Results from the INMUNOSUN-SOGUG trial: a prospective phase II study of sunitinib as a second-line therapy in patients with metastatic renal cell carcinoma after immune checkpoint-based combination therapy.

BACKGROUND: The INMUNOSUN trial had the objective of prospectively evaluating the efficacy and safety of sunitinib as a pure second-line treatment in patients with metastatic renal cell carcinoma (mRCC) who have progressed to first-line immune checkpoint inhibitor (ICI)-based therapies. PATIENTS AND METHODS: A multicenter, phase II, single-arm, open-label study was carried out in patients with a histologically confirmed diagnosis of mRCC with a clear-cell component who had progressed to a first-line regimen of ICI-based therapies. All patients received sunitinib 50 mg once daily orally for 4 weeks, followed by a 2-week rest period following package insert instructions. The primary outcome was the objective response rate. RESULTS: Twenty-one assessable patients were included in the efficacy and safety analyses. Four patients [19.0%, 95% confidence interval (CI) 2.3% to 35.8%] showed an objective response (OR), and all of them had partial responses. Additionally, 14 (67%) patients showed a stable response, leading to clinical benefit in 18 patients (85.7%, 95% CI 70.7% to 100%). Among the four assessable patients who showed an OR, the median duration of the response was 7.1 months (interquartile range 4.2-12.0 months). The median progression-free survival (PFS) was 5.6 months (95% CI 3.1-8.0 months). The median overall survival (OS) was 23.5 months (95% CI 6.3-40.7 months). Patients who had better antitumor response to first-line ICI-based treatment showed a longer PFS and OS with sunitinib. The most frequent treatment-emergent adverse events were diarrhea (n = 11, 52%), dysgeusia (n = 8, 38%), palmar-plantar erythrodysesthesia (n = 8, 38%), and hypertension (n = 8, 38%). There was 1 patient who exhibited grade 5 pancytopenia, and 11 patients experienced grade 3 adverse events. Eight (38%) patients had serious adverse events, four of which were considered to be related to sunitinib. CONCLUSION: Although the INMUNOSUN trial did not reach the pre-specified endpoint, it demonstrated that sunitinib is active and can be safely used as a second-line option in patients with mRCC who progress to new standard ICI-based regimens.

A multidisciplinary consensus on the morphological and functional responses to immunotherapy treatment

The implementation of immunotherapy has radically changed the treatment of oncological patients. Currently, immunotherapy is indicated in the treatment of patients with head and neck tumors, melanoma, lung cancer, bladder tumors, colon cancer, cervical cancer, breast cancer, Merkel cell carcinoma, liver cancer, leukemia and lymphomas. However, its efficacy is restricted to a limited number of cases. The challenge is, therefore, to identify which subset of patients would benefit from immunotherapy. To this end, the establishment of immunotherapy response criteria and predictive and prognostic biomarkers is of paramount interest. In this report, a group of experts of the Spanish Society of Medical Oncology (SEOM), the Spanish Society of Medical Radiology (SERAM), and Spanish Society of Nuclear Medicine and Molecular Imaging (SEMNIM) provide an up-to-date review and a consensus guide on these issues (AU)

A multidisciplinary consensus on the morphological and functional responses to immunotherapy treatment.

The implementation of immunotherapy has radically changed the treatment of oncological patients. Currently, immunotherapy is indicated in the treatment of patients with head and neck tumors, melanoma, lung cancer, bladder tumors, colon cancer, cervical cancer, breast cancer, Merkel cell carcinoma, liver cancer, leukemia and lymphomas. However, its efficacy is restricted to a limited number of cases. The challenge is, therefore, to identify which subset of patients would benefit from immunotherapy. To this end, the establishment of immunotherapy response criteria and predictive and prognostic biomarkers is of paramount interest. In this report, a group of experts of the Spanish Society of Medical Oncology (SEOM), the Spanish Society of Medical Radiology (SERAM), and Spanish Society of Nuclear Medicine and Molecular Imaging (SEMNIM) provide an up-to-date review and a consensus guide on these issues.

A new concept of a transparent photocapacitor.

A solid-state transparent photocapacitor has been prepared for the first time by the use of two transparent electrodes (TiO2 and LiFeO2) and also a transparent ion gel-based electrolyte between them, reaching a transmittance of 57% at λ = 555 nm, a specific capacitance of 2.98 µF cm-2 and a specific energy of 0.54 µJ cm-2.

Predictive biomarker candidates to delineate efficacy of antiangiogenic treatment in renal cell carcinoma.

Antiangiogenic therapy is currently considered as the cornerstone of treatment in metastatic kidney cancer. A monoclonal antibody against the vascular endothelial growth factor (VEGF) and several tyrosine kinase inhibitors targeting the VEGF receptors demonstrated, 7 years ago, to deeply impact the outcome of this tumor and became a model of integration of molecular knowledge into clinical practice. Unfortunately, no further improvement in survival has been made and 20-25 % of cases remain primary refractory to these drugs, with an overall dismal prognosis. Since biomarker predictors of activity are lacking, their development could highly help in the process of making clinical decisions when choosing the best option for every patient or prompting the inclusion in clinical trials. This unmet medical need could become even more relevant if new immunotherapy confirms its initial promising results in this pathology. In this article, we provide an insight of current state of the art regarding the prediction of antiangiogenic efficacy in kidney cancer and propose new strategies for the implementation of such markers in clinical practice.

Elaboración mediante el método Delphi de recomendaciones para el manejo coordinado (reumatólogo/dermatólogo) de la artritis psoriásica / Recommendations for the Coordinated Management of Psoriatic Arthritis by Rheumatologists and Dermatologists: A Delphi Study

La artritis psoriásica es una enfermedad inflamatoria crónica que afecta al sistema musculoesquelético, se asocia a psoriasis y suele producir destrucción articular con pérdida de función y calidad de vida. Su presentación clínica es heterogénea, con extremos fenotípicos que pueden solaparse con la artritis reumatoide o la espondilitis anquilosante. La psoriasis suele preceder a la artritis psoriásica, y la consulta de dermatología es el lugar clave para su detección precoz. Muchos tratamientos utilizados en psoriasis también se utilizan en artritis psoriásica, por tanto las recomendaciones terapéuticas para la psoriasis deben realizarse teniendo en cuenta el tipo y la gravedad de la artritis psoriásica, y viceversa. El objetivo de este documento es establecer pautas para el manejo coordinado (reumatólogo/dermatólogo) de la artritis psoriásica. Ha sido elaborado mediante la técnica Delphi por un grupo multidisciplinar (6 reumatólogos, 6 dermatólogos y 2 epidemiólogos) y contiene recomendaciones, tablas y algoritmos para diagnóstico, criterios de derivación y tratamiento de la artritis psoriásica

Psoriatic arthritis, a chronic inflammatory musculoskeletal disease that is associated with psoriasis, causes joint erosions, accompanied by loss of function and quality-of-life. The clinical presentation is variable, with extreme phenotypes that can mimic rheumatoid arthritis or ankylosing spondylitis. Because psoriasis usually presents before psoriatic arthritis, the dermatologist plays a key role in early detection of the latter. As many treatments used in psoriasis are also used in psoriatic arthritis, treatment recommendations should take into consideration the type and severity of both conditions. This consensus paper presents guidelines for the coordinated management of psoriatic arthritis by rheumatologists and dermatologists. The paper was drafted by a multidisciplinary group (6 rheumatologists, 6 dermatologists, and 2 epidemiologists) using the Delphi method and contains recommendations, tables, and algorithms for the diagnosis, referral, and treatment of patients with psoriatic arthritis

Recommendations for the coordinated management of psoriatic arthritis by rheumatologists and dermatologists: a Delphi study.

Psoriatic arthritis, a chronic inflammatory musculoskeletal disease that is associated with psoriasis, causes joint erosions, accompanied by loss of function and quality-of-life. The clinical presentation is variable, with extreme phenotypes that can mimic rheumatoid arthritis or ankylosing spondylitis. Because psoriasis usually presents before psoriatic arthritis, the dermatologist plays a key role in early detection of the latter. As many treatments used in psoriasis are also used in psoriatic arthritis, treatment recommendations should take into consideration the type and severity of both conditions. This consensus paper presents guidelines for the coordinated management of psoriatic arthritis by rheumatologists and dermatologists. The paper was drafted by a multidisciplinary group (6rheumatologists, 6dermatologists, and 2epidemiologists) using the Delphi method and contains recommendations, tables, and algorithms for the diagnosis, referral, and treatment of patients with psoriatic arthritis.

Impact of antiplatelet therapy in the development of severe ischemic complications and in the outcome of patients with giant cell arteritis.

OBJECTIVE: To evaluate whether concomitant treatment with low-dose aspirin or other antiplatelet agents have an impact on the risk of severe ischemic complications and in the outcome of patients with giant cell arteritis (GCA). METHODS: A retrospective follow-up study of an unselected population of 121 patients with GCA. RESULTS: Thirty-seven patients (30.5%) received antiplatelet therapy before the onset of GCA symptoms and continued taking it during the corticosteroid treatment (30 received aspirin and 7 other antiplatelet agents). No statistically significant reduction in the incidence of ischemic manifestations (including jaw claudication, visual manifestations, cerebrovascular accidents, ischemic heart disease, and limb claudication due to large artery stenosis) was observed in this group compared with the remaining patients. When we analyzed follow-up data, we found no significant differences between groups in terms of frequency of relapses and percentage of patients recovered from GCA. Corticosteroid requirements among patients in long-lasting remission were lower in those under antiplatelet therapy, but this reduction was fairly modest, statistically non significant and thus of uncertain clinical significance. Similar results were found when only aspirin exposed patients (n=30) were compared to non-exposed patients. Logistic regression analysis showed that antiplatelet therapy (p=0.54, OR 1.31; 95% CI: 0.54-3.19) had not an independent protective effect against ischemic events when adjusted for age, sex, and the presence of atherosclerotic risk factors. CONCLUSION: We did not observe a significant benefit derived from the use of antiplatelet therapy in either the incidence of severe ischemic events or the disease outcome. Although our results do not discard a potential therapeutic effect of high-dose aspirin, they do not confirm its suggested protective effect in preventing ischemic complications when used at antiplatelet doses.

Talalgias / Talagia

No disponible

Osteoporotic vertebral fracture in clinical practice. 669 Patients diagnosed over a 10 year period.

OBJECTIVE: Few data are available on clinically diagnosed vertebral fracture. Information about osteoporotic vertebral fracture has mainly been obtained via inferences from epidemiological studies of vertebral deformity. We evaluated the characteristics of patients with osteoporotic vertebral fracture diagnosed in a rheumatology department over a 10 year period. METHODS: Patients with back pain and vertebral fracture diagnosed between January 1990 and December 1999 were recruited from our data base. Patients with high energy trauma, malignancies, and metabolic bone diseases other than osteoporosis were excluded. These variables were analyzed: sex, age at diagnosis, type of osteoporosis (primary vs secondary), number of fractures at diagnosis (single vs multiple), and percentage of admissions and length of stay. RESULTS: Of the 669 patients, 534 (80%) were women and 135 (20%) were men. Age at diagnosis ranged from 30 to 91 yrs, mean 67.1 +/- 9.1. Secondary osteoporosis was diagnosed in 177 (26%) patients and the frequency was significantly higher in men than women (55% vs 19%; p < 0.001); the most common associations for secondary osteoporosis were oral corticosteroids, chronic obstructive airway disease, and rheumatoid arthritis. At diagnosis, half of the patients presented with multiple fractures. One hundred twenty (18%) patients were admitted; length of stay ranged from 5 to 56 days, mean 15.9 +/- 7.7. The frequency of admissions was higher in men than women (27% vs 16%; p < 0.001), higher in patients with secondary osteoporosis than in those with primary osteoporosis (33% vs 12%; p < 0.001), and higher in patients with multiple fractures than in those with single fractures (27% vs 8%; p < 0.001). CONCLUSION: Characteristics of patients recruited from a clinical setting differ significantly from those of subjects included in the epidemiological studies. In a rheumatology practice, frequency of secondary osteoporosis, mainly associated with corticosteroid treatment, is notably high. Admission is by no means a rare event.

Pyarthrosis in patients with rheumatoid arthritis: a detailed analysis of 10 cases and literature review.

OBJECTIVES: 1) To analyze the clinical features and outcome of patients with rheumatoid arthritis and pyarthrosis seen in a rheumatology department during a 9-year period; 2) To review the available literature about this association in the last decade. METHODS: From the database of our department, we collected all hospitalized cases of infectious arthritis in native joints between January 1990 and December 1998. In 10 cases (27%), pyarthrosis occurred in patients with rheumatoid arthritis. A detailed analysis of each patient was performed. The literature was reviewed by using MEDLINE from 1990 to 1999. RESULTS: The mean age of patients was 63.2 years; six were female. Most patients had long-standing disease and poor functional class, and all received glucocorticoid treatment. Mean diagnostic delay was 7.3 days. Causative organisms were Staphylococcus aureus (4 cases), gram-negative bacilli (3 cases), anaerobic bacteria (2 cases), and Streptococcus pneumoniae (n = 1). Two patients died. In all but two patients who survived, joint function worsened. CONCLUSIONS: Rheumatoid arthritis is a relevant host-related risk factor for septic arthritis. Pyarthrosis in these patients is associated with considerable morbidity and mortality.

Osteonecrosis of the knee: differences among idiopathic and secondary types.

OBJECTIVE: To describe the clinical and imaging features of patients with osteonecrosis of the knee, emphasizing the differences among idiopathic and secondary types. METHODS: A retrospective chart review of 37 consecutive patients (41 knees) with osteonecrosis of the knee confirmed by bone scintigraphy and/or magnetic resonance imaging (MRI), and a comparison of idiopathic and secondary types of osteonecrosis. RESULTS: Twenty-four patients had idiopathic osteonecrosis, and in 13 patients one or more predisposing factors were identified (secondary osteonecrosis). Idiopathic osteonecrosis of the knee was typically a disease of the elderly, characterized by severe knee pain of sudden onset, unilateral involvement, and restriction of the lesions generally to one femoral condyle or tibial plateau, with predilection for the medial compartment of the joint. Secondary osteonecrosis generally occurred in younger patients and frequently had an insidious onset with mild or vague pain, the lateral compartment of the knee was often involved, and the lesions were generally larger than lesions arising spontaneously; in the great majority of cases they involved the femoral condyles and/or tibial plateaus. Bilateral distribution and multifocal involvement was also seen in these forms. Magnetic resonance imaging was helpful in confirming the suspected diagnosis when conventional radiographs were normal or equivocal, and demonstrated different patterns of abnormalities in idiopathic and secondary types. CONCLUSION: There are significant differences between idiopathic and secondary osteonecrosis, especially in regard to clinical presentation and the location, extent and MRI appearance of the lesions. These differences are probably due to a difference in the pathogenetic mechanism.

Bone mineral density in patients with peripheral psoriatic arthritis.

BACKGROUND: Little information is available on the occurrence of generalized osteopenia in psoriatic arthritis. The only two published studies of bone mass in psoriatic arthritis produced conflicting results. METHODS: We compared bone mineral density measured at the lumbar spine and femoral neck using dual-energy X-ray absorptiometry in 52 patients with active peripheral psoriatic arthritis and in 52 controls. The psoriatic arthritis group included 19 males, 14 premenopausal women, and 19 post-menopausal women. Controls were matched to the patients on sex, age, and menopausal status. RESULTS: In the overall study population no significant differences were found between psoriatic arthritis patients and controls. Postmenopausal psoriatic arthritis patients had a lower femoral neck bone mineral density than the relevant subgroup of controls. No significant differences in lumbar spine bone mineral density were found in the analyses of the male, premenopausal female, and postmenopausal female subgroups. Neither was femoral neck density significantly different between male or premenopausal female psoriatic arthritis patients and controls. CONCLUSION: These results suggest that peripheral psoriatic arthritis is not associated with significant generalized bone loss.

[Prognostic factors in the evolution of psoriatic arthritis]. / Factores pronósticos de evolución en la artritis psoriásica.

BACKGROUND: The aim of this study is to determine the evolution and prognostic factors in the patients with psoriatic arthritis. PATIENTS AND METHODS: We have reviewed retrospectively the follow-up of 96 patients with psoriatic arthritis seen in our service. We have collected the following data at onset of the disease: age and sex, age at onset of cutaneous and articular manifestations, clinical form, distal interphalangeal affection, axial involvement, erythrocyte sedimentation rate, rheumatoid factor, antinuclear antibody and HLA antigen. Likewise, we have collected the present functional class. We have correlated the data at onset of the disease with the present functional class. RESULTS: Mean +/- SD age of 96 patients (48 male, 48 female) was 51 +/- 14 years. The majority of patients (78%) were in ACR functional class I or II. The most frequent clinical form was the oligoarticular (46%), except in the female group, in which the most frequent was the symmetric polyarticular one (46%). We found statistically significant correlation between the present functional class and the clinical form at onset and the disease duration. We didn't found a statistically correlation between the present functional class and the axial involvement. CONCLUSIONS: Patients with psoriatic arthritis and symmetric polyarthritis are more frequently female, and have a worse prognosis. The axial involvement does not imply a worse prognosis.

Posterior tibial tendon dysfunction as a cause of acquired flatfoot in the adult: value of magnetic resonance imaging.

Dysfunction of the posterior tibial tendon is the most common cause of acquired flatfoot in adults; despite this, the condition is not commonly recognized. We report three cases with flatfoot secondary to spontaneous tendon rupture, in whom magnetic resonance imaging (MRI) was a helpful non-invasive technique to confirm the suspected diagnosis. This disabling entity, and the usefulness of MRI in the diagnosis and planning the appropriate treatment, are reviewed.

[Seroprevalence of B19 parvovirus infection in patients with acute polyarthritis]. / Seroprevalencia de la infección por parvovirus B19 en pacientes afectos de poliartritis aguda.

Over a period of 29 months, from January 1991 to December 1994, all cases of acute polyarthritis seen at the Rheumatology Service in our Institution were studied to determine the seroprevalence of parvovirus B19 (B19) infection. The variables studied included: age and sex of patients, presence of fever and rash, Anti-B19 IgM and IgE serological determinations (ELISA, Mardix Lab.), follow-up time and final diagnosis. The study included 36 patients (22 women and 14 men, mean age 34 +/- 19 years). Thirteen and seven patients had fever and cutaneous rash, respectively. Anti-B19 IgM serology was positive in 4 patients; in 2 of them IgG seroconversion was confirmed. The mean follow-up time was 14 +/- 9 months. Final diagnoses included undifferentiated polyarthritis, rheumatoid arthritis, B19 polyarthritis, systemic lupus erythematosus, and miscellaneous in 19, 7, 4, 2, and 4 patients, respectively. Seroprevalence of B19 infection in acute polyarthritis in our area was 11%, approximately.

Termination of disease-modifying drugs in psoriatic arthritis: study of 109 courses of treatment.

Our aim is to study the termination of disease-modifying anti-rheumatic drugs (DMARDs) in psoriatic arthritis (PsA) and the causes of withdrawal. We have reviewed the prospective protocols of patients with PsA and collected the data on treatments and causes of withdrawal. Fifty-four out of 96 patients (48 male and 48 female) have undergone one or more courses of DMARD (n = 109). The life-table analysis shows a survival rate of 6 months for gold sodium thiomalate (GOLD) and sulphasalazine (SSZ), and 16 months for methotrexate (MTX). The Mantel-Haenszel test finds statistical differences between GOLD and MTX. There are no differences between MTX and SSZ or between GOLD and SSZ. The absence of differences for MTX and SSZ could be explained by the heterogeneity of both groups. The most common cause of withdrawal for GOLD and SSZ are adverse effects.