Search

To assess the golimumab retention rate during up to 8 years of follow up, and any associated factors.Retrospective analysis of the BIOBADASER (Spanish registry of biological drugs) database, assessing all adults who had ever started golimumab6 months before the analysis for an approved indication (rheumatoid arthritis [RA], axial spondyloarthritis [SpA] or psoriatic arthritis [PsA]).Among 885 patients (RA 267, axial SpA 370, PsA 248) receiving 944 cycles of golimumab, the retention rate of golimumab was 71.1% (95% confidence interval: 68.0-73.9) at year 1% and 37.7% (95% CI: 33.3-42.1) at year 7 and at year 8. Retention was higher when golimumab was used as the first biological drug (81.7% at year 1, 49.9% at year 7, p 0.001). In Cox regression analysis, factors associated with golimumab retention included use as first-line therapy (hazard ratio [HR] for discontinuation 1.52 for second- and 1.79 for third/later-line vs. first-line), use in axial SpA or PsA rather than RA (HR for axial SpA vs. RA 0.59, for PsA vs. Rheumatoid arthritis 0.67), and treatment with concomitant methotrexate (HR 0.67). Factors associated with golimumab discontinuation were corticosteroid use (HR 1.46) and disease activity above median (HR 1.29) at golimumab initiation.Based on this retrospective analysis of the BIOBADASER registry, nearly two-fifths (37.7%) of adult rheumatology patients initiating golimumab will remain on treatment for 8 years, with a higher probability of retention in axial SpA or PsA indications and when golimumab is used as first biologic.

Purpose Chronic cough (cough that persists for ≥ 8 weeks) can cause a range of physical symptoms and psychosocial effects that significantly impair patients’ quality of life. Refractory chronic cough (RCC) and unexplained chronic cough (UCC) are challenging to diagnose and manage, with substantial economic implications for healthcare systems. Methods This retrospective multicenter non-interventional study aimed to characterize the profile and health resource consumption of patients with RCC or UCC who attended outpatient clinics at Spanish hospitals. Data were collected from medical records of patients with RCC or UCC for up to 3 years before study inclusion. Results The patient cohort (n = 196) was representative of the chronic cough population (77.6% female, mean age 58.5 years). Two-thirds of patients (n = 126) had RCC. The most frequently visited doctors were pulmonologists (93.4% of patients) and primary care physicians (78.6%), with a mean of 5 visits per patient over three years’ observation. The most common diagnostic tests were chest x-ray (83.7%) and spirometry with bronchodilation (77.0%). The most commonly prescribed treatments were proton pump inhibitors (79.6%) and respiratory medications (87.8%). Antibiotics were prescribed empirically to 56 (28.6%) patients. Differences between RCC or UCC groups related mainly to approaches used to manage cough-associated conditions (gastroesophageal reflux disease, asthma) in patients with RCC. Conclusion RCC and UCC are responsible for high health resource utilization in Spanish hospitals. Specific treatments targeting the pathological processes driving chronic cough may provide opportunities to reduce the associated burden for patients and healthcare systems.

PurposeThe aim of this study was to understand the perception of family physicians, pulmonologists, and allergists with respect to diagnostic tests performed on patients with chronic cough and treatments prescribed to patients with refractory or unexplained chronic cough. We also assessed how these health professionals perceived the effectiveness of these treatments.MethodsAn anonymous survey was distributed by the scientific societies SEPAR, SEAIC, SEMERGEN, semFYC, and SEMG. Respondents were asked how often they perform diagnostic tests and prescribe treatments (responses from 1 = never to 10 = always) and how they perceived the effectiveness of the drugs used (from 1 = not at all to 10 = very effective). The correlation between perceived effectiveness and frequency of prescription was analyzed.ResultsThe respondents comprised 620 family physicians, 92 pulmonologists, and 62 allergists. The most frequently performed diagnostic tests were chest x-ray and, among pulmonologists and allergists, simple spirometry and bronchodilator tests. The most frequently prescribed drugs were bronchodilators (percentages scoring 8–10 for each specialty: 43.2%, 42.4%, and 56.5%;p = 0.127), inhaled corticosteroids (36.9%, 55.4%, and 54.8%;p 5 (between 6 and 7). Correlation coefficients (ρ2) suggested that approximately 45% of prescription was related to perceived effectiveness.ConclusionAlthough chronic cough is a common problem, diagnosis and treatment differ among specialists. The perceived effectiveness of drugs is generally low.

INTRODUCTION Analgesics are widely used, but evidence regarding whether their use increases the risk of inflammatory bowel disease (IBD) flares or complications is unclear. Therefore, self-medication with analgesics in IBD is usually not recommended. The aim of this study was to explore the prevalence of self-medication with analgesics in a cohort of ulcerative colitis (UC) patients and to identify reasons and factors associated with self-medication. METHODS This cross-sectional study included consecutive unselected adult patients with UC. Participants were asked to complete an anonymous web-based survey with multiple-choice questions and closed responses. No clinical data were collected. RESULTS A total of 546 patients (61.2% women, mean age 39.9 years) completed the survey. The prevalence of self-medication with analgesics was 49.8% (272/546). Paracetamol (45.2%) and metamizole (21.2%) were the most frequently used drugs; frequencies of self-medication were

Aim: To assess adherence to subcutaneous biologicals in adults with inflammatory rheumatic diseases or inflammatory bowel disease and evaluate factors possibly associated with adherence. Materials & methods: Systematic searches were conducted of main databases from January 2000 to June 2019. Results: 41 articles (32 full papers and nine abstracts) were included in the review. Among studies which used a medication possession ratio threshold of ≥80% as the end point, adherence varied from 28.8 to 89.4%. Possible predictors of adherence were older age, professional or family member support, belief in medication necessity, lower concerns about medication and monthly versus weekly administration. Conclusion: Considerable variability in adherence rates across published studies reflects study heterogeneity and the absence of a ‘gold standard’ to measure adherence.

BACKGROUND Few studies have examined self-medication with corticosteroids among patients with ulcerative colitis (UC). AIMS To assess the frequency of self-medication with oral corticosteroids in UC patients, and associated factors and reasons. METHODS An anonymous, voluntary, web-based survey was administered to adults with UC recruited via a Spanish patient association (ACCU) and hospital gastroenterology departments. Information was provided by patients; no clinical data were collected. Descriptive statistics and comparisons of frequencies are displayed. RESULTS Among 546 respondents (mean age 39.9 years, median duration of UC since diagnosis 7 years,) 36 (6.6%) reported self-medication with oral corticosteroids during the past year (once: 23 patients; 2-3 times: 10 patients; >3 times: 3 patients). Self-medication was more common among patients managed in general gastroenterology vs. inflammatory bowel disease clinics [23 (9.0%) vs. 11 (2.9%), P = 0.019], patients with no regular follow-up [4 (22.2%) vs. 32 (6.1%), P = 0.026] and patients with more flares (P < 0.001). Patients who stored steroids from previous flares (17.9% vs. 6.0%, P < 0.001) or who lived with a partner taking steroids (9.3% vs. 1.1%, P = 0.038) were more likely to self-medicate than other patients. Common reasons for self-medicating included the need for quick symptom relief (55.6%), fear of worsening (47.2%) and difficulty in getting an appointment (25.0%). Only seven patients (19.4%) informed their physician when they started self-medicating and only four (11.1%) declared they would not start corticosteroids again. CONCLUSION Self-medication with oral corticosteroids is not a common practice among patients with UC in Spain, but several areas of improvement exist.

Short report [Abstract] 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.

Purpose Information regarding patients' needs, fears and experiences/perceptions in the perioperative setting is limited. Through two focus groups, we explored the needs, fears and experiences of patients who had recently undergone, or were scheduled for, surgery under general anaesthesia, with regard to the entire perioperative process. Materials and Methods Adults were invited to participate in a focus group if they had (a) undergone abdominal or gynaecological surgery with general anaesthesia in the past 4 months (focus group 1) or (b) been indicated for abdominal or gynaecological surgery and were waiting for the assigned surgery date (focus group 2). Discussions were audio recorded and, through thematic analysis, patients' needs and experiences/perceptions regarding perioperative surgical stages were obtained/coded. Analysis of code co-occurrence was performed using a codes matrix. Results Focus groups consisted of 13 females, 1 male (50% aged >45 years). The immediate postoperative period generated the highest number of co-occurrences, followed by the indication of surgery. The most frequent code was the need for information, especially at the indication of surgery, the pre-anaesthesia clinic and in the postoperative period. Fears were described particularly at the indication of surgery, the waiting period, the surgical room, anaesthesia induction and the postoperative period, particularly after hospital discharge; pain was cited most commonly in the postoperative period. Stress/anxiety and emotional impact were also cited in the postoperative period including home arrival. Conclusion Information collected in these patients' focus groups should inform future research and healthcare planning. Patients demand receiving more comprehensive and understandable information and more involvement in several steps; this could reduce fears and stress/anxiety described across the perioperative process. Importantly, findings also extend to the postoperative period and home arrival.

Resumen Objetivos En el estudio ARCO, la adherencia al biologico subcutaneo en pacientes con artritis reumatoide fue mejor con administracion mensual. Evaluamos si la satisfaccion y el cumplimiento de expectativas pueden relacionarse con la adherencia al tratamiento. Pacientes y metodos La adherencia se evaluo calculando el indice de posesion de medicacion, y satisfaccion y cumplimiento de expectativas mediante el cuestionario «EXPRESAR». Resultados En 346 pacientes, los porcentajes satisfechos/muy satisfechos con eficacia y tolerabilidad fueron ≥ 80 y 64,4%, sin diferencias entre pautas semanal, cada 2 semanas o mensual. Sobre el cumplimiento de expectativas, el 59,9% considero el efecto del tratamiento mayor al esperado, y el 52,6% las molestias bastante/mucho menores a las esperadas, porcentaje mayor en pacientes con administracion mensual (p = 0,049). Los porcentajes de no-adherencia fueron del 15,6% (molestias mayores a las esperadas), 18,5% (molestias esperadas) y 11,1% (menores/sin molestias) (p = 0,189). Conclusiones La satisfaccion y el cumplimiento de expectativas fueron altos. El cumplimiento de expectativas de tolerabilidad fue mejor con administracion mensual, lo que podria contribuir a una mejor adherencia.

Objectives In the ARCO study, adherence to subcutaneous biological agents by patients with rheumatoid arthritis improved with monthly administration. We assess whether adherence can be related to fulfilment of expectations and satisfaction with treatment. Patients and methods Adherence was assessed by calculating the Medication Possession Ratio, and satisfaction and fulfilment of expectations using the EXPRESAR group questionnaire. Results In 346 patients, those who were satisfied/very satisfied with efficacy and tolerability were ≥80% and 64.4%, with no differences between weekly, biweekly or monthly administration regimens. Regarding the fulfilment of expectations, 59.9% considered the effect of the treatment greater than expected and 52.6% reported lower/much lower than expected discomfort; the latter percentage was higher in patients with monthly administration (P = .049). The percentages for nonadherence were 15.6% (discomfort greater than expected), 18.5% (expected discomfort) and 11.1% (lower than expected or no discomfort) (P = .189). Conclusions Satisfaction and fulfilment of expectations were high. Fulfilment of expectations of tolerability was better with monthly administration, which could contribute to better adherence.

Resumen Objetivo Conocer las fuentes de las que los pacientes espanoles con enfermedades reumaticas tratados con farmacos biologicos subcutaneos obtienen informacion, cuales consideran mas relevantes y su satisfaccion con la informacion recibida en el hospital. Metodos Reumatologos de 50 hospitales entregaron una encuesta anonima, desarrollada ad hoc por 4 reumatologos y 3 pacientes, a 20 pacientes consecutivos con artritis reumatoide, espondiloartritis axial o artritis psoriasica tratados con biologicos subcutaneos. La encuesta incluyo 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 reumatologo fue mencionado como la fuente de informacion mas importante (75%), seguido del medico de atencion primaria, la enfermeria y los recursos electronicos. El 45,2% recibio informacion oral y por escrito sobre el biologico, el 46,1% solo oral, el 6% solo por escrito. Un 8,7% declaro no haber sido ensenado a inyectarse el biologico. El porcentaje de pacientes satisfechos con la informacion recibida fue elevado (87,2%), aunque la satisfaccion fue menor en temas relacionados con la seguridad. Si la informacion provenia del reumatologo, la satisfaccion era mayor (89,6%) que cuando provenia de otras vias (59,6%; p Conclusiones El reumatologo es clave a la hora de transmitir informacion satisfactoria al paciente en tratamiento biologico. Debe ademas actuar de guia, ya que un elevado porcentaje busca informacion en fuentes distintas.

Altres ajuts: Merck Sharp & Dohme Spain. 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 4years of treatment.

BackgroundNeuromuscular blocking (NMB) agents are often administered to facilitate tracheal intubation and prevent patient movement during surgical procedures requiring the use of general anesthetics. Incomplete reversal of NMB, can lead to residual NMB, which can increase the risk of post-operative pulmonary complications. Sugammadex is indicated to reverse neuromuscular blockade induced by rocuronium or vecuronium in adults. The aim of this study is to estimate the clinical and economic impact of introducing sugammadex to routine reversal of neuromuscular blockade (NMB) with rocuronium in Spain.MethodsA decision analytic model was constructed reflecting a set of procedures using rocuronium that resulted in moderate or deep NMB at the end of the procedure. Two scenarios were considered for 537,931 procedures using NMB agents in Spain in 2015: a scenario without sugammadex versus a scenario with sugammadex. Comparators included neostigmine (plus glycopyrrolate) and no reversal agent. The total costs for the healthcare system were estimated from the net of costs of reversal agents and overall cost offsets via reduction in postoperative pneumonias and atelectasis for which incidence rates were based on a Spanish real-world evidence (RWE) study. The model time horizon was assumed to be one year. Costs were expressed in 2019 euros (€) and estimated from the perspective of a healthcare system. One-way sensitivity analysis was carried out by varying each parameter included in the model within a range of +/− 50%.ResultsThe estimated budget impact of the introduction of sugammadex to the routine reversal of neuromuscular blockade in Spanish hospitals was a net saving of €57.1 million annually. An increase in drug acquisition costs was offset by savings in post-operative pulmonary events, including 4806 post-operative pneumonias and 13,996 cases of atelectasis. The total cost of complications avoided was €70.4 million. All parameters included in the model were tested in sensitivity analysis and were favorable to the scenario with sugammadex.ConclusionsThis economic analysis shows that sugammadex can potentially lead to cost savings for the reversal of rocuronium-induced moderate or profound NMB compared to no reversal and reversal with neostigmine in the Spanish health care setting. The economic model was based on data obtained from Spain and from assumptions from clinical practice and may not be valid for other countries.

Luis Cea-Calvo,1 Ignacio Marín-Jiménez,2 Javier de Toro,3 María J Fuster-RuizdeApodaca,4,5 Gonzalo Fernández,1 Nuria Sánchez-Vega,1 Domingo Orozco-Beltrán6 1Medical Affairs Department, MSD Spain, Madrid, Spain; 2IBD Unit, Gastroenterology Department, Clinical Research Institute Gregorio Marañón (IiSGM), Gregorio Marañón University Hospital, Madrid, Spain; 3Rheumatology Department, A Coruña University Hospital, A Coruña, Spain; 4SEISIDA (Spanish AIDS Multidisciplinary Society), Madrid, Spain; 5Department of Social and Organizational Psychology, Universidad Nacional de Educación a Distancia (UNED), Madrid, Spain; 6Clinical Medicine Department, Miguel Hernandez University, San Juan de Alicante, SpainCorrespondence: Luis Cea-CalvoMedical Affairs Department, MSD Spain, Josefa Valcárcel 38, Madrid 28027, SpainTel +34 913210740Email luis.cea@merck.comPurpose: To investigate relationships between intentional and non-intentional non-adherence behaviors and patient experience with healthcare and beliefs in medications.Patients and Methods: This is a post hoc analysis of a cross-sectional anonymous survey distributed between May and September 2017 to patients with rheumatic disease, inflammatory bowel disease, HIV infection or diabetes mellitus from outpatient and primary care clinics in Spain. Patients answered five questions about non-adherence behaviors and completed questionnaires on their experience with healthcare (IEXPAC: Instrument to Evaluate the EXperience of PAtients with Chronic diseases) and beliefs about medicines (BMQ: Beliefs About Medicines Questionnaire).Results: Among 1530 respondents, 53% showed ≥ 1 non-adherence behavior; 35% had ≥ 1 non-intentional non-adherence behavior, and 33% had ≥ 1 intentional non-adherence behavior. Patients with HIV infection had the lowest frequency of intentional non-adherence behaviors. Non-intentional non-adherence was associated with patient beliefs (inversely with BMQ overall score) and patient experiences (inversely with IEXPAC Factor 3 sub-score, self-management). Intentional non-adherence was strongly associated with beliefs scores (directly with BMQ concerns and inversely with BMQ necessity sub-score) and inversely associated with HIV infection.Conclusion: The different associations of intentional and non-intentional non-adherence behaviors found in this study help to understand how patient experiences and beliefs influence medical non-adherence, and in the development of strategies for reducing non-adherence.Keywords: BMQ, chronic disease, IEXPAC, intentional behavior, medication adherence, patient beliefs

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.

Background and Aim In ulcerative colitis (UC), the main goals of treatment are to control disease activity and normalize health-related quality of life (HRQoL). In this study, we explored the relationship between disease activity (measured using the Simple Clinical Colitis Activity Index [SCCAI]) and patient HRQoL (measured using the EuroQoL [EQ]-5D-5L). Methods A total of 199 patients with UC were followed for 6 months. At months 3 and 6, patients completed an online SCCAI. Within 2 days of completing the SCCAI, patients completed an at-clinic EQ-5D-5L questionnaire and the treating gastroenterologist completed the SCCAI. Results A consistent and approximately linear relationship was identified between patient HRQoL and patient-completed and physician-completed SCCAIs. A lower SCCAI score corresponded to a higher EQ-5D-5L index value. Correlation between EQ-5D-5L index values and patient-completed online SCCAIs was moderate (ρ −0.49; P

Background Ulcerative colitis (UC) is a debilitating chronic condition that affects the large intestine and courses with episodes of flare and remission, being steroid-free remission the main treatment goal. Our aim was to assess the prevalence of self-medication with analgesics, and its associated factors in a Spanish cohort of UC patients. Methods An anonymous cross-sectional survey was developed by 3 IBD experts from the Spanish working group on Crohn’s disease (CD) and Ulcerative Colitis (GETECCU), one nurse of the Spanish nursing working group on inflammatory bowel disease (GETEII) and two patients from the Spanish confederation of associations of patients with CD and UC (ACCU). A link to the online survey was distributed to the ACCU affiliates and to other adult patients with UC through 50 inflammatory bowel disease (IBD) units from Spain. Participants voluntarily answered to the survey based on their own experiences during the last year. Results We collected data from 546 patients, 61% women, mean age 40 years old. Of these, 51% patients were followed-up by IBD specialists and 47% by a general gastroenterologist. Patients’ self-reported disease activity during the last year was: 125 (23%) inactive, 188 (34%) mild, 170 (31%) moderate and 63 (12%) severe. Visits to the emergency room (24%), urgent telephone calls (43%) and hospital admissions (10%) were reported by patients during the last year. A total of 320 (59%) patients declared to have self-medicated with analgesics during the past year, mostly with paracetamol [n = 247 (45%)] and metamizole [118 (22%)], followed by ibuprofen [26 (5%)] and codeine [23 (4%)]. The frequency of self-medication was higher in those patients who declared having a moderate (57%) to severe (65%) disease activity, compared with those who felt their disease was mild (45%) or inactive (39%), (p < 0.001). In addition, patients who needed urgent telephone assistance showed a higher frequency of self-medication (n = 139, 59%) [OR 2 (95% CI:1–3), p < 0.001]. Multivariate analysis revealed that self-medication with analgesics was associated to female gender [OR 2 (95% CI: 1–3), p < 0.001], intravenous (IV) biological therapy [OR 3 (95% CI: 2–5), p < 0.001] and visits to the emergency room [OR 3 (95% CI: 2–4), p < 0.001]. Conclusion Self-medication with analgesics is a common practice in patients with UC from Spain. Factors like being a woman, treatment with IV biological drugs, needing urgent telephone assistance and attending to the emergency room, were associated with self-medication with analgesics. This project was endorsed by GETECCU, GETEII, ACCU and funded by MSD Spain.

Background Medical treatment of mild-to-moderate flares of ulcerative colitis (UC) is based on topical and oral mesalazine, steroids or a combination of both. Sometimes self-medication with any of them can occur during a flare and it could interfere with clinical practice. Our aim was to assess the prevalence of self-medication with steroids in UC-patients and the reasons for this behaviour. Methods An anonymous cross-sectional survey was developed by representatives of the Spanish working group on Crohn’s disease and UC (GETECCU), the Spanish nursing working group on Inflammatory bowel disease (IBD) (GETEII) and the Spanish associations of patients with CD and UC (ACCU). A link to the online survey was distributed to adult UC patients through 50 Spanish IBD units as well as in the ACCU webpage. Participants voluntarily answered to the survey based on their own experiences. Results A total of 546 patients were included, 61% women, mean age 40 years old. Half of them (51%) were followed-up by IBD specialists, while 47% by general gastroenterologists. Thirty-six (6.6%) patients self-medicated with steroids. The main reasons to self-medicate with steroids were the need for quick relief of symptoms (n = 20, 56%), fear of worsening (n = 17, 47%) and difficulty for getting a medical appointment or being previously prescribed by the doctor (n = 9, 25%, both). Sixty-four per cent of them self-medicate once per year, while 8% self-medicate more than three times per year. Of these patients, 175 (32%) reported that self-medication lasted less than one month, while in 9 (18%) lasted for more than 3 months. Factors related to self-medication with steroids were the increased number of flares (p < 0.001), living with someone who uses oral steroids (p = 0.04), keeping the steroids left after finishing the treatment (p < 0.001), and prescription of corticosteroids in case of worsening by the primary care doctor (p = 0.02). Self-medication was less frequent in those patients who were attended by an IBD specialist (11, 3%), compared of those followed by an internal medicine physician (2, 33%), (p = 0.007), or by a general gastroenterologist (n = 23, 9%), (p = 0.02). Multivariate analysis showed that a higher number of flares [OR 7 (95% CI: 1–32), p < 0.001] and being attended by a general gastroenterologist [OR 0.08 (95% CI=0.01–0.5), p = 0.007] were both associated with a greater frequency of self-medication. Conclusion Self-medication with steroids is not a common practice in patients with UC from Spain. However, there is still room for improvement in clinical practice. Characteristics of the healthcare system and the disease may influence the rate of self-medication in UC patients. This project was endorsed by GETECCU, GETEII, ACCU and funded by MSD Spain.

Supplemental digital content is available in the text., Background Patients' experience with health care is becoming a key component for the provision of a patient-centered health care model. The aim of this study was to assess the experience with health care of patients with inflammatory arthritis and patient- and health care–related factors. Methods Patients responded to an anonymous survey provided by their treating clinical teams. The survey comprised the validated 12-item IEXPAC (Instrument to Evaluate the EXperience of PAtients with Chronic diseases) tool and demographic variables and health care–related characteristics that may affect patients' experience. Results A total of 359 of 625 surveys were returned (response rate, 57.4%). Overall, patient responses were positive (>60% gave “always/mostly” answers) for statements assessing the interaction between patients and health care professionals or patient self-management following health care professional guidance. However, positive patient responses for items regarding patient interaction with the health care system via the internet or with other patients were less than 13%. Only 25.6% of patients who had been hospitalized reported receiving a follow-up call or visit following discharge. In the bivariate analysis, experience scores were higher (better experience) in men, those seen by fewer specialists or by the same physician, and in patients treated with a fewer number of drugs or with subcutaneous/intravenous drugs. Multivariate analyses identified regular follow-up by the same physician and treatment with subcutaneous/intravenous drugs as variables associated with a better patient experience. Conclusions This study identifies areas of care for patients with inflammatory arthritis with the potential to improve patients' experience and highlights the importance of patient-physician relationships and comprehensive patient care.

Background: Surgery in Crohn’s disease (CD) may be associated with poor prognosis and clinical and surgical recurrence. The aim of this study was to describe and compare the post-operative management and outcomes of patients with CD who underwent first vs recurrent surgeries. Methods: Observational study that included adult CD patients from 26 Spanish hospitals who underwent ileocolonic resection with ileocolonic anastomosis between January 2007 and December 2010. Data were retrospectively collected from the medical records. Results: Data from 314 patients were analysed, of whom 262 (83%) underwent first surgery and 52 (17%) referred to previous CD surgeries. Baseline characteristics were similar between the two groups except for a higher rate of stricturing behavior at diagnosis among re-operated patients (P¼0.03). After surgery, a higher proportion of re-operated patients received prophylactic treatment with immunomodulators compared with patients with first surgery (P¼0.04). In re-operated patients, time to clinical recurrence was not associated with the fact of receiving or not prophylaxis, whereas, in patients with first surgery, recurrence-free survival was greater when prophylaxis was received (P¼0.03). Conclusions: After surgery, a higher proportion of patients with previous surgeries received prophylactic treatment with immunomodulators compared with patients with first surgery. Although prophylactic treatment was beneficial for preventing clinical recurrence in patients operated on for the first time, it did not significantly reduce the risk of further recurrence in patients with previous surgeries. This suggests that effective prophylactic therapies are still needed in this subset of patients, This study was funded by Merck Sharp & Dohme of Spain, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA

Background Non-adherence to medication may lead to poorer clinical outcomes and should be prevented. Objectives We describe the frequency of non-adherence behaviors in patients with rheumatic diseases and its relationship to potentially modifiable variables. Methods Data were obtained through an anonymous survey handed to patients by physicians or nurses from 25 rheumatology clinics from Spain. Patients completed the survey anonymously at home and returned it by pre-paid post mail. Five different non-adherence behaviors were defined. Co-variables analyzed were patients’ demographics, medication characteristics, experience with healthcare (assessed with IEXPAC “Instrument to Evaluate the EXperience of PAtients with Chronic diseases” scoring 0 [worst] to 10 [best experience]), and beliefs in medicines (Beliefs About Medicines Questionnaire [BMQ], composed of a necessity and a concerns subscales and scoring -20 [weaker] to +20 [stronger beliefs]). Variables associated to non-adherence were studied with a multivariate logistic regression model. Results The survey was handed to 625 patients with rheumatic diseases, of which 336 (53.8%) returned it with the necessary data completed (mean age 55 [14] years, 64% women). Of them, 188 (56.0%) described at least one non-adherence behavior. The frequencies of the specific non-adherence behaviors were: 1) Forgetfulness in taking medication: 28.6%; 2) Taking medication at unscheduled hours: 5.6%; 3) Stopping medication when feeling well: 10.1%; 4) Stopping medication when feeling sick: 33.0% and 5) Stopping medication after reading the patients’ information leaflet: 11.5%. The frequency of at least one non-adherence behavior was similar by age, gender, educational level, working status or by number of medicines. It was slightly higher in patients needing to take their medication 3-4 times a day (63.2%) versus 1-2 times a day (52.4%, p= 0.089). IEXPAC scores were similar in patients with or without non-adherence behaviors (5.5 [2.0] in both groups, p= 0.960). BMQ overall score was lower in patients with non-adherence behaviors (4.3 versus 6.5 in those without non-adherence behaviors, p= 0.001). The frequency of non-adherence behaviors did not differ by quartiles of IEXPAC score, but it was higher in patients with lower BMQ score (Q1: 59.5%, Q2: 65.9%, Q3: 54.3%, Q4: 52.0%, p-trend = 0.014). The multivariate model (table) confirmed a relationship of non-adherence behaviors with lower BMQ beliefs scores. Conclusion Non-adherence behaviors are frequent in patients with rheumatic diseases and are mainly associated to patients’ beliefs in their medications (assessed with BMQ). This is an important aspect that can be addressed by clinical teams to improve adherence and clinical outcomes. Acknowledgement: Funded by Merck Sharp & Dohme of Spain and endorsed by 4 patients associations: ACCU, CONARTRITIS, SEISIDA, FEDE. Disclosure of Interests Maria L. Garcia Vivar: None declared, Javier de Toro-Santos: None declared, Lucia Pantoja: None declared, Cristina Lerin Lozano: None declared, Silvia Garcia-Diaz: None declared, Sabela Fernandez Employee of: MSD, Yvonne Mestre Employee of: MSD, Lidia Feo-Lucas Employee of: MSD, Luis Cea-Calvo Employee of: MSD

Background Survival, or persistence in treatment with a biological drug can be considered an indirect measure of efficacy, safety and tolerability Objectives We assessed the probability of persistence (survival) of treatment with golimumab in patients with rheumatic diseases and the factors associated to persistence with up to 6 years of follow-up. Methods BIOBADASER is the Spanish registry of biological drugs of the Spanish Society of Rheumatology and the Spanish Medicines Agency. A data-base analysis was done in December 2018 on all the patients aged 18 years or more who had initiated golimumab for one of the approved indications (rheumatoid arthritis [RA], axial spondyloarthritis [SpA] or psoriatic arthritis [PsA]). The probability of persistence was calculated with a Kaplan-Meier test. Factors related to persistence were analyzed with a Cox-regression model. Results 581 patients were included (165 [28.4%] RA, 249 [42.9%] axial SpA and 167 [28.7%] PsA), mean age 51 [12] years, 53% women). Median duration of disease at the onset of golimumab was 8.0 (3.0-14.7) years. Golimumab was prescribed as first biological drug in 37.9% of the patients, as second in 32.1% and as third or further in 30.0%. Concomitant medications at golimumab initiation included steroids (28.2%), methotrexate (MTX) (35.5%), sulphasalazine (7.2%) and leflunomide (13.9%). The probability of persistence of treatment with golimumab since treatment initiation was 74.3% at year 1 (95% CI 70.3 – 77.8), 63.5% at year 2 (59.0 – 67.6), 60.5% at year 3 (55.9 – 65.8), 54.5% (49.1 – 59.7) at year 4 and 5, and 52.1% (44.9 – 57.7) at year 6. Persistence was higher when golimumab was used as first biological agent (p log-rank Conclusion The probability of persistence (survival) on therapy with golimumab was high up to 6 years of follow-up and was higher in patients treated with golimumab as first biological drug or for PsA and SpA, and lower in those needing steroids, DMARDs different to MTX and in women. Acknowledgement This study was funded by Merck Sharp & Dohme of Spain. Disclosure of Interests Manuel Pombo: None declared, Carlos Sanchez-Piedra: None declared, Eduardo Cuende: None declared, Raquel Martin-Domenech: None declared, Javier del Pino: None declared, Cristina Campos Fernandez: None declared, Javier Manero: None declared, Blanca Garcia-Magallon: None declared, Fernando Sanchez-Alonso: None declared, Federico Diaz-Gonzalez Grant/research support from: MSD, Abbvie, Roche, Novartis, Consultant for: Lilly, Novartis, Pfizer, Amgen, Biogen, Celgene, Speakers bureau: MSD, Lilly, Janssen, BMS, Roche, Maria J. Arteaga Employee of: MSD, Luis Cea-Calvo Employee of: MSD, Juan J. Gomez-Reino: None declared

Background The experience of patients with healthcare has been associated to important outcomes. Objectives We describe the experience with healthcare of patients with rheumatic diseases from Spain self-reported through IEXPAC, a validated questionnaire, and the influence of demographic and health care-related factors. Methods The IEXPAC scale (“Instrument to Evaluate the EXperience of PAtients with Chronic diseases”, http://www.iemac.es/iexpac/) was developed and validated in Spain by health care professional and social organizations, experts in quality of healthcare and chronic patients (1). It consists of 12 items with Likert responses from “always” to “never” and yields an overall score from 0 (worst) to 10 (best experience). Three factors with sub-scores derive from the scale: Factor 1 (productive interactions, average of items 1, 2, 5 and 9, on patient-health care professionals relationship), Factor 2 (new relational model, average of items 3, 7 and 11, on the use of new technologies and contact with other patients) and Factor 3 (self-management, patients’ ability to self-care, average of items 4, 6, 8 and 10). Data were obtained through an anonymous survey to patients from 25 Spanish hospitals. Bivariate comparisons and a multivariate analysis were made to explore the association between scores and demographic and health care-related characteristics. Results 625 patients received the survey, 359 (57.4%) returned it (mean age 55 years, 67% women). The percentage of patients who responded “always” or “nearly always” to the different statements is displayed in table 1. Mean overall IEXPAC score was 5.5 (SD 2.0), sub-scores were: productive interactions: 7.5 (2.5); new relational model: 1.7 (2.1); self-care: 6.5 (2.5). Overall score was higher (better experience) in men (p= 0.022), in those needing follow-up in a different region (p= 0.004), seen by a lower number of physicians (p= 0.025), seen by the same physician each time (p Conclusion Through IEXPAC, patients with rheumatic diseases identified areas of improvement in healthcare, especially those related with access to reliable information and services, interaction with other patients and continuity of health care after hospital discharge. Better experience was associated to being seen by lower number of specialists or being followed-up by the same physician each time, and also with treatment with SC/IV drugs, maybe in relation to the more personalized care these patients receive. Acknowledgement Funded by MSD of Spain and endorsed by 4 patients associations: ACCU, CONARTRITIS, SEISIDA, FEDE. We thank the participant patients for providing this valuable information by completing the survey. Disclosure of Interests Javier de Toro-Santos: None declared, Maria L. Garcia Vivar: None declared, Lucia Pantoja: None declared, Cristina Lerin Lozano: None declared, Silvia Garcia-Diaz: None declared, Yvonne Mestre Employee of: MSD, Sabela Fernandez Employee of: MSD, Luis Cea-Calvo Employee of: MSD

This study is aimed at describing the prevalence of and risk factors associated with early post-operative complications after Crohn’s disease-related intestinal resection. Methods: This was a retrospective analysis of data from the PRACTICROHN cohort. Adult Crohn’s disease patients who underwent ileocolonic resection with ileocolonic anastomosis between January 2007 and December 2010 were included. The complications evaluated included death, ileus, anastomotic leak, abscess, wound infection, catheter-related infection, digestive bleeding and other extra-abdominal infections that occurred in the 30 days after surgery.Results: A total of 364 patients (median age at surgery 38 years and 50% men) were included. Indication for surgery was: stricturing disease (46.4%), penetrating disease (31.3%), penetrating and stricturing disease (14.0%) or resistance to medical treatment (5.8%). Early complications were recorded in 100 (27.5%) patients, with wound infection, intra-abdominal abscess and anastomotic leakage being the most frequent complications. Median hospitalization duration was 16 days for patients with complications vs. 9 days without complications (P, This study was supported by Merck Sharp and Dohme, Spain

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

Inflammatory bowel disease; Patients experience; Chronic disease Malaltia intestinal inflamatòria; Experiència dels pacients; Malalties cròniques Enfermedad intestinal inflamatoria; Experiencia de los pacientes; Enfermedades crónicas To assess inflammatory bowel disease (IBD) patients' experience of chronic illness care and the relationship with demographic and healthcare-related characteristics.This cross-sectional survey used the Instrument to Evaluate the EXperience of PAtients with Chronic diseases (IEXPAC) questionnaire to identify parameters associated with a better healthcare experience for IBD patients. IEXPAC questionnaire responses are grouped into 3 factors - productive interactions, new relational model, and patient self-management, scoring from 0 (worst) to 10 (best experience). Scores were analyzed by bivariate comparisons and multiple linear regression models.Surveys were returned by 341 of 575 patients (59.3%, mean age 46.8 (12.9) years, 48.2% women). Mean (SD) IEXPAC score was 5.9 (2.0); scores were higher for the productive interactions (7.7) and patient self-management factors (6.7) and much lower for the new relational model factor (2.2). Follow-up by a nurse, being seen by the same physician, and being treated with a lower number of medicines were associated with higher (better) overall patient experience score, and higher productive interactions and self-management factor scores. A higher productive interactions score was also associated with patients receiving medication subcutaneously or intravenously. Higher new relational model scores were associated with follow-up by a nurse, affiliation to a patients' association, receiving help from others for healthcare, a lower number of medicines and a higher educational level.In patients with IBD, a better overall patient experience was associated with follow-up by a nurse, being seen by the same physician, and being treated with a lower number of medicines.

Background : In patients with Crohn's disease (CD), endoscopic recurrence precedes clinical recurrence after ileocolonic resection. Guidelines recommend ileocolonoscopy within the first year after surgery. The study examined endoscopic monitoring and treatment decisions in CD patients in a real-world setting. Methods : The Practicrohn study involved adult patients from 26 Spanish hospitals who underwent ileocolonic resection with anastomosis from 2007 to 2010. Medical records data were collected retrospectively from diagnosis to index surgery and up to 5 years after surgery. Results : Of 314 analyzed patients, 262 (83%) underwent endoscopic evaluation, but only 30% (n = 95) had planned endoscopy as part of follow-up within the first year after surgery. An upward trend was observed in the proportion of endoscopies performed or planned within the first year after surgery across the selection period. More patients with than without endoscopic recurrence in the first year after surgery had a medication change, mainly for endoscopic activity in the absence of clinical symptoms (54 vs 13%; p = 0.02). Conclusions : Between 2007 and 2010, endoscopic monitoring of patients within the first year after CD-related surgery was less than adequate based on current standards, but showed improvement. Medication changes were in general agreement with current guideline recommendations. This work was presented as a poster (number P686) by M. Barreiro-de Acosta et al. at ECCO (European Crohn's and Colitis Organisation) '18 in Vienna, Austria, 14-17 February 2018.

Objective: The objective of the current work was to assess the frequency of non-adherence behaviors and potential association with patients’ experience with healthcare and beliefs in medicines self-reported by patients with four different chronic conditions. Methods: Patients responded anonymously to a survey comprising five non-adherence behaviors (based on physician and patient input), an assessment of patients’ experience with healthcare using the validated Instrument to Evaluate the EXperience of PAtients with Chronic diseases (IEXPAC), and a validated Spanish version of the Beliefs about Medicines Questionnaire (BMQ). Associations of non-adherence behavior were analyzed using logistic regression models. Results: Of 1530 respondents, 53.1% reported ≥1 non-adherence behavior. Non-adherence rates were 59.8% in diabetes mellitus (DM), 56.0% in rheumatic disease, 55.6% in inflammatory bowel disease, and 42.8% in human immunodeficiency virus (HIV) infection patients (p < .001). IEXPAC and BMQ scores were higher in adherent vs. non-adherent patients. In multivariate analysis, non-adherence behavior was strongly associated with lower overall BMQ, lower BMQ Necessity scores and higher BMQ Concerns scores (p < .001 for all), and with a lower IEXPAC self-management score (p = .007), but not with the overall IEXPAC score. Non-adherence was more frequent in DM patients compared with HIV infection patients (p < .001). Conclusions: Patients’ beliefs in medicines-a lower perception for the necessity of medication, and higher concerns in taking medication-and low patient self-management experience score were associated with non-adherence behavior. These are modifiable aspects that need to be addressed to increase medication adherence in chronic disease.

Resumen Objetivos Describir la incidencia a los 2 anos de nuevas manifestaciones extraarticulares (uveitis, psoriasis, enfermedad inflamatoria intestinal) en la cohorte de pacientes con espondiloartritis del estudio AQUILES. Pacientes Durante 2 anos se siguieron 513 pacientes con espondiloartritis (62,5% varones, edad media 48 anos) diagnosticados de espondilitis anquilosante (EA) (55,6%), artritis psoriasica (25,3%), espondiloartritis indiferenciada (16,2%), artritis enteropatica (2,5%) y otros diagnosticos (0,4%). Los nuevos diagnosticos se basaron en los informes de los respectivos especialistas (oftalmologos, dermatologos y gastroenterologos). Resultados Se establecieron 22 nuevos diagnosticos de las manifestaciones extraarticulares estudiadas (incidencia acumulada: 4,3% [intervalo de confianza del 95% 2,4-6,1]; tasa de incidencia: 17 casos por 10.000 pacientes-ano). La uveitis fue el diagnostico mas frecuente (incidencia acumulada del 3,1%), predominantemente en pacientes con EA. En el analisis multivariable, el diagnostico de EA fue el unico predictor de aparicion de nueva manifestacion extraarticular. Conclusiones En pacientes con espondiloartritis, la incidencia de uveitis, psoriasis y enfermedad inflamatoria intestinal a los 2 anos fue globalmente del 4,3%, principalmente por nuevos diagnosticos de uveitis en pacientes con EA.

Background:Persistence in treatment with a biological drug can be considered an indirect measure of efficacy,safety and tolerabilityObjectives:We assessed the probability of persistence of golimumab treatment in patients with rheumatic diseases and the factors associated with persistence up to 7 years of follow-upMethods:BIOBADASER is the Spanish registry of biological drugs of the Spanish Society of Rheumatology and the Spanish Medicines Agency.A data-base analysis was done in Dec 2019 on all the patients aged 18 years or older who had initiated golimumab for rheumatoid arthritis (RA),psoriatic arthritis (PsA) and axial spondyloarthritis (SpA).The probability of persistence was calculated with a Kaplan-Meier test.Factors related to persistence were analyzed with a Cox-regression modelResults:There were 685 patients included (195 [28.5%] RA, 294 [42.9%] axial SpA and 196 [28.6%] PsA) in the analysis (Mean age 51.3 [12.6] years, 53.7% women). Median duration of disease at the onset of golimumab therapy was 7.6 (3.0-14.5) years. Golimumab was prescribed as first biological drug in 36.4%, as second in 31.7% and as third or further in 31.9% of the patients. Concomitant medication at golimumab initiation included methotrexate (40.0%), corticosteroids (34.2%), leflunomide (17.8%) and sulphasalazine (8.1%). The probability of persistence with golimumab treatment was 71.7% (95% CI 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. As the first biological agent the probability of persistence was 83.2% at year 1 and 60.0% at year 5. As a second biological drug persistence was 70.4% and 39.9% (year 1 and 7). Cox-regression analysis (table) showed that the probability of persistence with golimumab treatment was higher in first vs second or third biological line (Hazard Ratio[HR] for discontinuation: 1.45 for second and 3.04 for third or further vs first line), in SpA and PsA patients (HR discontinuation vs RA:0.56 and 0.49 respectively) and in patients with methotrexate (HR:0.61) and lower in those needing corticosteroids(HR:1.71) or DMARDs different to methotrexate (HR:1.88) and in patients with higher disease activity at golimumab onset (HR:1.45)Conclusion:The probability of persistence on golimumab therapy was high and remained relatively stable up to 7 years of follow-up. A lower risk of treatment discontinuation was observed in patients who received golimumab as first biological agent and in PsA and SpA patients. Persistence was lower in patients needing corticosteroids, DMARDs different to methotrexate and in those with higher disease activity at golimumab onsetCox-regression analysis.HR for discontinuation of golimumabHR95% CIpAge at golimumab initiation1.01(0.99-1.02)0.480Gender (women vs men)1.15(0.69-1.90)0.595Smoking habit (smoker vs non-smoker)1.46(0.90-2.37)0.128Smoking habit (past smoker vs non-smoker)0.94(0.48-1.84)0.859Overweight (vs normal)1.10(0.63-1.93)0.728Obesity (vs normal)0.90(0.51-1.59)0.708SpA vs RA0.56(0.31-1.00)0.050PsA vs RA0.49(0.28-0.87)0.015Second vs first biological drug1.45(0.85-2.46)0.171Third or further vs first biological drug3.04(1.86-4.98)0.001MTX0.61(0.38-0.97)0.037Other DMARD1.88(0.90-3.93)0.091Corticosteroids1.71(1.04-2.83)0.036Activity higher than median1.45(0.96-2.19)0.078Acknowledgments:BIOBADASER is a multi-funded registry of The Spanish Society of Rheumatology (SER) and this specific analysis was funded by MSD Spain.Disclosure of Interests:Manuel Pombo: None declared, Carlos Sánchez-Piedra: None declared, Luis Cea-Calvo Employee of: MSD Spain, Sara Manrique Arija: None declared, Blanca Garcia-Magallon Consultant of: MSD, Speakers bureau: Pfizer, Amgen, Celgene, MSD, Cristina Campos Fernández: None declared, Irene Notario: None declared, Federico Diaz-Gonzalez: None declared, Juan Jesus Gomez-Reino: None declared

Background Self-medication, when agreed with the treating physician, is an essential component of self-care. We describe the associated factors and the reasons related to the practice of self-medication with steroids, aminosalcylates (AS) or analgesics in patients with ulcerative colitis (UC) in Spain. Methods Information was anonymoulsy provided by patients through a web-based cross-sectional survey developed by 3 inflammatory bowel disease (IBD) experts from the Spanish working group on IBD (GETECCU), one nurse from the Spanish nursing working group on IBD (GETEII) and two patients from the Spanish confederation of associations of patients with IBD (ACCU). Participants voluntarily answered to the survey based on their own experiences from February to April 2019. Reasons for self-medication are described as frequencies and associated factors through logistic regression models. Results A total of 546 patients (61% women, mean age 40 years old) responded. Of these, 36 (7%) patients self-medicated with corticosteroids, and was associated with higher number of UC self-reported flares during the past year [OR 7 (95% CI: 1–32), p < 0.001] and follow-up by a general gastroenterologist instead of in an IBD unit [OR 0.08 (0.01–0.5), p = 0.007]. Self-medication with AS was reported by 90 patients (16%) [oral 20 (22%) and topic 70 (78%)], and was associated with treatment with topical AS [OR 3 (95% CI: 2–4), p < 0.001]. Finally, 320 patients (59%) self-medicated with analgesics and this was associated with female gender [OR 2 (95% CI: 1–3), p < 0.001], need of intravenous (IV) biological therapy [OR 3 (95% CI: 2–5) p < 0.001] and emergency room visits within the past year [OR 3 (95% CI: 2–4), p < 0.001]. The main reasons for self-medication were ‘need for quick relief of symptoms’, ‘fear of worsening’ and, for AS, ‘agreed with the doctor’ (Table 1). Conclusion Self-medication in UC is not a common practice, but most of the times it is not agreed with the treating physician. Self-medication with analgesics was more frequent, probably reflecting a need of self-care. Female sex, number of flares, IV treatment, and need of emergency room care were factors associated to self-medication. This project was endorsed by GETECCU, GETEII, ACCU and funded by MSD Spain.

[Abstract] 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

Ulcerative colitis (UC) may cause many patients to miss out on important personal and professional opportunities. We therefore conducted a survey (UC-LIFE) to assess patients' perceptions of the impact of UC on social and professional lives.Consecutive unselected UC patients aged ≥18 years were recruited from 38 outpatient clinics in Spain. Patients completed the survey at home, returning it by post. The survey comprised 44 multiple-choice questions, including questions about the impact of UC on social, personal, professional, and academic activities.Of 585 patients invited, 436 (75%) returned the survey (mean age 46 years; 47% women). High proportions of patients considered their disease "sometimes", "frequently" or "mostly/always" influenced leisure activities (65.1%), recreational or professional activities (57.6%), or relationships with relatives or friends (9.9%). Patients also reported that UC influenced their decision to have children (17.2%), or their ability to take care of children (40.7%); these percentages were higher in women and in younger patients. Overall, 47.0% of patients declared that UC influenced the kind of job they performed, 20.3% had rejected a job due to UC, 14.7% had lost a job due to UC, and 19.4% had had academic problems due to UC.Beyond symptoms alone, UC imposes an enormous additional burden on patients' social, professional, and family lives. This extra burden clearly needs to be addressed so that the ultimate goal of IBD treatment - normalization of patient quality of life - can be attained by as many patients as possible.

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.

Background: Insights from patients are important for health care planning Objectives: In this study we describe the perception of patients with 4 different chronic conditions with health care in Spain through the IEXPAC scale (“Instrument to Evaluate the EXperience of PAtients with Chronic diseases”), a scale developed and validated in Spain. Methods: The IEXPAC scale (http://www.iemac.es/iexpac/) was developed and validated in Spain by health care professional and social organizations, experts in quality of health care and chronic patients. The scale is structured in 12 items with Likert responses from “always” to “never”, yields a score from 0 (worst experience) to 10 (best experience), and identifies aspects of health care needing improvement. A survey was handed to patients needing care in at least two different levels (i.e. primary care and hospital) and with one of the following chronic conditions A) Rheumatic diseases, B) Inflammatory bowel disease (IBD), C) Human immunodeficiency virus infection (HIV) and D) Diabetes mellitus (DM) plus cardiovascular or renal chronic disease. Patients completed the survey at home and responded by pre-paid mail. Results: 2474 patients received the survey, 1618 (65.4%) returned it (359 with rheumatic disease, 341 with IBD, 467 with HIV infection, 451 with DM, mean age 56 years, 41% women). Only 6.1% were affiliated to a patients association. Patients declared a median of 8 visits (IQR 25–75: 4–15) to primary care or specialty clinics in the last year and 29% had visited an emergency room. In the last 3 years 48% had been hospitalized. Up to 61% reported to search for information on diseases, therapies, lifestyle or diet in webpages, general or social media. Responses to the IEXPAC items (percentages that responded “mostly” + “always” to each item) are displayed in the table. In general, these % were higher in HIV patients, which represents a better experience with health care. In some items, patients with rheumatic diseases scored lower (table 1). Mean IEXPAC score was 6.0 (SD1.8) and was higher in HIV patients (table 1). Worst scores were seen in items related to access or guidance for getting reliable information on health and on social resources, contact with other patients and follow-up after hospital discharge. Conclusions: The IEXPAC questionnaire identified areas of improvement in chronic patients health care in Spain, especially those related with access to reliable information and services, interaction with other patients and continuity of health care after hospital discharge. Patients with HIV infection scored higher, maybe consequence of a more personalized care. In several items, patients with rheumatic diseases scored lower Acknowledgements: Funded by Merck Sharp & Dohme, Spain, with endorsement of 4 patients associations: CONARTRITIS (patients with rheumatid diseases), ACCU (patients with IBD), SEISIDA (HIV multidisciplinary group), FEDE (patients with DM) Disclosure of Interest: None declared

Background: Improving quality of life is a goal in the treatment of patients with rheumatic diseases. Objectives: In this work, we describe the self-assessment of quality of life made by patients with rheumatic diseases and with other chronic diseases through an anonymous survey in the context of a wider project on quality of care. Methods: In the context of a quality of care project, focused in the perceptions of chronic patients with health care in Spain (assessed with the IEXPAC scale (“Instrument to Evaluate the EXperience of PAtients with Chronic diseases”, http://www.iemac.es/iexpac/), a survey was handed patients with 4 different profiles of chronic diseases needing care in at least two different levels (i.e. hospital clinic and primary care): A) Patients with rheumatic diseases (rheumatoid arthritis or spondyloarthritis) from hospital clinics, B) Inflammatory bowel disease (IBD) patients from hospital clinics, C) Patients with human immunodeficiency virus (HIV) infection from HIV units and D) Patients with diabetes mellitus (DM) plus cardiovascular or renal chronic disease from primary care or endocrinology clinics. Patients were handed the survey and completed the survey at home, returning it by pre-paid mail. As part of the survey, they completed the quality of life questionnaire EQ-5D-5L. Results: 2474 patients received the survey, 1618 (65.4%) returned it (359 with rheumatic disease [mean age 55 years, 63% women], 341 with IBD [mean age 47 years, 48% women], 467 with HIV infection [mean age 52 years, 27% women], 451 with DM [mean age 70 years, 32% women). Patients with rheumatic diseases more frequently described moderate or severe problems with mobility, self-care and usual activities and reported more pain (table 1). Patients with rheumatic disease and IBD more frequently reported anxiety or depression (table 1). Scores in the Visual Analogic Scale “Your Health Today” (from 0 worst health to 100 best health) were lower in patients with rheumatic diseases (mean score 61.9 [SD 19.5]) than in patients with IBD (68.8 [17.8]), HIV infection (73.3 [19.1]) or DM (67.0 [17.1]), all multiple comparison tests rheumatic disease versus other, p Conclusions: Self-evaluation by patients showed that quality of life of patients with rheumatic diseases (rheumatoid arthritis, spondyloarthritis) is worse that that of patients with IBD, HIV infection or DM. Improving quality of life is an essential goal to achieve in the care of patients with these rheumatic diseases. Acknowledgements: Funded by Merck Sharp & Dohme of Spain and endorsed by 4 patients associations (CONARTRITIS: patients with arthritis; ACCU: patients with Crohn’s disease and ulcerative colitis; SEISIDA: AIDS multidiscipline group, FEDE: patients with diabetes mellitus). Disclosure of Interest: None declared

Objectives In this retrospective study we assess the 1 to 3 year probability of persistence on golimumab in patients with spondyloarthritis (SpA), axial SpA or psoriatic arthritis (PsA) who started treatment with golimumab as second biological (after withdrawal of a first anti TNF-alpha drug) Methods GO-BEYOND was a retrospective study undergone in 20 Spanish rheumatology clinics. Information was collected on all axial SpA and PsA patients who initiated golimumab between January 2013 and December 2015 as second anti TNF-alpha (i.e. after discontinuation of a first anti TNF-alpha drug). Centres in which all the patients could not be included were excluded from the analysis. The probability of persistence was calculated with a Kaplan-Meier test and comparisons were done with the log-rank test. Results 210 patients were included (131 with axial SpA and 79 with PsA, mean age 49 years [SD=12], 40% women, median duration of disease at the initiation of golimumab 80.5 months). Reasons for discontinuation of the first anti TNF-alpha were loss of efficacy (71.4%), poor tolerability or adverse event (11.0%) and patient or physician preference (17.6%). During a median follow-up of 29.3 months, 72 of 210 patients (34.3%) discontinued golimumab, due to primary failure (n=21), disease reactivation or secondary failure (n=29), poor tolerability (n=4), adverse events (n=10), inactive disease or patient-physician agreement (n=8). The probability of persistence on golimumab since treatment initiation was 80% at year 1 (95% CI 75–86), 70% at year 264 – 77 and 65% at year 3 [59 – 72]. The figures were similar in patients with axial SpA or PsA, and in patients who discontinued the first anti TNF-alpha due to loss of efficacy or to other reasons (p=0.121 and p=0.835, table 1). n=number at risk, SpA=Spondyloarthritis; PsA=Psoriatic arthriitis Conclusions After discontinuation of a first anti TNF-alpha, patients with spondyloarthritis showed a high probability of persistence on golimumab. The probability of persistence was similarly high in patients with axial SpA or PsA, and in patients who discontinued the first anti TNF-alpha due to loss of efficacy vs other reasons. Real life effectiveness of golimumab as second anti TNF-alpha is high and durable in SpA patients. Acknowledgements This Study was funded by Merck Sharp and Dohme, Spain Disclosure of Interest None declared

Objectives In patients with spondyloarthritis (SpA: axial SpA or psoriatic arthritis [PsA]), treated with golimumab as second biological therapy (after failure or withdrawal of a first anti TNF-α drug), we describe patients’ insights with regard to their beliefs and their satisfaction with golimumab therapy. Methods Patients on golimumab from GO-BEYOND, a retrospective study undergone in 20 Spanish rheumatology clinics, were requested to respond to the Beliefs About Medicines Questionnaire (BMQ). Statements of the BMQ include a 5-item necessity and a 5-item concern scale with Likert response options from “strongly agree” to “strongly disagree”. Patients also responded to questions on their satisfaction and experience with golimumab self-injection. Descriptive data are displayed, and responses to the BMQ in axial SpA vs PsA patients were compared with the chi-square test. Results 123 patients on golimumab as second anti TNF-α responded (81 axial SpA and 42 PsA, mean age 49 years [SD=11], 40% women). Patients showed strong beliefs in the necessity of golimumab for the treatment of their SpA (percentages of “agree” or “strongly agree” to the necessity statements: 50%–80%), but also concerns: half the patients agreed/strongly agreed to be worried about long term effects of golimumab, and ≈30% about becoming too dependent on the drug (table 1). Responses were similar in axial SpA and PsA patients (table 1). 111 patients declared to self-inject golimumab. Of these, 22.7% considered the experience with self-injection as very positive, 66.4% as positive, 10.0% neutral and only 0.9% unfavourable, and the use of the device very easy (37.3%), easy (57.3%), neutral (3.6%) and only 1.8% difficult. Finally 36.4% and 49.1% were very satisfied or satisfied with the interval of administration of golimumab, 11.8% were neutral and only 1.8% and 0.9% declared to be dissatisfied or very dissatisfied. Conclusions Patients with SpA currently using golimumab as second anti TNF-alpha describe strong beliefs in the necessity of golimumab and good experience and satisfaction with self-administration. The BMQ also identified concerns that should be addressed in the clinic. The study is limited to the subset of patients still on golimumab at the study visit. Acknowledgements Funded by Merck Sharp and Dohme, Spain Disclosure of Interest None declared

Background Adherence is a critical factor in the therapeutic response in rheumatoid arthritis (RA), which may be influenced by the doctor-patient relationship. In the ARCO study, we previously reported a percentage of lack of adherence to the subcutaneous biologic of 14.3% during the first 14 months of treatment, and that the adherence was better in patients without induction and with a monthly administration schedule.1 In this post hoc analysis, we explored whether doctor-patient disagreements may be related to lower adherence rates. Objectives To analyse the percentage of patients with discrepancies in the evaluation of the activity of the disease between doctors and patients and a possible association between the existence of disagreement and adherence to subcutaneous biological drugs. Methods The ARCO study was a multicenter, cross-sectional study in which patients with RA were included according to EULAR-ACR 2010 criteria, who had been prescribed a subcutaneous biological drug in the previous 12–18 months. As part of the evaluation of the disease, patients and doctors were asked to rate the disease on a visual analogue scale (VAS), with values ranging from 0 to 10; with higher values indicating worst symptoms. Disagreement was defined as a difference of >/=3 points between the absolute values. Adherence was assessed retrospectively by means of the Medication Posession Ratio (MPR), considering adherence those patients with MPR >80%. The association between adherence and disagreement was studied using bi and multivariate logistic regression models with covariates-adjustments. Results We included 360 patients (77.5% women, mean age: 55±0.6 years). Disagreement was detected in 56 (15.5%). In patients with disagreement, the mean VAS score of the patient was 5.75±1.8 versus 2.7±2.2 in the group without disagreement (p Conclusions We observed a disagreement between patients and doctor VAS scores in 15.5% of cases, with higher values coming from patients. We did not observed an association between this disagreement and adherence to subcutaneous biological drugs. Reference [1] Calvo-Alen J, Monteagudo I, Salvador G, Vazquez-Rodriguez TR, Tovar-Beltran JV, Vela P, et al. Non-adherence to subcutaneous biological medication in patients with rheumatoid arthritis: a multicentre, non-interventional study. Clin Exp Rheumatol2017;35(3):423–30. Acknowledgements This is a secondary analysis of the ARCO study, which was financed by Merck Sharp and Dohme Spain. Disclosure of Interest T. Oton: None declared, J. Calvo-Alen : None declared, L. Cea-Calvo Employee of: Merck Sharp and Dohme S.A, L. Carmona: None declared

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

Health Administration; Public Health; Quality of Life Research Administración sanitaria; Salud pública; Investigación de calidad de vida Administració sanitària; Salut pública; Investigació sobre la qualitat de vida Background Patient experience is acknowledged as a principal aspect of quality healthcare delivery, and it has implications with regard to outcomes. Objectives Our objective was to evaluate the healthcare experience of patients with chronic diseases to identify patient-perceived healthcare gaps and to assess the influence of demographic and healthcare-related variables on patient experiences. Methods A cross-sectional survey was delivered to adult patients with chronic diseases: diabetes mellitus (DM), human immunodeficiency virus (HIV) infection, inflammatory bowel disease (IBD) or rheumatic diseases. Patient experiences were assessed with the Instrument for Evaluation of the Experience of Chronic Patients (IEXPAC) questionnaire, with possible scores ranging from 0 (worst) to 10 (best experience). Results Of the 2474 patients handed the survey, 1618 returned it (response rate 65.4%). Patients identified gaps in healthcare related mainly to access to reliable information and services, interaction with other patients and continuity of healthcare after hospital discharge. The mean ± standard deviation (SD) IEXPAC score was 6.0 ± 1.9 and was higher for patients with HIV (6.6 ± 1.7) than for those with rheumatic disease (5.5 ± 2.0), IBD (5.9 ± 2.0) or DM (5.9 ± 1.9) (p

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.