[Faecal microbiota study reveals specific dysbiosis in spondyloarthritis according to subtype, disease activity and treatment]. / Estudio de microbiota fecal revela disbiosis específica en espondiloartritis, según subtipo, actividad de la enfermedad y tratamiento.

OBJECTIVE: To compare the diversity and composition of the gastrointestinal microbiome of patients with SpA. METHODS: MiSeq sequencing of the V3-V4 region of the 16S ribosomal RNA gene was performed on DNA isolated from stool. Patients with concurrent SpA and IBD were excluded. Differences were assessed for richness and diversity indices by QIIME 2™. Differences between means >0,2% with a p-value<0,05 were assumed significant. Institutional Ethics Committee endorsement. RESULTS: 69 individuals included, 49 with SpA (ankylosing spondylitis-AS 72,9%, psoriatic arthritis-PsA 18,8%, reactive arthritis-ReA 8,3%) 5 positive controls-dysbiosis and 15 controls-eubiosis. Conventional treatment in 42,9%, anti-IL-17 16,3% and anti-TNF 40,8%. By subtype, statistically significant differences in favour of AS were found for the diversity indices. AS vs PsA there was a difference in favour of AS for Clostridium clostridioforme (p=0,002), Gemmiger formicilis (p=0,009), Roseburia inulivorans (p=0,008) and Lachnospira pectinoschiza. AS vs ReA there was a difference in favour of AS for L. pectinoschiza (p=0,009), Ruminococcus callidus (p=0.006), Clostridium ruminantium (p=0.031); G. formicilis (p=0,034). Diversity and richness showed differences in patients with high activity for Simpson's and Pielou's indices. In high activity, lower enrichment of Bacteroides eggerthii (p= 0,0003), C. ruminantium (p= 0,026) and Alistipes putredinis (p=0,035) was found. The number of ASV was higher in the anti-IL-17 vs conventional group (p=0.025) and a trend between anti-IL-17 vs anti-TNF (p=0.09). In anti-TNF there was a lower proportion for C. clostridioforme (p=0.023), G. formicilis (p=0.030) and R. callidus (p= 0.003). In anti IL-17, Alistipes indistinctus (p= 0.012) was decreased. CONCLUSIONS: There are differences in microbial diversity for SpA subtypes. The level of disease activity is plausible to influence the composition of the faecal microbiota. Anti-TNFα treatment may influence the microbiome environment favouring restoration of the gut microbiota, while anti-IL-17 may maintain an inflammatory environment.

OBJETIVO: Comparar la diversidad y composición del microbioma gastrointestinal de pacientes con EspA. MÉTODOS: La secuenciación MiSeq de la región V3-V4 del gen ARN ribosomal 16, se realizó en ADN aislado de heces. Se excluyeron pacientes con EspA y EII simultánea. Se evaluaron diferencias para los índices de riqueza y diversidad por medio de QIIME 2™. Las diferencias entre medias> 0,2%, con un valor de p< 0,05, se asumieron significativas. Aval del Comité de Ética Institucional. RESULTADOS: 69 individuos incluidos, 49 con EspA (espondilitis anquilosante-EA 72,9%, artritis psoriásica-APs 18,8%, artritis reactiva-ARe 8,3%), cinco controles positivos-disbiosis y 15 controles-eubiosis. El tratamiento convencional en 42,9%, anti-IL-17 16,3%, y anti-TNF 40,8%. Por subtipo-EasP, se encontraron diferencias estadísticamente significativas a favor de EA para los índices de diversidad. Entre EA vs APs, hubo diferencia a favor de EA para Clostridium clostridioforme (p=0,002), Gemmiger formicilis (p=0,009), Roseburia inulivorans (p=0,008) y Lachnospira pectinoschiza. Entre EA vs ARe hubo diferencia a favor de EA para L. pectinoschiza (p=0,009), Ruminococcus callidus (p = 0,006), Clostridium ruminantium (p=0,031); G. formicilis (p=0,034). La diversidad y riqueza mostraron diferencias en pacientes con alta actividad para los índices de Simpson y Pielou. En alta actividad, se encontró menor enriquecimiento de Bacteroides eggerthii (p=0,0003), C. ruminantium (p= 0,026) y Alistipes putredinis (p= 0,035). El número de ASV fue superior en el grupo de anti IL-17 vs convencional (p=0.025), y una tendencia entre anti IL-17 vs anti-TNF (p=0,09). En anti TNF hubo menor proporción para C. clostridioforme (p=0,023), G. formicilis (p=0,030) y R. callidus (p= 0,003). Y en anti IL-17, Alistipes indistinctus (p= 0,012), estuvo disminuida. CONCLUSIONES: Existen diferencias en la diversidad microbiana para los subtipos de EspA. El nivel de actividad de la enfermedad es plausible para influir en la composición de microbiota fecal. El tratamiento con anti-TNFα, puede influenciar el ambiente del microbioma favoreciendo la restauración de la microbiota intestinal, mientras los anti IL-17 podrían mantener un ambiente inflamatorio.

Streptococcus pneumoniae as a colonizing agent of the Nasopharynx - Oropharynx in adults: A systematic review and meta-analysis.

BACKGROUND: Streptococcus pneumoniae (Spn) is a commensal pathogen that usually colonizes the upper respiratory tract of children. Likewise, Spn colonization has been considered a critical factor in the development of pneumococcal invasive disease. However, Spn prevalence in adults remains unclear. This study performs a systematic review and meta-analysis to explore the prevalence of Spn Nasopharynx - Oropharynx Colonization (NOC) in adults. METHODS: A Systematic review of scientific databases was utilized to identify eligible studies that follow strict selection criteria. Subsequently, a meta-analysis was conducted to establish NOC prevalence in adults (≥18 years old). The heterogeneity and sensitivity analyses were assessed using the microorganism identification technique, sample type, and age subgroups. RESULTS: Initial selection includes 69 studies, with 37 selected for the meta-analysis, involving 23,724 individuals. The overall prevalence (95 % CI) of Spn NOC among adults was 6 % (5-9). The subgroup analysis revealed that young adults (YA), 18-64 years old, had a prevalence of 10 %, whereas older adults (OA), ≥65 years old, had a prevalence of 2 %. The identification of Spn NOC may vary depending on the method of diagnosis used. High heterogeneity (I2 > 90 %) was observed but diminished to 70 % when the analysis was restricted to oropharyngeal swabs as an identification method. Furthermore, heterogeneity decreased to 58 % when exclusively employing traditional culture as the identification method. CONCLUSIONS: This study found a low prevalence of Spn NOC in adults. Notably, the prevalence of Spn NOC was higher in younger adults than in older adults. It is essential to highlight a significant heterogeneity among studies, which indicates there is no standardized method of Spn NOC identification.

Physical exercise and major depressive disorder in adults: systematic review and meta-analysis.

The objective of this study was to assess the benefits and potential risks associated with different physical exercise modalities for managing symptoms in adults with major depressive disorder who were not receiving second-generation antidepressants or cognitive behavioral therapy. A systematic review and meta-analysis of randomized controlled trials (RCTs) were conducted. The search included multiple databases: Medline, Cochrane Central Register of Controlled Trials (CENTRAL), Embase, PsycInfo, Web of Science, Clinical Trials repository, gray literature, and manual search. No language restrictions were applied. Eligible studies involved RCTs of adults with major depressive disorder who were not on antidepressants or receiving psychological therapy, comparing various exercise modalities with second-generation antidepressants or cognitive behavioral therapy, body-mind exercise, or no exercise interventions. Nine RCTs involving 678 adults were analyzed. The pooled results indicated a small clinical effect favoring exercise in reducing depressive symptoms, although the difference was not statistically significant (SMD = 0.27, 95% CI [- 0.58, 0.04], P = 0.09). Subgroup analyses suggested that intervention duration, frequency, intensity, supervision, age, overweight/obesity status, and diagnosis of depression could influence treatment outcomes. A sensitivity analysis was conducted for studies with controls without exercise interventions and a low risk of bias in the domains related to the randomization process and deviations from the intended interventions. The results showed that there are no statistically significant differences when interventions are compared with medication and body-mind exercise (p = 0.12, I2 = 78%). Furthermore, the analysis showed a moderate effect size favoring exercise, but no statistically significant difference between groups (p = 0.05), with high heterogeneity (I2 = 85%). The evidence quality was generally low to very low, and methodological limitations compromised the certainty of the findings. Adverse events associated with exercise were manageable. The study emphasizes the need for well-designed RCTs to provide clearer insights into the potential benefits of exercise in managing major depressive disorder symptoms. Caution is warranted in interpreting these results due to the limitations of the included studies.Systematic review registration: PROSPERO CRD42022356741.

Implementation of screening criteria for inflammatory bowel disease in patients with spondyloarthritis and its association with disease and endoscopic activity.

There is little literature on the implementation of screening criteria for inflammatory bowel disease (IBD) in patients with spondyloarthritis (SpA). This study aimed to apply IBD screening criteria in a group of patients with SpA without IBD diagnosis and correlate them to endoscopic findings and disease activity. A total of 82 patients with SpA were included. The IBD screening test and ileocolonoscopy with digital chromoendoscopy with magnification and histological analysis were performed. The data were analysed with Chi-square test/Fisher's exact test and multiple correspondence analysis. The major screening criteria found in 48.7% of the patients were associated with a history of infection (p = 0.037). Rectal bleeding was associated with the diagnosis of ankylosing spondylitis, acute inflammation, enthesitis and tissue architecture alteration in the ileum (p < 0.050). Diarrhoea was associated with a higher disease activity score (p = 0.02). Minor screening criteria were associated with painful inflammatory joint (p = 0.05), high disease activity score (p = 0.001) and high calprotectin levels (p = 0.050). Abdominal pain (36.9%) was associated with axial/peripheral compromise (p = 0.017), inflammatory back pain (p = 0.01), enthesitis (p = 0.021), higher disease activity score (p = 0.023) and acute ileum inflammation (p = 0.046). Diarrhoea of 4 weeks and abdominal pain were the most prevalent major and minor screening criteria, respectively, being related to early manifestations of inflammatory bowel compromise and higher disease activity score. This screening test grants a chance of opportune referral of SpA patients from rheumatology to gastroenterology.

Oral manifestations associated with inflammatory bowel disease and early endoscopic findings in patients with spondyloarthritis.

BACKGROUND AND AIMS: Spondyloarthritis (SpA) is a group of autoinflammatory disorders, of which the primary extra-articular manifestation is inflammatory bowel disease (IBD). The oral cavity being a part of gastrointestinal tract, is significantly compromised in IBD, and in many cases, it is the first site of clinical manifestations of IBD. This study aimed to identify changes in the oral mucosa associated with the onset of IBD and their association with endoscopic/histological findings. MATERIALS AND METHODS: The study assessed 80 patients with SpA and 52 healthy controls. Oral, rheumatological, and gastroenterological assessments were performed. The ileocolonoscopy was performed via digital magnification chromoendoscopy. The statistical analysis consisted of Chi-square, Fisher's exact, and multiple correspondence discriminant analysis tests. RESULTS: From the disease cohort, 63.0% patients showed oral lesions (p = 0.050). These manifestations ranged from gingivitis (55.0%, p = 0.001), aphthous stomatitis (3.8%, p = 0.091), angular cheilitis (2.6%, p = 0.200), and perioral erythema with scaling (1.3%, p = 0.300). All patients who presented with alterations in colonic mucosa also had oral lesions associated with IBD (p = 0.039), specifically gingivitis/aphthous stomatitis (p = 0.029). CONCLUSION: The patients with SpA without IBD present significant oral signs and symptoms. Gingivitis seems to be the most relevant because of its associations with early endoscopic and histological findings. CLINICAL RELEVANCE: An integral approach to the diagnostic tests that includes evaluations of oral, rheumatological and gastroenterological tissues may favor timely attention and improve patients' quality of life.

Cumulative additional information does not improve the neuromuscular control during postural responses to perturbations in postural instability/gait disorders subtype of Parkinson's disease.

BACKGROUND: Postural response impairments in postural instability and gait disorders (PIGD) subtype patients may be attributed to Parkinson's disease (PD)-deterioration in central-set (programing/modulating of central outputs during motor responses). Although additional information improves some PD motor impairments, an unanswered question is whether additional information can benefit postural response in PIGD subtype. OBJECTIVE: To analyze the effect of cumulative additional information on postural responses after perturbation in PIGD and neurologically healthy older adults (CG). METHODS: Perturbations were applied in 16 PIGD and 19 CG by the support-base translation. Participants performed 3 blocks of 5 trials without additional information (B1-B3, Day 1) and 5 trials of each cumulative additional information (C1-C4, Day 2): information about perturbation (C1), visual (C2), verbal (C3), and somatosensory information (C4). Electromyography and center of pressure (CoP) parameters were analyzed by ANOVAs with Group (PIGD × CG) and Block (B1 × B2 × B3) and with Group (PIGD × CG) and Condition (B3 × C1 × C2 × C3 × C4). RESULTS: PIGD decreased the range of CoP in B3 while CG decreased both range of CoP and the integral of antagonist's muscle activity (iEMG) in B2. Also, PIGD decreased the recovery time in C4 while CG increased the iEMG of agonist's muscle in C2 and antagonist's muscle in all conditions except C2. CONCLUSION: Additional information provided before postural control assessment influences the postural response in PIGD and CG differently. PIGD demonstrated inflexibility of central-set in modulating the neuromuscular control regardless of additional information. CG presents a flexible system evidenced by the increase of agonist muscle iEMG when provided visual information.

2021 clinical practice guideline for the early detection, diagnosis, treatment, and monitoring of patients with axial spondyloarthritis. Colombian Association of Rheumatology / Guía de práctica clínica 2021 para la detección temprana, el diagnóstico, el tratamiento y el seguimiento de los pacientes con espondiloartritis axial. Asociación Colombiana de Reumatología

Abstract Introduction: Axial spondyloarthritis is a rheumatic condition affecting young patients with social and occupational consequences. Diagnosis delay is associated with functional impairment and impact on quality of life, requiring a multidisciplinary approach. Objective: To develop a set of recommendations based on the best available evidence for the early detection, diagnosis, treatment, and monitoring of adult patients with axial spondy-loarthritis. Methods: A working group was established, questions were developed, outcomes were graded, and a systematic search for evidence was conducted. A multidisciplinary panel of members was established (including patient representatives), minimizing bias in relation to conflicts of interest. The GRADE approach "Grading of Recommendations Assessment, Development and Evaluation" was used to assess the quality of the evidence as well as the direction and strength of recommendations. In total, 11 recommendations on diagnosis (n=2), pharmacological treatment (n=6), non-pharmacological treatment (n=2) and monitoring (n=1) are presented. Results: Sacroiliac joint radiography as the first diagnostic method, and the use of disease activity scales for patient monitoring (ASDAS or BASDAI), are recommended. Nonsteroidal anti-inflammatory drugs are the first treatment option; in case of intolerance or residual pain, acetaminophen or opioids are recommended. In patients with axial involvement, it is recommended not to use conventional disease-modifying antirheumatic drugs or systemic or local glucocorticoids. In patients with failure to non-steroidal anti-inflammatory drugs, anti-TNF or anti-IL17A are recommended. In those patients presenting with anti-TNF failure, starting an anti-IL17A is recommended. Exercise, physical and occupational therapy are recommended as part of treatment. It is recommended not to use unconventional therapies as the only treatment option. Conclusions: This set of recommendations provides an updated guideline for the diagnosis, treatment, and monitoring of patients with axial spondyloarthritis.

RESUMEN Introducción: La espondiloartritis axial es una enfermedad reumatológica que afecta a individuos jóvenes y tiene una gran repercusión sociolaboral. El retraso en el diagnóstico y el tratamiento se asocia con un mayor deterioro funcional y un impacto negativo en la calidad de vida, por lo que requiere un abordaje multidisciplinario. Objetivo: Desarrollar y formular un conjunto de recomendaciones específicas basadas en la mejor evidencia disponible para la detección temprana, el diagnóstico, el tratamiento y el seguimiento de los pacientes adultos con espondiloartritis axial. Métodos: Se configuró un grupo desarrollador, se formularon preguntas clínicas contestables, se graduaron los desenlaces y se realizó la búsqueda sistemática de la evidencia. El panel de la guía fue multidisciplinario (incluyendo representantes de los pacientes) y balanceado, minimizando el sesgo por conflictos de intereses. Se utilizó la aproximación Grading of Recommendations Assessment, Development and Evaluation (GRADE) para evaluar la calidad de la evidencia, al igual que la dirección y la fortaleza de las recomendaciones. Se presentan 11 recomendaciones relacionadas con diagnóstico (n = 2), tratamiento farmacológico (n = 6), tratamiento no farmacológico (n = 2) y seguimiento (n = 1). Resultados: Se recomienda la radiografía de articulaciones sacroilíacas como primer método diagnóstico, y el uso de escalas de actividad para el seguimiento de los pacientes (ASDAS o BASDAI). Los antiinflamatorios no esteroideos son la primera opción de tratamiento; en caso de intolerancia o dolor residual se recomienda acetaminofén u opioides. En pacientes con compromiso axial se recomienda abstenerse de utilizar medicamentos antirreumáticos modificadores de la enfermedad convencionales ni glucocorticoides sistémicos o locales. En pacientes con falla a los antiinflamatorios no esteroideos, se recomienda un anti-TNFα o un anti-IL17A. En pacientes con falla a anti-TNFα, se recomienda iniciar un anti-IL17A. El ejercicio y la terapia física y ocupacional se recomiendan como parte del tratamiento. Se recomienda no utilizar las terapias no convencionales como única opción de tratamiento. Conclusiones: Este conjunto de recomendaciones proporciona una guía actualizada sobre el diagnóstico y el tratamiento de la espondiloartritis axial.

Guía de práctica clínica 2021 para la detección temprana, el diagnóstico, el tratamiento y el seguimiento de los pacientes con espondiloartritis axial. Asociación Colombiana de Reumatología / 2021 clinical practice guideline for the early detection, diagnosis, treatment, and monitoring of patients with axial spondyloarthritis. Colombian Association of Rheumatology

Antecedentes: La espondiloartritis axial es una enfermedad reumatológica que afecta a individuos jóvenes y tiene una gran repercusión sociolaboral. El retraso en el diagnóstico y el tratamiento se asocia con un mayor deterioro funcional y un impacto negativo en la calidad de vida, por lo que requiere un abordaje multidisciplinario. Objetivo: Desarrollar y formular un conjunto de recomendaciones específicas basadas en la mejor evidencia disponible para la detección temprana, el diagnóstico, el tratamiento y el seguimiento de los pacientes adultos con espondiloartritis axial. Métodos: Se configuró un grupo desarrollador, se formularon preguntas clínicas contestables, se graduaron los desenlaces y se realizó la búsqueda sistemática de la evidencia. El panel de la guía fue multidisciplinario (incluyendo representantes de los pacientes) y balanceado, minimizando el sesgo por conflictos de intereses. Se utilizó la aproximación Grading of Recommendations Assessment, Development and Evaluation (GRADE) para evaluar la calidad de la evidencia, al igual que la dirección y la fortaleza de las recomendaciones. Se presentan 11 recomendaciones relacionadas con diagnóstico (n=2), tratamiento farmacológico (n=6), tratamiento no farmacológico (n=2) y seguimiento (n=1). Resultados: Se recomienda la radiografía de articulaciones sacroilíacas como primer método diagnóstico y el uso de escalas de actividad para el seguimiento de los pacientes (ASDAS o BASDAI). Los antiinflamatorios no esteroideos son la primera opción de tratamiento; en caso de intolerancia o dolor residual se recomienda acetaminofén u opioides. En pacientes con compromiso axial se recomienda abstenerse de utilizar medicamentos antirreumáticos modificadores de la enfermedad convencionales ni glucocorticoides sistémicos o locales. En pacientes con fallo a los antiinflamatorios no esteroideos, se recomienda un anti-TNF-α o un anti-IL-17A.(AU)

Background: Axial spondyloarthritis is a rheumatic condition affecting young patients with social and occupational consequences. Diagnosis delay is associated with functional impairment and impact on quality of life, requiring a multidisciplinary approach.ObjectiveTo develop a set of recommendations based on the best available evidence for the early detection, diagnosis, treatment, and monitoring of adult patients with axial spondyloarthritis. Methods: A working group was established, questions were developed, outcomes were graded, and a systematic search for evidence was conducted. A multidisciplinary panel of members was established (including patient representatives), minimizing bias in relation to conflicts of interest. The GRADE approach Grading of Recommendations Assessment, Development and Evaluation was used to assess the quality of the evidence as well as the direction and strength of recommendations. In total, 11 recommendations on diagnosis (n=2), pharmacological treatment (n=6), non-pharmacological treatment (n=2) and monitoring (n=1) are presented. Results: Sacroiliac joint radiography as the first diagnostic method, and the use of disease activity scales for patient monitoring (ASDAS or BASDAI), are recommended. Nonsteroidal anti-inflammatory drugs are the first treatment option; in case of intolerance or residual pain, acetaminophen or opioids are recommended. In patients with axial involvement, it is recommended not to use conventional disease-modifying antirheumatic drugs or systemic or local glucocorticoids. In patients with failure to non-steroidal anti-inflammatory drugs, anti-TNF or anti-IL17A is recommended. In those patients presenting with anti-TNF failure, starting an anti-IL17A is recommended. Exercise, physical and occupational therapy are recommended as part of treatment. It is recommended not to use unconventional therapies as the only treatment option.(AU)

2021 clinical practice guideline for the early detection, diagnosis, treatment, and monitoring of patients with axial spondyloarthritis. Colombian Association of Rheumatology.

BACKGROUND: Axial Spondyloarthritis is a rheumatic condition affecting young patients with social and occupational consequences. Diagnosis delay is associated with functional impairment and impact on quality of life, requiring a multidisciplinary approach. OBJECTIVE: To develop a set of recommendations based on the best available evidence for early detection, diagnosis, treatment and monitoring adult patients with axial spondyloarthritis. METHODS: A working group was established, questions were developed, outcomes were graded, and a systematic search for evidence was conducted. A multidisciplinary panel of members was established (including patient representatives), minimizing bias in relation to conflicts of interest. The GRADE approach "Grading of Recommendations Assessment, Development and Evaluation" was used to assess the quality of the evidence as well as the direction and strength of recommendations. In total, 11 recommendations with regard to diagnosis (n = 2), pharmacological treatment (n = 6), non-pharmacological treatment (n = 2) and monitoring (n = 1) are presented. RESULTS: Sacroiliac joint radiography as the first diagnostic method, and the use of disease activity scales for patient monitoring (ASDAS or BASDAI), are recommended. Nonsteroidal anti-inflammatory drugs are the first treatment option; in case of intolerance or residual pain, acetaminophen or opioids are recommended. In patients with axial involvement, it is recommended not to use conventional disease-modifying antirheumatic drugs or systemic or local glucocorticoids. In patients with failure to non-steroidal anti-inflammatory drugs, anti-TNF or anti-IL17A is recommended. In those patients presenting with anti-TNF failure, starting an anti-IL17A is recommended. Exercise, physical and occupational therapy are recommended as part of treatment. It is recommended not to use unconventional therapies as the only treatment option. CONCLUSIONS: This set of recommendations provides an updated guide on the diagnosis, treatment and monitoring of patients with axial spondyloarthritis.

2021 clinical practice guidelines for the diagnosis, treatment, and follow-up of patients with peripheral spondyloarthritis. Colombian Association of Rheumatology / Guía de práctica clínica 2021 para el diagnóstico, el tratamiento y el seguimiento de pacientes con espondiloartritis periférica. Asociación Colombiana de Reumatología

ABSTRACT Background: Peripheral spondylarthritis is a chronic Inflammatory disease whose clinical presentation is related to the presence of arthritis, enthesitis and/or dactylitis. This term is used interchangeably with some of its subtypes such as psoriatic arthritis, reactive arthritis, and undifferentiated spondyloarthritis. Objective: To develop and formulate a set of specific recommendations based on the best available evidence for the diagnosis, treatment, and monitoring of adult patients with peripheral spondyloarthritis. Methods: A working group was established, clinical questions were formulated, outcomes were graded, and a systematic search for evidence was conducted. The guideline panel was multidisciplinary (including patient representatives) and balanced. Following the for mal expert consensus method, the GRADE methodology "Grading of Recommendations Assessment, Development and Evaluation" was used to assess the quality of the evidence and generate the recommendations. The clinical practice guideline includes ten recommendations related to monitoring of disease activity (n = 1) and treatment (n = 9). Results: In patients with peripheral spondyloarthritis, the use of methotrexate or sulfasalazine as the first line of treatment is suggested, and local injections of glucocorticoids are conditionally recommended. In patients with failure to cDMARDs, an anti TNFα or an anti IL17A is recommended. In case of failure to bDMARDs, it is suggested to use another bDMARD or JAK inhibitor. In patients with peripheral spondylarthritis associated with inflammatory bowel disease, it is recommended to start treatment with cDMARDs; in the absence of response, the use of an anti TNFα over an anti-IL-17 or an anti-IL-12-23 is recom mended as a second line of treatment. In patients with psoriatic arthritis, the combined use of methotrexate with a bDMARD is conditionally recommended for optimization of dosing. To assess disease activity in Psoriatic Arthritis, the use of DAPSA or MDA is suggested for patient monitoring. Conclusions: This set of recommendations provides an updated guideline on the diagnosis and treatment of peripheral spondyloarthritis.

RESUMEN Antecedentes: La espondiloartritis periférica es una patología Inflamatoria crónica cuya presentación clínica está determinada por la presencia de artritis, entesitis y/o dactilitis. Este término se utiliza indistintamente con algunos de sus subtipos como artritis psoriásica, artritis reactiva y espondiloartritis indiferenciada. Objetivo: Desarrollar y formular un conjunto de recomendaciones específicas basadas en la mejor evidencia disponible para el diagnóstico, el tratamiento y el seguimiento de pacientes adultos con espondiloartritis periférica. Métodos: Se constituyó un grupo desarrollador, se formularon preguntas clínicas, se graduaron los desenlaces y se realizó la búsqueda sistemática de la evidencia. El panel de la guía fue multidisciplinario (incluyendo representantes de los pacientes) y balanceado. Siguiendo el método de consenso formal de expertos, se utilizó la metodología GRADE (Grading of Recommendations Assessment, Development and Evaluation) para para evaluar la calidad de la evidencia y generar las recomendaciones. La guía de práctica clínica incluye 10 recomendaciones: una sobre seguimiento de la actividad de la enfermedad y nueve sobre tratamiento. Resultados: En pacientes con espondiloartritis periférica se sugiere usar metotrexato o sulfasalazina como primera línea de tratamiento y se recomienda en forma condicional la inyección local de glucocorticoides. En los pacientes que fallan a cDMARDs, se recomienda iniciar un anti TNFα o un anti IL17A. Ante falla terapéutica a la primera línea con bDMARDs, se sugiere usar otro bDMARD o un inhibidor JAK. En pacientes con espondiloartritis periférica y enfermedad inflamatoria intestinal asociada, se recomienda iniciar tratamiento con cDMARDs; en ausencia de respuesta, se recomienda el uso de un anti TNFα sobre un anti IL-17 o un anti IL-12-23 como segunda línea de tratamiento. En pacientes con artritis psoriásica se recomienda, de forma condicional, el uso combinado de metotrexato con bDMARD para favorecer la optimización de la dosis de estos. Para evaluar la actividad de la enfermedad en artritis psoriásica, se sugiere el uso del DAPSA o MDA para el seguimiento de los pacientes. Conclusiones: Este conjunto de recomendaciones proporcionan una guía actualizada sobre el diagnóstico y el tratamiento de la espondiloartritis periférica.

2021 clinical practice guidelines for the diagnosis, treatment, and follow-up of patients with peripheral spondyloarthritis. Colombian Association of Rheumatology.

BACKGROUND: Peripheral spondyloarthritis is a chronic inflammatory disease in which clinical presentation is related to the presence of arthritis, enthesitis and/or dactylitis. This term is used interchangeably with some of its subtypes such as psoriatic arthritis, reactive arthritis, and undifferentiated spondyloarthritis. OBJECTIVE: To develop and formulate a set of specific recommendations based on the best available evidence for the diagnosis, treatment and monitoring of adult patients with peripheral spondyloarthritis. METHODS: A working group was established, clinical questions were formulated, outcomes were graded, and a systematic search for evidence was conducted. The guideline panel was multidisciplinary (including patient representatives) and balanced. Following the formal expert consensus method, the GRADE methodology "Grading of Recommendations Assessment, Development and Evaluation" was used to assess the quality of the evidence and generate the recommendations. The Clinical Practice Guideline includes ten recommendations; related to monitoring of disease activity (n = 1) and treatment (n = 9). RESULTS: In patients with peripheral spondyloarthritis, the use of methotrexate or sulfasalazine as the first line of treatment is suggested, and local injections of glucocorticoids is recommended conditionally. In patients with failure to cDMARDs, an anti TNFα or an anti IL17A is recommended. In case of failure to bDMARDs, it is suggested to use another bDMARD or JAK inhibitor. In patients with peripheral spondyloarthritis associated to inflammatory bowel disease, it is recommended to start treatment with cDMARDs; in the absence of response, the use of an anti TNFα over an anti-IL-17 or an anti-IL-12-23 is recommended as a second line of treatment. In patients with psoriatic arthritis, the combined use of methotrexate with bDMARD is conditionally recommended for optimization of dosing. To assess disease activity in Psoriatic Arthritis, the use of DAPSA or MDA is suggested for patient monitoring. CONCLUSIONS: This set of recommendations provides an updated guide on the diagnosis and treatment of peripheral spondyloarthritis.

Guía de práctica clínica 2021 para el diagnóstico, el tratamiento y el seguimiento de pacientes con espondiloartritis periférica. Asociación Colombiana de Reumatología / 2021 Clinical Practice Guidelines for the Diagnosis, Treatment, and Follow-up of Patients with Peripheral Spondyloarthritis. Colombian Association of Rheumatology

Antecedentes: La espondiloartritis periférica es una patología inflamatoria crónica cuya presentación clínica está determinada por la presencia de artritis, entesitis y/o dactilitis. Este término se utiliza indistintamente con algunos de sus subtipos como artritis psoriásica, artritis reactiva y espondiloartritis indiferenciada. Objetivo: Desarrollar y formular un conjunto de recomendaciones específicas basadas en la mejor evidencia disponible para el diagnóstico, el tratamiento y el seguimiento de pacientes adultos con espondiloartritis periférica. Métodos: Se constituyó un grupo desarrollador, se formularon preguntas clínicas, se graduaron los desenlaces y se realizó la búsqueda sistemática de la evidencia. El panel de la guía fue multidisciplinario (incluyendo representantes de los pacientes) y balanceado. Siguiendo el método de consenso formal de expertos, se utilizó la metodología GRADE (Grading of Recommendations Assessment, Development and Evaluation) para para evaluar la calidad de la evidencia y generar las recomendaciones. La guía de práctica clínica incluye 10 recomendaciones: una sobre seguimiento de la actividad de la enfermedad y nueve sobre tratamiento. Resultados: En pacientes con espondiloartritis periférica se sugiere usar metotrexato o sulfasalazina como primera línea de tratamiento y se recomienda en forma condicional la inyección local de glucocorticoides. En los pacientes que fallan a cDMARDs, se recomienda iniciar un anti TNFα o un anti IL17A. Ante falla terapéutica a la primera línea con bDMARDs, se sugiere usar otro bDMARD o un inhibidor JAK. En pacientes con espondiloartritis periférica y enfermedad inflamatoria intestinal asociada, se recomienda iniciar tratamiento con cDMARDs; en ausencia de respuesta, se recomienda el uso de un anti TNFα sobre un anti IL-17 o un anti IL-12-23 como segunda línea de tratamiento.(AU)

Background: Peripheral spondyloarthritis is a chronic inflammatory disease whose clinical presentation is related to the presence of arthritis, enthesitis and/or dactylitis. This term is used interchangeably with some of its subtypes such as psoriatic arthritis, reactive arthritis, and undifferentiated spondyloarthritis. Objective: To develop and formulate a set of specific recommendations based on the best available evidence for the diagnosis, treatment, and monitoring of adult patients with peripheral spondyloarthritis. Methods: A working group was established, clinical questions were formulated, outcomes were graded, and a systematic search for evidence was conducted. The guideline panel was multidisciplinary (including patient representatives) and balanced. Following the formal expert consensus method, the GRADE methodology “Grading of Recommendations Assessment, Development and Evaluation” was used to assess the quality of the evidence and generate the recommendations. The clinical practice guideline includes ten recommendations related to monitoring of disease activity (n=1) and treatment (n=9). Results: In patients with peripheral spondyloarthritis, the use of methotrexate or sulfasalazine as the first line of treatment is suggested, and local injections of glucocorticoids are conditionally recommended. In patients with failure to cDMARDs, an anti TNFα or an anti IL17A is recommended. In case of failure to bDMARDs, it is suggested to use another bDMARD or JAK inhibitor. In patients with peripheral spondyloarthritis associated with inflammatory bowel disease, it is recommended to start treatment with cDMARDs; in the absence of response, the use of an anti TNFα over an anti-IL-17 or an anti-IL-12-23 is recommended as a second line of treatment. In patients with psoriatic arthritis, the combined use of methotrexate with a bDMARD is conditionally recommended for optimization of dosing.(AU)

Estimation of the Difference in Colistin Plasma Levels in Critically Ill Patients with Favorable or Unfavorable Clinical Outcomes.

In recent decades, antimicrobial resistance (AMR) has led to an increased use of therapeutic alternatives. Among these options, colistin continues to be an option for the treatment of multi-resistant (MDR) Gram-negative bacterial infections. However, due to its high toxicity (nephrotoxicity and neurotoxicity) and narrow therapeutic window, colistin treatment must be utilized carefully. Colistin-treated patients have been observed to have higher mortality due to inadequate therapeutic levels. The objective of this study was to estimate the difference in colistin plasma levels in critically ill patients, and its relationship to favorable or unfavorable clinical outcomes. This prospective observational study was conducted between September 2017 and June 2020 at the Universidad de La Sabana Clinic, in patients who had been treated with colistimethate sodium (CMS) for at least 72 h until day 7 of drug treatment in the critical care unit of a university hospital. There were no statistically significant differences in colistin levels between groups with favorable or unfavorable clinical outcomes (0.16 SD vs. 0.54 SD p-value = 0.167). There was higher mortality in patients with subtherapeutic levels (18% vs. 0%), and additionally, there was a greater rate of renal failure in the group with higher therapeutic levels (50% vs. 20.7%). Due to the loss of power of the study, we were unable to demonstrate a possible difference between colistin levels related to favorable or unfavorable clinical outcomes at day 7. However, we recommend further studies to evaluate the impact of measuring levels in terms of mortality and security.

Impact on Antibiotic Resistance, Therapeutic Success, and Control of Side Effects in Therapeutic Drug Monitoring (TDM) of Daptomycin: A Scoping Review.

Antimicrobial resistance (AR) is a problem that threatens the search for adequate safe and effective antibiotic therapy against multi-resistant bacteria like methicillin-resistant Staphylococcus aureus (MRSA), and vancomycin-resistant Enterococci (VRE) and Clostridium difficile, among others. Daptomycin is the treatment of choice for some infections caused by Gram-positive bacteria, indicated most of the time in patients with special clinical conditions where its high pharmacokinetic variability (PK) does not allow adequate plasma concentrations to be reached. The objective of this review is to describe the data available about the type of therapeutic drug monitoring (TDM) method used and described so far in hospitalized patients with daptomycin and to describe its impact on therapeutic success, suppression of bacterial resistance, and control of side effects. The need to create worldwide strategies for the appropriate use of antibiotics is clear, and one of these is the performance of therapeutic drug monitoring (TDM). TDM helps to achieve a dose adjustment and obtain a favorable clinical outcome for patients by measuring plasma concentrations of an administered drug, making a rational interpretation guided by a predefined concentration range, and, thus, adjusting dosages individually.

Adherencia a medicamentos orales en pacientes con artritis reumatoide, una experiencia colombiana / Adherence to oral disease-modifying anti-rheumatic drugs in patients with rheumatoid arthritis: a Colombian experience

RESUMEN Introducción: El uso de los fármacos modificadores de la enfermedad (FAME) en pacientes con artritis reumatoide (AR) es esencial para alcanzar y mantener un control adecuado de la enfermedad y prevenir un daño funcional irreversible. Sin embargo, la tasa de adherencia a la terapia farmacológica varía entre el 20% y el 107%. Esta variabilidad puede deberse a los métodos de medición utilizados en los diferentes estudios. Objetivo: Evaluar la adherencia global al tratamiento oral con FAME en pacientes con AR mediante el autodiligenciamiento del cuestionario Compliance Questionnaire on Rheumatology (CQR) y la actividad de la enfermedad e identificar los factores potenciales asociados con la baja adherencia. Métodos: Estudio descriptivo transversal que incluyó pacientes mayores de 18 años con AR clasificados por criterios ACR-EULAR 2010, con prescripción de FAME durante al menos 3 meses y control con reumatólogo en el último año. Los participantes llenaron el cuestionario CQR y se les indagó acerca del conocimiento de la enfermedad, la percepción sobre el tratamiento, los efectos adversos, el índice de comorbilidad de Charlson, el índice global de apoyo social, el número de medicamentos y FAME prescritos, el acceso a los servicios de salud y la actividad de la enfermedad por DAS 28 o CDAI. Se definió como buena adherencia un punto de corte de CQR >80 y ausencia de actividad (remisión o actividad baja). Para la búsqueda de factores asociados con adherencia se analizaron los datos por medio de mediana y rango intercuartílico, así como frecuencias y proporciones. La comparación entre los grupos de adherentes y no adherentes se hizo con comparaciones absolutas, por medio de test de Mann-Whitney para las variables continuas y chi-cuadrado (para valores esperados > 5), o Fisher (para valor esperado < 5) para variables categóricas, tomando como nivel de significancia un valor de p<0,05. Se utilizaron OR y sus respectivos intervalos de confianza al 95% (IC95%). Resultados: De los 170 participantes incluidos, el 50% (n = 85) tuvo un valor de CQR mayor de 80 (buena adherencia). La mayoría de los pacientes se encontraba en remisión (60,6%) o baja actividad de la enfermedad (17%). El análisis posterior únicamente encontró asociación estadísticamente significativa entre adherencia medida por CQR y el número de amigos (p = 0,0012) y entre adherencia medida por actividad de la enfermedad y el índice de soporte social global (p = 0,004). Conclusiones: Este estudio muestra un nivel de adherencia similar al reportado en otras poblaciones, lo cual puede deberse a comportamientos propios de nuestra población, aunque los autores percibieron dificultades reportadas por los pacientes para entender los enunciados del instrumento en todos los niveles de escolaridad. Únicamente las variables de soporte social tuvieron una asociación estadísticamente significativa con la adherencia, asociación descrita en la literatura. Se requieren más estudios para evaluar las características operacionales del CQR en nuestra población.

ABSTRACT Introduction: The use of disease modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA) is essential in order to achieve and maintain adequate disease control, and thus preventing irreversible functional damage. However, the rate of adherence to drug therapy has been reported to be between 20% and 107%. This variability may be due to the measurement methods used in the different studies. Objective: To test the overall medication adherence to oral treatment with DMARD in patients with RA using the self-report Spanish version Compliance Questionnaire on Rheumatology (CQR) and to identify potential factors associated with non-adherence. Methods: A cross-sectional descriptive study was conducted that included patients older than 18 years with RA diagnosed according to the ACR-EULAR 2010 criteria. They also had to have been prescribed oral DMARD for the previous 3 months, and had been seen by a rheumatologist in the last year. Patients completed the CQR to assess adherence, and were asked about disease knowledge, perception about treatment, side effects, Charlson Comorbidity Index, global index of social support, number of medications and DMARD prescribed, access to health resources, and disease activity measured by DAS 28 or CDAI. Good adherence was defined as a cut-off point of CQR > 80 or non-activity (remission or low activity). In the search for factors associated with adherence, the data were analysed using means of median and interquartile range, as well as frequencies and proportions. The comparison between adherent and non-adherent groups was performed using absolute comparisons, with the Mann-Whitney test for continuous, and chi-squared (for expected values > 5), or Fisher (for expected values < 5) tests for categorical variables, taking as a level of significance a value of P < .05. OR and their respective 95% confidence intervals (95% CI) were used. Results: Of 170 participants included, 50% (n = 85) had a value greater than 80% (good drug adherence). Most patients had remission (60.6%) or low disease activity (17%). The subsequent analysis showed statistically significant association between adherence measured by CQR and the number of friends (P = .0012). An association was also found between disease activity as an indirect indicator of adherence and the global social support index (P = .004). Conclusions: This study found a similar level of adherence to that reported in other populations, which could be due to the behaviour of our population, although the authors perceived difficulties reported by patients in understanding the statements of the questionnaire at all levels of education. Only the social support variables had a statistically significant relationship with adherence, which had also been described in the literature. Further studies are required to evaluate the operational characteristics of the CQR in our population.

Clinical Evidence of Magistral Preparations Based on Medicinal Cannabis.

Cannabis has been widely used as a medicinal plant for millennia; however, studies related to its main components were first conducted in 1960. Subsequently, laboratories have produced new components and structures related to its active biological properties. Countries that have approved the medicinal use of cannabis impose regulations that govern its clinical and scientific use. One means of administering medicinal cannabis is via a magistral preparation that must have a medical prescription and be prepared in an establishment that meets quality standards to ensure the quantities of its main components, such as tetrahydrocannabinol (THC) and cannabidiol (CBD). Furthermore, suppliers must have a clear indication of its use in the patient before prescription. This review shows the published evidence regarding the clinical use of medicinal cannabis magistral preparations in the management of post-chemotherapy nausea and vomiting, neuropathic pain in multiple sclerosis, and anorexia and cachexia in patients with HIV.

P050 Oral Inflammatory Changes Associated With Inflammatory Bowel Disease in Spondyloarthritis Associated With Early Endoscopic Findings.

BACKGROUND: Spondyloarthritis (SpA) is a heterogeneous group of chronic autoinflammatory disorders that can present extra-articular gastrointestinal manifestations. Among them is mainly inflammatory bowel disease (IBD). Although IBD mainly affects the intestinal tract, it can include early manifestations evident in the oral cavity. No comparative data on these oral manifestations in patients with SpA were found in the literature. OBJECTIVE: To identify oral clinical manifestations due to changes in the oral mucosa associated with IBD in patients with SpA without a diagnosis of IBD and associate them with endoscopic and histological findings. METHODS: 80 patients with SpA and 52 healthy controls were evaluated. They were assessed intra- and extra-orally, following the modified World Health Organization guideline. In addition, by clinical parameters of rheumatological, gastrointestinal and laboratory activity. Ileocolonoscopy was performed with digital chromoendoscopy with magnification and histological analysis. Comparative analyzes were performed by Chi square tests, Fisher's exact tests, confirmed by univariate regression and discriminant analysis of multiple correspondences. Institutional ethics committee approval cod-2017-023. RESULTS: The patients with SpA had 56% male gender, mean age of 42.8 years (SD ± 10.4) and a BMI in the range of 23.9 - 28.4. The healthy controls, 54% of the male gender with an average age of 41 years (SD ± 13.6) and a body mass index-BMI in the range of 22.9 - 27.6. The patients reported smoking only in 6.2%, however as a smoking history in 31% and passive smokers (15%), the majority employed (41%), married (56%) and professionals (49%). Of the healthy controls, they smoked (15%), with a history of smoking (31%), passive smokers (21%), the majority employed (77%), with their own home (67%), and professionals (54%). The patients with SpA reported a greater presence of some signs and symptoms of gastrointestinal origin 69%, while in the controls it was 7.7% (p = 0.001). Forty one of them were referred to colonoscopy with magnification being in 17.1 % changes in the mucosa of the rectum and in the same frequency changes in the mucosa of the sigmoid colon. Regarding the ileum, changes in the mucosa were evidenced in 41.5% of the cases. The presence of oral lesions was evident and predominated in them (63%) compared to controls p = 0.050. The main oral lesions associated with IBD were gingivitis (55%) (p = 0.001), followed by aphthous stomatitis (3.8%), angular cheilitis (2.6%) and perioral erythema with scaling (1.3%). 100% of the patients who presented alteration of the colonic mucosa presented oral lesions associated with IBD (p = 0039), which was also significantly associated with the presence of gingivitis/aphthous stomatitis (p = 0.029). CONCLUSION: Patients with SpA without a diagnosis of IBD have more oral signs and symptoms compared to healthy controls. Gingivitis is important given its association with early endoscopic and histological findings. Manifestations in the oral cavity can precede intestinal manifestations, therefore the clinical assessment by the oral pathologist in conjunction with gastroenterology and rheumatology allows a timely referral to gastroenterology and an endoscopic and histological evaluation, impacting the quality of life of patients.

P060 Screening Criteria of Inflammatory Bowel Disease: Application in Colombian Patients With Spondyloarthritis.

BACKGROUND: The Spondyloarthritis (SpA) is a group of chronic inflammatory rheumatic diseases, in which 5-10% of extra-articular manifestations are gastrointestinal such as the inflammatory bowel disease. Objective: To apply the clinical criteria for the screening of inflammatory bowel disease (IBD) in patients with SpA with gastrointestinal symptoms and its association with disease activity and function. METHODS: A Cross-sectional study included 82 patients with SpA, according to ASAS classification criteria without diagnosis of IBD. We applied the Screening criteria for IBD developed by Sanz et al, in the SpA patients. Clinical evaluation by rheumatologist and in patients with ≥ 2 gastrointestinal symptoms clinical evaluation by gastroenterologist and IBD screening criteria were performed. Digital chromoendoscopy, magnification colonoscopy, and histological analysis were performed. Lab tests included, C-reactive protein, sedimentation rate, serum levels of transferrin, ferritin and vitamin B12. The association between clinical variables and colonoscopy and histological variables were evaluated using the Chi-square or Fisher's exact test (Ethical / Cod. 2017-023). RESULTS: Of the 82 individuals evaluated, 58 of them were referred to gastroenterology with a direction to perform colonoscopy with chromeondospia, and 41 of them were able to intervene to whom the IBD screening criteria were applied. 53.7% are men, 7.3% actively smoke. 100% of the population presented some gastrointestinal symptoms, the most frequent being diarrhea of more than 4 weeks in 61%. 68.3% had at least one of the three major criteria. Rectorrhagia was associated with BASFI>4, p=0.050, axial compromise p = 0.043, diagnosis of PsA p = 0.090 and alterations in the architecture of the ileum p=0.034. Diarrhea was associated with ESR> 20, p = 0.050, BASFI>4 p = 0.012. In addition, 70.75 of the patients had at least one of the minor screening criteria associated with higher BASFI levels, p = 0.01. Aphthous stomatitis was reported as extra-intestinal manifestations in 7.3% and abdominal pain in 87.8% of the patients, which was associated with BASDAI>4 p = 0.023, ASDASCRP> 2.1, p = 0.043 and inflammation in the ileum, p = 0.046. No patients with positive iron deficiency anemia were found. However, ferritin alteration was observed in 22% associated with chronic inflammation of the colon, p = 0.042. There were no cases of fever or family history of IBD. Noting that in 17.1% of the cases a decrease in vitamin B12 levels was detected, associated with the presence of ulcers (p = 0.035) and acute inflammation in the ileum, p = 0.032. Weight loss was found in 31.7% of the cases and was associated with smoking history p = 0.039. CONCLUSION: We found a high frequency of major and minor symptoms of IBD, both of which were associated with a high activity of spondyloarthritis and an important functional compromise as well as inflammation markers in this group of patients. The application of the screening criteria for IBD in SpA without IBD reflects a high frequency of intestinal symptoms of sufficient intensity that affect quality of life and disease activity. Early detection of gastrointestinal compromise allows patients to benefit from comprehensive treatment of the disease in its initial stages.

P062 Chromoendoscopy With Magnification Colonoscopy: Analysis of Mucosa of Colon And Ileum In Patients With Gastrointestinal Symptoms Without IBD.

BACKGROUND: Digital chromoendoscopy (Narrow Band Imaging By Olympus) or BLI (Blue Light Imaging By Fujifilm), with the magnification endoscope, allows a detailed evaluation of the mucosal surface and its vascular network, which facilitates the diagnosis and monitoring of early lesions. This technique has demonstrated a better detection, which allows optical diagnosis during a colonoscopy examination. Patients with SpA with nonspecific gastrointestinal symptoms, subclinical intestinal inflammation are defined as endoscopic and histologically. The aim was to detect early structural inflammatory changes by chromoendoscopy and magnification colonoscopy in colonic/ileum digestive mucosa, and establish its association with clinical variables in SpA and gastrointestinal symptoms. Study approved by Institutional Ethics Committee, code HMC 2017-023. METHODS: Clinical evaluation by rheumatologist in SpA patients (ASAS/criteria), fecal calprotectin levels, and HLA-B*27 were evaluated. In patients with ≥2 gastrointestinal symptoms, clinical evaluation by gastroenterologist, digital chromoendoscopy (NBI) or (BLI), magnification colonoscopy, and histological analysis were performed. The association between clinical and colonoscopy variables were established using the Chi-square or Fisher's exact test. RESULTS: In total, 62 SpA patients were included, with mean age of 45.1 ± 11.3 years, axial SpA (77.4%) peripheral SpA (12.9%), biological treatment (69.4%), ASDAS-CRP>2,1 (67.7%), presence of HLA-B*27 (41.9%). Patients with ≥2 gastrointestinal symptoms were found in 67.7%. The most important symptoms were abdominal pain (66.1%), abdominal distension (64.5%), and food intolerance (59.7%). 22.6% of patients showed high level of calprotectin. In those patients with gastrointestinal symptoms, chromoendoscopy and magnification colonoscopy were performed. The mean age of those patients was 45.4 ± 10.5, 57.6% were male, BMI>25 in 69.7%, presence of HLA-B*27 in 39.4%, 33.3% were former smokers, axial SpA in 84.8% and ASDAS-CRP>21 in 78.8%. In total, 27.27% of the patients presented high levels of calprotectin, of which 66.0% had more than two gastrointestinal symptoms (p = 0.015). 77.8% presented alterations in ileal mucosa (p=0.060). The most frequent alteration was the loss of vascular pattern (p = 0.002). By histological analysis, 5 patients had acute inflammation in the ileum, of which 4 had increased levels of fecal calprotectin (p = 0.013). 30.8% of patients positive for HLAB*27:05:02 had ulcers in ileum (p = 0.017) and 61.5% had chronic inflammatory patterns (p=0.020). CONCLUSION: Chromoendoscopy provided an enhanced, detailed contrast of the gastrointestinal mucosa surface, mainly in the loss of vascular pattern in ileum. The active search for symptoms, signs, and biomarkers of gastrointestinal involvement in addition to an objective endoscopic and histological evaluation may offer new perspectives at the evaluation of SpA patients and may provide guidance for specific clinical and therapeutic management.

Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview.

Since we have gained an understanding of the immunological pathophysiology of rheumatic diseases such as rheumatoid arthritis and systemic lupus erythematosus, treatment based on biological drugs has become a fundamental axis. These therapies are oriented towards the regulation of cytokines such as tumour necrosis factor-alpha (TNF-α), interleukin (IL)-6, IL-1, and the modulation of cell-mediated immunity (B cells and T cells) by anti CD20 or anti CTAL-4 agents, and can increase the risk of associated infections or adverse events (AE). In this context, the entry of biotherapeutics represented a challenge for pharmacovigilance, risk management and approval by the main global regulatory agencies regarding biosimilars, where efficacy and safety are based on comparability exercises without being an exact copy in terms of molecular structure. The objective of this review is divided into three fundamental aspects: (i) to illustrate the evolution and focus of pharmacovigilance at the biopharmaceutical level, (ii) to describe the different approved recommendations of biopharmaceuticals (biological and biosimilars) and their use in rheumatic diseases (RDs) such as rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE) and other less frequent RD like cryopyrin-associated autoinflammatory syndromes (CAPS), and (iii) to identify the main AE reported in the post-marketing phase of RD biopharmaceuticals.