Severe osteoporosis: Principles for pharmacological therapy in Mexico. / Osteoporosis severa: fundamentos para su terapia farmacológica en México.

BACKGROUND: This article presents evidence and recommendations regarding the efficacy and safety of the approved and available therapies in Mexico to treat severe or established osteoporosis with the aim of developing a position regarding therapeutics in this stage of the disease, according to the descriptive cards of the National Drug Formulary of the National General Health Council of Mexico. METHODS: We performed a systematic and narrative review of the evidence of teriparatide and denosumab, from their pharmacological profile, effectiveness, and safety derived from clinical trials, as well as an analysis of the general recommendations of the national and international clinical practice guidelines. RESULTS: The evidence establishes that teriparatide and denosumab belong to different therapeutic classes, with biologically opposed mechanisms of action and indications of use, which are clearly differentiated in their respective national codes, therefore these drugs cannot be substitutable or interchangeable in severe osteoporosis therapy. Both represent the best options currently available for this stage of the disease; being similar in their efficacy in preventing new vertebral fragility fractures, with an RR of .35 (CI 95%; .22-.55) for teriparatide, and .32 (CI 95%: .26-.41) for denosumab. The absolute risk reduction is higher with teriparatide 9.3% (21 months) compared with denosumab at 4.8% (36 months). CONCLUSIONS: Our results agree with the recommendations available in national and international clinical practice guidelines, with both therapies proposed as a sequential, but not a substitute, treatment.

Autoantibodies in prediction of the development of rheumatoid arthritis among healthy relatives of patients with the disease.

OBJECTIVE: Although blood bank-based studies have shown that rheumatoid arthritis (RA)-related autoantibodies are present before the onset of RA, information on their positive predictive value (PPV) for development of RA in healthy individuals is scarce. This study was undertaken to assess the 5-year PPV of serum IgM rheumatoid factor (IgM-RF) and anti-cyclic citrullinated peptide (anti-CCP) for the development of RA among healthy relatives of patients with RA. METHODS: Healthy relatives of RA patients were invited to participate in a cohort study. At baseline, information on participants' medical history was obtained, and serum levels of IgM-RF and anti-CCP antibodies were determined (by nephelometry and second-generation anti-CCP enzyme-linked immunosorbent assay, respectively). The subjects were followed up every 4 months via a structured interview (Community Oriented Program for Control of Rheumatic Diseases [COPCORD] questionnaire). When the COPCORD questionnaire indicated possible arthritis, subjects underwent an in-office rheumatology assessment including joint count. The study end point was defined as fulfillment of the American College of Rheumatology criteria for RA. RESULTS: Eight hundred nineteen initially healthy relatives of 252 patients with RA were included (69% female, 41% offspring, mean ± SD age 35 ± 12 years). Eleven (1.3%) were positive for both anti-CCP-2 and RF, 12 (1.5%) only for anti-CCP-2, and 16 (2%) only for RF. RA developed in 17 (2.1%) of the relatives during the 5-year followup (3,313 person-years for the seronegative group and 60.8 person-years for the anti-CCP-2-positive group). The PPV was 64% when both anti-CCP-2 and RF were positive and 58% when only anti-CCP-2 was positive. Offspring of patients with RA had an independent 3-fold increased risk of developing RA. CONCLUSION: Results of the present study indicate that the magnitude of risk for developing RA in healthy relatives of patients with RA can be estimated using simple routine laboratory tests.

Effect of belimumab on vaccine antigen antibodies to influenza, pneumococcal, and tetanus vaccines in patients with systemic lupus erythematosus in the BLISS-76 trial.

OBJECTIVE: In patients with systemic lupus erythematosus (SLE), evidence suggests that most vaccines (except live-virus vaccines) are safe, although antibody response may be reduced. This substudy from the phase III, randomized, double-blind, placebo-controlled BLISS-76 trial evaluated the effects of belimumab on preexisting antibody levels against pneumococcal, tetanus, and influenza antigens in patients with SLE. METHODS: In BLISS-76, patients with autoantibody-positive, active SLE were treated with placebo or belimumab 1 or 10 mg/kg every 2 weeks for 28 days and every 28 days thereafter, plus standard SLE therapy, for 76 weeks. This analysis included a subset of patients who had received pneumococcal or tetanus vaccine within 5 years or influenza vaccine within 1 year of study participation. Antibodies to vaccine antigens were tested at baseline and Week 52, and percentage changes in antibody levels from baseline and proportions of patients maintaining levels at Week 52 were assessed. Antibody titers were also assessed in a small number of patients vaccinated during the study. RESULTS: Consistent with preservation of the memory B cell compartment with belimumab treatment, the proportions of patients maintaining antibody responses to pneumococcal, tetanus, and influenza antigens were not reduced. In a small group receiving influenza vaccine on study, antibody responses were frequently lower with belimumab, although titer levels were > 1:10 in all patients treated with 10 mg/kg and in the majority treated with 1 mg/kg. CONCLUSION: Treatment with belimumab did not affect the ability of patients with SLE to maintain antibody titers to previous pneumococcal, tetanus, and influenza immunizations. [ClinicalTrials.gov registration number NCT 00410384].

Uso apropiado de los antiinflamatorios no esteroideos en reumatología: documento de consenso de la Sociedad Española de Reumatología y el Colegio Mexicano de Reumatología / Appropriate use of non-steroidal anti-inflammatory drugs in rheumatology: guidelines from the Spanish Society of Rheumatology and the Mexican College of Rheumatology

Objetivos: Elaborar recomendaciones para el uso apropiado de AINE en reumatología. Métodos: Se utilizó una metodología modificada de RAND/UCLA. Se seleccionaron dos grupos de panelistas, uno por el CMR y otro por la SER. A partir de grupos nominales, se obtuvieron propuestas de recomendaciones, que fueron sometidas a la prueba de acuerdo entre los reumatólogos de ambas sociedades mediante encuesta Delphi a dos rondas. Del análisis de la segunda ronda Delphi, se extrajeron las recomendaciones finales y posteriormente se revisó el nivel de evidencia y el grado de acuerdo de la recomendación según el Centro de Medicina Basada en la Evidencia de Oxford. Finalmente, se efectuó revisión sistemática de cinco recomendaciones sin acuerdo. Resultados: Se presentan recomendaciones sobre el uso seguro de los AINE en las enfermedades reumáticas, con base en la mejor evidencia disponible, la opinión de expertos, el acuerdo entre reumatólogos y la revisión de la literatura. La tendencia es disminuir la frecuencia, la duración y la dosis de AINE en favor de medidas no farmacológicas, analgésicos o fármacos modificadores de los síntomas o del curso de la enfermedad. Además, es obligado identificar perfiles de mayor riesgo de toxicidad, en especial gastrointestinal y cardiovascular. Se recomiendan pautas de actuación y monitorización en los diferentes grupos de riesgo y en pacientes con empleo de antiagregantes plaquetarios, anticoagulación o con terapias concomitantes. El porcentaje de acuerdo es elevado en la mayoría de los casos. Conclusiones: Los AINE son medicamentos seguros y eficaces en el tratamiento de las afecciones reumáticas. No obstante, dado su perfil de riesgo, es necesario individualizar su uso (AU)

Objective: To develop guidelines for the appropriate use of NSAIDs in rheumatology. Methods: We used a methodology modified from the one developed by RAND/UCLA. Two groups of panellists were selected, one by the CMR and another by the SER. Recommendations were proposed from nominal groups and the agreement to them was tested among rheumatologists from both societies by a tworound Delphi survey. The analysis of the second Delphi round supported the generation of the final set of recommendations and the assignment of a level of agreement to each of them. Systematic reviews of five recommendations in which the agreement was low or was divided were also carried out. Results: Here we present recommendations for the safe use of NSAIDs in rheumatic diseases, based on the best available evidence, expert opinion, the agreement among rheumatologists, and literature review. The trend is to reduce the frequency, duration and dose of NSAIDs in favour of non-pharmacological measures, analgesic drugs or disease modifying drugs. In addition, the recommendations help to identify profiles for increased toxicity, with an emphasis on gastrointestinal and cardiovascular risks. The recommendations deal with the course of action and monitoring in different risk groups and in patients using antiplatelet or anticoagulant drugs. The overall level of agreement is high. Conclusions: The NSAIDs are safe and effective drugs for the treatment of rheumatic diseases. However, it is necessary to individualize its use according to their risk profile (AU)

[Appropriate use of non-steroidal anti-inflammatory drugs in rheumatology: guidelines from the Spanish Society of Rheumatology and the Mexican College of Rheumatology]. / Uso apropiado de los antiinflamatorios no esteroideos en reumatología: documento de consenso de la Sociedad Española de Reumatología y el Colegio Mexicano de Reumatología.

OBJECTIVE: To develop guidelines for the appropriate use of NSAIDs in rheumatology. METHODS: We used a methodology modified from the one developed by RAND/UCLA. Two groups of panellists were selected, one by the CMR and another by the SER. Recommendations were proposed from nominal groups and the agreement to them was tested among rheumatologists from both societies by a tworound Delphi survey. The analysis of the second Delphi round supported the generation of the final set of recommendations and the assignment of a level of agreement to each of them. Systematic reviews of five recommendations in which the agreement was low or was divided were also carried out. RESULTS: Here we present recommendations for the safe use of NSAIDs in rheumatic diseases, based on the best available evidence, expert opinion, the agreement among rheumatologists, and literature review. The trend is to reduce the frequency, duration and dose of NSAIDs in favour of non-pharmacological measures, analgesic drugs or disease modifying drugs. In addition, the recommendations help to identify profiles for increased toxicity, with an emphasis on gastrointestinal and cardiovascular risks. The recommendations deal with the course of action and monitoring in different risk groups and in patients using antiplatelet or anticoagulant drugs. The overall level of agreement is high. CONCLUSIONS: The NSAIDs are safe and effective drugs for the treatment of rheumatic diseases. However, it is necessary to individualize its use according to their risk profile.

El beneficio del alendronato sódico en el tratamiento de la osteoporosis evaluada mediante densitometría ósea / Benefits of sodium alendronate in the treatment of osteoporosis assessed by bone densitrometry

El alendronato sódico es un fármaco empleado como inhibidor de la resorción ósea y con ello para el manejo de la osteoporosis. Se presentan los resultados en 42 pacientes diagnosticados con osteoporosis por medio de densitometría ósea (DO) que fueron sometidos a tratamiento con alendronato sódico durante 21 meses en promedio. El tipo de osteoporosis fue principalmente posmenopáusica. Además, todos los pacientes recibieron indicaciones de continuar la ingestión de calcio oral. La DO reveló ganancia ósea a nivel de columna lumbar en 40 (95 por ciento) de los 42 pacientes cuyó valor medio fue 6 por ciento comparando con la densitometría inicial (p<0.01) y a nivel de cuello femoral la ganancia observada aunque ocurrió en algunos casos, en el conjunto del grupo no fue significativa desde el punto de vista estadístico. Con base en estos resultados, se conluye que el alendronato sódico fue eficaz para lograr incremento de la masa ósea medida por DO-principalmente en columna lumbar- en pacientes con osteoporosis