Satisfaction and effectiveness of switching from intravenous to subcutaneous belimumab treatment in daily clinical practice.

BACKGROUND: In 2017, belimumab (BEL) was approved in subcutaneous (SQ) administration. The effectiveness after switching from intravenous (IV) to SQ and patient satisfaction in daily clinical practice has not been studied. During the pandemic, patient follow-up and treatment were significantly affected, and some patients need a change from IV to SQ. Our aim was to evaluate daily clinical practice satisfaction to SQ BEL therapy in patients previously treated IV BEL. We hypothesized that SQ BEL in SLE patients previously treated with IV BEL was similar in effectiveness and conferred higher satisfaction. METHODS: Observational, multicenter study, conducted in 7 reference centers in Catalonia. We included stable SLE patients (EULAR/ACR 2019) on treatment with SQ BEL and previous use of IV BEL (at least 3 months on IV BEL before switching). Since there are no well-validated tools for SQ BEL treatment satisfaction, we used RASQ-SQ, validated in patients with lymphoma who switched from IV Rituximab to SQ treatment, and modified for BEL treatment. RESULTS: Twenty-seven patients were included. The more prevalent clinical manifestations observed were related to the skin and joints and the patients had a mean baseline SLEDAI of 2.96 (SD 2.4) and SLICC score of 0.67 (SD 0.88). The median time from treatment with IV BEL before switching to SQ was 21 months (range). 84% of patients reported confidence in SQ BEL. 85.2% felt that treatment with SQ BEL was convenient or very convenient. 85% felt they had gained time with the change. 89% would recommend the SQ injection to other patients. Disease activity (mean SLEDAI) and remission rates remain stable after switching. No major new adverse effects were reported. CONCLUSIONS: Overall satisfaction, satisfaction with via of administration, and satisfaction with the time taken to receive BEL were higher for SQ BEL treatment. A switching SQ strategy is a reasonable alternative for BEL patients.

Neutrophilic Activity Biomarkers (Plasma Neutrophil Extracellular Traps and Calprotectin) in Established Patients with Rheumatoid Arthritis Receiving Biological or JAK Inhibitors: A Clinical and Ultrasonographic Study.

INTRODUCTION: This study assesses the accuracy of neutrophil activation markers, including neutrophil extracellular traps (NETs) and calprotectin, as biomarkers of disease activity in patients with established rheumatoid arthritis (RA). We also analyse the relationship between NETs and various types of therapies as well as their association with autoimmunity. METHODS: Observational cross-sectional study of patients with RA receiving treatment with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors (JAK-inhibitors) for at least 3 months. Plasma calprotectin levels were measured using an enzyme-linked immunosorbent assay test kit and NETs by measuring their remnants in plasma (neutrophil elastase-DNA and histone-DNA complexes). We also assessed clinical disease activity, joint ultrasound findings and autoantibody status [reumatoid factor (RF), anti-citrullinated peptide/protein antibodies (ACPAs) and anti-carbamylated protein (anti-CarP)]. Associations between neutrophilic biomarkers and clinical or ultrasound scores were sought using correlation analysis. The discriminatory capacity of both neutrophilic biomarkers to detect ultrasound synovitis was analysed through receiver-operating characteristic (ROC) curves. RESULTS: One hundred fourteen patients were included. Two control groups were included to compare NET levels. The active control group consisted of 15 patients. The second control group consisted of 30 healthy subjects. Plasma NET levels did not correlate with clinical disease status, regardless of the clinic index analysed or the biological therapy administered. No significant correlation was observed between NET remnants and ultrasound synovitis. There was no correlation between plasma NET and autoantibodies. In contrast, plasma calprotectin positively correlated with clinical parameters (swollen joint count [SJC] rho = 0.49; P < 0.001, Clinical Disease Activity Index [CDAI] rho = 0.30; P < 0.001) and ultrasound parameters (rho > 0.50; P < 0.001). Notably, this correlation was stronger than that observed with acute phase reactants. CONCLUSION: While NET formation induced by neutrophils may play a role in RA pathogenesis, our study raises questions about the utility of NET remnants in peripheral circulation as a biomarker for inflammatory activity. In contrast, this study strongly supports the usefulness of calprotectin as a biomarker of inflammatory activity in patients with RA.

Calprotectin in Patients with Rheumatic Immunomediated Adverse Effects Induced by Checkpoints Inhibitors.

BACKGROUND: this is an exploratory study to evaluate calprotectin serum levels in patients with rheumatic immune-related adverse events (irAEs) induced by immune checkpoint inhibitor (ICI) treatment. METHODS: this is a retrospective observational study including patients with irAEs rheumatic syndromes. We compared the calprotectin levels to those in a control group of patients with RA and with a control group of healthy individuals. Additionally, we included a control group of patients treated with ICI but without irAEs to check calprotectin levels. We also analysed the performance of calprotectin for the identification of active rheumatic disease using receiver operating characteristic curves (ROC). RESULTS: 18 patients with rheumatic irAEs were compared to a control group of 128 RA patients and another group of 29 healthy donors. The mean calprotectin level in the irAE group was 5.15 µg/mL, which was higher than the levels in both the RA group (3.19 µg/mL) and the healthy group (3.81 µg/mL) (cut-off 2 µg/mL). Additionally, 8 oncology patients without irAEs were included. In this group, calprotectin levels were similar to those of the healthy controls. In patients with active inflammation, the calprotectin levels in the irAE group were significantly higher (8.43 µg/mL) compared to the RA group (3.94 µg/mL). ROC curve analysis showed that calprotectin had a very good discriminatory capacity to identify inflammatory activity in patients with rheumatic irAEs (AUC of 0.864). CONCLUSIONS: the results suggest that calprotectin may serve as a marker of inflammatory activity in patients with rheumatic irAEs induced by treatment with ICIs.

Imaging Findings in Patients with Immune Checkpoint Inhibitor-Induced Arthritis.

Immune checkpoint inhibitor (ICI)-induced arthritis is an increasingly recognized adverse event in patients with oncologic disease during immunotherapy. Four patterns are well described, including rheumatoid arthritis (RA)-like, polymyalgia rheumatica (PMR)-like, psoriatic arthritis (PsA)-like, and oligo-monoarthritis, among others. Despite better clinical recognition of these syndromes, information about the main imaging findings is limited. METHODS: We conducted a retrospective observational study including all adult patients referred to the Rheumatology Department of a single-center due to ICI-induced arthritis who underwent imaging studies [ultrasound (US), magnetic resonance imaging (MRI), and 18F-FDG PET/CT)] between January 2017 and January 2022. RESULTS: Nineteen patients with ICI-induced arthritis with at least one diagnostic imaging assessment were identified (15 US, 4 MRI, 2 18F-FDG PET/CT). Most patients were male (84.2%), with a median age at inclusion of 73 years. The main underlying diagnoses for ICI treatment were melanoma in five cases. The distribution of ICI-induced arthritis was as follows: PMR-like (5, 26.2%), RA-like (4, 21.1%), PsA-like (4, 21.1%), and others (6, 31.6%). All RA-like patients had US findings indistinguishable from conventional RA patients. In addition, 3/5 (60%) of PMR-like patients had significant involvement of the hands and wrists. Abnormal findings on MRI or PET-CT were reported by clinical symptoms. No erosions or myofascitis were seen. CONCLUSIONS: ICI-induced arthritis patients present inflammatory patterns on imaging studies similar to conventional inflammatory arthropathies, and therefore these syndromes should be followed carefully and treated according to these findings.

Validation of a Questionnaire of Food Education Content on School Catering Websites in Spain.

The aim of this study was to design and validate a questionnaire on quality and food education on catering company websites. For the validation of the questionnaire, its reliability, feasibility and content validity characteristics were determined. For content validity, a panel of experts was used and the overall and item-wise Content Validity Index (CVI) of the experts' responses was calculated. Reliability was determined by the inter-judge agreement method with the analysis of 30 websites using the intraclass correlation coefficient (ICC) and the Bland and Altman plot. Adequate content validity was verified by obtaining a very high CVI (above 0.80) in the analysis of the expert panel's responses and excellent inter-observer agreement with a very high global ICC (above 0.90) value in the determination of test-retest reliability. The questionnaire is a valid instrument for the evaluation of the quality of school catering websites and their content in food education, as it has good feasibility, high content validity and excellent reliability.

High Sensitivity C Reactive Protein in Patients with Rheumatoid Arthritis Treated with Antibodies against IL-6 or Jak Inhibitors: A Clinical and Ultrasonographic Study.

BACKGROUND: We examined whether high-sensitivity CRP (hsCRP) reflected the inflammatory disease status evaluated by clinical and ultrasound (US) parameters in RA patients receiving IL-6 receptor antibodies (anti-IL-6R) or JAK inhibitors (JAKi). METHODS: We conducted a cross-sectional study of patients with established RA receiving anti-IL-6R (tocilizumab, sarilumab) or JAKi (tofacitinib, baricitinib). Serum hsCRP and US synovitis in both hands were measured. Associations between hsCRP and clinical inflammatory activity were evaluated using composite activity indices. The association between hsCRP and US synovitis was analyzed. RESULTS: 63 (92% female) patients (42 anti- IL-6R and 21 JAKi) were included, and the median disease duration was 14.4 (0.2-37.5) years. Most patients were in remission or had low levels of disease. Overall hsCRP values were very low, and significantly lower in anti-IL-6R patients (median 0.04 mg/dL vs. 0.16 mg/dL). Anti-IL-6R (82.4%) patients and 48% of JAKi patients had very low hsCRP levels (≤0.1 mg/dL) (p = 0.002). In the anti-IL-6R group, hsCRP did not correlate with the composite activity index or US synovitis. In the JAKi group, hsCRP moderately correlated with US parameters (r = 0.5) but not clinical disease activity, and hsCRP levels were higher in patients with US synovitis (0.02 vs. 0.42 mg/dL) (p = 0.001). CONCLUSION: In anti-IL-6R RA-treated patients, hsCRP does not reflect the inflammatory disease state, but in those treated with JAKi, hsCRP was associated with US synovitis.

Efectos de un programa alternativo de promoción de la alimentación saludable en comedor escolar / Effects of an alternative program to promote healthy eating in school canteen

Resumen El objetivo del estudio fue determinar los efectos sobre los hábitos alimentarios de escolares en una intervención educativa alternativa al modelo convencional de promoción de alimentación a un centro con comedor y proyecto de huerto ecológico. Estudio observacional descriptivo de corte transversal y comparativo de 111 niños y niñas entre 9 y 12 años, en el periodo 2013-15. Se comparó un colegio con intervención alternativa con otro que únicamente incluía contenidos propios del currículo de Educación Infantil y Primaria, mediante evaluación de adherencia a la dieta mediterránea del alumnado con cuestionario validado Kidmed. El centro de intervención presentó mayor adherencia a la dieta mediterránea que el centro control. En el centro de intervención el porcentaje de alumnado con dieta óptima (64,52%) fue mayor que los que necesitaban mejorar su dieta (33,87%), mientras que en el centro fue inferior (42,86% y 51,02% respectivamente). Los escolares del centro de intervención presentaron mayor porcentaje de respuestas afirmativas en ítems Kidmed. El programa de promoción de alimentación saludable alternativo del centro de intervención podría ser efectivo para la adquisición de una dieta de mayor adherencia a la dieta mediterránea.

Abstract The objective of this study was to determine the effects on school feeding habits in an educational intervention alternative to the conventional model of feeding promotion to a center with school canteens and ecological garden project. Cross-sectional and comparative descriptive observational study of 111 boys and girls between 9 and 12 years old, in the 2013-15 period. A school with alternative intervention was compared with another one that only included contents of the Infant and Primary Education curriculum, by means of evaluation of adherence to the mediterranean diet of the students with a validated Kidmed questionnaire. The intervention center presented greater adherence to the mediterranean diet than the control center. In the intervention center, the percentage of students with optimal diet (64.52%) was higher than those who needed to improve their diet (33.87%), contrary to what occurs in control center (42.86% and 51.02% respectively). The students of the intervention center presented a higher percentage of affirmative answers in Kidmed test. The program of promotion of healthy alternative food of the intervention center could be effective for the acquisition of a diet of greater adherence to the mediterranean diet.

[Effects of an alternative program to promote healthy eating in school canteen]. / Efectos de un programa alternativo de promoción de la alimentación saludable en comedor escolar.

The objective of this study was to determine the effects on school feeding habits in an educational intervention alternative to the conventional model of feeding promotion to a center with school canteens and ecological garden project. Cross-sectional and comparative descriptive observational study of 111 boys and girls between 9 and 12 years old, in the 2013-15 period. A school with alternative intervention was compared with another one that only included contents of the Infant and Primary Education curriculum, by means of evaluation of adherence to the mediterranean diet of the students with a validated Kidmed questionnaire. The intervention center presented greater adherence to the mediterranean diet than the control center. In the intervention center, the percentage of students with optimal diet (64.52%) was higher than those who needed to improve their diet (33.87%), contrary to what occurs in control center (42.86% and 51.02% respectively). The students of the intervention center presented a higher percentage of affirmative answers in Kidmed test. The program of promotion of healthy alternative food of the intervention center could be effective for the acquisition of a diet of greater adherence to the mediterranean diet.

El objetivo del estudio fue determinar los efectos sobre los hábitos alimentarios de escolares en una intervención educativa alternativa al modelo convencional de promoción de alimentación a un centro con comedor y proyecto de huerto ecológico. Estudio observacional descriptivo de corte transversal y comparativo de 111 niños y niñas entre 9 y 12 años, en el periodo 2013-15. Se comparó un colegio con intervención alternativa con otro que únicamente incluía contenidos propios del currículo de Educación Infantil y Primaria, mediante evaluación de adherencia a la dieta mediterránea del alumnado con cuestionario validado Kidmed. El centro de intervención presentó mayor adherencia a la dieta mediterránea que el centro control. En el centro de intervención el porcentaje de alumnado con dieta óptima (64,52%) fue mayor que los que necesitaban mejorar su dieta (33,87%), mientras que en el centro fue inferior (42,86% y 51,02% respectivamente). Los escolares del centro de intervención presentaron mayor porcentaje de respuestas afirmativas en ítems Kidmed. El programa de promoción de alimentación saludable alternativo del centro de intervención podría ser efectivo para la adquisición de una dieta de mayor adherencia a la dieta mediterránea.