Long-Term Survival of Subcutaneous Biosimilar Tumor Necrosis Factor Inhibitors Compared to Originators: Results From a Multicenter Prospective Registry.

OBJECTIVE: To analyze the long-term survival of subcutaneous biosimilar tumor necrosis factor inhibitors compared to the originator molecules in patients with rheumatic diseases, as well as the factors associated with drug discontinuation. METHODS: Retrospective analysis of BIOBADASER, the Spanish multicenter prospective registry of patients with rheumatic disease receiving biologic and targeted disease-modifying antirheumatic drugs. Patients who started etanercept (ETN) or adalimumab (ADA) from January 2016 to October 2023 were included. The survival probabilities of biosimilars and originators were compared using Kaplan-Meier estimating curves. To identify factors associated with differences in the retention rates, hazard ratios (HR) were estimated using Cox regression models for all and specific causes (inefficacy or adverse events [AEs]) of discontinuation. RESULTS: A total of 4162 patients received 4723 treatment courses (2991 courses of ADA and 1732 courses of ETN), of which 722 (15.29%) were with originator molecules and 4001 (84.71%) were with biosimilars. The originators were more frequently discontinued than biosimilars (53.32% vs 33.37%, respectively). The main reason for discontinuation was inefficacy (60.35% of the treatments). The risk of overall discontinuation was lower for biosimilars (adjusted HR 0.84, 95% CI 0.75-0.95). Female sex, obesity, and second or later treatment lines increased the risk of discontinuation, whereas disease duration and the use of concomitant methotrexate were associated with a greater survival. When assessing cause-specific reasons of discontinuation, excluding nonmedical switching, the results from the crude and adjusted analyses showed no significant differences in the retention rate between biosimilars and originators. CONCLUSION: No significant differences were found between treatments in long-term survival due to inefficacy or AEs.

Giant cell arteritis with spontaneous remission.

The case of a 75-year-old woman diagnosed with polymyalgia rheumatica (PMR), treated with low doses of prednisone, and with clinical and analytical remission is reported. Two years later, she presented with a clinical picture of giant cell arteritis (GCA), including headache, diplopia, jaw pain, feeling of swelling in both temples, and elevation of acute phase reactants. Symptoms spontaneously subsided 2 weeks later, while analytical parameters improved without any treatment. A high-resolution colour Doppler ultrasound showed thickening of the intima-media complex with 'halo' sign in the right temporal artery. A biopsy of the right temporal artery was performed, although it was not successful, as no artery could be found, and the procedure became more complicated with an eyebrow ptosis due to a lesion in the frontal branch of the facial nerve. GCA diagnosis was based on the clinical, laboratory, and ultrasound findings. The patient was treated with prednisone and methotrexate, without clinical or analytical relapse. Comments are presented on the described cases of GCA with spontaneous remission, and the most appropriate treatments in these cases are discussed. Other peculiarities of the case, such as the progression to GCA more than 2 years after the onset of PMR, and the complications from the temporal artery biopsy are also mentioned.

[Giant Cell Arteritis and Charles Bonnet Syndrome. The Case of Saint Martin of Leon] / Arteritis de Células Gigantes y Síndrome de Charles Bonnet/Giant Cell Arteritis and Charles Bonnet Syndrome. El caso de Santo Martino de León

Saint Martin of Leon was a monk who lived in the 12th century. The details of his life are known because they were described by his contemporary, Lucas de Tuy, in the Liber de Miraculis Sancti Isidori. Saint Martin of Leon was a venerable old man who suffered from severe headaches, considerable difficulties in raising or maintaining his arms raised, asthenia, and anorexia. In addition, he is represented in his codex Concordia with an unusual hyperpigmentation of the temples suggesting a therapeutic intervention on temporal arteries. These data lead us to think that this could be the first described case of giant cell arteritis with some clinical information. Moreover, he experienced a singular and curious appearance of Saint Isidore of Seville, who made him swallow a booklet, which might correspond to a complex visual hallucination or associated Charles Bonnet syndrome. Historical data on the disease are reviewed and discussed, as well as its evolution and treatment before giving steroids.

Santo Martino de León fue un clérigo leonés del siglo XII. Se conocen algunos detalles de su vida porque fueron descritos por su coetáneo Lucas de Tuy en el Liber de Miraculis Sancti Isidori. Santo Martino era un anciano venerable que padecía fuertes dolores de cabeza, notables dificultades para elevar o mantener elevados los brazos, cansancio y anorexia. Además, aparece representado en su obra Concordia con una inusual hiperpigmentación de las sienes que sugiere alguna intervención terapéutica sobre las arterias temporales. Estos datos nos llevan a pensar que podría ser el primer caso descrito de arteritis de células gigantes con alguna información clínica. Por otra parte, sufrió una singular y curiosa aparición de San Isidoro de Sevilla que le hizo tragar un librillo, que pudiera corresponder a una alucinación visual compleja o síndrome de Charles Bonnet asociado. Se comentan los datos históricos de la enfermedad, así como su evolución y tratamiento antes de los corticoides.

Spontaneous coronary artery dissection in systemic lupus erythematosus: case-based review.

Patients with systemic lupus erythematosus (SLE) present an increased prevalence of coronary heart disease. The majority of cases of acute coronary syndrome (ACS) in patients with SLE are due to atherosclerosis. Less common causes include thrombosis of an angiographically normal coronary artery and coronary vasculitis. Spontaneous coronary artery dissection (SCAD) is a rare cause of ACS in these patients. We report the case of a 53-year-old female diagnosed of SLE presenting with an ACS caused by SCAD. She was treated medically and her clinical course was favorable. A literature search identified seven additional cases of SCAD associated with SLE. The main clinical features found in these reports are revised. ACS caused by SCAD in SLE patients is a condition likely under-reported in literature. SCAD should be suspected in patients with SLE and ACS, especially in younger women without evident cardiovascular risk factors. An early accurate diagnosis of SCAD is key to provide specific treatment, which differs from that of usual atherosclerotic ACS.

Carbamazepine-induced systemic lupus erythematosus: A case-based review.

A case of carbamazepine-induced systemic lupus erythematosus (CBZ-DILE) is presented, along with a literature review, with the aim to define the clinical and serological characteristics of this group, and compare them with systemic lupus erythematosus (SLE) triggered by other drugs (DILE). A 31-year-old woman presented with a 6-month history of hand arthritis and nasal ulcers. She had been diagnosed with epilepsy at 12 years of age and had continued treatment with carbamazepine (CBZ) for the past 18 years with excellent clinical control. Laboratory data revealed antinuclear antibodies (ANA) positive to a titer of 1/1280, and positive anti-nucleosome antibodies. The patients' clinical symptoms disappeared after the CBZ discontinuation and did not reappear during the 1-year follow-up period. A search was made in the PubMed/Medline database of the (CBZ-DILE) published cases. A total of 26 cases of CBZ-DILE were found in the search. CBZ-DILE cases are characterized by variable latency periods that often last for years and are not related to the dose of CBZ. Most frequent clinical findings of CBZ-DILE in patients are arthralgia/arthritis, mucocutaneous manifestations, constitutional symptoms, and pleuritis or pericarditis. The renal involvement has not been reported in CBZ-DILE. Antihistone antibodies were observed less frequently, and anti-dsDNA antibodies were observed more frequently than in the "classic" DILE. The ANA remained positive in over 60% of cases during the follow-up after withdrawal. The CBZ-DILE has significant clinical and laboratory manifestations that distinguish it from classic DILE or idiopathic SLE.

[Approach to illness and death of Vadinienses in roman Hispania (I-IV centuries)]. / Aproximación a la enfermedad y muerte de los Vadinienses en la Hispania romana (siglos I-IV).

The Vadinienses were a Cantabrian people who lived between the first and fourth centuries in the north of the Iberian Peninsula, northeast of the present province of León and the corresponding part of the current territory of Asturias. In this paper we study the possible causes of illness and death of the Vadinienses represented in their gravestones. The analysis of Vadinienses epitaphs shows that two-thirds of the deaths occurred in people between the ages of 20-30, a finding that is not interpreted as representative of the usual age of death at that time. The most likely causes of death are infections and violent deaths in sports competitions or work accidents. Analyzing females independently, almost half of the deceased were under the age of 20, being the main possibilities the deaths related to pregnancy and childbirth at very early ages.

Los vadinienses fueron un pueblo cántabro que habitó entre los siglos I y IV en el norte de la península ibérica -noreste de la actual provincia de León y la parte correspondiente de la actual Asturias-. En este trabajo se estudian las posibles causas de enfermedad y muerte de la población vadiniense representada en sus lápidas funerarias. Dos terceras partes de los vadinienses, según los datos de sus epitafios, murieron entre los 20-30 años, hallazgo que no se interpreta como representativo de la edad de muerte habitual en la época. Se consideran como las causas de muerte más probables las infecciones y las muertes violentas en competiciones deportivas o en accidentes laborales. Cuando se analiza de modo independiente al sexo femenino, casi la mitad de las fallecidas lo hicieron antes de los 20 años de edad, valorando como principales posibilidades las muertes relacionadas con embarazos y partos en edades muy precoces.

[Hyperuricemia and gout; the role of diet]. / Hiperuricemia y gota; el papel de la dieta.

From ancient times, gout has been related with excessive eating and drinking; however, it has not been until the last decade that a broader knowledge on dietary factors associated with hyperuricemia and gout has been achieved. Obesity, excessive intake of red meats and alcoholic beverages were already recognized as causal factors from Antiquity. Legumes and purine rich vegetables have been exculpated after the studies. New risk factors, not previously recognized, have been described such as fructose and sweetened beverages. Finally, protective factors have also been described, such as skimmed dairy products. Gout is characterized not only by an increase in uric acid, eventual episodes of arthritis, and chronic joint damage, but also by association with several comorbidities and increased cardiovascular risk. The adoption of more healthier dietary habits may contribute to better management of uricemia and also to a reduction of associated diseases. The most common practice recommendations according to current knowledge and the main treatment guidelines are reviewed. Additional studies are needed on the actual efficacy in clinical practice of the adoption of specific dietary measures on the management and clinical course of patients with hyperuricemia and gout.

Desde la antigüedad se ha relacionado a la gota con los excesos en el comer y en el beber; sin embargo, ha sido en la última década cuando se ha llegado a un mayor conocimiento sobre los factores dietéticos asociados con el desarrollo de hiperuricemia y gota. La obesidad, el abuso en la ingesta de carnes y las bebidas alcohólicas ya eran vistos como culpables desde la antigüedad. Las legumbres y las verduras ricas en purinas han sido exculpadas tras los estudios. Se han descrito nuevos factores de riesgo, no reconocidos anteriormente, como la fructosa y las bebidas edulcoradas. Finalmente, también se han descrito factores protectores, como los lácteos desnatados. La gota se caracteriza no sólo por el aumento del ácido úrico, eventuales episodios de artritis y el daño crónico articular, sino también por su asociación con diversas comorbilidades y con el aumento del riesgo cardiovascular. La adopción de hábitos dietéticos más sanos puede contribuir a un mejor control de la uricemia y también a una reducción de las enfermedades asociadas. Se recogen las recomendaciones prácticas más habituales según los conocimientos actuales y siguiendo los consejos de las principales guías de tratamiento. Son necesarios más estudios sobre la eficacia real en la práctica clínica de la adopción de unas y otras medidas dietéticas en el tratamiento y evolución de los pacientes con hiperuricemia y gota.

Hiperuricemia y gota: el papel de la dieta / Hyperuricemia ang gout: the role of diet

Desde la antigüedad se ha relacionado a la gota con los excesos en el comer y en el beber; sin embargo, ha sido en la última década cuando se ha llegado a un mayor conocimiento sobre los factores dietéticos asociados con el desarrollo de hiperuricemia y gota. La obesidad, el abuso en la ingesta de carnes y las bebidas alcohólicas ya eran vistos como culpables desde la antigüedad. Las legumbres y las verduras ricas en purinas han sido exculpadas tras los estudios. Se han descrito nuevos factores de riesgo, no reconocidos anteriormente, como la fructosa y las bebidas edulcoradas. Finalmente, también se han descrito factores protectores, como los lácteos desnatados. La gota se caracteriza no sólo por el aumento del ácido úrico, eventuales episodios de artritis y el daño crónico articular, sino también por su asociación con diversas comorbilidades y con el aumento del riesgo cardiovascular. La adopción de hábitos dietéticos más sanos puede contribuir a un mejor control de la uricemia y también a una reducción de las enfermedades asociadas. Se recogen las recomendaciones prácticas más habituales según los conocimientos actuales y siguiendo los consejos de las principales guías de tratamiento. Son necesarios más estudios sobre la eficacia real en la práctica clínica de la adopción de unas y otras medidas dietéticas en el tratamiento y evolución de los pacientes con hiperuricemia y gota (AU)

From ancient times, gout has been related with excessive eating and drinking; however, it has not been until the last decade that a broader knowledge on dietary factors associated with hyperuricemia and gout has been achieved. Obesity, excessive intake of red meats and alcoholic beverages were already recognized as causal factors from Antiquity. Legumes and purine rich vegetables have been exculpated after the studies. New risk factors, not previously recognized, have been described such as fructose and sweetened beverages. Finally, protective factors have also been described, such as skimmed dairy products. Gout is characterized not only by an increase in uric acid, eventual episodes of arthritis, and chronic joint damage, but also by association with several comorbidities and increased cardiovascular risk. The adoption of more healthier dietary habits may contribute to better management of uricemia and also to a reduction of associated disea ses. The most common practice recommendations according to current knowledge and the main treatment guidelines are reviewed. Additional studies are needed on the actual efficacy in clinical practice of the adoption of specific dietary measures on the management and clinical course of patients with hyperuricemia and gout (AU)

Severe Guillain-Barré syndrome in a patient receiving anti-TNF therapy. Consequence or coincidence. A case-based review.

The adverse effects of anti-tumour necrosis factor alpha (TNFα) drugs include an increase in the risk of infections, congestive heart failure, lupus-like syndrome, and the onset or worsening of various demyelinating diseases such as, multiple sclerosis, optic neuritis, and Guillain-Barrè syndrome (GBS), among others. We describe the case of a patient who developed GBS while she was on treatment with adalimumab. A 50-year-old woman with rheumatoid arthritis (RA) was admitted to the hospital due to progressive severe bilateral symmetric weakness of the legs, which quickly extended to the upper limbs and to the respiratory muscles. Adalimumab was started 13 months before. GBS was diagnosed and the anti-TNFα therapy discontinued. The serological test for Campylobacter jejuni was positive. She required invasive mechanical ventilatory support for 9 months. Twelve months later, the patient was using a wheelchair following a rehabilitation programme, and at 24 months she was walking a few steps with assistive devices. The relevant literature on the relationship between GBS and anti-TNFα is reviewed. Twenty three cases of GBS occurring during anti-TNFα therapy have been reported so far in the literature. In several cases, there was no clear temporal association, more than half had a possible previous infection, and in two cases the drug was reintroduced without recurrence of GBS. Our case, which is best explained by C. jejuni infection, as well as some of the cases described are probably not a direct result of anti-TNFα treatment, but an accidental coincidence. We also discuss the potential therapeutic options after anti-TNFα discontinuation.

Uric acid and evolution.

Uric acid (UA) is the end product of purine metabolism in humans due to the loss of uricase activity by various mutations of its gene during the Miocene epoch, which led to humans having higher UA levels than other mammals. Furthermore, 90% of UA filtered by the kidneys is reabsorbed, instead of being excreted. These facts suggest that evolution and physiology have not treated UA as a harmful waste product, but as something beneficial that has to be kept. This has led various researchers to think about the possible evolutionary advantages of the loss of uricase and the subsequent increase in UA levels. It has been argued that due to the powerful antioxidant activity of UA, the evolutionary benefit could be the increased life expectancy of hominids. For other authors, the loss of uricase and the increase in UA could be a mechanism to maintain blood pressure in times of very low salt ingestion. The oldest hypothesis associates the increase in UA with higher intelligence in humans. Finally, UA has protective effects against several neurodegenerative diseases, suggesting it could have interesting actions on neuronal development and function. These hypotheses are discussed from an evolutionary perspective and their clinical significance. UA has some obvious harmful effects, and some, not so well-known, beneficial effects as an antioxidant and neuroprotector.

Artritis reactiva por Mycoplasma pneumoniae / Reactive arthritis following Mycoplasma pneumoniae infection

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