Utilidad de la consulta electrónica entre los centros de atención primaria y el Servicio de Reumatología de un hospital terciario / Usefulness of an electronic consultation system between primary care health centres and the rheumatology department of a tertiary hospital

Introducción y objetivo: Las enfermedades reumáticas representan casi el 30% de las consultas atendidas en los centros de atención primaria españoles. El objetivo principal fue analizar la demanda de consultas reumatológicas desde atención primaria y su resolución mediante el sistema de consulta electrónica. Pacientes y métodos: Estudio descriptivo retrospectivo de las consultas electrónicas procedentes de los centros de atención primaria del área sanitaria al Servicio de Reumatología de un hospital terciario, entre los meses de julio de 2020 y mayo de 2021. Resultados: Se recogieron las últimas 500 consultas consecutivas. La media de edad de los pacientes fue 59 años; el 74% eran mujeres. Los principales motivos de consulta fueron la osteoporosis y el tratamiento de pacientes en seguimiento por el servicio por artritis reumatoide y espondiloartritis. El tiempo medio de respuesta fue de dos días; el 57% necesitaron ser citados en consulta externa. Discusión: La consulta electrónica permitió resolver, en una media de dos días, las consultas del 42,6% de los pacientes.(AU)

Background and objective: Rheumatic diseases account for almost 30% of consultations attended in Spanish primary care centres. The main objective was to analyse the demand for rheumatology consultations from Primary Care and their resolution using the electronic consultation system. Patients and methods: Retrospective descriptive study of electronic consultations from primary care centres in the health area to the Rheumatology service of a tertiary hospital, between July 2020 and May 2021. Results: The last 500 consecutive consultations were collected. Mean age of patients was 59.5 years; 74.2% were women. Main reasons for consultation were osteoporosis and treatment of patients with rheumatoid arthritis and spondyloarthritis under follow-up by the department. Mean response time was 2 days. Fifty-seven per cent of patients required outpatient appointments. Discussion: Over 40% of queries were resolved thanks to the electronic consultation system in an average of 2 days, otherwise patients would have been referred to specialized care.(AU)

Usefulness of an electronic consultation system between primary care health centres and the rheumatology department of a tertiary hospital.

BACKGROUND AND OBJECTIVE: Rheumatic diseases account for almost 30% of consultations attended in Spanish primary care centres. The main objective was to analyse the demand for rheumatology consultations from Primary Care and their resolution using the electronic consultation system. PATIENTS AND METHODS: Retrospective descriptive study of electronic consultations from primary care centres in the health area to the Rheumatology service of a tertiary hospital, between July 2020 and May 2021. RESULTS: The last 500 consecutive consultations were collected. Mean age of patients was 59.5 years; 74.2% were women. Main reasons for consultation were osteoporosis and treatment of patients with rheumatoid arthritis and spondyloarthritis under follow-up by the department. Mean response time was 2 days. Fifty-seven per cent of patients required outpatient appointments. DISCUSSION: Over 40% of queries were resolved thanks to the electronic consultation system in an average of 2 days, otherwise patients would have been referred to specialized care.

Usefulness of implementing the OHIP-14 questionnaire to assess the impact of xerostomia and hyposalivation on quality of life in patients with primary Sjögren's syndrome.

BACKGROUND: The aim of this study is to analyze if the results of the Oral Health Impact Profile-14 questionnaire (OHIP-14) in patients with primary Sjögren's syndrome (pSS) are correlated with salivary flow and level of xerostomia. METHODS: This observational cross-sectional study was conducted in 61 patients (60 women, one man, mean age 57.64 [13.52]) diagnosed of pSS according to the American-European Criteria (2002). After recording demographic, medical and dental data (decayed-missing-filled teeth index [DMFT]), unstimulated (UWS) and stimulated (SWS) salivary flows were collected. Subsequently, UWS flow was categorized into two groups (<0.1 ml/min and ≥0.1 ml/min) and SWS into three groups (<0.1 ml/min, 0.1-0.7 ml/min and >0.7 ml/min). Patients also filled out a visual analog scale (VAS) for xerostomia and OHIP-14 for self-reported quality of life (QoL). RESULTS: Data showed positive and significant correlation between OHIP-14 and xerostomia, based on VAS results (r = 0.52; p = 0.001). Furthermore, there was a negative correlation between UWS and OHIP-14 scores (r = -0.34; p = 0.006) and VAS for xerostomia (r = -0.22; p = 0.09). No significant correlation was found between SWS and OHIP-14 or VAS neither between DMFT and OHIP-14. When assessing the level of QoL by the UWS and SWS flow categories a significant association was found for UWS (p = 0.001) but not for SWS (p = 0.11). The OHIP-14 values were higher in the groups with lower salivary flow. The multiple linear regression to predict OHIP-14 only selected VAS for xerostomia as a statistically significant predictor. CONCLUSIONS: Increased level of xerostomia and reduced UWS flow decrease oral health-related QoL in patients with pSS.

Efficacy of belimumab in Primary Sjögren's syndrome: A systematic review / Eficacia del belimumab en el síndrome de Sjögren primario: una revisión sistemática

Objective: To evaluate the efficacy and safety of belimumab in patients with Primary Sjögren's syndrome (pSS). Methods: The search included manuscripts assessing the efficacy or safety of belimumab in patients with pSS (American-European Consensus Criteria 2002) published between 2004 and 2017 in MEDLINE, EMBASE or Cochrane databases. Two reviewers independently selected the articles, extracted data and evaluated the quality of the evidence following Scottish Intercollegiate Guidelines Network (SIGN) recommendation grades. Results: Out of 135 citations, only 3 articles were included. All of them publishing results from the same study at different time points including 28 patients. At week 28 improvement was reported for visual analogue scale (VAS) dryness score and glandular manifestations in 37% and 77% of patients, respectively, which persisted at week 52 (W52). Belimumab was well tolerated and safely administered. Conclusion: Published evidence to determine the efficacy of belimumab in pSS is limited. Belimumab seems to be effective to reduce systemic activity, parotid enlargement, lymphadenopathies, articular manifestation and B cell biomarkers.(AU)

Objetivo: Evaluar la eficacia y la seguridad de belimumab en pacientes con síndrome de Sjögren primario (SSp). Métodos: La búsqueda incluyó manuscritos que evaluaban la eficacia o seguridad de belimumab en pacientes con SSp (Criterios Europeo-Americanos del 2002) publicados entre 2004 y 2007 en MEDLINE, EMBASE o Cochrane database. Dos revisores independientes seleccionaron los artículos, extrajeron los datos y evaluaron la calidad de la evidencia según los grados de recomendación de la Scottish Intercollegiate Guidelines Network (SIGN). Resultados: De 135 artículos se incluyeron 3. Todos publicaban resultados del mismo estudio en diferentes momentos, incluyéndose 28 pacientes. En la semana 28 presentaban una mejoría en la puntuación de sequedad en la escala analógica visual (VAS) y en las manifestaciones glandulares un 37 y 77% de los pacientes, respectivamente, que persistieron en la 52. La administración de belimumab fue segura y bien tolerada. Conclusión: Belimumab parece ser efectivo para reducir la actividad sistémica, el aumento parotídeo, las linfadenopatías, las manifestaciones articulares y los biomarcadores de células B, aunque con evidencia limitada.(AU)

Evaluación protocolizada odontológica en el paciente con síndrome de Sjögren primario. Proyecto EPOX-SSp: metodología y objetivos / Protocolised odontological assessment of patients with primary Sjögren's syndrome

Objetivo: El objetivo de este estudio es describir los hallazgos de una evaluación odontológica protocolizada en pacientes con síndrome de Sjögren primario (SSp) atendidos en las consultas de reumatología de la Comunidad de Madrid. Métodos: Estudio descriptivo multicéntrico en el que se incluyeron pacientes con SSp clasificados según criterios del consenso Europeo-Americano de 2002. Se recogieron datos demográficos, clínicos y serológicos. Se realizó una exploración oral, se recogió el flujo salival y el índice de caries CAOD. Los pacientes rellenaron la escala visual analógica para xerostomía, el cuestionario Oral Health Impact Profile-14 y un cuestionario de salud oral. Resultados: Se reclutaron 61 pacientes. El 98% fueron mujeres y la edad media fue de 57 años. El 52,5% presentaban signos orales patológicos (flujo salival no estimulado/sialografía/gammagrafía de glándulas salivales) y el 90,2% antiRo/antiLa+. El 92% de los pacientes referían xerostomía y un 61% hiposialia. Treinta y cinco pacientes presentaron lesiones de la mucosa oral. El índice CAOD fue de 16,97±7,93 y la escala visual analógica para la xerostomía fue de 46,69±14,43. Los resultados del Oral Health Impact Profile-14 fueron de 23,13±14,16. Los pacientes con signos orales patológicos obtuvieron una puntuación en el Oral Health Impact Profile-14 significativamente mayor (p=0,03), al igual que los pacientes con afectación del sistema nervioso periférico (p=0,001). Conclusiones: La prevalencia de xerostomía en esta cohorte de pacientes con SSp fue muy elevada y el 61% de los enfermos presentaron hiposialia. Más de la mitad de los pacientes sufrieron lesiones orales. La salud oral presentó un impacto negativo en la calidad de vida de los pacientes con SSp, siendo mayor en aquellos pacientes con signos orales objetivos patológicos y en los que presentaban afectación del sistema nervioso periférico.(AU)

Objective: The aim of this study is to describe the findings of a protocolised odontological evaluation of patients with primary Sjögren's syndrome (pSS) treated in rheumatology units in the Community of Madrid. Methods: Multicentric descriptive study in which pSS patients classified according to the American-European consensus of 2002 criteria were included. We collected the demographic, clinical and serological data of each patient. A complete oral examination was performed and salivary flow and the CAOD caries index were collected. The patients completed the visual analogue scale for xerostomia, the Oral Health Impact Profile-14 questionnaire and an oral health questionnaire. Results: Sixty-one patients were recruited. Ninety-eight percent were women and the mean age of the patients was 57 years. Pathological oral signs (unstimulated salivary flow/salivary glands sialography/scintigraphy) were present in 52.5% of the patients, anti-Ro/anti-La were positive in 90.2%. Ninety-two percent of the patients reported xerostomia and 61% of the patients suffered from hyposialia. Thirty-five patients presented oral mucosa lesions. CAOD index was 16.97±7.93 and visual analogue scale for xerostomia was 46.69±14.43. The results of the OHIP-14 questionnaire were 23.13±14.16. Patients with pathological oral signs obtained a significantly higher Oral Health Impact Profile-14 score (P=.03). We also found that patients with peripheral nervous system involvement obtained a significantly higher Oral Health Impact Profile-14 score (P=.001) Conclusions: The presence of xerostomia in this cohort of pSS patients was high and hyposialia was present in 61% of the patients. Oral lesions appeared in more than half of the subjects. Oral health had a negative impact on the quality of life of patients with pSS, being higher in those with pathological objective oral signs and in those with peripheral nervous system involvement.(AU)

Protocolised odontological assessment of patients with primary Sjögren's syndrome. / Evaluación protocolizada odontológica en el paciente con síndrome de Sjögren primario. Proyecto EPOX-SSp: metodología y objetivos.

OBJECTIVE: The aim of this study is to describe the findings of a protocolised odontological evaluation of patients with primary Sjögren's syndrome (pSS) treated in rheumatology units in the Community of Madrid. METHODS: Multicentric descriptive study in which pSS patients classified according to the American-European consensus of 2002 criteria were included. We collected the demographic, clinical and serological data of each patient. A complete oral examination was performed and salivary flow and the CAOD caries index were collected. The patients completed the visual analogue scale for xerostomia, the Oral Health Impact Profile-14 questionnaire and an oral health questionnaire. RESULTS: Sixty-one patients were recruited. Ninety-eight percent were women and the mean age of the patients was 57 years. Pathological oral signs (unstimulated salivary flow/salivary glands sialography/scintigraphy) were present in 52.5% of the patients, anti-Ro/anti-La were positive in 90.2%. Ninety-two percent of the patients reported xerostomia and 61% of the patients suffered from hyposialia. Thirty-five patients presented oral mucosa lesions. CAOD index was 16.97±7.93 and visual analogue scale for xerostomia was 46.69±14.43. The results of the OHIP-14 questionnaire were 23.13±14.16. Patients with pathological oral signs obtained a significantly higher Oral Health Impact Profile-14 score (P=.03). We also found that patients with peripheral nervous system involvement obtained a significantly higher Oral Health Impact Profile-14 score (P=.001) CONCLUSIONS: The presence of xerostomia in this cohort of pSS patients was high and hyposialia was present in 61% of the patients. Oral lesions appeared in more than half of the subjects. Oral health had a negative impact on the quality of life of patients with pSS, being higher in those with pathological objective oral signs and in those with peripheral nervous system involvement.

Efficacy of belimumab in Primary Sjögren's syndrome: A systematic review.

OBJECTIVE: To evaluate the efficacy and safety of belimumab in patients with Primary Sjögren's syndrome (pSS). METHODS: The search included manuscripts assessing the efficacy or safety of belimumab in patients with pSS (American-European Consensus Criteria 2002) published between 2004 and 2017 in MEDLINE, EMBASE or Cochrane databases. Two reviewers independently selected the articles, extracted data and evaluated the quality of the evidence following Scottish Intercollegiate Guidelines Network (SIGN) recommendation grades. RESULTS: Out of 135 citations, only 3 articles were included. All of them publishing results from the same study at different time points including 28 patients. At week 28 improvement was reported for visual analogue scale (VAS) dryness score and glandular manifestations in 37% and 77% of patients, respectively, which persisted at week 52 (W52). Belimumab was well tolerated and safely administered. CONCLUSION: Published evidence to determine the efficacy of belimumab in pSS is limited. Belimumab seems to be effective to reduce systemic activity, parotid enlargement, lymphadenopathies, articular manifestation and B cell biomarkers.

Digestive involvement in primary Sjögren's syndrome: analysis from the Sjögrenser registry.

OBJECTIVES: Digestive involvement (DI) has been reported in 10-30% of primary Sjögren's syndrome (pSS) patients, and few studies have systematically analysed the prevalence of DI in pSS patients. The aim of this study was to describe DI prevalence in pSS patients from the Sjögrenser Study, and to analyse its clinical associations. METHODS: All patients included in the Sjögrenser study, a Spanish multicentre randomised cohort, containing demographic, clinical and histologic data, have been analysed retrospectively. Patients were classified according to the presence of DI (oesophageal, gastric, intestinal, hepatic and pancreatic), and we have performed DI clinical associations, descriptive statistics, Student t or χ2 test, and uni and multivariate logistic regression. RESULTS: From 437 included patients, 95% were women, with a median age of 58 years, 71 (16.2%) presented DI: 21 (29.5%) chronic atrophic gastritis, 12 (16.9%) oesophageal motility dysfunction, 3 (4.2%) lymphocytic colitis, 18 (25.3%) primary biliary cholangitis, 15 (21.1%) autoimmune hepatitis, 7 (9.8%) pancreatic involvement and 5 (7%) coeliac disease. Half of them developed DI at the same time or after pSS diagnosis. Patients with DI were significantly older at pSS diagnosis (p=0.032), more frequently women (p=0.009), presented more autoimmune hypothyroidism and C3 hypocomplementaemia (p=0.040), and were treated more frequently with glucocorticoids, immunosuppressant and biologic therapies. Patients with pancreatic involvement presented more central nervous system and renal involvement, Raynaud's phenomenon, lymphoma and C3/C4 hypocomplementaemia. CONCLUSIONS: DI is frequent in Sjögrenser patients, mainly in the form of autoimmune disorders, and seem to be associated with a more severe phenotype. Our results suggest that DI should be evaluated in pSS patients, especially those with more severe disease.

Clinically significant renal involvement in primary Sjögren's syndrome is associated with important morbidity: data from the Spanish Sjögrenser cohort.

OBJECTIVES: To investigate the prevalence, associated factors, and effects of primary overt renal disease on morbidity in patients with primary Sjögren's syndrome (pSS). METHODS: All patients in the Sjögrenser (registry of adult pSS patients of the Spanish Society of Rheumatology) cohort were retrospectively investigated for the presence of clinically significant renal involvement directly related to pSS activity. RESULTS: Of the 437 patients investigated, 39 (9%) presented overt renal involvement during follow-up. Severe renal disease necessitating kidney biopsy was relatively rare (2%). Renal involvement may complicate pSS at any time during the disease course and is associated with severe disease (indicated by higher scores of involvement, activity, and damage), systemic multiorgan involvement, and a higher frequency of lymphoma. Multivariate analysis showed that older age (odds ratio [OR] 1.03, 95% confidence interval [CI] 1.00-1.07), higher European League Against Rheumatism Sjögren's Syndrome Disease Activity Index scores (OR 1.1, CI 1.03-1.18), serum anti-La/SSB positivity (OR 6.65, CI 1.41-31.372), and non-vasculitic cutaneous involvement (OR 5.47, 1.03-29.02) were independently associated with this complication. Chronic renal failure developed in 23 of 39 patients (59%); only 1 of them progressed to end-stage renal disease necessitating renal replacement therapy. Patients with overt renal disease showed higher Sjögren's syndrome disease damage index scores, higher rates of hospitalisation due to disease activity and higher rates of clinically relevant comorbidities. CONCLUSIONS: Overt renal involvement in pSS is not uncommon. Although it usually shows a favourable prognosis, is associated with significant morbidity.

Risk factors related to oral candidiasis in patients with primary Sjögren's síndrome

BACKGROUND: Candidiasis is the most frequent mycotic infection of the oral cavity. The aim of this study was to investigate the presence of clinical oral candidiasis and Candida albicans yeast in a population diagnosed of primary Sjögren's syndrome (pSS) and to study the possible factors associated with this infection. MATERIAL AND METHODS: An observational cross-sectional study was conducted in 61 pSS patients (60 women, 1 man, mean age 57.64 ± 13.52) where patient based information (demographic and medical, tobacco and alcohol consumption history), intraoral parameters (presence of dentures, clinical signs of candidiasis), salivary analytical information (number of Candida albicans as colony-forming units per millilitre (CFU/mL), salivary pH levels, unstimulated whole saliva (UWS) and stimulated whole saliva (SWS) were collected. RESULTS: 13.1% of pSS patients presented oral signs of candidiasis. Denture stomatitis and angular cheilitis were the most common lesions. 87.5% of patients with clinical candidiasis presented reduced pH levels and salivary flow in both UWS and SWS. A significant statistical negative correlation was found between CFU/mL of Candida albicans and levels of UWS and SWS. A negative correlation was found between pH levels and CFU/mL, although not statistically significant. CONCLUSIONS: A reduced salivary flow may predispose pSS patients to Candida albicans overgrowth, which may show with clinical signs. Preventive measures are of great importance to avoid and to treat this condition promptly

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Prevalence and factors associated with osteoporosis and fragility fractures in patients with primary Sjögren syndrome.

This study aimed at determining socio-demographic and clinical factors of primary Sjögren syndrome (pSS) associated with osteoporosis (OP) and fragility fracture. SJOGRENSER is a cross-sectional study of patients with pSS, classified according to American European consensus criteria developed in 33 Spanish rheumatology departments. Epidemiological, clinical, serological and treatment data were collected and a descriptive analysis was conducted. Bivariate and multivariate analyses were performed using a binomial logistic regression to study the factors associated with OP and fragility fracture in pSS. 437 patients were included (95% women, with a median age of 58.6 years). 300 women were menopausal (76.4%). Prevalence of OP was 18.5% [in men (N = 21) this measured 19%]. A total of 37 fragility fractures were recorded. In the multivariate analysis, there was an association between OP and age: in the 51-64 age range (menopausal women), the OR measured 9.993 (95% CI 2301-43,399, p = 0.002); In the age > 64 years group, OR was 20.610 (4.679-90.774, p < 0.001); between OP and disease duration, OR was 1.046 (1.008-1085, p = 0.017); past treatment with corticosteroids, OR 2.548 (1.271-5.105, p = 0.008). Similarly, an association was found between fragility fractures and age: in the 51-64 age group, OR measured 5.068 (1.117-22,995, p = 0.035), age > 64 years, OR was 7.674 (1.675-35,151, p < 0.009); disease duration, OR 1.049 (CI 1.003-1097, p < 0.036) and the ESSDAI index, OR 1.080 (1.029-1134, p = 0.002). Patients with pSS can develop osteoporosis and fragility fractures over the course of the disease. Age, corticosteroids treatment and disease duration were associated with the development of OP. Disease duration and ESSDAI were associated with the development of fractures in patients with pSS.

Association of salivary inflammatory biomarkers with primary Sjögren's syndrome.

BACKGROUND: Primary Sjogren's syndrome (pSS) is an autoimmune disease that leads to salivary and lacrimal gland dysfunction. The adaptive immune response associated with T helper-2 lymphocytes appears to be altered in these patients. Therefore, the objective of this study was to determine the salivary levels of interleukin (IL)-6, IL-5, and IL-4 in patients with pSS when compared to a healthy control (HC) group. The secondary objectives were to study whether ILs levels in pSS patients were associated with salivary flow, patient-reported outcomes (PROMs) for xerostomia and oral health quality of life (Oral Health Impact Profile-14 [OHIP-14]), pSS classification criteria and presence of extraglandular manifestations. METHODS: A case-control study was conducted in 36 patients with pSS and 35 HCs. Cytokine levels were measured using high-sensitivity multiplex map human immunoassays. Unstimulated and stimulated whole saliva were collected and patients filled out questionnaires. The Mann-Whitney U test, chi-squared test, and Spearman correlation test were used. RESULTS: Interleukin-6 was significantly higher in pSS patients than in HCs (P = .0001). IL-6 was significantly higher in pSS patients with a positive salivary gland biopsy (P = .04), whole stimulated saliva hyposalivation (P = .02), and presence of musculoskeletal disorders (P = .03). There was a non-significant positive correlation between IL-6 levels and PROMs for xerostomia (r = .31; P = .06) and OHIP-14 (r = .07; P = .68) in pSS patients. Levels of IL-4 and IL-5 were not detected in both pSS and HCs patients. CONCLUSIONS: Salivary IL-6 levels are significantly associated with pSS patients, and therefore, it is hypothesized that this biomarker may be useful in the diagnosis and follow-up of this disease.

Evaluation of the immune response to hepatitis B vaccine in patients on biological therapy: results of the RIER cohort study.

To evaluate the response to hepatitis B virus (HBV) vaccine in patients on biological therapy. Adults with autoimmune inflammatory diseases on biological therapy such as anti-TNFα, rituximab, tocilizumab, abatacept, or anakinra were included. Hepatitis B surface antibody (anti-HBs) was measured by ELISA before and after vaccination. Seroconversion was considered when an anti-HBs titer > 10 mIU/mL was achieved. The effect of treatment on the immunoprotective state was studied. The response was compared with that obtained in patients on synthetic disease modifying anti-rheumatic drugs (DMARDs) and healthy controls. A total of 187 patients on biologicals, 48 on synthetic DMARDs, and 49 on healthy controls were analyzed. More than 80% of patients on biologics responded to the vaccine but required more boosters and second vaccine series. Patients who achieved seroconversion were younger than those who did not (47.10 ± 12.99 vs. 53.18 ± 10.54 years, p = 0.012). Being on etanercept or golimumab was associated with seroconversion, while being on rituximab was not. Seroconversion was achieved in 93.75% of patients on synthetic DMARDs and 97.96% of healthy controls. The seroconversion rate in the biologics group was lower than in the synthetic DMARD group (p = 0.043) and tended to be lower than in the healthy group (p = 0.056). In patients on biological therapy, a high rate of HBV vaccine response can be achieved when a complete vaccination schedule is administered. Vaccination while not on biological agents reduces the requirement for boosters and revaccination. Key points: • Patients on biological therapy can achieve high rates of immune response to HBV vaccine when complete vaccination schedules are administered. • However, to achieve such a high seroconversion rate, more boosters and second vaccination series are required. • This supports the proposal already made to provide HBV vaccination to all patients with an autoimmune inflammatory disease after the diagnosis is made and not when the use of a biological treatment is under consideration.

Oral lesions in patients with primary Sjögren's syndrome. A case-control cross-sectional study

BACKGROUND: To evaluate the presence of oral lesions in a group of patients with primary Sjögren's syndrome (pSS) and compare these results with a matched control group (CG). MATERIAL AND METHODS: An observational cross-sectional study was conducted. 61 pSS patients (60 women, 1 man, mean age 57.64 ± 13.52) diagnosed according to the American European Criteria (2002), and 122 matched control patients (120 women, 2 men, mean age 60.02 ± 13.13) were included. Demographic and medical data, oral lesions and salivary flow rate were collected. RESULTS: Compared with the controls, pSS patients were 3.95 more likely to have oral lesions (OR 3.95; 95% CI 2.06-7.58; p = 0.0001). 57.4% pSS patients presented oral lesions compared to 25.4% in CG. The most common were candidiasis (13.1% vs 2.5%), traumatic lesions (13.1% vs 4.1%), apthae (8.2% vs 0), and fissuration of the tongue (8.2% vs 0.8%). pSS patients with oral lesions had lower salivary flow levels (stimulated and unstimulated), although these differences were not significant. Significant associations were found between the presence of oral lesions and systemic manifestations and history of parotid gland enlargement in pSS patients. CONCLUSION: pSS patients suffer more oral lesions than general population and these lesions may aggravate the pSS disease

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Recomendaciones SER sobre la utilización de fármacos biológicos en el síndrome de Sjögren primario / SER recommendations on the use of biological drugs in primary Sjögren's syndrome

OBJETIVO: Elaborar recomendaciones SER sobre el uso de agentes biológicos en el síndrome de Sjögren primario (SSp). MÉTODOS: Se identificaron preguntas clínicas de investigación relevantes sobre el uso de agentes biológicos en el SSp. Las preguntas clínicas se reformularon en 4 preguntas PICO. Se diseñó una estrategia de búsqueda y se realizó una revisión de la evidencia científica de estudios publicados hasta mayo de 2017. Se revisó sistemáticamente la evidencia científica disponible. Se evaluó el nivel global de la evidencia científica utilizando los niveles de evidencia del SIGN. Tras ello, se formularon recomendaciones específicas. RESULTADOS: Se recomienda rituximab como el fármaco biológico de elección para las manifestaciones extraglandulares refractarias al tratamiento convencional. Se desaconseja el uso de agentes anti-TNF. La evidencia científica es escasa con belimumab y abatacept, por lo que deberían considerarse solamente en los casos resistentes a rituximab. CONCLUSIONES: El rituximab es el fármaco biológico de elección en las manifestaciones graves extraglandulares del SSp. Belimumab o abatacept podrían ser de utilidad en casos seleccionados

OBJECTIVE: To formulate SER recommendations for the use of biological agents in primary Sjögren's syndrome (pSS). METHODS: Relevant clinical research questions were identified on the use of biological agents in pSS. The clinical questions were reformulated into 4 PICO questions. A search strategy was designed and a review of the scientific evidence of studies published until May 2017 was carried out. The scientific evidence available was systematically reviewed. The overall level of scientific evidence was assessed using the SIGN evidence levels. After that, specific recommendations were made. RESULTS: Rituximab is recommended as the biological agent of choice for extraglandular manifestations refractory to conventional treatment. The use of anti-TNF agents is discouraged. The scientific evidence with belimumab and abatacept is scarce, so they should be considered only in cases refractory to rituximab. CONCLUSIONS: Rituximab is the biological agent of choice in severe extraglandular manifestations of pSS. Belimumab or abatacept may be useful in selected cases

Antibody responses to influenza vaccine in patients on biological therapy: Results of RIER cohort study / Respuesta a la vacuna contra la gripe en pacientes que reciben tratamientos biológicos: resultados del estudio de cohortes RIER

Background and objectives: Influenza vaccine is recommended for patients with autoimmune inflammatory rheumatic diseases who receive biological therapy. To evaluate if biological therapy impairs immunization after seasonal influenza vaccine. Material and methods: Patients with inflammatory arthopathies, psoriasis, inflammatory bowel disease or connective tissue diseases who were receiving or were going to initiate biological therapy were included and vaccinated during 2014-2015 influenza season. ELISA was used to measure influenza antigen A and B antibodies, before and after vaccination. Demographic parameters, diagnosis and kind of treatment were recorded and their influence on the final serological status against influenza was studied. Results: 253 subjects were analyzed. After vaccination, 77% of participants presented detectable antibodies against antigen A and 50.6% of them had detectable antibodies against antigen B. Final seropositivity rate against antigen B antibodies increased from baseline (50.6% vs 43.5%, p<0.001). Anti-TNF drugs were associated with better response and rituximab with the worst (79.2% vs 55.0% for final seropositivity against antigen A, p=0.020). Vaccine response in the rituximab group tended to improve when the interval between the drug administration and the vaccination was at least 12 weeks (seropositivity rate 80.0% in those with the longer interval vs 25.0% in the other group, p=0.054). Conclusions: Among the patients on biological therapy vaccinated against influenza, anti-TNF therapy was identified as a predictive factor of final seropositivity. Rituximab presented a lower rate of final seropositivity, which could be increased with an accurate administration schedule

Antecedentes y objetivos: La vacunación antigripal está recomendada en pacientes con enfermedades autoinmunes sistémicas que reciben tratamientos biológicos. Evaluar si la terapia biológica puede perjudicar la inmunización después de la administración de la vacuna contra la gripe estacional. Material y métodos: Los pacientes con artropatías inflamatorias, psoriasis, enfermedad inflamatoria intestinal o enfermedades del tejido conectivo, que estaban en tratamiento o que iban a iniciar tratamiento con terapia biológica, fueron incluidos en el estudio y vacunados durante la temporada de influenza 2014-2015. Se utilizó ELISA para medir los anticuerpos contra los antígenosA y B de la gripe, antes y después de la vacunación. Se registraron los datos demográficos, diagnósticos y el tipo de tratamiento y se estudió su influencia sobre el estado serológico final contra la influenza. Resultados: Se analizaron 253 sujetos. Después de la vacunación, el 77% de los participantes presentaron anticuerpos detectables contra el antígeno A y el 50,6% de ellos tenían anticuerpos detectables contra el antígeno B. La tasa de seropositividad final de anticuerpos contra el antígeno B aumentó desde los valores basales (50,6% frente a 43,5%, p<0,001). Los fármacos anti-TNF se asociaron con la mejor respuesta y rituximab con la peor (79,2% vs. 55,0% para la seropositividad final contra el antígeno A, p=0,020). La respuesta a la vacuna en el grupo de rituximab tuvo tendencia a mejorar cuando el intervalo entre la administración del fármaco y la vacunación fue por lo menos de 12 semanas (tasa de seropositividad del 80,0% en aquellos con el intervalo más largo frente al 25% en el otro grupo, p=0.054). Conclusiones: Entre los pacientes en terapia biológica vacunados contra la influenza, la terapia anti-TNF se identificó como un factor predictivo de la seropositividad final. Rituximab presentó una tasa más baja de seropositividad final, que podría aumentarse con un programa de administración preciso

Antibody responses to influenza vaccine in patients on biological therapy: Results of RIER cohort study.

BACKGROUND AND OBJECTIVES: Influenza vaccine is recommended for patients with autoimmune inflammatory rheumatic diseases who receive biological therapy. To evaluate if biological therapy impairs immunization after seasonal influenza vaccine. MATERIAL AND METHODS: Patients with inflammatory arthopathies, psoriasis, inflammatory bowel disease or connective tissue diseases who were receiving or were going to initiate biological therapy were included and vaccinated during 2014-2015 influenza season. ELISA was used to measure influenza antigen A and B antibodies, before and after vaccination. Demographic parameters, diagnosis and kind of treatment were recorded and their influence on the final serological status against influenza was studied. RESULTS: 253 subjects were analyzed. After vaccination, 77% of participants presented detectable antibodies against antigen A and 50.6% of them had detectable antibodies against antigen B. Final seropositivity rate against antigen B antibodies increased from baseline (50.6% vs 43.5%, p<0.001). Anti-TNF drugs were associated with better response and rituximab with the worst (79.2% vs 55.0% for final seropositivity against antigen A, p=0.020). Vaccine response in the rituximab group tended to improve when the interval between the drug administration and the vaccination was at least 12 weeks (seropositivity rate 80.0% in those with the longer interval vs 25.0% in the other group, p=0.054). CONCLUSIONS: Among the patients on biological therapy vaccinated against influenza, anti-TNF therapy was identified as a predictive factor of final seropositivity. Rituximab presented a lower rate of final seropositivity, which could be increased with an accurate administration schedule.

ESSDAI activity index of the SJÖGRENSER cohort: analysis and comparison with other European cohorts.

The objective of the study was to assess the ESSDAI index characteristics in the SJÖGRENSER cohort (Spanish Rheumatology Association's registry of patients with Primary Sjögren Syndrome [PSS]). SJÖGRENSER is a prospective multicentric study on a cohort of Spanish patients with PSS who meet the 2002 American-European consensus from rheumatology units. 298 variables were studied in patients for the inclusion of the study from an anonymous list from each department. The ESSDAI (EULAR Sjögren's syndrome disease activity index) includes 12 domains and measures systematic activity in PSS patients. Each domain is divided into 3-4 levels, (0: no activity; 1: low activity; 2: moderate activity; 3: high activity) and is attributed a weight. Each domain score is obtained by multiplying the activity level by the weight assigned. According to ESSDAI: low activity < 5; moderate activity 5-13, and high activity ≥ 14. ESSDAI was compared between several European PSS cohorts (EULAR, ASSES, GEAS, GRISS, Ducth). 437 patients were included from 33 Spanish rheumatology units. 95.2% were women with a median age of 58.63 years [p25-p75: 50.02-67.98 years] and average PSS evolution of 10.4 years (6-16 years). ESSDAI median on entering the study was 2 (0-4). 31% of patients had ESSDAI 0; low activity 49%, moderate activity 15%, and high activity 5%. Those with greater activity were the joint, haematological and biological domains, whereas the lung was the most affected organ with pleural and parenchymatous involvement. Unlike other European cohorts, the initial SJÖGRENSER cohort was characterised by low-zero systemic activity in 80% of patients, which differentiates it from other cohorts and provides a prospective study opportunity.

SER recommendations on the use of biological drugs in primary Sjögren's syndrome. / Recomendaciones SER sobre la utilización de fármacos biológicos en el síndrome de Sjögren primario.

OBJECTIVE: To formulate SER recommendations for the use of biological agents in primary Sjögren's syndrome (pSS). METHODS: Relevant clinical research questions were identified on the use of biological agents in pSS. The clinical questions were reformulated into 4PICO questions. A search strategy was designed and a review of the scientific evidence of studies published until May 2017 was carried out. The scientific evidence available was systematically reviewed. The overall level of scientific evidence was assessed using the SIGN evidence levels. After that, specific recommendations were made. RESULTS: Rituximab is recommended as the biological agent of choice for extraglandular manifestations refractory to conventional treatment. The use of anti-TNF agents is discouraged. The scientific evidence with belimumab and abatacept is scarce, so they should be considered only in cases refractory to rituximab. CONCLUSIONS: Rituximab is the biological agent of choice in severe extraglandular manifestations of pSS. Belimumab or abatacept may be useful in selected cases.

Effects of Xerostom® products on xerostomia in primary Sjögren's syndrome: A randomized clinical trial.

OBJECTIVES: To assess the effects of Xerostom® toothpaste and mouthwash in primary Sjögren's syndrome (pSS) patients with xerostomia. SUBJECTS AND METHODS: A double-blinded, randomized study where patients were assigned at baseline test or control products. Patients used the products 3 times/day/28 days. We used a visual analogue scale (VAS) for xerostomia and an Oral Health Impact Profile-14 (OHIP-14), baseline and after treatment, to assess possible improvement. RESULTS: A total of 28 patients with pSS were included in this study, but only 24 finished it (all women, mean age 55.21 ± 11.87), and 13 patients received the test and 11 the control. VAS and OHIP-14 scores decreased in both groups after treatment but significant differences between groups were not found. We do not detect VAS intragroup significant differences before and after treatment in test and control groups. A significant improvement in OHIP-14 was identified in the treatment group, while no significant differences were observed in the control group. No adverse effects were present. CONCLUSIONS: Xerostom® toothpaste and mouthrinse may alleviate and improve quality of life without associated side effects, but further research with a larger number of participants and follow-up are necessary to establish the positive efficacy of these topical products in pSS patients.