Usefulness of Lung Ultrasound as a Method for Early Diagnosis of Interstitial Lung Disease in Patients with Rheumatoid Arthritis.

Purpose: To determine the value of lung ultrasound (LUS) compared to high-resolution computed tomography (HRCT) in the early diagnosis of interstitial lung disease (ILD) in patients with rheumatoid arthritis (RA). Patients and Methods: An observational prospective study was performed. Were included patients with respiratory symptoms or/and, patients with crackles in auscultation during medical consultation. All patients underwent to chest X-rays, LUS, HRCT,and respiratory function tests. Results: A total of 192 patients with RA were included. Mean disease duration was 16.8 ± 11.1 years. 72% were positive for rheumatoid factor or anti-citrullinated antibodies. Of the total number of subjects, 54.7% had respiratory symptoms. The other patients did not have respiratory symptoms, but they did have had crackles on pulmonary auscultation. B lines > 11.5 on the ROC curve predicted ILD (AUC 0.63; CI 95%: 0.55-0.71; p < 0.003). A DLCO value of <7.13 significantly predicted the presence of ILD (AUC 0.61; 95% CI: 0.52-0.70; p < 0.028). Conclusion: The findings of this study suggest that LUS is a valuable tool for the early diagnosis of ILD in patients with RA, and together with DLCO, can adequately predict the presence of ILD in this population. LUS also helps to determine which patients with respiratory symptoms and signs suggestive for ILD are undergo to HRCT.

Burden of Disease in Psoriatic Arthritis in Latin America: a Systematic Literature Review.

INTRODUCTION: Psoriatic arthritis is a chronic inflammatory pathology that generates a substantial and progressive deterioration of functionality and quality of life. It is associated with comorbidities (cardiovascular and metabolic) and involvement of mental health. In Latin America, information regarding the disease is limited. This study reviews the burden of disease (disease activity, functional involvement, clinical manifestations, comorbidities, patient-reported outcomes, quality of life, and use of health resources) in PsA patients in Latin America. METHODS: Systematic literature review of publications in PUBMED, EMBASE, Cochrane Database of Systematic Reviews-CDSR/Database of Abstracts of Reviews of Effects, LILACS, Scielo, Redalyc, conference abstracts, and grey literature. Two independent assessors selected studies and extracted information. Quality was assessed according to the type of study. RESULTS: We identified 692 references, selecting 50 studies: 41 cross-sectional, four economic-studies, four cohort studies and one systematic review. The information comes mainly from Brazil, Argentina, and Mexico. The estimated disease prevalence for Latin America ranges from 0.004 to 0.08% (95% CI 0.02-0.20). Measurements with validated instruments suggest suboptimal assessment of disease domains, significant functional compromise, loss of productivity, and high frequency of comorbidities, including mental health. Methodological and population considerations limit the generalizability of the findings. CONCLUSIONS: The available information reports a considerable burden of disease in patients with PsA in Latin America, with involvement of quality of life associated with disability in relation to disease activity and its various manifestations. Future research and funding efforts should be aimed at generating more standardized information about the impact of PsA in the region. Key Points •The functional involvement related to disease activity, the impact on the quality of life, and the frequency of cardiometabolic and psychological comorbidities are remarkable in Latin American patients with PsA. •The current synthesis offers an overview of the burden of disease (disease activity, functional involvement, clinical manifestations, comorbidities, patient-reported outcomes, quality of life, and use of health resources) in PsA patients in Latin America. •Future research efforts and clinical strategies are required in order to generate standardized data on the patients and better estimate the burden of disease in the region.

Polyautoimmunity in systemic lupus erythematosus patients: New insights from a cross-sectional study.

Objective: To assess the frequency of polyautoimmunity (PolyA) in a cohort of Colombian patients with systemic lupus erythematosus (SLE) and to identify associated factors. Methods: This is an analytical cross-sectional study in a specialized center., a comprehensive review of the medical records of SLE patients was performed from 2015 to 2020 in order to obtain demographic, clinical data, laboratory, and treatment information. Associations between PolyA, demographic, and characteristics of the disease were explored. Results: A total of 463 patients were included in the analysis. The average age was 47.3 ± 15 years. Most of this population were female (87.4%), whom were diagnosed with SLE in a long-term SLE (10.6 ± 10.1 years). Out of the total patients, 34.7% were diagnosed with PolyA. Among the most frequent clinical criteria for SLICC, arthritis (65%), kidney impairment (39.5%), and alopecia (34.8%) were found. The most frequent SLE-associated PolyA were antiphospholipid syndrome (APS) and Sjögren's syndrome (SS) (16.63% and 10.58%, respectively). PolyA-associated factors were age, xerophthalmia, central nervous system occlusion, and deep vein thrombosis (DVT). In contrast, renal impairment was significantly less frequent in PolyA patients after multivariate analysis. Conclusion: The results have showed associated factors with PolyA like age, xerophthalmia, central nervous system occlusion, and deep vein thrombosis in this cohort. On the other hand, lupus nephritis was less frequent in patients with PolyA. This study provides a spotlight of a specific SLE population as real-life evidence for a better characterization of PolyA in the future.

Metabolic Abnormalities, Cardiovascular Disease, and Metabolic Syndrome in Adult Rheumatoid Arthritis Patients: Current Perspectives and Clinical Implications.

Aim: Rheumatoid arthritis is a prevalent worldwide disease, associated with an increased risk of multiple metabolic abnormalities that generate a higher disease burden. Objective: To gather the available evidence on the epidemiology, pathophysiology, current perspectives, clinical implications and prognosis of metabolic abnormalities in patients with rheumatoid arthritis. Methods: This is a narrative literature review. Search was conducted in PubMed, OVID, and Taylor & Francis databases, using the following MeSH terms: "Arthritis Rheumatoid", "Metabolic Diseases", and "Metabolic Syndrome". Results: This study describes the main metabolic manifestations of rheumatoid arthritis. Research has recognized that rheumatoid arthritis and metabolic abnormalities share pathophysiological mechanisms with an additive effect that increases cardiovascular risk. In that context, appropriate antirheumatic treatment can also impact on cardiovascular risk. Conclusion: There are metabolic abnormalities in rheumatoid arthritis patients that increase cardiovascular risk. Therefore, it is crucial to evaluate cardiovascular risk to provide appropriate comprehensive management to reduce morbidity and mortality in patients with this disease.

Better Clinical Results in Rheumatoid Arthritis Patients Treated Under a Multidisciplinary Care Model When Compared with a National Rheumatoid Arthritis Registry.

Purpose: To describe clinical characteristics and effectiveness of health care in patients with rheumatoid arthritis (RA) as part of a multidisciplinary care model (MCM) in a specialized rheumatology center, compared with the results of a national registry of RA (NARRA) as evidence of real-world management. Patients and Methods: We conducted a real-world study (July 1, 2018 to June 30, 2019) based on an analysis of electronic health records of a cohort of RA patients managed with the "Treat-to-Target" strategy in a specialized rheumatology center in Colombia with an MCM, compared with the NARRA that includes different models of usual care. Results: We have analyzed 7053 subjects with RA treated at a specialized rheumatology center and 81,492 patients from the NARRA. Cohorts were similar in their baseline characteristics, with women in predominance and diagnosis age close to 50 years. At the time of diagnosis, a higher proportion of clinical diagnostic test use and rheumatology consultation access was observed in the specialized rheumatology center than in the national registry (4-6 per year versus three or less). In addition, higher proportions of patients in remission and low disease activity were reported for the specialized rheumatology center, with a >40% amount of data lost in the national registry. Pharmacological management was similar regarding the analgesic use. In the specialized center, Certolizumab was more frequently used than in the NARRA registry; also, there were significant differences in methotrexate, leflunomide, and sulfasalazine use, being higher in the specialized rheumatology center. Conclusion: The MCM of a specialized center in RA can guarantee comprehensive care, with better access to all the services required to manage the disease. It ensures specialist management and evidence-based care that facilitates the achievement of therapeutic objectives. In addition, better patient records and follow-ups are available to evaluate health outcomes.

Impact of immunoprophylaxis with palivizumab on respiratory syncytial virus infection in preterm infants less than 35 weeks in Colombian hospitals.

OBJECTIVE: To evaluate the impact of immunoprophylaxis with palivizumab in preterm infants less than 35 weeks in terms of hospitalization rate, intensive care unit requirement, and mortality. METHODS: A prospective cohort study was conducted at six Colombian hospitals. Preterm infants less than 35 weeks who received at least one dose of palivizumab during the first 6 months of life were included. The primary outcome was the hospitalization rate related to respiratory syncytial virus (RSV) infection. RESULTS: A total of 222 newborns participated in the study; 204 (91.8%) completed the 6-month follow-up, and three died during the study. 88.7% received a second dose of palivizumab, 79.7% a third, 34.7% a fourth, and 25.2% a fifth. The nonadjusted incidence rate of RSV infection was 2.4%, and the overall RSV-positive hospitalization rate was 1.9%. The proportion of patients that required Neonatal Intensive Care Unit (NICU) and mechanical ventilation in relation to RSV infection was 1.4%. Discharge with home oxygen, pulmonary dysplasia, and being younger than 6 months were significantly associated with respiratory infection. Furthermore, exposition to cigarette smoke was the only factor associated with increased risk of hospitalization. The group that required hospitalization received fewer doses of palivizumab (p = 0.049). No discontinuation of treatment due to adverse events were reported. No death was judged to be related to palivizumab. CONCLUSION: The hospitalization rate and the need for NICU admission were lower than those reported in the literature. In this real-life setting, palivizumab appears to be effective in preventing serious cases of RSV infection.

Budget impact analysis of primary screening with the HPV test and genotyping against conventional cytology in Colombia / Análisis del impacto presupuestal en Colombia de la prueba de HPV con genotipificación comparada con la citología

Introduction: The detection of the human papillomavirus (HPV) through the combination of the HPV test and other techniques such as cytology has impacted the detection and timely treatment of lesions associated with cervical cancer. Objective: To estimate the budgetary impact of the strategy of early detection of HPV with DNA test genotyping with reflex cytology versus conventional cytology in women aged 30 to 65 years attending the cervical cancer screening program at a health benefit managing entity in Colombia. Materials and methods: Using a decision tree and a Markov model, the clinical implications and direct costs of screening, diagnosis, and treatment were estimated in a cohort of women. The analysis considered two screening cycles and their annual costs. The data on the prevalence of clinical results and the costs were taken from the health managing entity. The information on the progression, persistence, and regression of the health states were taken from the ATHENA study. Results: The screening scheme with the HPV test, genotyping, and reflex cytology compared to conventional cytology was cost-saving. The average cost per screening cycle with the HPV test was estimated at COP $ 129,201,363 and with cytology at COP $ 186,309,952, i.e., a saving of COP $ 57,108,589 (30.7%). Conclusion: The implementation of the screening strategy under evaluation suggests prospective savings derived from the early detection of health states associated with the development of cervical cancer.

Introducción. La detección del virus del papiloma humano mediante la combinación de la prueba de HPV y otras técnicas como la citología, ha demostrado su eficacia en el diagnóstico y tratamiento oportuno de lesiones asociadas con el cáncer de cuello uterino. Objetivo. Estimar el impacto presupuestal de la estrategia de detección temprana del HPV mediante la prueba de genotipificación combinada con la citología en comparación con la citología convencional, en mujeres de 30 a 65 años participantes en el programa de tamizaje de cáncer de cuello uterino en una Entidad Administradora del Plan de Beneficios en salud (EAPB) en Colombia. Materiales y métodos. Utilizando un árbol de decisiones y un modelo de Markov, se estimaron las implicaciones clínicas y los costos directos anuales de dos ciclos de tamizaje, diagnóstico y tratamiento, en una cohorte de mujeres. Las prevalencias de los resultados clínicos y los costos se tomaron de la base de datos de una EAPB y la información de la progresión, persistencia y regresión de los estados de salud provinieron del estudio ATHENA. Resultados. El esquema de tamizaje con la prueba de HPV, la genotipificación y la citología resultó en un ahorro de costos comparado con la citología convencional. El costo promedio por ciclo de tamizaje con la prueba de HPV se estimó en COP $129'201.363 y con la citología en COP $186'309.952, es decir, un ahorro de COP $57'108.589 (30,7 %). Conclusión. La implementación de la estrategia de tamizaje evaluada sugiere que habría ahorros derivados de la detección temprana de los estados de salud asociados con el desarrollo de cáncer de cuello uterino.

Is Tofacitinib Effectiveness in Patients with Rheumatoid Arthritis Better After Conventional Than After Biological Therapy? - A Cohort Study in a Colombian Population.

Purpose: Tofacitinib is recommended for treatment of rheumatoid arthritis (RA) in patients with moderate to severe disease activity, but there is not enough evidence on its effectiveness after conventional DMARDs vs its use after biologics. The aim was evaluating the effectiveness of tofacitinib in RA as first-line treatment (after conventional DMARDs) in a real-life setting in Colombian (Latin-American) patients. Patients and Methods: Retrospective cohort study conducted at a specialized center for RA management. A complete statistical analysis was performed to compare the values of the change in the DAS28 at months 3, 6, and 12 in both treatment groups. Results: A total of 152 RA patients who received tofacitinib: first-line 85 patients (55.9%) after failure on conventional DMARDs or second-line 67 patients (44.1%) after failure on biologic DMARDs. Comparative analysis of response to treatment showed a reduction in DAS28 at 3, 6, and 12 months in both study groups without statistical differences, but a higher proportion of first-line patients achieved remission (45% vs 23%). Nonresponse at three months were associated with no response at six months of follow-up. Baseline DAS28 was significantly associated with response at 12 months (OR: 1.87, 95%CI: 1.06-3.30, p-value 0.028). In second-line patients, response to tofacitinib was not related to number of biologic DMARDs previously used. Conclusion: Tofacitinib is an effective treatment option for patients with RA, maybe better after conventional DMARDs than after biologic therapy failure. Further studies are required to determine the role of tofacitinib in different lines of RA treatment and in other groups of patients.

Immune Checkpoint Inhibitor Combination Therapy versus Sunitinib as First-Line Treatment for Favorable-IMDC-Risk Advanced Renal Cell Carcinoma Patients: A Meta-Analysis of Randomized Clinical Trials.

BACKGROUND: Novel combination therapies have been shown to improve the outcomes of treatment-naive patients with locally advanced or metastatic renal cell carcinoma (aRCC). However, the optimal systemic therapy for aRCC of favorable risk has yet to be clarified. We aimed to evaluate the efficacy and safety of different immunotherapy (IO) combinations, either with another IO (IO-IO) or with an antiangiogenic (IO-TKI), versus sunitinib in the first-line setting in aRCC patients with favorable IMDC risk. METHODS: We conducted a systematic search for evidence in PubMed, Ovid MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials published up to February 2021. The GRADE approach was used to assess the quality of evidence. Survival hazard ratios were extracted for analysis in the favorable-risk aRCC subgroup (IMDC). A sensitivity analysis was performed excluding trials of combination therapy without TKI. RESULTS: Five randomized controlled phase III trials with a total of 1088 patients were included in the analysis. The studies compared different combinations versus sunitinib monotherapy. All clinical trials reported overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) data. Four out of five trials reported complete response (CR). There was no difference in OS nor PFS between treatment arms in the IMDC favorable-risk subgroup analysis (OS: HR = 1.07, 95% CI = 0.81-1.41; PFS: HR = 0.74, 95% CI = 0.46-1.19). A benefit in ORR and CR was found for combination therapy vs. sunitinib (ORR: HR = 1.89, 95% CI = 1.29-2.76; CR: HR = 3.58, 95% CI = 2.04-6.28). In the sensitivity analysis, including only IO-TKI vs. sunitinib, no difference in OS was found; however, an advantage in PFS was observed (OS: HR = 0.99, 95% CI 0.69-1.43; PFS: HR = 0.60 (0.45-0.81). The safety profile reported is consistent with previous reports. We did not find differences in the incidence of any adverse event (AE) or of grade ≥3 AEs. CONCLUSION: This meta-analysis shows that combinations of IO-KI as first-line treatment in favorable-IMDC-risk aRCC improve PFS, ORR, and CR, but not OS, versus sunitinib.

Certolizumab Can Also Be Effective in Monotherapy for the Treatment of Rheumatoid Arthritis Patients.

OBJECTIVE: Although it is known that methotrexate (MTX) increases the effectiveness of biological drugs (mainly anti-TNFs) in patients with rheumatoid arthritis (RA), in real life, it is known that many patients using anti-TNFs are on monotherapy due to many causes. This article compares the effectiveness of certolizumab as monotherapy as combined with MTX or leflunomide (LFN) in RA patients with failure to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in a real-world setting. METHODS: A retrospective observational cohort study was conducted at a specialized centre for RA management in Colombia. Patients treated with certolizumab as monotherapy or in combination with MTX, LFN, or MTX+LFN, between 2011 and 2020 with a minimum 3-month follow-up were included. Demographics and RA clinical characteristics were recorded; effectiveness was assessed as the improvement in Disease Activity Score (DAS28) getting remission or low disease activity at 3, 6, and 12 months of treatment. RESULTS: A total of 181 patients were included, 24 received certolizumab as monotherapy, 62 certolizumab plus MTX, 47 certolizumab plus LFN and 48 certolizumab plus MTX+LFN. At 3 months of follow-up, 80% of the patients showed decreased disease activity, with no significant differences between groups; at 12 months of treatment, response in certolizumab monotherapy group was 94.4% compared to 81.8% in combination with MTX, 80.5% in combination with LFN and 51.4% in combination with MTX+LFN. Response at 3 months (OR 4.04; 95% CI 1.28-12.69) and positive anti-CCP (OR 3.83; 95% CI 1.11-13.21) were associated with 12-month response. CONCLUSION: Certolizumab seems to be effective as monotherapy in the treatment of RA patients with failure to csDMARDs.

Diagnostic precision of sentinel lymph node biopsy in penile cancer.

INTRODUCTION: Sentinel lymph node biopsy (SLNB) was designed as a minimally invasive method for evaluation of nodal involvement in patients with penile cancer and nonpalpable lymph nodes. Nevertheless, SLNB is not used in a regular basis due to the lack of studies that adequately characterize the performance of this procedure. The purpose of this study was to evaluate the diagnostic performance of SLNB in patients with infiltrative penile carcinoma without palpable inguinal lymph nodes in a Colombian population. MATERIALS AND METHODS: This is a retrospective observational study of 89 patients diagnosed with infiltrative penile squamous cell carcinoma with nonpalpable inguinal lymph nodes. These patients underwent partial or complete penectomy, along with SLNB, between 2008 and 2017. Those individuals with a positive SLNB underwent inguinal lymphadenectomy, while those with a negative SLNB were followed on a quarterly basis with a physical examination and imaging to assess relapse. Statistical analysis was done using the STATA 14 software. A contingency table was made to calculate sensitivity, specificity, positive predictive value, negative predictive value, and exactitude, each one with its own confidence interval (CI) of 95%. RESULTS: There was an average follow-up of 31.4 months, and all 89 patients were evaluated; most primary tumors were T2 (55%), followed by T1 (37%), all of which were subclassified as T1b and T3 (8%). Tumours were most frequently located in the glans (43%). All patients were classified as cN0 and underwent SLNB. Sixty-one patients (69%) tested negative in the SLNB, four of whom (6%) presented with lymph node relapse. On the other hand, 28 patients (31%) tested positive in the SLNB and consequently underwent inguinal lymphadenectomy, seven of whom had negative lymph nodeinvolvement (25% false positives). According to the results, the sensitivity was 84% (95% CI, 65.3-93.6) and the specificity was 89% (95% CI, 79.4-94.7), with a false-negative rate of 6.5%. CONCLUSIONS: The SLNB using radiotracer can be a useful method for lymph node staging in patients with penile cancer and nonpalpable lymph nodes when performed in experienced centers.