Recientemente la Dra. Chamaida Plasencia y yo, hemos tenido la oprtunidad de estudiar este importante aspecto relacionado con la seguridad de los biológicos. Tras revisar extensamente la literatura hemos llegado a las siguientes conclusiones
• En primer lugar, es muy complicado establecer una relación entre una enfermedad tan frecuente como el cáncer y el tratamiento con biológicos. Los motivos son diversos, pero entre ellos hay que destacar los distintos factores exógenos y genéticos que están relacionados con el origen de la enfermedad tumoral y la dificultad que existe para deslindar éstos del efecto causal de un determinado medicamento, como en este caso serían los biológicos. Si a esto le sumamos, que cualquier factor externo causal de un tumor, puede desarrollar la enfermedad muchos años después de haber sido eliminado (el mejor ejemplo es el tabaco, ya que se estima que desde su suspensión y aunque la probabilidad de desarrollar un cáncer va disminuyendo de forma paulatina, el riesgo de padecer un cáncer, probablemente, siempre será algo superior que el de la población que no fue fumadora), las conclusiones se complican aún más.
• Con respecto a las enfermedades autoinmunes y cáncer, hoy parece establecido, que algunas de ellas ya tienen per se mayor probabilidad de desarrollar un tumor, al margen de la terapia. El ejemplo más representativo es el linfoma no Hodgkin y la artritis reumatoide. Hoy está aceptado que esta enfermedad cuando no se controla adecuadamente, tiene un riesgo superior a desarrollar este linfoma que la población general. Sin embargo, y aunque existen estudios contradictorios, la inmensa mayoría de los metaanálisis y estudios de registros, no han podido demostrar que la terapia biológica aumente ese riesgo. Si el etanercept, el único anti-TNF que no es un anticuerpo monoclonal, tiene menos riesgo para desarrollar linfoma que los anticuerpos monoclonales, sigue siendo tema de debate, aunque los estudios de autores franceses y británicos apuntarían en esa dirección.
SAN DIEGO – A new study offers a double message about the potential impact of obesity on systemic lupus erythematosus (SLE) in women: Excess pounds are linked to a higher risk of patient-reported outcomes such as pain and fatigue, and body mass index may be an appropriate tool to study weight issues in this population.
For the new study, Dr. Patterson and her colleagues analyzed findings from surveys of 148 participants in the Arthritis Body Composition and Disability study. All participants were women with a verified SLE diagnosis.
About two-thirds of the sample were white, 14% were Asian, and 13% were African American. The average age was 48 years, the average disease duration was 16 years, and 45% took glucocorticoids.
Researchers used two measurements of obesity: BMI of 30 kg/m2 or greater and fat mass index (FMI) of 13 kg/m2 or greater.
They calculated FMI with data collected via whole dual x-ray absorptiometry. Of the participants, 32% and 30% met criteria for obesity under FMI and BMI definitions, respectively.
Researchers also collected survey data regarding measurements of disease activity, depressive symptoms, pain and fatigue.
The study authors controlled their results to account for factors such as age, race, and prednisone use. They found that those defined as obese via FMI had more disease activity and depression than did nonobese women: 14.8 versus 11.5, P = .010, on the Systemic Lupus Activity Questionnaire scale, and 19.8 versus 13.1, P = .004, on the Center for Epidemiologic Studies Depression scale.
On two other scales of pain and fatigue, obese patients scored lower – a sign of worse status – compared with nonobese women: 38.7 versus 44.2, P = .004, on the Short Form 36 (SF-36) Health Survey pain subscale and 39.6 versus 45.2, P= .010, on the SF-36 vitality subscale. The researchers reported similar findings when using BMI to assess obesity.
It’s not clear why obesity and lupus may be linked, Dr. Patterson said, though she noted that inflammation is a shared factor. “People with lupus have arthritis and chronic pain, so there may be this vicious feedback cycle with hindrances to be able to live healthy lifestyles,” she added.
The study has limitations, including that the sample is largely white, while lupus is more common among minority women. In addition, the study does not include underweight patients or track patients over time. “It will be important to look at obesity and patient-reported outcomes to determine whether weight loss results in better outcomes,” Dr. Patterson said.
The study does provide an extra benefit by suggesting that BMI is not an inferior tool to measure the effects of obesity in the SLE population, Dr. Patterson said. BMI has been criticized as a misleading measurement of obesity. But the BMI and FMI measures produced similar results in this study. “That’s really good news in a way for the practicalities of using this information,” she said.
But FMI may still be a better measurement of obesity in the general population, where BMI may be more likely to be thrown off by high muscle mass.
It may seem obvious that obesity is linked to worse lupus outcomes, but rheumatologist Bryant England, MD, of the University of Nebraska, Omaha, said that this research is noteworthy because it highlights the importance of focusing on obesity in the clinic.
Rheumatologists shouldn’t leave obesity to primary care physicians but instead confront it themselves, said Dr. England, who moderated a discussion of new research at an ACR annual meeting press conference. But he cautioned that prudence is especially important when talking about obesity with lupus patients because they may be sensitive about medication-related weight gain.
Dr. Patterson and the other study authors reported having no relevant disclosures. Dr. England also reported no relevant disclosures. The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
Hi friends, on these days I’m in Brazil visiting my colleagues of this beautiful country. One of the principal purposes of this trip is to discuss with them the important issue of tapering (or discontinuing) biologics in rheumatic conditions, once the patient has achieved a good clinical status (remission or low disease activity). There is a lot of evidence, but unfortunately, many studies have been conducted in patients (that in our clinical setting) they shouldn’t be candidates to receive biologics. Nonetheless, after an extensive review, I could achieve some conclusions that I intend to share with you once my visit has ended. Then, it will be great getting your feedback. Now as a starter, I attach the outline of my presentation. Cheers…
El reumatólogo es el especialista del área de la Medicina Interna que tiene como misión fundamental el diagnóstico y el tratamiento de las enfermedades del Aparato Locomotor. Muchos de estos procesos tienen un origen autoinmune (por un trastorno de la inmunidad que aparece en el paciente) y otros son producto de mecanismos inflamatorios crónicos de origen, algunas veces, mal conocido. De este último grupo, la artrosis (para los anglosajones, la osteoartritis) representa el grupo más numeroso.
El reumatólogo al ser un especialista del área de la Medicina Interna, también se encarga de tratar o coordinarse con otros especialistas cuando existen complicaciones de órganos tan importantes como la piel, el ojo (uvea y córnea) riñón, pulmón, intestino etc…. Estas complicaciones pueden aparecer especialmente en enfermedades como la Artritis Reumatoide, las espondiloartritis, la artritis crónica, y las enfermedades autoinmunes sistémicas, siendo el Lupus (Eritematoso Sistémico) la enfermedad más representativa de este último grupo.
Finalmente y a modo de resumen el reumatólogo también se encarga de las enfermedades óseas, de las cuales la Osteoporosis representa la más frecuente.
A pesar de lo que mucha gente piensa, los reumatólogos no estamos centrados en ver personas de edad avanzada. Muchos de nuestros pacientes son jóvenes con enfermedades que debutan en la segunda o tercera década de la vida.
Adalimumab, a fully human anti–tumor necrosis factor α monoclonal antibody, is effective in the treatment of juvenile idiopathic arthritis (JIA). We tested the efficacy of adalimumab in the treatment of JIA-associated uveitis.
In this multicenter, double-blind, randomized, placebo-controlled trial, we assessed the efficacy and safety of adalimumab in children and adolescents 2 years of age or older who had active JIA-associated uveitis. Patients who were taking a stable dose of methotrexate were randomly assigned in a 2:1 ratio to receive either adalimumab (at a dose of 20 mg or 40 mg, according to body weight) or placebo, administered subcutaneously every 2 weeks. Patients continued the trial regimen until treatment failure or until 18 months had elapsed. They were followed for up to 2 years after randomization. The primary end point was the time to treatment failure, defined according to a multicomponent intraocular inflammation score that was based on the Standardization of Uveitis Nomenclature criteria.
The prespecified stopping criteria were met after the enrollment of 90 of 114 patients. We observed 16 treatment failures in 60 patients (27%) in the adalimumab group versus 18 treatment failures in 30 patients (60%) in the placebo group (hazard ratio, 0.25; 95% confidence interval [CI], 0.12 to 0.49; P<0.0001 [the prespecified stopping boundary]). Adverse events were reported more frequently in patients receiving adalimumab than in those receiving placebo (10.07 events per patient-year [95% CI, 9.26 to 10.89] vs. 6.51 events per patient-year [95% CI, 5.26 to 7.77]), as were serious adverse events (0.29 events per patient-year [95% CI, 0.15 to 0.43] vs. 0.19 events per patient-year [95% CI, 0.00 to 0.40]).
Adalimumab therapy controlled inflammation and was associated with a lower rate of treatment failure than placebo among children and adolescents with active JIA-associated uveitis who were taking a stable dose of methotrexate. Patients who received adalimumab had a much higher incidence of adverse events and serious adverse events than those who received placebo. (Funded by the NIHR Health Technology Assessment Programme and Arthritis Research UK; SYCAMORE EudraCT number, 2010-021141-41.)
Background New drugs and new evidence concerning the use of established treatments have become available since the publication of the first European League Against Rheumatism (EULAR) recommendations for the management of gout, in 2006. This situation has prompted a systematic review and update of the 2006 recommendations.
Methods The EULAR task force consisted of 15 rheumatologists, 1 radiologist, 2 general practitioners, 1 research fellow, 2 patients and 3 experts in epidemiology/methodology from 12 European countries. A systematic review of the literature concerning all aspects of gout treatments was performed. Subsequently, recommendations were formulated by use of a Delphi consensus approach.
Results Three overarching principles and 11 key recommendations were generated. For the treatment of flare, colchicine, non-steroidal anti-inflammatory drugs (NSAIDs), oral or intra-articular steroids or a combination are recommended. In patients with frequent flare and contraindications to colchicine, NSAIDs and corticosteroids, an interleukin-1 blocker should be considered. In addition to education and a non-pharmacological management approach, urate-lowering therapy (ULT) should be considered from the first presentation of the disease, and serum uric acid (SUA) levels should be maintained at<6 mg/dL (360 µmol/L) and <5 mg/dL (300 µmol/L) in those with severe gout. Allopurinol is recommended as first-line ULT and its dosage should be adjusted according to renal function. If the SUA target cannot be achieved with allopurinol, then febuxostat, a uricosuric or combining a xanthine oxidase inhibitor with a uricosuric should be considered. For patients with refractory gout, pegloticase is recommended.
Conclusions These recommendations aim to inform physicians and patients about the non-pharmacological and pharmacological treatments for gout and to provide the best strategies to achieve the predefined urate target to cure the disease.
Recent insights in rheumatoid arthritis (RA) necessitated updating the European League Against Rheumatism (EULAR) RA management recommendations. A large international Task Force based decisions on evidence from 3 systematic literature reviews, developing 4 overarching principles and 12 recommendations (vs 3 and 14, respectively, in 2013). The recommendations address conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GC); biological (b) DMARDs (tumour necrosis factor (TNF)-inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, clazakizumab, sarilumab and sirukumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (Janus kinase (Jak) inhibitors tofacitinib, baricitinib). Monotherapy, combination therapy, treatment strategies (treat-to-target) and the targets of sustained clinical remission (as defined by the American College of Rheumatology-(ACR)-EULAR Boolean or index criteria) or low disease activity are discussed. Cost aspects were taken into consideration. As first strategy, the Task Force recommends MTX (rapid escalation to 25 mg/week) plus short-term GC, aiming at >50% improvement within 3 and target attainment within 6 months. If this fails stratification is recommended. Without unfavourable prognostic markers, switching to—or adding—another csDMARDs (plus short-term GC) is suggested. In the presence of unfavourable prognostic markers (autoantibodies, high disease activity, early erosions, failure of 2 csDMARDs), any bDMARD (current practice) or Jak-inhibitor should be added to the csDMARD. If this fails, any other bDMARD or tsDMARD is recommended. If a patient is in sustained remission, bDMARDs can be tapered. For each recommendation, levels of evidence and Task Force agreement are provided, both mostly very high. These recommendations intend informing rheumatologists, patients, national rheumatology societies, hospital officials, social security agencies and regulators about EULAR’s most recent consensus on the management of RA, aimed at attaining best outcomes with current therapies.