The Sjögren's Working Group: The 2023 OMERACT meeting and provisional domain generation.

Sjögren's disease (SjD) is a systemic autoimmune exocrinopathy with key features of dryness, pain, and fatigue. SjD can affect any organ system with a variety of presentations across individuals. This heterogeneity is one of the major barriers for developing effective disease modifying treatments. Defining core disease domains comprising both specific clinical features and incorporating the patient experience is a critical first step to define this complex disease. The OMERACT SjD Working Group held its first international collaborative hybrid meeting in 2023, applying the OMERACT 2.2 filter toward identification of core domains. We accomplished our first goal, a scoping literature review that was presented at the Special Interest Group held in May 2023. Building on the domains identified in the scoping review, we uniquely deployed multidisciplinary experts as part of our collaborative team to generate a provisional domain list that captures SjD heterogeneity.

Pregnancy outcomes in 1869 pregnancies in a large cohort from the Spanish Society of Rheumatology Lupus Register (RELESSER).

INTRODUCTION: Obstetric complications are more common in women with systemic lupus erythematosus (SLE) than in the general population. OBJECTIVE: To assess pregnancy outcomes in women with SLE from the RELESSER cohort after 12 years of follow-up. METHODS: A multicentre retrospective observational study was conducted. In addition to data from the RELESSER register, data were collected on obstetric/gynaecological variables and treatments received. The number of term pregnancies was compared between women with pregnancies before and after the diagnosis of SLE. Further, clinical and laboratory characteristics were compared between women with pregnancies before and after the diagnosis, on the one hand, and with and without complications during pregnancy, on the other. Bivariate and multivariate analyses were carried out to identify factors potentially associated with complications during pregnancy. RESULTS: A total of 809 women were included, with 1869 pregnancies, of which 1395 reached term. Women with pregnancies before the diagnosis of SLE had more pregnancies (2.37 vs 1.87) and a higher rate of term pregnancies (76.8% vs 69.8%, p < 0.001) compared to those with pregnancies after the diagnosis. Women with pregnancies before the diagnosis were diagnosed at an older age (43.4 vs 34.1 years) and had more comorbidities. No differences were observed between the groups with pregnancies before and after diagnosis in antibody profile, including anti-dsDNA, anti-Sm, anti-Ro, anti-La, lupus anticoagulant, anticardiolipin or anti-beta-2-glycoprotein. Overall, 114 out of the 809 women included in the study experienced complications during pregnancy, including miscarriage, preeclampsia/eclampsia, foetal death, and/or preterm birth. Women with complications had higher rates of antiphospholipid syndrome (40.5% vs 9.9%, p < 0.001) and higher rates of positivity for IgG anticardiolipin (33.9% vs 21.3%, p = 0.005), IgG anti-beta 2 glycoprotein (26.1% vs 14%, p = 0.007), and IgM anti-beta 2 glycoprotein (26.1% vs 16%, p = 0.032) antibodies, although no differences were found regarding lupus anticoagulant. Among the treatments received, only heparin was more commonly used by women with pregnancy complications. We did not find differences in corticosteroid or hydroxychloroquine use. CONCLUSIONS: The likelihood of term pregnancy is higher before the diagnosis of SLE. In our cohort, positivity for anticardiolipin IgG and anti-beta-2- glycoprotein IgG/IgM, but not lupus anticoagulant, was associated with a higher risk of poorer pregnancy outcomes.

What do patients on methotrexate need and expect at the clinic? An online patient survey.

To verify, via a survey, the experience and needs of patients receiving methotrexate (MTX), their general management and the quality of the information provided by the rheumatologist. We conducted a 51-item online survey between May and July 2020 addressed to persons diagnosed with an immune-mediated disease and treated with MTX (regardless of the route of administration). Recruitment was done via Twitter. We obtained 294 responses, of which 283 were complete and could be analysed. Almost 82% of the respondents were women, 80% resided in Spain, 75% were between 31 and 60 years old, and 57% were active workers. Diseases included psoriasis (41%), lupus, Sjögren's or vasculitides (33%), and rheumatoid arthritis (16%), among others. Eighty per cent had read the leaflet inserted in the package, of whom 62% found it helpful. Only 15% of the respondents reported having been offered additional written material, which was considered barely functional (33 out of 100). Most patients (88%) responded that they had not received advice on any reliable sources to consult on the internet, and those who received it considered it unhelpful (24 out of 100). Patients receiving MTX due to an autoimmune disease demand more and better-quality written or web-based information than what is currently offered at their clinics.

Response to local corticosteroid injections in carpal tunnel syndrome with normal conduction studies.

INTRODUCTION: Nerve conduction studies (NCS) have been considered as the gold standard in carpal tunnel syndrome (CTS) diagnosis, despite correlation between clinical symptomatology and NCS severity has shown to be poor. In fact, clinical symptoms precede NCS changes in months or years. Few papers have been published about the clinical response to treatment of clinically typical CTS, but with normal NCS (NNCS). OBJECTIVE: To compare the clinical response to local corticosteroid injections (LCI) in clinically typical CTS, with NNCS and abnormal NCS (ANCS). METHOD: We included patients older than 18, with typical CTS symptoms (ongoing daily nocturnal pain/paresthesias in hand, at least during 3 months). Follow-up was done at 3, 6 and 12 months. Primary outcome was the visual analog scale for pain (p-VAS), comparing NNCS CTS wrists with ANCS CTS wrists. Statistic signification was established by the Student's t test, Mann-Whitney's "U", χ2 test and Yates' correction. RESULTS: We included 44 wrists in the NNCS group, and 83 in the ANCS group. There was no statistical significance between data in both groups, except in the 12-month follow-up, where the NNCS group achieved better results than the ANCS group in the 20% response (p=0.006). There was a trend toward a better 50% response in the 12-month follow-up. CONCLUSIONS: Our data suggest that LCI are similarly effective in both CTS with NNCS and ANCS. Nonetheless, there is a mild better effect in NNCS than in ANCS at 12-month follow-up.

Response to local corticosteroid injections in carpal tunnel syndrome with normal conduction studies / Respuesta a infiltraciones locales de corticoides en el Síndrome del túnel carpiano con estudios de conducción nerviosa normales

Introduction: Nerve conduction studies (NCS) have been considered as the gold standard in carpal tunnel syndrome (CTS) diagnosis, despite correlation between clinical symptomatology and NCS severity has shown to be poor. In fact, clinical symptoms precede NCS changes in months or years. Few papers have been published about the clinical response to treatment of clinically typical CTS, but with normal NCS (NNCS). Objective: To compare the clinical response to local corticosteroid injections (LCI) in clinically typical CTS, with NNCS and abnormal NCS (ANCS).Method: We included patients older than 18, with typical CTS symptoms (ongoing daily nocturnal pain/paresthesias in hand, at least during 3 months). Follow-up was done at 3, 6 and 12 months. Primary outcome was the visual analog scale for pain (p-VAS), comparing NNCS CTS wrists with ANCS CTS wrists. Statistic signification was established by the Student's t test, Mann–Whitney's “U”, χ2 test and Yates’ correction.Results: We included 44 wrists in the NNCS group, and 83 in the ANCS group. There was no statistical significance between data in both groups, except in the 12-month follow-up, where the NNCS group achieved better results than the ANCS group in the 20% response (p=0.006). There was a trend toward a better 50% response in the 12-month follow-up. Conclusions: Our data suggest that LCI are similarly effective in both CTS with NNCS and ANCS. Nonetheless, there is a mild better effect in NNCS than in ANCS at 12-month follow-up.(AU)

Introducción: Los estudios de conducción nerviosa (NCS) se consideran el patrón oro diagnóstico del síndrome del túnel carpiano (CTS), aunque la correlación entre síntomas clínicos y gravedad de NCS es escasa. De hecho, los síntomas preceden a los cambios en NCS en meses o años. Hay pocos estudios publicados sobre la respuesta al tratamiento del CTS con sintomatología típica, pero NCS normales (NNCS).Objetivo: comparar la respuesta clínica a infiltraciones locales de corticoides en CTS con sintomatología típica, con NNCS vs. NCS anormales (ANCS).Método: Incluimos pacientes mayores de 18 años, con síntomas típicos de CTS (dolor y/o parestesias continuas, nocturnas, en la mano, un mínimo 3 meses seguidos). El seguimiento se realizó a los 3, 6 y 12 meses. La medida de resultado primaria fue por la escala analógica visual para el dolor, comparando los CTS con NNCS y los CTS con ANCS. Establecimos la significación estadística mediante la «t» de Student, «U» de Mann-Whitney, el test de χ2 y la corrección de Yates.Resultados: Incluimos 44 muñecas en el grupo de NNCS y 83 en el grupo de ANCS. No hubo diferencias estadísticamente significativas entre ambos grupos, excepto en el seguimiento a 12 meses, en donde el grupo NNCS obtuvo mejores resultados que el grupo ANCS en la respuesta al 20% (p=0,006). Hubo una tendencia similar en la mejoría de la respuesta al 50%, en el seguimiento a 12 meses.Conclusiones: Nuestros datos sugieren que las infiltraciones locales de corticoides son de similar eficacia en ambos grupos de CTS, los de NNCS y los ANCS. No obstante, hay una discreta mejoría en el grupo NNCS sobre el ANCS en el seguimiento a 12 meses.(AU)

Use of parenteral methotrexate in rheumatic diseases: A systematic review.

OBJECTIVE: To analyse the efficacy, adherence, patient satisfaction, safety, pharmacodynamics and cost-effectiveness of parenteral methotrexate (MTX) in patients with rheumatic diseases. METHODS: A systematic review of literature was carried out in Medline, Embase and Cochrane Central from the beginning until June 2019. Studies including adult patients with rheumatic diseases being treated with parenteral MTX were identified and data on efficacy, adherence, satisfaction, safety, pharmacokinetics, and cost-effectiveness analysed. As for the designs, systematic reviews, clinical trials, or observational studies were permitted, including cross-sectional and small-sample studies if they were pharmacokinetic studies. RESULTS: Out of 4160 identified articles, 80 articles were finally included. The efficacy profile of parenteral MTX seems useful in general and in those patients with insufficient response to oral MTX. The parenteral route does not seem to increase the rate or severity of adverse events due to the use of MTX. The use of parenteral MTX is an appropriate way to reduce costs in patients with inadequate response to oral MTX. Adherence and satisfaction are favoured by training programmes in the use of the parenteral route. The results in rheumatic diseases other than rheumatoid arthritis (RA) are very scarce and do not enable obtaining conclusive data. CONCLUSIONS: Parenteral MTX can be an alternative to the use of oral MTX, due to its profile of efficacy, safety, adherence and pharmacoeconomic results, especially in those patients with RA.

Revisión sistemática del uso de metotrexato por vía parenteral en enfermedades reumáticas / Use of Parenteral Methotrexate in Rheumatic Diseases: A Systematic Review

Objetivo: Analizar la eficacia, adherencia, satisfacción del paciente, seguridad, farmacodinámica y costo-efectividad del metotrexato (MTX) parenteral en pacientes con enfermedades reumáticas. Métodos: Se llevó a cabo una revisión sistemática basada en una estrategia de búsqueda en Medline, Embase y Cochrane Library (inicio-06/2019). Se identificaron estudios que incluyeran pacientes adultos con enfermedades reumáticas en tratamiento con MTX parenteral y que analizaran datos de eficacia, adherencia, satisfacción, seguridad, farmacocinética o costo-efectividad. En cuanto a los diseños se permitieron revisiones sistemáticas, ensayos clínicos o estudios observacionales, incluyendo transversales y estudios con muestras pequeñas si eran estudios de farmacocinética. Resultados: De 4.160 artículos identificados, se incluyeron finalmente 80. El MTX parenteral parece útil de manera general y en especial en aquellos pacientes con respuesta insuficiente a MTX oral. La vía parenteral no parece aumentar la tasa ni la gravedad de los eventos adversos con respecto a la oral y podría reducir costes en aquellos pacientes con respuesta inadecuada a MTX oral. La adherencia y satisfacción se ven favorecidas por programas de entrenamiento en la vía parenteral. Los resultados en enfermedades reumáticas distintas a la artritis reumatoide (AR) son muy escasos y no permiten obtener datos concluyentes. Conclusiones: El MTX por vía parenteral podría ser una alternativa al uso de MTX oral, por su perfil de eficacia, seguridad, adherencia, satisfacción y resultados fármaco-económicos, especialmente en pacientes con AR.(AU)

Objective: To analyse the efficacy, adherence, patient satisfaction, safety, pharmacodynamics and cost-effectiveness of parenteral methotrexate (MTX) in patients with rheumatic diseases. Methods: A systematic review of literature was carried out in Medline, Embase and Cochrane Central from the beginning until June 2019. Studies including adult patients with rheumatic diseases being treated with parenteral MTX were identified and data on efficacy, adherence, satisfaction, safety, pharmacokinetics, and cost-effectiveness analysed. As for the designs, systematic reviews, clinical trials, or observational studies were permitted, including cross-sectional and small-sample studies if they were pharmacokinetic studies. Results: Out of 4160 identified articles, 80 articles were finally included. The efficacy profile of parenteral MTX seems useful in general and in those patients with insufficient response to oral MTX. The parenteral route does not seem to increase the rate or severity of adverse events due to the use of MTX. The use of parenteral MTX is an appropriate way to reduce costs in patients with inadequate response to oral MTX. Adherence and satisfaction are favoured by training programmes in the use of the parenteral route. The results in rheumatic diseases other than rheumatoid arthritis (RA) are very scarce and do not enable obtaining conclusive data. Conclusions: Parenteral MTX can be an alternative to the use of oral MTX, due to its profile of efficacy, safety, adherence and pharmacoeconomic results, especially in those patients with RA.(AU)

Biologic therapy in refractory neurobehçet's disease: a multicentre study of 41 patients and literature review.

OBJECTIVES: To assess efficacy and safety of biologic therapy (BT) in neurobehçet's disease (NBD) refractory to glucocorticoids and at least one conventional immunosuppressive drug. METHODS: Open-label, national, multicentre study. NBD diagnosis was based on the International Consensus Recommendation criteria. Outcome variables were efficacy and safety. Main efficacy outcome was clinical remission. Other outcome variables analysed were glucocorticoid-sparing effect and improvement in laboratory parameters. RESULTS: We studied 41 patients [21 women; age 40.6 (10.8) years]. Neurological damage was parenchymal (n = 33, 80.5%) and non-parenchymal (n = 17, 41.5%). First BTs used were infliximab (n = 19), adalimumab (n = 14), golimumab (n = 3), tocilizumab (n = 3) and etanercept (n = 2). After 6 months of BT, neurological remission was complete (n = 23, 56.1%), partial (n = 15, 37.6%) and no response (n = 3, 7.3%). In addition, median (IQR) dose of oral prednisone decreased from 60 (30-60) mg/day at the initial visit to 5 (3.8-10) mg/day after 6 months (P < 0.001). It was also the case for mean erythrocyte sedimentation rate [31.5 (25.6)-15.3 (11.9) mm/1st h, P = 0.011] and median (IQR) C-reactive protein [1.4 (0.2-12.8) to 0.3 (0.1-3) mg/dl, P = 0.001]. After a mean follow-up of 57.5 months, partial or complete neurological remission persisted in 37 patients (90.2%). BT was switched in 22 cases (53.6%) due to inefficacy (n = 16) or adverse events (AEs) (n = 6) and discontinued due to complete prolonged remission (n = 3) or severe AE (n = 1). Serious AEs were observed in two patients under infliximab treatment. CONCLUSIONS: BT appears to be effective and relatively safe in refractory NBD.

Long-term Outcome of Local Steroid Injections Versus Surgery in Carpal Tunnel Syndrome: Observational Extension of a Randomized Clinical Trial.

Background: In a previous paper, we have demonstrated that: (1) local injection of corticosteroids for carpal tunnel syndrome (CTS) is as effective as decompressive surgery, at 1-year follow-up; and (2) surgery has an additional benefit in the 2-year follow-up. In this study, we assess the long-term outcomes of both therapies in an observational extension of the patients originally enrolled in our randomized clinical trial. Methods: Patients were included in an open, randomized clinical trial, comparing injections versus surgery in CTS. After the end of the clinical trial, patients received the treatment prescribed by their general practitioner or specialist. Therapeutic failure was defined as the need of any new therapeutic intervention on the involved wrist. Comparison between groups was made using Cox multiple regression analysis. Estimation of the accumulated incidence of new therapeutic failure was made considering the withdrawal as a competitive risk (Gooley's test). Results: Of 163 randomized wrists at the beginning of the study, only 148 were available at the final follow-up. The mean follow-up was 6.3 and the median was 5.9 years. In the long-term follow-up, the accumulated incidence of therapeutic failure in the surgery group was 11.6% versus 41.8% in the injection group. The Cox multiple regression analysis showed a risk of failure associated with injection group of 4.5 (95% confidence interval [CI], 2.1-9.8; P < .0001). Conclusions: In long-term follow-up, surgery seems more effective than local corticosteroid injections in primary CTS. Nonetheless, about 58% of the patients in the injection group will not need further therapeutic interventions during the follow-up.

Patient's experiences of the barriers and facilitators to Methotrexate.

OBJECTIVE: To investigate the barriers and facilitators of adherence to methotrexate (MTX) in people with rheumatic diseases and to explore the experience of shared decision-making. METHODS: A qualitative study was carried out. People diagnosed with inflammatory arthritides or systemic autoimmune diseases and who were treated with MTX were invited to participate in focus groups. The discourse was coded and synthesised with a content analysis approach. RESULTS: The groups included 12 representative patients (rheumatoid arthritis, spondylarthritis, and systemic lupus erythematosus, taking either oral or subcutaneous MTX). Four main themes were identified: (1) drug-related aspects (package insert, adverse events, administration, and difficulties with treatment); (2) patient-physician relationship; (3) social environment (lack of visibility of rheumatic diseases and the support of patient associations); and (4) medication and medical care practicalities (information, reliable sources, and expanding knowledge in other health areas). CONCLUSIONS: Aspects identified might help improve adherence, including quality information, especially on adverse events, the role of the setting, and shared decision-making.

Response to Local Corticosteroid Injections in Carpal Tunnel Syndrome With Normal Conduction Studies.

INTRODUCTION: Nerve conduction studies (NCS) have been considered as the gold standard in carpal tunnel syndrome (CTS) diagnosis, despite correlation between clinical symptomatology and NCS severity has shown to be poor. In fact, clinical symptoms precede NCS changes in months or years. Few papers have been published about the clinical response to treatment of clinically typical CTS, but with normal NCS (NNCS). OBJECTIVE: To compare the clinical response to local corticosteroid injections (LCI) in clinically typical CTS, with NNCS and abnormal NCS (ANCS). METHOD: We included patients older than 18, with typical CTS symptoms (ongoing daily nocturnal pain/paresthesias in hand, at least during 3 months). Follow-up was done at 3, 6 and 12 months. Primary outcome was the visual analog scale for pain (p-VAS), comparing NNCS CTS wrists with ANCS CTS wrists. Statistic signification was established by the Student's t test, Mann-Whitney's "U", χ2 test and Yates' correction. RESULTS: We included 44 wrists in the NNCS group, and 83 in the ANCS group. There was no statistical significance between data in both groups, except in the 12-month follow-up, where the NNCS group achieved better results than the ANCS group in the 20% response (p=0.006). There was a trend toward a better 50% response in the 12-month follow-up. CONCLUSIONS: Our data suggest that LCI are similarly effective in both CTS with NNCS and ANCS. Nonetheless, there is a mild better effect in NNCS than in ANCS at 12-month follow-up.

Nódulo reumatoide benigno en sóleo. Reporte de un caso / Benign rheumatoid nodule in the soleus muscle. Case report

RESUMEN Los nódulos reumatoides benignos son nódulos subcutáneos, idénticos en su morfología e histología a los que ocurren en el transcurso de la artritis reumatoide (AR), que aparecen en personas sin síntomas de artritis y con factor reumatoide (FR) negativo. Se presenta el caso de un varón de 46 arios de raza caucasiana que consultó por tumoración en la pierna derecha. Destacaba negatividad de factor reumatoide, anticuerpos anti péptido citrulinado, anticuerpos antinucleares y anticuerpos anticitoplasma de neutrófilo, así como normalidad de los reactantes de fase aguda. Una ecografía musculoesquelética mostró una tumoración sólida de 3,5 x 1,5 cm, de márgenes bien definidos, en músculo sóleo, con una estructura heterogénea hipoecoica con vascularización intra y perilesional. La resonancia magnética evidenció una tumoración de carácter fibroso sin datos sugestivos de agresividad. Una biopsia guiada por ecografía mostró histología característica de nódulo reumatoide. Se discuten la clínica, el diagnóstico, el diagnóstico diferencial y el tratamiento de los nódulos reumatoides benignos.

ABSTRACT Benign rheumatoid nodules are subcutaneous nodules, identical in morphology and histo logy to those that occur in the course of rheumatoid arthritis. They appear in people without symptoms of arthritis and with negative rheumatoid factor. The case is presented of a 46-year-old Caucasian man who consulted for a tumour inthe right leg. He was negative for rheumatoid factor, anti-citrullinated protein antibodies, antinuclear antibodies, and antineutrophil cytoplasmic antibodies, as well as for acute phase reactants. A musculoskeletal ultrasound showed a solid tumour of 3.5 × 1.5 cm with well-defined margins in the soleus muscle, and with a heterogeneous hypoechoic structure with intra- and peri-lesional vascularisation. The magnetic resonance imaging showed a fibrous tumour with no signs suggestive of aggressive growth. An ultrasound-guided biopsy sho wed the characteristic histology of the rheumatoid nodule. The clinical picture, diagnosis, differential diagnosis, and treatment of benign rheumatoid nodules are discussed.

Treat-to-target strategy in patients with rheumatoid arthritis: Audit of adherence from real world clinical data / Estrategia de tratar por objetivos en pacientes con artritis reumatoide: auditoría de la adherencia en práctica clínica habitual

Introduction: The current paradigm of the management of rheumatoid arthritis (RA) recommends achieving a state of remission or low disease activity through the treat-to-target strategy. Our study assesses adherence to this strategy. Method: Patients with RA (ACR-EULAR 2010 criteria) were included. From each centre, 19 patients were randomly selected. Clinical histories (CH) were assessed by independent auditors, checking compliance with predefined quality criteria. The study was approved by ethics committees. Results: We included 856 patients (mean age 54 years; 71% women). The use of a combined index (CI) was recorded in 61% of cases. Visits were recorded every 4 weeks using a CI in 4% of CH while attempts were made to achieve remission. Monitoring of disease activity every 6–8 months after reaching the target was recorded in 73% of cases. Conclusions: The implementation of the treat-to-target strategy is barely recorded in patients with RA in routine clinical practice.(AU)

Introducción: El paradigma actual del manejo de la artritis reumatoide (AR) recomienda alcanzar un estado de remisión o baja actividad mediante la estrategia de «tratar por objetivos». Nuestro estudio evalúa la adhesión a esta estrategia. Método: Se incluyeron pacientes con AR (criterios ACR-EULAR 2010). De cada centro, se eligieron al azar 19 pacientes. Auditores independientes evaluaron las historias clínicas (HC), verificando el cumplimiento de criterios de calidad predefinidos. El estudio fue aprobado por los comités de ética. Resultados: Se incluyeron 856 pacientes (edad media, 54 años; 71% mujeres). El uso de un índice combinado (IC) se recogió en el 61% de los casos. En el 4% de las HC se registraron visitas cada 4 semanas utilizando un IC mientras se intentaba alcanzar la remisión. La monitorización de actividad cada 6-8 meses tras alcanzar el objetivo se registró en el 73% de los casos. Conclusiones: La implementación de la estrategia de «tratar por objetivos» apenas está registrada en pacientes con AR en práctica clínica habitual.(AU)

Use of Parenteral Methotrexate in Rheumatic Diseases: A Systematic Review. / Revisión sistemática del uso de metotrexato por vía parenteral en enfermedades reumáticas.

OBJECTIVE: To analyse the efficacy, adherence, patient satisfaction, safety, pharmacodynamics and cost-effectiveness of parenteral methotrexate (MTX) in patients with rheumatic diseases. METHODS: A systematic review of literature was carried out in Medline, Embase and Cochrane Central from the beginning until June 2019. Studies including adult patients with rheumatic diseases being treated with parenteral MTX were identified and data on efficacy, adherence, satisfaction, safety, pharmacokinetics, and cost-effectiveness analysed. As for the designs, systematic reviews, clinical trials, or observational studies were permitted, including cross-sectional and small-sample studies if they were pharmacokinetic studies. RESULTS: Out of 4160 identified articles, 80 articles were finally included. The efficacy profile of parenteral MTX seems useful in general and in those patients with insufficient response to oral MTX. The parenteral route does not seem to increase the rate or severity of adverse events due to the use of MTX. The use of parenteral MTX is an appropriate way to reduce costs in patients with inadequate response to oral MTX. Adherence and satisfaction are favoured by training programmes in the use of the parenteral route. The results in rheumatic diseases other than rheumatoid arthritis (RA) are very scarce and do not enable obtaining conclusive data. CONCLUSIONS: Parenteral MTX can be an alternative to the use of oral MTX, due to its profile of efficacy, safety, adherence and pharmacoeconomic results, especially in those patients with RA.

Actualización del Documento de posicionamiento de la Sociedad Española de Reumatología sobre fármacos biosimilares / Update of the Position Paper of the Spanish Society of Rheumatology on Biosimilar Drugs

En el año 2015 la Sociedad Española de Reumatología (SER) publicó su posicionamiento sobre fármacos biosimilares. En esta actualización, la SER, sigue manifestando su compromiso inequívoco con la sostenibilidad del sistema sanitario de nuestro país y se alinea con las medidas que, sin reducir la calidad asistencial, estén encaminadas a asegurar su sostenibilidad. Desde la publicación del anterior posicionamiento la Comisión Europea ha autorizado la comercialización de nuevos fármacos biosimilares, lo que abre una excelente oportunidad de avanzar en la eficiencia de la atención sanitaria. En este nuevo escenario de incremento de la oferta terapéutica de biológicos, la SER considera imprescindible preservar la libertad de prescripción de los médicos que realizan la indicación de fármacos basándose exclusivamente en las características y circunstancias individuales de cada paciente, sin olvidar los aspectos económicos que se derivan de dicha actuación.(AU)

In 2015 the Spanish Society of Rheumatology (Sociedad Española de Reumatología [SER]) published its position paper on biosimilar drugs. In this update, the SER, continues to manifest its unequivocal commitment to the sustainability of the health system of our country and is aligned with the measures that, without reducing quality of care, are aimed at ensuring its continuity. Since the publication of the previous position paper, the European Commission has authorized new biosimilar drugs, which provides an excellent opportunity to advance the efficiency of health care. In this new scenario of increased therapeutic offer of biologics, the SER considers it crucial to preserve the freedom of prescription of physicians who prescribe drugs based exclusively on the characteristics and individual circumstances of each patient, without forgetting the economic aspects there of.(AU)

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)

Treat-to-target strategy in patients with rheumatoid arthritis: Audit of adherence from real world clinical data.

INTRODUCTION: The current paradigm of the management of rheumatoid arthritis (RA) recommends achieving a state of remission or low disease activity through the treat-to-target strategy. Our study assesses adherence to this strategy. METHOD: Patients with RA (ACR-EULAR 2010 criteria) were included. From each centre, 19 patients were randomly selected. Clinical histories (CH) were assessed by independent auditors, checking compliance with predefined quality criteria. The study was approved by ethics committees. RESULTS: We included 856 patients (mean age 54 years; 71% women). The use of a combined index (CI) was recorded in 61% of cases. Visits were recorded every 4 weeks using a CI in 4% of CH while attempts were made to achieve remission. Monitoring of disease activity every 6-8 months after reaching the target was recorded in 73% of cases. CONCLUSIONS: The implementation of the treat-to-target strategy is barely recorded in patients with RA in routine clinical practice.

Update of the Position Paper of the Spanish Society of Rheumatology on Biosimilar Drugs. / Actualización del Documento de posicionamiento de la Sociedad Española de Reumatología sobre fármacos biosimilares.

In 2015 the Spanish Society of Rheumatology (Sociedad Española de Reumatología [SER]) published its position paper on biosimilar drugs. In this update, the SER, continues to manifest its unequivocal commitment to the sustainability of the health system of our country and is aligned with the measures that, without reducing quality of care, are aimed at ensuring its continuity. Since the publication of the previous position paper, the European Commission has authorized new biosimilar drugs, which provides an excellent opportunity to advance the efficiency of health care. In this new scenario of increased therapeutic offer of biologics, the SER considers it crucial to preserve the freedom of prescription of physicians who prescribe drugs based exclusively on the characteristics and individual circumstances of each patient, without forgetting the economic aspects there of.

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.