D. Gomez

OP0148 Effectiveness of Conventional DMARDS Using A Treat to Target Strategy in the Context of A Large Cohort of Rheumatoid Arthritis Patients

Background The importance of early effective therapy, implications of disease activity in progression and use of composite disease activity measures in rheumatoid arthritis (RA), led to developing of defined therapeutic targets and tools to achieve them resulting in the Treat to Target (T2T) initiative. This strategy is being used last 2 years in Colombia in a specialized in RA center. Objectives The aim of this study was to describe general change in Disease Activity Score 28 (DAS28) using A T2T strategy during a 24 month period in a large cohort of RA patients treated with conventional DMARDs. Methods A descriptive cross-sectional study was performed. Patients from a rheumatologic center with diagnosis of RA (ACR 1987 and 2010 ACR/EULAR criteria) were assessed applying a T2T strategy. A standardized follow-up was designed using DAS28: every 3-5 weeks (DAS28 >5.1), every 7-9 weeks (DAS28 ≥3.2 and ≤5.1), and every 11-13 weeks (DAS28 <3.2). In case of DAS28 >3.2 it was mandatory to introduce adjustments in treatment based on a predetermined clinical guideline. We calculated percentages and averages from this data and divided patients in four groups: remission (Rem), low disease activity (LDA), moderate disease activity (MDA) and severe disease activity (SDA). Global change in DAS28 was determined at beginning, 6, 12, and 24 months an assessed using Chi-square test. Results 705 patients were included in this study, 560 (79.3%) women and 145 (20.5%) men. All patients had established disease (more than 2 years of duration) and average age 60.1 y/o. Regarding the entire cohort, majority of patients were using DMARDs alone or in combination 450 (63.8)% of patients were using methotrexate, 481 (68.22%) leflunomide, 176 (24.9%) sulfasalazine, and prednisolone 126 (17.8%). The difference of medians for each variable showed improvement with statistical significance (p<0.00). Activity Month 0, n (%) 6 Months, n (%) 12 Months, n (%) 24 Months, n (%) REM 292 (41.4) 432 (61.2) 498 (70.5) 523 (74.1) LDA 108 (15.3) 143 (20.3) 90 (12.7) 87 (12.3) MDA 254 (36.0) 113 (16.0) 99 (14.0) 80 (11.3) SDA 51 (7,2) 17 (2.4) 18 (2.5) 15 (2.1) p<0.00. Conclusions This study shows general improvement of DAS28 in RA patients treated with conventional DMARDs applying a T2T strategy; it was found a globally increase in the percentage of patients in remission group and decrease in MDA/SDA groups. Standard T2T follow-up in patients with RA should be done based on: correct use of disease activity scores and visits/treatment decisions based on, and was proved that achieving remission/LDA using only conventional DMARDs is a realistic goal in clinical practice. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.4824

SAT0108 Misdiagnosis of Rheumatoid Arthritis – The Photography

Background There is a lack of expertise in rheumatoid arthritis (RA) diagnosis in primary level of Colombian medical centers, leading to misdiagnosis; many times osteoarthritis (OA) and another rheumatic diseases are misdiagnosed as RA which derives in wrong treatment for patients with clinical and health economics implications. Objectives The objective of this study was to describe demographic and clinical characteristics of a cohort of patients derived to a specialized RA center with presumptive RA diagnosis and finally diagnosed as osteoarthritis. Methods A descriptive, cross sectional study. Were included patients who were referred from primary care centers to a RA specialized center in a 36 month period with presumptive diagnosis of this disease. Each patient was evaluated to confirm or rule-out diagnosis of RA as follows: a rheumatologist fulfilled a complete medical record, including joint counts; it was assessed rheumatoid factor and anti-citrullinated antibodies, and other laboratories depending on each case. Also were made x-rays of hands and feet, and in some cases of persistent doubt about the diagnosis was requested comparative MRI of hands or/and feet. Frequencies and percentages were calculated for the demographic and clinical characteristics of the cohort of patients in which the diagnosis of RA was ruled-out. Results Of the 4780 patients evaluated, in 2905 patients (60.7%) diagnosis of RA was confirmed, the remaining 1875 patients (39.3%) had a wrong diagnosis of RA. Of these misdiagnosed patients, 1377 (73.5%) were women, and 498 (26.5%) men, with an average age of 57.6 (±12 years). Between differential diagnosis which were found in this cohort of misdiagnosed patients: osteoarthritis in 1108 patients (50.1%), systemic lupus erythematosus (SLE) in 84 patients (4.5%), Sjögren syndrome in 62 patients (3.3%), spondyloarthropathies in 21 patients (1.1%), gout in 31 patients (1.7%), and (39,3%) other diagnoses in of the remaining population. Conclusions Almost half patients with presumptive RA diagnosis in primary care centers in Colombia are misdiagnosed as shown in this large cohort. The most important cofounding diagnosis was osteoarthritis and many patients were receiving DMARDs for treatment. For this reason there is an urgent need of education strategies for primary care physicians and the implementation of centers of excellence in RA, in order to conduct a proper diagnose and avoid clinical and health economics consequences of misdiagnosis. Disclosure of Interest None declared

THU0576 Reduction in Adverse Events to Biological Therapy in Patients with Rheumatoid Arthritis After the Implementation of One Educational Strategy for Patients and Physicians and a Scheme of Infection Risk Prevention

Background Pharmacovigilance is a key medicine safety aspect, which is an important principle of patient care and a critical component of quality management. Improving it requires a comprehensive approach, a task that affects the operation of the whole system; therefore it is essential to implement educational strategies targeted to health personnel and patients themselves, in order to timely intervene in the presence of adverse events (AE) to medicines. Objectives The aim of this study was to describe and compare the record of adverse events between the periods (2011, 2012, 2013 years) and after implementation (2014) of educational strategies focused on prevention of adverse events and the implementation of a prevention scheme of infections in patients with rheumatoid arthritis (RA) who were receiving biological therapy Methods In 2011 a low level of reporting of adverse events compared with literature was observed, so in early 2012 at our rheumatology center we began to conduct educational seminars for groups of patients and health personnel involved in the processing of reports of adverse events in order to improve reports. In late 2013 a scheme to prevent risk of infection in RA patients with recommendations on vaccination and care of immunosuppressed patients according to the type of therapy was implemented. A review and analysis of reports of adverse events at committee of pharmacovigilance in 2011, 2012, 2013 and 2014 in a specialized center in AR was conducted. Results 374 adverse events were reported in patients with RA using biologic drugs between 2011 and 2014. In 2011 13 adverse events were reported; in 2012 95 adverse events were reported; in 2013 199 adverse events were reported biologics. As above mentioned, between 2011 and 2013 was observed an increase in reporting of adverse events attributed to education for better reporting. But in 2014 after the implementation of educational strategies and a scheme of infection prevention was observed a decrease in reporting of adverse events (n=67), which compared with 199 adverse events observed in 2013, implies a decrease more than 60% of cases statistically significant. Between biological more than 50% of cases of adverse events were with infliximab. Conclusions It is concluded that during the first year there was an underreporting of patients with adverse events, which increased in next two years because educational programs; subsequently with the implementation of educational strategies and infection prevention scheme is achieved lower percentage of adverse events with biologicals in patients with RA. Disclosure of Interest None declared

FRI0112 Dermatologic Adverse Events in a Cohort of Patients with Rheumatoid Arthritis Using Biological Therapy in a Real-Life Setting

Background Biological therapy is a major therapeutic tool to prevent clinical and radiological progression of rheumatoid arthritis (RA). On the other hand, adverse effects of these medications are a problem in clinical practice. Objectives The aim of this study was to describe and compare the most frequent dermatologic adverse events with the use of biologic therapy in patients with RA in a real-life ambulatory setting. Methods A descriptive study was done. A review of dermatological adverse event reports presented in pharmacovigilance committee was completed monthly during last 45 months in a specialized in RA center in Colombia. Descriptive epidemiology was used, percentages and averages were calculated. Results 680 patients were using biological therapy in a cohort of 2905 RA patients last 45 months; 579 women (85.2%) and 101 (14.8%) men. Mean age 60.3 years old. In 153 (22.5% of all patients who received biologics) patients were reported dermatologic adverse events (AE); AE were categorized according WHO classification in mild, moderate and severe; between them 53 (34.6%) were mild, 88 (57.5%) were moderate and 12 (7.8%) were severe. From 153 events reported, only 3 (1.9%) needed a biopsy to clarify what type of dermatologic reaction presented. Regarding therapeutic approach in 54 patients (35.2%) biologics were temporally suspended, in 21 (13.7%) was permanently withdrawn, 27 patients (17.6%) were switched to another biological, and 51 (33.3%) patients were followed for drug and reactions surveillance. From 153 events reported, 11 (7.1%) were acute dermatitis, 51 (33.3%) were dermatologic symptoms due to allergic skin rashes, 20 (13.1%) infection by Herpes zoster, 24 (15.6%) were dermatologic symptoms due to infection causes and the other 47 cases (30.7%) were due to other causes. Concerning to type of biologic, in 124 patients (81.0%) dermatologic adverse events were with anti-TNF therapies. Conclusions Dermatological adverse events using biologics are observed in a fifth of patients from a specialized RA center and are similar to those reported in literature; Biological therapy is considered a safe and recommended treatment for management of RA. Dermatologic AE were more mostly common with anti-TNFs subcutaneous therapies. Disclosure of Interest None declared

AB0303 Osteoarthritis is the Most Frequent Cause of Rheumathoid Arthritis Misdiagnosis in A Colombian Specialized Center

Background There is a lack of expertise in the rheumatoid arthritis (RA) diagnosis in primary level medical centers in Colombia. Frequently, patients with osteoarthritis (OA) are misdiagnosed as rheumatoid arthritis (RA) in primary care centers, leading to wrong treatment and consequent clinical and pharmacoeconomic impact. Objectives The objective of this study was to describe demographic and clinical characteristics of a cohort of patients derived to a specialized RA center with presumptive RA diagnosis and finally diagnosed as osteoarthritis. Methods A descriptive, cross sectional study. Patients were referred and assisted to a specialized RA center in a 24 month period with presumptive diagnosis of this disease. A complete medical record was fulfilled by a rheumatologist; it was measured rheumatoid factor and anti-citrullinated antibodies, and other laboratories depending on each case. Also were made x-rays of hands, and in some cases of persistent doubt about the diagnosis was requested comparative MRI of hands. Frequencies and Percentages were calculated for the demographic and clinical characteristics of the cohort of patients. Results From a total of 3665 Patients derived to specialized in RA center with presumptive RA diagnosis, after medical and laboratory evaluation 1451 (39.6%) had a wrong RA diagnosis; of them 1116 patients (76.9%) had finally osteoarthritis diagnosis. Of these patients 790 (70.7%) were women and 326 (29.2%) men, with an average age of 59.7 (±12 years). Majority of these patients were followed by general physicians or internists and treated with non-biologic and biologic disease modifying anti-rheumatic drugs (DMARDs) in the past, for an average time of 4.5 years. Conclusions In this cohort of patients the most frequent diagnosis of patients misdiagnosed with RA was osteoarthritis, being more than two thirds of them, predominantly women. This shows the need for the implementation of specialized clinics in RA and educational strategies for primary care physicians in order to avoid the impact of this wrong diagnosis. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.5344

AB1031 Misdiagnosis of Rheumatoid Arthritis in A Colombian Specialized Center and Socio-Demographic Characterization

Background There is a lack of expertise in the rheumatoid arthritis (RA) diagnosis in primary level medical centers in Colombia, leading to misdiagnosis, which derives in wrong treatment for patients and pharmacoeconomic implications. Objectives The aim of this study was to describe demographic and clinical characteristics of a cohort of patients with misdiagnosis of RA in a specialized center in Colombia. Methods A descriptive, cross sectional study. Patients were referred from non-specialized centers to a RA specialized center in a 24 month period with presumptive diagnosis of this disease. A complete medical record was fulfilled by a rheumatologist; it was assessed rheumatoid factor and anti-citrullinated antibodies, and other laboratories depending on each case. Also were made x-rays of hands and foot, and in some cases of persistent doubt about the diagnosis was requested comparative MRI of hands. Frequencies and percentages were calculated for the demographic and clinical characteristics of the cohort of patients in which the diagnosis of RA was ruled-out. Results Of the 3665 patients evaluated, in 2214 patients (60.4%) diagnosis of RA was confirmed, the remaining 1451 patients (39.5%) had a wrong diagnosis of RA. Of these misdiagnosed patients, 1009 (69.5%) were women, and 442 (30.5%) men, with an average age of 59.7 (±12 years). Between differential diagnosis which were found in this cohort of misdiagnosed patients: osteoarthritis in 1116 patients (76.1%), systemic lupus erythematosus (SLE) in 85 patients (5.8%), Sjögren syndrome in 62 patients (4.3%), spondyloarthropathies in 22 patients (1.5%), gout in 32 patients (2.2%) and other diagnoses in the remaining population (8%). Conclusions Almost half patients with presumptive RA diagnosis in primary care centers in Colombia are misdiagnosed as shown in this large cohort. The most important cofounding diagnosis was osteoarthritis and many patients were receiving DMARDs for treatment. For this reason there is an urgent need of education strategies for primary care physicians and the implementation of centers of excellence in RA, in order to conduct a proper diagnose and avoid clinical and pharmacoeconomic consequences of misdiagnosis. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.5327

SAT0057 Cost Savings through Decreasing the Number of Eligible Patients for Biological Therapy Using A Treat to Target Strategy

Background The importance of early effective therapy, implications of disease activity in progression and use of composite disease activity measures in rheumatoid arthritis (RA), led to developing of defined therapeutic targets and tools to achieve them resulting in the Treat to Target (T2T) initiative. This strategy is being used last 2 years in Colombia in a specialized in RA center. On the other hand costs of treating disease are increasing because introduction of biologic therapies. Objectives The aim of this study was to describe the reduction in Disease Activity Score 28 (DAS28) in patients with moderate-severe disease activity (MDA/SDA) using a T2T strategy for 24 months in a Colombian specialized center in RA and cost savings for health care system associated with such reduction in disease activity levels. Methods A descriptive cross-sectional study was performed. Records of patients from specialized in RA center were reviewed; those patients were followed-up under T2T standards. Clinical follow-up was designed by the authors according to DAS28 as follows: every 3-5 weeks (DAS28 >5.1), every 7-9 weeks (DAS28 ≥3.1 and ≤5.1), and every 11-13 weeks (DAS28 <3.1). In case of DAS28 >3.2 it was mandatory to introduce adjustments in treatment based on a predetermined clinical guideline. We divided patients in two groups: remission-low disease activity (Rem/LDA) patients and moderate-severe disease activity (MDA/SDA) patients. The median was analyzed using t-Student assuming normality for DAS28 distribution. Results 310 patients were included in this study, 256 (82.5%) women and 54 (17.4%) men. Mean age 61 years. These patients were in moderate-severe disease activity (MDA/SDA); mean DAS28 was 4.3 at the beginning, and after 24 months using T2T strategy and treating patients only with conventional DMARS we found that 252 patients (81.2%) got in remission-low disease activity (Rem/LDA) with a mean DAS28 of 2.6. On average, costs of biological therapy at this time was 16,595 USD/year for individual patient, and so for 252 patients costs savings were about 4.181.940 USD for a year, ranging between 2.975.228 USD (in case of most cheaper biological) and 5.824.849 USD (in case of using most expensive biological). Conclusions This study showed that it is possible to decrease disease activity and therefore a significant reduction in costs, of moderate-severe disease activity (MDA/SDA) patients, by using a model with therapeutic goals and not only pharmacological. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.4832

FRI0031 Better Outcomes of Disease Activity in A Large Cohort of Rheumatoid Arthritis Patients Treated under Treat to Target Recommendations

Background The importance of early effective therapy, implications of disease activity in progression and use of composite disease activity measures in rheumatoid arthritis (RA), led to developing of defined therapeutic targets and tools to achieve them resulting in the Treat to Target (T2T) initiative. This strategy is being used last 2 years in Colombia in a specialized in RA center. Objectives The aim of this study was to describe global change in Disease Activity Score 28 (DAS28) using T2T strategy for a 24 month period in a large cohort of patients from a Colombian specialized in RA center. Methods A descriptive cross-sectional study was performed. Records of patients from specialized in RA center were reviewed; those patients were followed-up under T2T standards. Clinical follow-up was designed by the authors according to DAS28 as follows: every 3-5 weeks (DAS28 >5.1), every 7-9 weeks (DAS28 ≥3.1 and ≤5.1), and every 11-13 weeks (DAS28 <3.1). In case of DAS28 >3.2 it was mandatory to introduce adjustments in treatment based on a predetermined clinical guideline. We calculated percentages and averages from this data and distributed patients in four groups: remission (Rem), low disease activity (LDA), moderate disease activity (MDA) and severe disease activity (SDA). Global change in DAS28 was determined at beginning, 6, 12, and 24 months an assessed using Chi-square test. The median of each variable was analyzed using t-Student assuming normality for DAS28 distribution and the level of disease activity was analyzed using Pearsons statistics. Results 1046 patients were included in this study, 865 (82.7%) women and 181 (17.3%) men. Mean age 60.1 years. With regard to treatment it was found that 340 (32.5%) patients were treated with biologics, and 706 (67.5%) patients with conventional therapy. The mean of DAS28 was 3.4 at the beginning and 24 months after was 2.6. The difference of medians for each variable showed improvement with statistical significance (p<0.00). Activity Month 0 6 months 12 months 24 months n (%) n (%) n (%) n (%) REM 390 (37.3) 562 (53.7) 668 (63.9) 750 (71.7) LDA 159 (15.2) 214 (20.5) 136 (13.0) 123 (11.8) MDA 388 (37.1) 215 (20.6) 196 (18.7) 139 (13.3) SDA 109 (10.4) 55 (5.3) 46 (4.4) 34 (3.3) p<0.00. Conclusions This study shows improvement of DAS28 in a cohort of RA patients from a specialized center in Colombia treated under recommendations of T2T strategy; it was found a global increase in the percentage of patients in remission (REM) and decrease in moderate and severe disease activity (MDA/SDA) group. This study shows de importance of T2T strategy for following-up and treating this disease. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.4830

THU0592-HPR PRECIPITATING, PREDISPOSING AND MAINTENANCE FACTORS ASSOCIATED WITH SEXUAL DISORDERS IN PATIENTS WITH RHEUMATOID ARTHRITIS

Background Sexuality is an important dimension of personality and human body, therefore any involvement in this area should be considered as important. Sexual disturbances in rheumatoid arthritis (RA) patients are poorly described in literature. On the other hand, there are predisposing, precipitating and maintenance factors for sexual disturbances in patients with RA. Objectives The aim of this study using CIE-10 was to describe different type of factors that may influence the prevalence and worsening of sexual disturbances in patients with RA. Methods A descriptive cross-sectional study was performed in a specialized clinic dedicated to Ra patients care. Patients seen by the area of psychology, information was collected through semi-structured interviews and non-probability sampling. Descriptive epidemiology was done, using averages and percentages for categorical and qualitative variables; and Pearsons statistics for bi-variated analysis. Results The total sample of patients was 349, 279 (79.9%) were women and 70 (20.0%) were men, average DAS28-2.46. Average age is 58.1 years. 146 (52.3%) of women reported no sexual activity, while 133 (47.6%) report sexual activity. 18 (25.7%) of men reported no sexual activity, while 54 (70.2%) report sexual activity. Precipitating factors in women: 26 (9.3%) infidelity, 17 (6.0%) anxiety about sexual performance, 36 (12.9%) loss of attraction, 35 (12.5%) alteration of self-image. while in men: 19 (27.1%) insecurity in sexual male role, 12 (30.7%) loss of attraction, 4 (5.7%) infidelity, 4 (5.7%) alteration of self-image. Predisposing factors in women: 73 (26.1%) biological causes, 36 (12.9%) infidelity, 19 (6.8%) poor or inadequate information, 13 (4.6%) insecurity about sexual performance, while in men 13 (18.5%) biological causes, 5 (7.1%) infidelity, 5 (7.1%) poor or inadequate information, 11 (15.7%) insecurity about sexual performance. Maintenance factors in women: 61 (21.8%) biological causes, 42 (15.0%) general alteration of couple relationship, 19 (6.8%) depression and anxiety, 18 (6.4%) infidelity, 2 (0.7%) partners sexual dysfunction, while in men: 16 (22.8%) general alteration of couple relationship, 14 (20%) biological causes, 12 (17.1%) anxiety about sexual performance. It was not established a correlation between precipitating, predisposing or maintenance factors and RA disease activity. Conclusions According to these findings sexual disorders are present in a half of patients with RA both men and women. There are many factors that may influence the prevalence and worsening of sexual disturbances. However sexual disturbances do not affect disease activity, but quality of life probably is very affected. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.5404

AB0336 Sexual Disturbances in Patients with Rheumatoid Arthritis and It's Relation with Disease Activity

Background Sexuality is an important dimension of personality and human body, therefore any involvement in this area should be considered as important. Sexual disturbances in rheumatoid arthritis (RA) patients are poorly described in literature. Objectives The aim of this study was to describe sexual disturbances using CIE-10 classification in a population with RA and a possible correlation with disease activity. Methods A descriptive cross-sectional study was performed in a specialized clinic dedicated to care patients with RA. 349 patients were included in the study, which were seen by the area of psychology, which information was collected through semi-structured interviews and non-probability sampling. Descriptive epidemiology was applied for continuous variables, using measures of central tendency and dispersion for categorical and qualitative variables by averages and percentages. By means of Pearsons statistics it was analyzed bi-variated correlations. Results The total sample of patients was 349, 279 (79.9%) were women and 70 (20.0%) were men, average DAS28-2.46. Average age is 58.1 years. 146 (52.3%) of women reported no sexual activity, while 133 (47.6%) report sexual activity. Concerning women with sexual activity, 27 (18.4%) reported satisfactory sexual activity, 33 (22.6%) reported no-satisfactory sexual activity, 25 (18.3%) reported lack or loss of sexual desire, 53 (36.3%) reported dyspareunia, and 4 (2.9%) orgasmic dysfunction. On the other hand 18 (25.7%) of men reported no sexual activity, while 54 (70.2%) report sexual activity. Concerning men with sexual activity, 6 (11.1%) reported premature ejaculation, 8 (14.8%) reported satisfactory sexual activity, 5 (12.8%) reported no-satisfactory sexual activity, 5 (9.2%) reported lack or loss of sexual desire, 7 (12.9%) orgasmic dysfunction, 4 (7.4%) reported dyspareunia. It was not established a correlation between level of sexual activity and disease activity using DAS28. Conclusions According to these findings almost a half of men and women have a high percentage of sexual disturbances in relation to RA affecting their quality of life; on the other hand higher DAS28 is not correlated with fewer level of sexual activity. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.5391