting from comprehensive management of patients with RA and patient volume, continuous improvement, and quality of health care, constituting an interdisciplinary team. The REAL-PANLAR group suggested that the inclusion of the strategy "Treat to Target", and patient education improves patient conditions and understanding of the disease. RA is a prevalent and costly disease. The creation of comprehensive care centers of the CoE type is an initiative that improves the prognosis of RA. This document aims to encourage rheumatologists and scientific societies to structure CoE in an interdisciplinary endeavor.

Evaluación de la eficacia y seguridad del ácido hialurónico por vía oral asociado con glucosamina sulfato, condroitín sulfato y metilsulfonilmetano comparado con la asociación por vía oral de glucosamina sulfato, condroitín sulfato y metilsulfonilmetano en la osteoartritis de rodilla / Evaluation of the efficacy and safety of the orally association of hyaluronic acid, glucosamine sulfate, chondroitin sulfate and methylsulfonylmethane compared with the association of glucosamine sulfate, chondroitin sulfate and methylsulfonylmethane in knee osteoarthritis

Objetivo. Comparar la eficacia y la seguridad de la asociación de ácido hialurónico (AH), glucosamina sulfato (GS), condroitina sulfato (CS) y metilsulfonilmetano (MSM) versus GS, CS y MSM en el control de los síntomas de la osteoartritis (OA) de rodilla. Material y Método. Estudio comparativo, aleatorizado prospectivo, a doble ciego, en pacientes con OA de rodilla, divididos en dos grupos, durante tres meses de tratamiento diario, vía oral. El grupo 1 recibió AH 120 mg + GS 1 500 mg + CS 1 200 mg + MSM 1 000 mg y el grupo 2, la misma asociación pero sin AH. Se incluyeron hombres y mujeres mayores de 40 años y menores de 80 años con diagnóstico de OA de rodilla, según el criterio modificado del Colegio Americano Reumatología (ACR). Se realizaron cuatro evaluaciones, inicial y a las 4, 8 y 12 semanas de tratamiento. El dolor se evalúo con la escala de WOMAC 3.1 y la escala visual análoga (EVA) y el estado de salud, con el cuestionario SF-36 versión 2. En todas las visitas se proporcionó al paciente un formulario para que anote la presencia de algún evento adverso. Resultados. Los grupos 1 y 2 tuvieron similares datos en edad, género, grado de instrucción y tiempo de enfermedad, sin diferencia estadística significativa. Todos los pacientes cumplieron con los criterios del ACR. El grupo 1 tuvo mejores puntajes con diferencia estadísticamente significativa en la variable EVA entre todos los grupos en la semana 12 y en la variable SF-36 en la semana 12. Conclusiones. Se puede concluir que la asociación GS-CS-MSM-AH por vía oral sería más eficaz y de igual seguridad que la asociación GS-CS-MSM en el control de los síntomas de la OA de rodilla.

Objective. To compare the efficacy and safety of the orally combination of hyaluronic acid (HA), glucosamine sulfate (GS), chondroitin sulfate (CS) and methylsulfonylmethane (MSM) versus GS, CS and MSM for controlling the symptoms of osteoarthritis (OA) knee. Material and Methods. Prospective randomized, double-blind, comparative study, in patients with knee OA were divided into two groups for three months of daily treatment, orally. Group 1 received HA 120 mg + GS 1500 mg + CS 1200 mg + MSM 1000 mg, and group 2, the same association but without HA. Men and women aged 40 years and under 80 years diagnosed with knee OA were included, according to the modified criteria of the American College of Rheumatology (ACR). Four evaluations, initial and at 4, 8 and 12 weeks of treatment were made. Pain was assessed with the WOMAC 3.1 scale and visual analogue scale (VAS) and health status with the SF-36 version 2 questionnaire. In all patient visits provided a form to record the presence of any adverse events. Results. Groups 1 and 2 were similar in age, gender, level of education and sick time, without statistically significant differences. All patients fulfilled the ACR criteria. Group 1 had better scores with statistically significant difference in VAS variable among all groups at week 12 and the SF-36 variable in week 12. Conclusions. It can be concluded that HA-GS-CS-MSM orally association would be more effective and equally safety that GS-CS-MSM association in controlling the symptoms of knee OA.

Controlled trial of methotrexate versus CH-1504 in the treatment of rheumatoid arthritis.

OBJECTIVE: To investigate the clinical efficacy, safety, tolerability, and toxicity profile of a metabolically stable antifolate, CH-1504, compared to methotrexate (MTX) in the treatment of rheumatoid arthritis (RA). METHODS: A 24-week open-label trial of MTX and CH-1504 was performed in 20 patients with RA. RESULTS: Improvements in clinical and laboratory indicators were observed in both study groups. Improvement in the CH-1504 group was greater than in the MTX group. Both treatments were generally well tolerated; however, the liver function test abnormalities and gastrointestinal related adverse events expected with this class of medication were not seen with CH-1504. CONCLUSION: CH-1504 appears to be clinically efficacious and may possess a superior safety and tolerance profile compared to MTX.

Artritis piógena en niños / Septic arthritis in children

Se realizó un estudio retrospectivo de los casos de Artritis Piógena en la población pediátrica del Hospital Cayetano heredia, encontrando 99 casos en un período de 14 años; la tercera parte de ellos fueron lactantes. El cuadro fue monoarticular en 94 por ciento de los casos, siendo la rodilla la articulación más comúnmente afectada.El germen que aisló con mayor frecuencia fue Stafilococo aureus. El tratamiento consistió fundamentalmente en antibióticos apropiados y artrocentesis evacuatorias; 16 casos requirieron artrotomía. El tiempo de enfermedad antes del tratamiento médico o drenaje articular, así como el compromiso por Stafilococo aureus y Pseudonoma aeruginosa fueron factores que influyeron en la evolución del paciente