Factors associated with long-term retention of treatment with golimumab in rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis: an analysis of the Spanish BIOBADASER registry.

BACKGROUND: Retention of biological treatment provides a marker of drug effectiveness and patient satisfaction. Retention of golimumab was high in clinical trial extensions and real-world studies up to 5 years in patients with immune-mediated rheumatic diseases. OBJECTIVE: To assess the probability of real-world long-term retention of treatment with golimumab up to 7 years after treatment initiation. METHODS: This retrospective noninterventional study involved analysis of the Spanish biological drugs registry, BIOBADASER. Adults who had ever received golimumab for rheumatoid arthritis (RA), axial spondyloarthritis (SpA), or psoriatic arthritis (PsA), and had initiated it > 6 months before the analysis date, were included. RESULTS: Among 685 patients (28.5% RA, 42.9% SpA, 28.6% PsA), the overall probability of retention of golimumab treatment since initiation was 71.7% (95% confidence interval 68.1-74.9) at year 1, 60.5% (56.5-64.2%) at year 2, 55.6% (51.5-59.5%) at year 3, 50.6% (46.2-54.8%) at year 4, 45.1% (40.1-50.0%) at year 5, 44.2% (39.0-49.3) at year 6, and 39.5% (32.8-46.2) at year 7. Retention was greater in patients with axial SpA or PsA versus RA (p < 0.001) and when golimumab was used as first-line treatment versus third or later lines (p < 0.001). Factors associated with greater golimumab retention in Cox regression included use as first-line biological therapy, having axial SpA or PsA rather than RA, and concomitant methotrexate therapy. Steroids were associated with lower retention. CONCLUSION: In this real-world study of RA, axial SpA, and PsA patients, the retention rate of golimumab was 39.5% at year 7. Key Points • Retention of biological treatment provides a marker of drug effectiveness and patient satisfaction. • This real-world study of 685 patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA), or psoriatic arthritis (PsA) showed that golimumab treatment had a retention rate up to 39.5% at year 7. • Greater golimumab retention was associated with use as first-line biological therapy, having axial SpA or PsA rather than RA, and concomitant methotrexate therapy.

Effectiveness and persistence of golimumab as a second biological drug in patients with spondyloarthritis: A retrospective study.

ABSTRACT: This observational, longitudinal retrospective, noncomparative study was designed to assess the persistence and effectiveness of golimumab as a second anti-tumor necrosis factor (TNF) drug in patients with spondyloarthritis requiring discontinuation from a first anti-TNF drug.Data were collected retrospectively for all patients with axial spondyloarthritis or psoriatic arthritis from 20 rheumatology clinics in Spain who started golimumab as a second anti-TNF drug between January 2013 and December 2015. Golimumab persistence was assessed with Kaplan-Meier survival analysis, and associated factors were assessed with Cox regression analysis.210 patients started golimumab as a second anti-TNF drug: 131 with axial spondyloarthritis and 79 with psoriatic arthritis. In axial spondyloarthritis patients, the mean (standard deviation) Bath Ankylosing Spondylitis Disease Activity Index score at baseline was 5.5 (2.1), decreasing to 3.9 (2.0) at month 3 and 3.5 (2.0) at year 1, and remaining stable thereafter. In psoriatic arthritis patients, mean (standard deviation) baseline Disease Activity Score was 4.0 (1.3), reducing to 2.5 (1.2) at month 3 and to 2.2 (1.3) at year 1. Corresponding improvements were recorded from baseline in C-reactive protein levels and erythrocyte sedimentation rates. The probability of persistence of treatment with golimumab was 80% at year 1, 70% at year 2 and 65% at years 3 and year 4, and was similar in those who had stopped the first anti-TNF due to loss of efficacy or other reasons. Cox regression analysis showed that the probability of survival with golimumab was higher in patients with higher erythrocyte sedimentation rate, in patients with axial spondyloarthritis than with psoriatic arthritis, and in those who had discontinued adalimumab as first anti-TNF. Seventy-two patients (34.3%) discontinued golimumab during follow-up, 50 of them due to lack of efficacy.In patients with spondyloarthritis requiring discontinuation from a first anti-TNF drug, treatment with golimumab was effective and showed a high probability of persistence up to 4 years of treatment.

Patients' perceptions on shared decision making during prescription of subcutaneous biological drug treatments for inflammatory arthritis: The RHEU-LIFE survey.

OBJECTIVES: The aim of this study was to explore the preferences of patients with rheumatic diseases and their perceived experience regarding participation in shared decision making (SDM) when they were prescribed a subcutaneous (SC) biological drug. METHODS: A printed survey was handed to 1,000 patients with inflammatory rheumatic diseases treated with SC biological drug. The survey included closed questions about preferences regarding decision making and about patients' experience when they were prescribed an SC biological drug. Descriptive statistics were performed with stratification by patient profiles, using chi-square for comparisons between groups. RESULTS: A total of 592 surveys were received (response rate 59.2%, mean age 51.7 years, 57.6% women). Some 28.2% of patients reported preferring to take part in treatment selection, a percentage that was higher in younger patients, in those with higher academic degree and in those who search information in sources different to that of health care professionals. Over half of patients (56.3%) perceived that the rheumatologist considered their opinion when prescribing an SC biological drug, a percentage higher in younger people. Only in 40.8% of cases did the patients' preference match their perception of their participation in the process. No differences were observed by sex, disease or number of biologics. CONCLUSIONS: Patients with inflammatory rheumatic diseases want information about their treatments but mostly leave the prescription decision to the rheumatologist. Younger people, or those with higher academic degree, more often want to participate in the SDM. There are discrepancies between patient preferences and perceptions of this process.

Percepciones de los pacientes con enfermedades reumáticas tratados con biológicos subcutáneos sobre su nivel de información. Encuesta RHEU-LIFE / Perceptions of patients with rheumatic diseases treated with subcutaneous biologicals on their level of information: RHEU-LIFE Survey

OBJETIVO: Conocer las fuentes de las que los pacientes españoles con enfermedades reumáticas tratados con fármacos biológicos subcutáneos obtienen información, cuáles consideran más relevantes y su satisfacción con la información recibida en el hospital. MÉTODOS: Reumatólogos de 50 hospitales entregaron una encuesta anónima, desarrollada ad hoc por 4 reumatólogos y 3 pacientes, a 20 pacientes consecutivos con artritis reumatoide, espondiloartritis axial o artritis psoriásica tratados con biológicos subcutáneos. La encuesta incluyó preguntas con respuestas cerradas sobre los aspectos mencionados previamente. RESULTADOS: Recibieron la encuesta 1.000 pacientes, 592 la devolvieron cumplimentada (tasa de respuesta: 59,2%). El reumatólogo fue mencionado como la fuente de información más importante (75%), seguido del médico de atención primaria, la enfermería y los recursos electrónicos. El 45,2% recibió información oral y por escrito sobre el biológico, el 46,1% solo oral, el 6% solo por escrito. Un 8,7% declaró no haber sido enseñado a inyectarse el biológico. El porcentaje de pacientes satisfechos con la información recibida fue elevado (87,2%), aunque la satisfacción fue menor en temas relacionados con la seguridad. Si la información provenía del reumatólogo, la satisfacción era mayor (89,6%) que cuando provenía de otras vías (59,6%; p < 0,001). La satisfacción también era mayor si se dio oral y por escrito (92,8%) frente a solo oral (86,1%; p = 0,013). Un 45,2% declaró haber buscado información en fuentes fuera del hospital. CONCLUSIONES: El reumatólogo es clave a la hora de transmitir información satisfactoria al paciente en tratamiento biológico. Debe además actuar de guía, ya que un elevado porcentaje busca información en fuentes distintas

OBJECTIVE: To investigate, in Spanish patients with rheumatic diseases treated with subcutaneous biological drugs, their sources of information, which sources they consider most relevant, and their satisfaction with the information received in the hospital. METHODS: Rheumatologists from 50 hospitals handed out an anonymous survey to 20 consecutive patients with rheumatoid arthritis, axial spondyloarthritis or psoriatic arthritis treated with subcutaneous biologicals. The survey was developed ad hoc by 4 rheumatologists and 3 patients, and included questions with closed-ended responses on sources of information and satisfaction. RESULTS: The survey was handed-out to 1,000 patients, 592 of whom completed it (response rate: 59.2%). The rheumatologist was mentioned as the most important source of information (75%), followed by the primary care physician, nurses, and electronic resources; 45.2% received oral and written information about the biological, 46.1% oral only, and 6.0% written only; 8.7% stated that they had not been taught to inject the biological. The percentage of patients satisfied with the information received was high (87.2%), although the satisfaction was lower in relation to safety. If the information came from the rheumatologist, the satisfaction was higher (89.6%) than when coming from other sources (59.6%; P<.001). Satisfaction was also higher if the information was provided orally and written (92.8%) than if provided only orally (86.1%; P=.013); 45.2% reported having sought information from sources outside the hospital. CONCLUSIONS: The rheumatologist is key in transmitting satisfactory information on biological treatment to patients. He or she must also act as a guide, since a high percentage of patients seeks information in other different sources

Discordance between doctor and patient assessments and non-adherence to subcutaneous biological drugs.

To estimate the agreement level between patient and physician assessment of disease activity and to explore whether agreement is associated with adherence to subcutaneous (SC) biological drugs in rheumatoid arthritis (RA). Cross-sectional study of RA patients who had been prescribed a SC biological drug in the past 12-18 months was performed. Patients and physicians global disease activity on visual analogue scale (VAS) were collected. Disagreement was defined as an absolute difference ≥ 3 points between VAS scores. Adherence was assessed by the Medication Possession Ratio (MPR), considering adherence an MPR > 80%. We analysed 360 patients of whom 15.5% presented disagreement with their physicians. The mean patient global VAS was 5.75 ± 1.8 (median 5.5 [5-7]) in the disagreement group versus 2.7 ± 2.2 (median 2 [1-4]) in the agreement group (p < 0.001). There were also differences in physicians global VAS between groups (p = 0.01). The non-adherence to SC biological drugs rate was 10.7% and 14.5% in the disagreement and agreement groups (p = 0.45). No association between adherence and discordance was found. Disagreement in the global disease activity between patients and physicians was detected in 15.5% of patients. In general, patients perceived higher disease activity. No associations between patient-physician disagreement in VAS and adherence were observed.

Perceptions of patients with rheumatic diseases treated with subcutaneous biologicals on their level of information: RHEU-LIFE Survey. / Percepciones de los pacientes con enfermedades reumáticas tratados con biológicos subcutáneos sobre su nivel de información. Encuesta RHEU-LIFE.

OBJECTIVE: To investigate, in Spanish patients with rheumatic diseases treated with subcutaneous biological drugs, their sources of information, which sources they consider most relevant, and their satisfaction with the information received in the hospital. METHODS: Rheumatologists from 50 hospitals handed out an anonymous survey to 20 consecutive patients with rheumatoid arthritis, axial spondyloarthritis or psoriatic arthritis treated with subcutaneous biologicals. The survey was developed ad hoc by 4 rheumatologists and 3 patients, and included questions with closed-ended responses on sources of information and satisfaction. RESULTS: The survey was handed-out to 1,000 patients, 592 of whom completed it (response rate: 59.2%). The rheumatologist was mentioned as the most important source of information (75%), followed by the primary care physician, nurses, and electronic resources; 45.2% received oral and written information about the biological, 46.1% oral only, and 6.0% written only; 8.7% stated that they had not been taught to inject the biological. The percentage of patients satisfied with the information received was high (87.2%), although the satisfaction was lower in relation to safety. If the information came from the rheumatologist, the satisfaction was higher (89.6%) than when coming from other sources (59.6%; P<.001). Satisfaction was also higher if the information was provided orally and written (92.8%) than if provided only orally (86.1%; P=.013); 45.2% reported having sought information from sources outside the hospital. CONCLUSIONS: The rheumatologist is key in transmitting satisfactory information on biological treatment to patients. He or she must also act as a guide, since a high percentage of patients seeks information in other different sources.

The beliefs of rheumatoid arthritis patients in their subcutaneous biological drug: strengths and areas of concern.

Patients' beliefs about their prescribed medication are an important factor influencing intentional non-adherence. This study describes rheumatoid arthritis (RA) patients' beliefs about their subcutaneous (SC) biological medication through the Beliefs about Medicines Questionnaire (BMQ), and potential associations. As part of the ARCO study (Study on Adherence of Rheumatoid arthritis patients to subCutaneous and Oral drugs), patients completed the BMQ specifically for their SC biological medication, encompassing a necessity and a concerns scale. The medication possession ratio (MPR) was calculated to assess adherence to the SC biological medication. The BMQ was completed by 321 patients. Between 71.0 and 89.7% of patients agreed/strongly agreed with necessity scale statements, and only 7.2% had low necessity scores. Between 20.0 and 49.8% of patients agreed/strongly agreed with four of five concern scale statements, and 72.3% agreed/strongly agreed with the concern statement regarding long-term medication effects. The percentage with high concerns was 58.9%, and was higher in patients not satisfied with, or with less fulfillment of, tolerability expectations. Non-adherence percentages were, respectively, 13.8 and 13.0% (p = 0.919) in those with high or low necessity, and 16.0 and 10.6% (p = 0.171) in those with high or low concerns. Most patients were categorized as 'ambivalent' (58.5%; high necessity/high concerns) or 'accepting' (36.1%; high necessity/low concerns) of their SC biological medication. The BMQ identified patients' concerns with their SC biological medication. Because patients' concerns could influence non-adherence to medication and future outcomes, physicians should address this issue in the clinic by informing patients and setting clear expectations.

Correction to: The beliefs of rheumatoid arthritis patients in their subcutaneous biological drug: strengths and areas of concern.

In the original publication, the family name of the last author was incorrect. The correct name should read as Jaime Calvo-Alén.

High Reproducibility of an Automated Measurement of Mobility for Patients with Axial Spondyloarthritis.

OBJECTIVE: Conventional measures of spinal mobility used in the assessment of patients with axial spondyloarthritis (axSpA), such as the Bath Ankylosing Spondylitis Metrology Index and its components, are subject to interobserver variability. The University of Córdoba Ankylosing Spondylitis Metrology Index (UCOASMI) is a validated composite index based on a motion video-capture system, UCOTrack. Our objective was to assess its reproducibility in clinical practice settings. METHODS: We carried out an observational study of repeated measures in 3 centers. Video-capture systems were installed and adapted to clinical rooms. Patients with axSpA and stable disease were selected by consecutive stratified sampling [disease duration, sex, and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)]. Intraobserver reliability of the UCOASMI and of conventional measures was tested 3-5 days apart. For interobserver reliability, 3 patients from each center were evaluated in the other centers, within 3-7 days. The intraclass correlation coefficients (ICC) were calculated. RESULTS: Thirty patients were included (73% men, mean age 53 yrs, mean BASDAI 3.0). Interobserver and intraobserver ICC of the UCOASMI was 0.98. Conventional measurements showed lower but adequate reproducibility as well, except for interobserver reliability of lateral flexion (0.41), cervical rotation (0.61), and Schöber test (0.07), and intraobserver reliability of tragus-to-wall distance (0.30). CONCLUSION: Reproducibility of the UCOASMI seems very high, and apparently more reliable than conventional measures of mobility.

Perceptions of patients with rheumatic diseases on the impact on daily life and satisfaction with their medications: RHEU-LIFE, a survey to patients treated with subcutaneous biological products.

OBJECTIVE: The aim of this study was to explore perceptions of patients with rheumatic diseases treated with subcutaneous (SC) biological drugs on the impact on daily life and satisfaction with current therapy, including preferred attributes. METHODS: A survey was developed ad hoc by four rheumatologists and three patients, including Likert questions on the impact of disease and treatment on daily life and preferred attributes of treatment. Rheumatologists from 50 participating centers were instructed to handout the survey to 20 consecutive patients with rheumatoid arthritis (RA), axial spondyloarthritis (ax-SpA), or psoriatic arthritis (PsA) receiving SC biological drugs. Patients responded to the survey at home and sent it to a central facility by prepaid mail. RESULTS: A total of 592 patients returned the survey (response rate: 59.2%), 51.4% of whom had RA, 23.8% had ax-SpA, and 19.6% had PsA. Patients reported moderate-to-severe impact of their disease on their quality of life (QoL) (51.9%), work/daily activities (49.2%), emotional well-being (41.0%), personal relationships (26.0%), and close relatives' life (32.3%); 30%-50% patients reported seldom/never being inquired about these aspects by their rheumatologists. Treatment attributes ranked as most important were the normalization of QoL (43.6%) and the relief from symptoms (35.2%). The satisfaction with their current antirheumatic therapy was high (>80% were "satisfied" or "very satisfied"), despite moderate/severe impact of disease. CONCLUSION: Patients with rheumatic diseases on SC biological therapy perceive a high disease impact on different aspects of daily life, despite being highly satisfied with their treatment; the perception is that physicians do not frequently address personal problems. Normalization of QoL is the most important attribute of therapies to patients.

Non-adherence to subcutaneous biological medication in patients with rheumatoid arthritis: a multicentre, non-interventional study.

OBJECTIVES: To evaluate non-adherence to prescribed subcutaneous biologicals in rheumatoid arthritis (RA) patients in Spain. METHODS: ARCO (Study on Adherence of Rheumatoid Arthritis patients to SubCutaneous and Oral Drugs) was a multicentre, non-interventional retrospective study involving 42 rheumatology clinics from representative hospitals throughout Spain. The primary objective was to assess the percentage of patients (aged ≥18 years with an established RA diagnosis) with non-adherence to prescribed subcutaneous biologicals using clinical records and hospital pharmacy dispensing logs as the primary information sources. Adherence was assessed using the Medication Possession Ratio (MPR). Additionally, patients completed the Morisky-Green Medication Adherence Questionnaire. RESULTS: A total of 364 patients (77.5% females, mean age 54.9 years, median RA duration since diagnosis 7.8 years) were enrolled in ARCO. Non-adherence (MPR ≤80%) was reported in 52/363 evaluable patients (14.3%), and was lower in patients receiving initial monthly drug administration (6.4%) than with weekly (17.4%; p=0.034) or every two weeks (14.4%; p=0.102) administration. By multivariate analysis, non-adherence was positively associated with RA duration above the median and with using induction doses. Monthly administration, compared to weekly administration, was inversely associated with non-adherence. Age, gender, order of administration, and changes in the interval of administration, showed no association with non-adherence. Compared with the MPR, the Morisky-Green questionnaire performed poorly in detecting non-adherence. CONCLUSIONS: Non-adherence to the prescribed subcutaneous biological drug occurred in 14.3% of patients with RA. Patients using the most convenient administration period (i.e. monthly) had better adherence than those using more frequent dosing schedules.

Eficacia y seguridad de golimumab añadido a fármacos antirreumáticos modificadores de la enfermedad en artritis reumatoide. Resultados del estudio GO-MORE en España / Efficacy and safety of golimumab as add-on therapy to disease-modifying antirheumatic drugs in rheumatoid arthritis: Results of the GO-MORE study in Spain

Objetivos: Analizar la eficacia y la seguridad de golimumab en los 140 pacientes incluidos en España en la parte 1 del estudio GO-MORE, un estudio multinacional en artritis reumatoide (AR) activa a pesar del tratamiento con distintos fármacos antirreumáticos modificadores de la enfermedad (FAME). Pacientes y métodos: Los pacientes recibieron golimumab 50 mg subcutáneo una vez al mes durante 6 meses. El criterio de valoración principal fue el porcentaje con respuesta DAS28-VSG EULAR buena o moderada tras 6 meses de tratamiento. Resultados: Se incluyó a 140 pacientes. El 76,4% tenía enfermedad muy activa (DAS28-VSG > 5,1). El 76,4% estaba tomando metotrexato, el 40,0% otros FAME en monoterapia o combinación, y el 65,0% esteroides. Al mes 6, el 82,9% de los pacientes logró una respuesta EULAR buena o moderada, el 41,4% alcanzó baja actividad y el 30,7% remisión. El porcentaje de pacientes con respuesta al mes de la primera dosis administrada fue del 69,3%. La eficacia fue similar en pacientes tratados con metotrexato u otro FAME, distintas dosis de metotrexato, con/sin esteroides o que habían fallado a uno o más FAME. El golimumab fue bien tolerado y el perfil de seguridad fue coherente con estudios previos. Se comunicaron acontecimientos adversos graves en 11 pacientes (7,9%). Conclusión: La adición de golimumab 50 mg subcutáneo mensual a distintos FAME en pacientes con AR activa deparó una respuesta moderada o buena a los 6 meses en el 82,9%. La respuesta comenzó a observarse tempranamente, ya al inicio del mes 2, tras una única dosis de golimumab (AU)

Objectives: To assess the efficacy and safety of golimumab in the 140 patients included in Spain as the first part of the GO-MORE trial, a multinational study involving patients with active rheumatoid arthritis (RA) despite treatment with different disease-modifying antirheumatic drugs (DMARDs). Patients and methods: The patients received subcutaneous golimumab 50 mg once a month during 6 months. The primary endpoint was the percentage of individuals with a good or moderate EULAR DAS28- ESR response after 6 months of treatment. Results: A total of 140 patients were included. Of these, 76.4% had very active disease (DAS28-ESR > 5.1). 76.4% were taking methotrexate, 40.0% other DMARDs in monotherapy or combined, and 65.0% received corticosteroids. After 6 months, 82.9% of the patients showed a good or moderate EULAR response, 41.4% had low disease activity, and 30.7% were in remission. The percentage of responders one month after the first dose was 69.3%. The efficacy was similar in patients treated with methotrexate or other DMARDs, with different methotrexate doses, with or without corticosteroids, or in subjects who had failed one or more DMARDs. The response to golimumab was observed from the first dose. Golimumab was well tolerated and its safety profile was consistent with the findings of previous studies. Serious adverse events were reported in 11 patients (7.9%). Conclusion: The addition of subcutaneous golimumab 50 mg once a month to different DMARDs in patients with active RA yielded a moderate or good response after 6 months in 82.9% of the cases. The response was observed early, from the start of the second month, after a single dose of golimumab (AU)

Manifestaciones extraarticulares en pacientes con espondiloartritis. Características basales de la cohorte de pacientes con espondiloartritis del estudio AQUILES / Extra-articular disease in patients with spondyloarthritis. Baseline characteristics of the spondyloarthritis cohort of the AQUILES study

Objetivos. Evaluar la prevalencia de enfermedad extraarticular (uveítis, psoriasis y enfermedad inflamatoria intestinal [EII]) en una cohorte de pacientes con espondiloartritis (EsA). Pacientes y métodos. AQUILES es un estudio observacional, prospectivo y multicéntrico, en 3 cohortes de pacientes con una de las siguientes enfermedades inflamatorias mediadas por inmunidad (EIMI): EsA, psoriasis y EII. En la cohorte presente se incluyó a pacientes ≥ 18 años con EsA atendidos en consultas hospitalarias de Reumatología. El objetivo principal fue evaluar la coexistencia de estas enfermedades y de uveítis, valorada sobre la base de la historia clínica del paciente hasta el momento de entrar en el estudio. Resultados. Se incluyó a 601 pacientes con EsA (varones: 63,1%, mujeres: 36,9%). Los diagnósticos fueron: espondilitis anquilosante (55,1%); artritis psoriásica (25,2%); espondiloartritis indiferenciada (16,1%); artritis enteropática (2,5%), y otros (1,3%). En el 43,6% (IC del 95%, 39,7-47,6) coexistió al menos una de las 3 enfermedades mencionadas, predominando psoriasis (prevalencia: 27,8%, IC del 95%, 24,4-31,5), uveítis (13,6%, IC del 95%m 11,1-16,6) y EII (5,1%, IC del 95%, 3,7-7,2). En pacientes con espondilitis anquilosante, la prevalencia fue del 25,3% (EII: 3,9%, psoriasis: 5,4%, uveítis: 19,0%) y en pacientes con artritis psoriásica fue del 94,7%, debido a la presencia de psoriasis (94,0%). La coexistencia de estas manifestaciones se asoció a mayor edad, sexo femenino y presencia de otras manifestaciones extraarticulares de las EsA distintas de las estudiadas. Conclusiones. La enfermedad extraarticular en pacientes con EsA es frecuente y en este estudio se asoció a la edad, el sexo femenino y la presencia de otras manifestaciones extraarticulares de EsA (AU)

Objectives. To describe the prevalence of extra-articular disease (uveitis, psoriasis and inflammatory bowel disease [IBD]), in a cohort of patients with spondyloarthritis (SpA). Patients and methods. AQUILES is an observational, prospective and multicentric study of three cohorts of patients with one of the following immune-mediated inflammatory diseases (IMID): SpA, psoriasis, or IBD. In the present cohort, patients ≥18 years of age with SpA were enrolled from Rheumatology clinics. The main objective was to assess the coexistence of these diseases and of uveitis, based on the patients’ clinical history up to the study entry. Results. A total of 601 patients with SpA (men: 63.1%; women: 36.9%) were enrolled. The specific diagnoses were: ankylosing spondylitis (55.1%), psoriatic arthritis (25.1%), undifferentiated spondyloarthritis (16.1%), enteropathic arthritis (2.5%), and others (1.3%). In 43.6% (95% CI: 39.7-47.6) of the patients, at least one of the three abovementioned diseases was encountered, predominantly psoriasis (prevalence 27.8%, 95% CI: 24.4-31.5), uveitis (13.6%, CI 95%: 11.1-16.6) and IBD (5.1%, 95% CI: 3.7-7.2). In patients with ankylosing spondylitis the proportion of other disease was 25.3% (IBD: 3.9%, psoriasis: 5.4%, uveitis: 19.0%) whilst it was 94.7% in psoriatic arthritis, due to the presence of psoriasis (94.0%). The coexistence of these diseases was associated with age, female gender and the presence of other extra-articular manifestations associated with SpA. Conclusions. Extra-articular disease in patients with SpA is common and, in this study, it was associated to age, female gender and the presence of other SpA-related extra-articular manifestations (AU)

Extra-articular disease in patients with spondyloarthritis. Baseline characteristics of the spondyloarthritis cohort of the AQUILES study.

OBJECTIVES: To describe the prevalence of extra-articular disease (uveitis, psoriasis and inflammatory bowel disease [IBD]), in a cohort of patients with spondyloarthritis (SpA). PATIENTS AND METHODS: AQUILES is an observational, prospective and multicentric study of three cohorts of patients with one of the following immune-mediated inflammatory diseases (IMID): SpA, psoriasis, or IBD. In the present cohort, patients ≥18 years of age with SpA were enrolled from Rheumatology clinics. The main objective was to assess the coexistence of these diseases and of uveitis, based on the patients' clinical history up to the study entry. RESULTS: A total of 601 patients with SpA (men: 63.1%; women: 36.9%) were enrolled. The specific diagnoses were: ankylosing spondylitis (55.1%), psoriatic arthritis (25.1%), undifferentiated spondyloarthritis (16.1%), enteropathic arthritis (2.5%), and others (1.3%). In 43.6% (95% CI: 39.7-47.6) of the patients, at least one of the three abovementioned diseases was encountered, predominantly psoriasis (prevalence 27.8%, 95% CI: 24.4-31.5), uveitis (13.6%, CI 95%: 11.1-16.6) and IBD (5.1%, 95% CI: 3.7-7.2). In patients with ankylosing spondylitis the proportion of other disease was 25.3% (IBD: 3.9%, psoriasis: 5.4%, uveitis: 19.0%) whilst it was 94.7% in psoriatic arthritis, due to the presence of psoriasis (94.0%). The coexistence of these diseases was associated with age, female gender and the presence of other extra-articular manifestations associated with SpA. CONCLUSIONS: Extra-articular disease in patients with SpA is common and, in this study, it was associated to age, female gender and the presence of other SpA-related extra-articular manifestations.

Efficacy and safety of golimumab as add-on therapy to disease-modifying antirheumatic drugs in rheumatoid arthritis: results of the GO-MORE study in Spain.

OBJECTIVES: To assess the efficacy and safety of golimumab in the 140 patients included in Spain as the first part of the GO-MORE trial, a multinational study involving patients with active rheumatoid arthritis (RA) despite treatment with different disease-modifying antirheumatic drugs (DMARDs). PATIENTS AND METHODS: The patients received subcutaneous golimumab 50mg once a month during 6 months. The primary endpoint was the percentage of individuals with a good or moderate EULAR DAS28-ESR response after 6 months of treatment. RESULTS: A total of 140 patients were included. Of these, 76.4% had very active disease (DAS28-ESR>5.1). 76.4% were taking methotrexate, 40.0% other DMARDs in monotherapy or combined, and 65.0% received corticosteroids. After 6 months, 82.9% of the patients showed a good or moderate EULAR response, 41.4% had low disease activity, and 30.7% were in remission. The percentage of responders one month after the first dose was 69.3%. The efficacy was similar in patients treated with methotrexate or other DMARDs, with different methotrexate doses, with or without corticosteroids, or in subjects who had failed one or more DMARDs. The response to golimumab was observed from the first dose. Golimumab was well tolerated and its safety profile was consistent with the findings of previous studies. Serious adverse events were reported in 11 patients (7.9%). CONCLUSION: The addition of subcutaneous golimumab 50 mg once a month to different DMARDs in patients with active RA yielded a moderate or good response after 6 months in 82.9% of the cases. The response was observed early, from the start of the second month, after a single dose of golimumab.