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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 Adequate information to patients on disease and therapies is important to improve lifestyle, adherence to treatments and outcomes. Objectives To describe which are the main sources of information for patients with rheumatic diseases treated with subcutaneous (SC) biological drugs, which ones they consider relevant, and their satisfaction with the information received from the clinical team. Methods RHEU-LIFE was a survey to patients >18 years with rheumatoid arthritis, axial spondyloarthritis or psoriatic arthritis treated with SC biological drugs, from 50 rheumatology outpatient clinics from Spain. The patients completed the survey anonymously at home. They selected from a list: 1) their sources of general information on disease (multiple choice), 2) the most important (one option), 3) who had informed them about the treatment alternatives (multiple choice) and 4) about the SC biological drug (multiple choice). Results The survey was given to 1000 patients, 592 responded (59.2%, mean age 51.7 years [SD 13.2], 42.4% men, 57.6% women). The main source of general information on disease was the rheumatologist (92.3%). Other sources mentioned were the primary care physician (21.7%), nurses (19.3%), medical websites (19.8%) or health related blogs (5.6%), brochures for patients (11.5%), friends or relatives (6.3%), patient associations (4.4%) or other patients (3.1%) and pharmacists (3.4%). Information about treatment options and the SC biological drug came mainly from the rheumatologist (>90%) and infrequently from nurses or hospital pharmacists (Table). 46.1% mentioned having received only oral information, 6.0% only written and 45.2% both ways. Some 44.5% and 42.6% reported to be “very satisfied” and “satisfied” with the information received respectively, 10.6% “neither satisfied nor dissatisfied” and 2.1% and 0.2% “dissatisfied” or “very dissatisfied”. 45.2% alleged to search for information about the biological treatment in sources other than the hospital clinical staff. Conclusions The rheumatologist is the main source of information for patients on SC biological drugs. Nurses and hospital pharmacists are seldom mentioned, even though being very often visited for drug dispensing. Satisfaction with the information received is high, however nearly half said to have searched for information on the biological drug in alternative sources. Acknowledgement This survey was financed by Merck Sharp & Dohme of Spain and endorsed by the patient9s association ConArtritis (Arthritis National Coordinator). Disclosure of Interest None declared

Background Lack of adherence to medication in rheumatoid arthritis (RA) can worsen disease activity. Objectives To evaluate the risk of non-adherence to disease modifying antirheumatic drugs (DMARD) in RA patients treated with subcutaneous (SC) biological therapy. Methods ARCO was a retrospective study in RA patients ≥18 years-old from 42 Spanish hospitals on SC biological therapy. The risk of non-adherence to oral DMARD was evaluated using the Compliance Questionnaire in Rheumatology (CQR), a questionnaire validated against an electronic medication-monitoring system, for a cut-off point of taking ≤80% of the doses. Patients completed the Beliefs About Medicines Questionnaire (BMQ) and the Carbonell satisfaction questionnaire (Spanish validated questionnaire on satisfaction with medication). Results 364 patients were included (mean age 54.9 years [SD 12.5]; 77.5% women median RA duration 7.8 years). Complete CQR was available for 304 patients, of which 21.7% showed risk of non-adherence to oral DMARD (95% CI: 17.4 – 26.7%). The percentage was similar in men and women, and greater in extremes of age (>63 and ≤48 years-old), in those currently working and in patients with no comorbidities (Table). There was a trend to a higher percentage at risk of non-adherence in non-Caucasian patients, those with higher educational level and in those with risk of alcoholism (AUDIT questionnaire) (Table). The percentage with risk of non-adherence was similar in patients with 1, 2 or >2 oral drugs for RA, and in those treated or not with SC methotrexate, and it was higher in those who considered that the effect of their treatment for RA on the symptoms had been less than expected (38.1% vs 17.9% in those who thought it had been greater, p=0.029). No differences were seen with regard to the result of the BMQ. Conclusions In patients with RA treated with SC biological therapy, 21.7% showed risk of non-adherence to DMARD according to the CQR (taking ≤80% of the doses). The percentage was higher in extremes of age, patients with university degree, employed, without comorbidities and in those who considered that the treatment effect on RA had been lower than expected. Acknowledgement The ARCO study was funded by Merck Sharp & Dohme Spain. Disclosure of Interest None declared

Background Preferences of patients and satisfaction with the medication are important to improve adherence and outcomes. Objectives In patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA) and psoriatic arthritis (PsA), we explored the attributes of drugs preferred by them, and the degree of satisfaction with the current medication. Methods RHEU-LIFE was a survey to patients >18 years-old with RA axial SpA or PsA treated with subcutaneous (SC) biological drugs, from 50 outpatient rheumatology hospital clinics. Patients responded anonymously to the survey. They ranked 5 treatment attributes from 1 (the most important) to 5 (the least important), and expressed their satisfaction with each one from “very satisfied” to “very dissatisfied”. Results The survey was given to 1000 patients, 592 responded (59.2%, mean age 51.7 years, 42.4% men and 57.6% women; underlying disease RA: 304 (54.2%), axial SpA: 141 (25.1%), PsA: 116 (20.7%), not identified: 31. The biological drug was first (60.4%), second (26.8%) and third or more (13.5%). The attributes mentioned most frequently as “the most important” were normalization of quality of life (QoL) and symptoms control (43.6% and 32.5%, table). The importance was similar in patients with different diseases or treated with first, second or third biologic. The percentage “satisfied” or “very satisfied” was high for every attribute (80% or higher, table) and similar between patients with different conditions. The percentage “satisfied” or “very satisfied” with symptoms control and normalization of QoL was greater in those receiving the first biologic (87.8% and 85.7%) and lower with the third or more (78.4% and 72.0%, both p Conclusions Patients with rheumatic diseases treated with SC biological drugs give more importance to normalization of the quality of life and symptom control than to tolerability, speed of action and the comfort or easeness of use, and express a high degree of satisfaction with their current treatment, especially those receiving therapy with a first biologic. Acknowledgement Financed by Merck Sharp & Dohme of Spain and endorsed by the patients9 association ConArtritis (Arthritis National Coordinator). Disclosure of Interest None declared

Background Lack of adherence to medication in rheumatoid arthritis (RA) can worsen disease activity, but data on adherence to biological drugs is scarce. Objectives To evaluate RA patients adherence to the subcutaneous (SC) biological treatment prescribed by the physician during the first year of treatment. Methods Retrospective study in RA patients ≥18 years-old from 42 Spanish hospitals, which had been prescribed a SC biological drug 12 to 18 months prior to the study visit. Data were collected from patients9 clinical records and hospital pharmacy drug-dispensing logs. Adherence was evaluated through the Medication Possession Ratio (MPR) (actual number of days covered by the taken medication/theoretical number of days covered by the prescribed medication). The number of days theoretically covered was calculated considering the interval of administration of the prescribed biological drug, if induction dose was prescribed, and if there were suspension periods or changes in the dose. The actual number of days covered was calculated with the number of vials that the patient had taken from the hospital pharmacy during the study period. Non-adherence was diagnosed if MPR was ≤80%. Results 364 patients were included (age 54.9 years [12.5]; 77.5% women, median RA duration 7.8 years). The initial interval of administration of the biological drug was weekly (44.2%), biweekly (39.1%) and monthly (17.3%); the median duration of the period studied was 14.8 months. For the primary analysis, 363 patients were valid, of which 52 patients were non-adherent (MPR ≤80%) to the prescribed schedule (14.3%; 95% CI: 11.1–18.3). There were no differences in adherence by age ranges, gender or other socio-demographic factors, such as level of education, smoking habit or alcohol intake, employment status, comorbidities or polypharmacy (all, p= NS). Non-adherence was less frequent in patients with a monthly administration schedule (6.4%) than in patients with a weekly (17.4%, p=0.034) or biweekly administration (14.4%, p=0.102), and slightly more frequent in those receiving induction (21.6% vs 12.5% without induction, p=0.068). No differences were observed between patients who used syringes or pen devices, or in patients who had periods of treatment interruption. Conclusions In RA patients, 14.3% were non-adherent to the prescribed SC biological medication during the first year of treatment, with no differences related to socio-demographic variables. Adherence was higher in those patients with monthly subcutaneous administration. Acknowledgement The ARCO study was funded by Merck Sharp & Dohme of Spain. Disclosure of Interest None declared

Background Patients9 perception on the usefulness of their medicines is important to implement actions that increment confidence and minimize concerns. Objectives To describe the beliefs that patients with rheumatoid arthritis (RA) treated with subcutaneous (SC) biological drugs have on their oral and SC biological medications for RA. Methods ARCO is a cross-sectional study in RA patients >18 years-old on SC biological drugs from 42 Spanish hospitals. The beliefs on medication was assessed with the Spanish version of the Beliefs About Medicines Questionnaire (BMQ), obtaining their agreement with each statement through a Liker scale from 1 (strongly disagree) to 5 (strongly agree). The BMQ score was obtained subtracting the “concerns subscale” score from that of the “necessity scale” Results 364 patients were included (mean age 54.9 years [SD 12.5]; 77.5% women, median RA duration 7.8 years). The mean scores of the BMQ for the oral and SC biological medication were 5.60 (SD 5.03) and 5.22 (SD 5.43) respectively; the median for both was 5 (p = NS). For the oral medication, 84.4% of the patients scored higher in the necessity subscale than in the concerns subscale, whereas for the SC biological the percentage was 78.3%. Some 73.3% scored necessity > concerns for both drugs, whilst 4.4% scored necessity Conclusions RA patients show strong positive beliefs about the necessity of their medicines for RA, although a substantial percentage also describes concerns. The beliefs are similar for oral and SC biological medicines. Rheumatologists should contribute to improve aspects related to specific patients9 concerns. Acknowledgement The ARCO study was funded by Merck Sharp & Dohme Spain. Disclosure of Interest None declared

Background Rheumatic diseases impair patients9 everyday life but this is rarely assessed in clinical studies. Objectives To describe the social and emotional impact perceived, as a consequence of the disease, by patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA) and psoriatic arthritis (PsA) treated with biological drugs. Methods RHEU-LIFE was a survey to patients with RA, axial SpA and PsA from Spain. Rheumatologists from 50 outpatient hospital clinics handed the survey to 20 consecutive patients >18 years-old who attended the clinic, they completed the survey at home and returned by pre-paid post mail. Patients were surveyed on the perceived impact of their rheumatic disease on five areas: 1) quality of life in general; 2) emotional state; 3) work or daily activity; 4) personal relations and 5) life of their families, responding with the options “no impact”, “some”, “moderate” or “severe”. Results The survey was given to 1000 patients; 592 responded (response rate 59.2%, mean age 51.7 years [SD 13.2], 42.4% men and 57.6% women). Patients9 disease were RA (n=304, 54.2%), axial SpA (n=141, 25.1%) and PsA (n=116, 20.7%). 31 patients did not identify their disease. The percentage of patients who considered that the disease moderately or severely affected the different areas is shown in the table. A higher percentage of women vs men declared that the disease moderately or greatly affected all the areas (table). Similarly, aged patients described a greater impact than those who were younger (table). No differences were observed with regard to the disease, with similar percentages of patients with RA, axial SpA or PSA declaring “moderate” or “severe” impact in all areas (all, p>0.1). Conclusions Patients with RA, axial SpA and PsA treated with biological drugs describe a significant impact in their quality of life, work or daily activity, emotional state, personal relations and life of their families, especially women and elderly patients. The impact was ranked similarly regarding the baseline disease. Acknowledgement This survey was financed by Merck Sharp & Dohme of Spain and endorsed by the patients9 association ConArtritis (Arthritis National Coordinator). Disclosure of Interest None declared

Background Patients with spondyloarthritis (SpA) frequently show other immune-mediated inflammatory diseases (IMID) Objectives To describe the 2-year incidence of new diagnoses of IMID in patients with SpA recruited for the AQUILES study Methods AQUILES was a prospective observational study on 3 independent cohorts of patients aged ≥18 years-old with SpA, inflammatory bowel disease (IBD) or psoriasis recruited from rheumatology, IBD and dermatology offices from 15 hospitals in Spain. Patients were followed for 2 years. In the SpA cohort, the diagnosis of new IMID was based on reports from gastroenterologists (IBD), dermatologists (psoriasis) or ophthalmologists (uveitis) Results A total of 513 patients with SpA completed the 2-year follow-up (mean age: 48 years-old; 37.5% females, 62.5% males). Median duration of disease was 7.8 years. The diagnoses at baseline were: ankylosing spondylitis (AS) (n=285), psoriatic arthritis (PsA) (n=130), enteropathic arthritis (n=13), undifferentiated arthritis (n=83) and others (n=2). At baseline, 45% had other IMID (4.9% IBD; 28.7% psoriasis; 14.6% uveitis). During the 2-year period, 22 new diagnoses of incident IMID were recorded (cumulative incidence: 4.3%, 95% CI: 2.4-6.1; incidence rate: 17 cases per 10,000 patients-year). The predominant incident IMID was uveitis (16 cases, cumulative incidence 3.1%, 95% CI: 1.5-4.7). In the subgroup with AS, there were 16 new cases of IMID (5.6%; 13 of them uveitis [4.6%], 1 IBD [0.4%] and 2 psoriasis [0.8%]). In patients with PsA only 2 patients developed a new IMID (2 new diagnoses of psoriasis [1.5%]). In those with undifferentiated SpA, there were 2 new diagnoses of uveitis (2.4%) and 1 psoriasis (1.2%), and 1 patient with enteropathic arthritis developed uveitis. There were no differences in the incidence by patient9s age, gender, duration of disease, extra-articular manifestations or family history of SpA, and the multivariate analysis identified the diagnosis of AS as the only predictor of development of new IMID (OR: 3.5 [1.0-15.3, p=0.049] versus psoriatic arthritis) Conclusions In SpA patients recruited for the AQUILES study, the 2-year cumulative incidence of new IMID was 4.3%, mostly due to new patients with diagnosis of uveitis in patients with AS. Diagnosis of AS at baseline was the only predictor for the development of a new IMID Acknowledgements The AQUILES study was funded by Merck Sharp & Dohme of Spain. The authors thank the investigators for the recruitment and follow-up of patients Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.3090