C.M. Romero-Barco

Eficiencia de diferentes dosis de rituximab en la artritis reumatoide

OBJECTIVE Evaluate the effectiveness, cost and safety of rituximab in patients with rheumatoid arthritis (RA) depending on the dose used. MATERIAL AND METHODS Retrospective observational study conducted on 52 patients with RA treated with at least one dose of rituximab for 135.3 patient-years were included. Three treatment groups were obtained: (G1) First course and following two 1g infusions separated by 15 days; (G2) First course 2 infusions of 1g followed by 2 infusions of 500mg; (G3) First course and followed by 2 infusions of 500mg separated by 15 days. Re-treatments were administered on-demand according to the clinical activity. The retention time (Log-Rank), retreats and adverse events rates (incidence rate ratio) and treatment costs per patient-month of rituximab were analysed by groups. RESULTS Group 2 showed a better cost-effectiveness ratio than group 1, as it was associated with a longer retention of rituximab (mean [95% CI] 65.7 [60.8 to 70.7] months vs 33.5 [22.7 to 44.3]; P<.001) and a lower rate of severe adverse events with only a slight increase in the rate of retreatment (courses/patient-year [95% CI] 1.66 [1.39 to 1.93] vs. 1.01 [0.69 to 1.34]; P=.005), and in the costs (median/patient-month, €484.89 vs. €473.45). Although group 3 was €41.20/patient-month cheaper than group 2, it was associated with a higher rate of re-treatments and shorter retention of rituximab (P<.001). CONCLUSIONS The use of full-dose rituximab at onset, followed by reduced doses in successive courses administered on-demand retreatment may be the most cost-effective option.

AB1078-HPR Telephone Follow-Up, Standardized To The Initiation of Biologic Therapy of Patients with Rheumatoid Arthritis (RA) in A Specific Unit of Biologic Therapy. Pilot Study

Objectives To know the usefulness of follow-up call legalized at the beginning of biologic therapy and patient contact with consultation of nursing after the start of treatment. Methods Observational study cross.Patients: We collected 120 patients who began treatment with biologic therapy, intravenous or subcutaneous from December 2013 to November 2015. Protocol: Protocol is education for self-management of subcutaneous biological therapy at the beginning of the treatment. This Protocol includes a follow-up call from the consultation of nursing that matches the first administration of the treatment at home or within 3–5 days after the first infusion. This call is made in the case of the biological subcutaneous as per guideline: etanercept (7 days), adalimumab (14 days), golimumab (28 days), tocilizumab (7days), certolizumab (14 days), abatacept (7days) either guideline prescribed in case of dose reduction. Offers the possibility of contact (telephone and e-mail) with the consultation of nurses in case of doubt or incidence during treatment and is analytical control to the month of the beginning of nurse telephone consultation. Statistical analysis: a descriptive analysis of the main variables. Results 120 patients with RA initiated treatments were: etanercept 33,3% (n40), adalimumab 8,3% (10), tocilizumab sc 20% (24), abatacept sc 12,5% (15), golimumab 13,3% (16), rituximab 6,7% (8), certolizumab pegol 3,3% (4), biosimilar 2,5% (3). In terms of the associated FAME: none 38,3% (46), methotrexate 49,2% (59), Leflunomide 8.3% (10), sulfasalazine 1,7% (2), hydroxychloroquine 2,5% (3).They were detected in the Protocol call patients with incidences 14,16% (17): local reaction3.3% (4), pruritus 5.8% (7), upset general 0.8% (1), diarrhea 0.8% (1), constipation 0.8% (1), headache 1.7% (2). The patients called the nursing consultation to communicate incidences 10.83% (13): anemia 0.8% (1), hypertransaminasemia 1,7% (2), implant dental 0.8% (1), bruising 0,8% (1), inefficiency 6.7% (8). Also communicated to the consultation of nursing infections during 16.6% (20): urinary tract infection 5,8% (7), upper respiratory tract infection 1,7% (2), upper respiratory tract infection+herpes simplex 0,8% (1), lower respiratory tract infection 3,3% (4), surgical wound infection 0.8% (1), dental infection 0,8% (1), herpes simplex 0,8% (1), gastroenteritis 0,8% (1), not frightening infection 1,7% (2).Patients who started biologic therapy in the period studied only 8.3% (10) changed treatment.The emergence of new comorbidities were detected during treatment with biologic therapy 4,16% (5): hypertension 0,8% (1), hypertension + diabetes mellitus II 1,7% (2), nonspecific Interstitial pneumonia 0,8% (1), psoriasis 0,8% (1). Conclusions The follow-up call is a useful tool for the control of security of the new beginnings of biological agents. It could foster adherence to treatment monitoring at home and offering the possibility to communicate with the nursing. Disclosure of Interest None declared

AB0113 Efficacy of treatment with probiotics in the inflammatory activity of patients with rheumatoid arthritis. systematic review of the literature

Objectives To study the effectiveness of the use of probiotics in the control of inflammatory activity of patients with rheumatoid arthritis and analyse its effect on their metabolic profile. Methods A bibliographic search was carried out in Medline and Embase. The search strategy included the terms MeSH and the free text of ”lactobacillus”, ”bacillus”, ”probiotics” and ”rheumatoid arthritis.” The search strategies were carried out by two authors, which were included according to the type of studies: meta-analysis, systematic reviews and clinical trials, depending on the type of participant: adults with RA who have received probiotics, the main outcome measures: changes in the Disease Activity Score (DAS28), Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI)), as well as each of the parameters that constitute them: C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), visual analogue scale of the doctor and the patient (EVA), number of painful joints (NAD) and inflamed (NAI) and functional status by Health Assessment Questionnaire (HAQ) Secondary variables: number of adverse events and parameters of metabolic activity. The quality of the evidence was analysed following the guidelines of the Scottish Network of Intercollegiate Guidelines (SIGN). Results After the selection of 34 articles, 9 articles were finally included. All were randomised, double-blind, placebo-controlled clinical trials (RCTs) with a level of evidence between 1+and 1++and a recommendation grade of A and B. Seven CDs showed improvement in arthritis measurements. In Peltonen et al. observed a high rate of improvement in the experimental group than in the control group (3.1 vs 2, p=0.027). Mandel et al. they described improvement of the EVA in the experimental group (p=0.046). Zamani the al. they described an improvement in DAS28 (−0.3±0.4 versus −0.1±0.4, p=0.01). Vaghef-Mehrabany et al defined this improvement (p<0.01). Pineda et al. showed an improvement in HAQ at 3 months in the experimental group (from 0.97 to 0.80, p=0.02), although not in ACR20 (p=0.33). Allipour et al. found improvements in CRP between the two groups (mean [95% CI]=2.03 [0.54–3.51], p=0.009); NAD: (mean [95% CI]=0.72 [0.25, 1.19], p=0.003); NAI: (mean [95% CI]=0.351 [0.13, 0.58], p=0.003); EVA: (mean [95% CI]=16.71 [8.91, 24.50] p<0.001; DAS-28: (average [CI] 95%]=0.31 [0.02, 0.61], p=0.039) and in cytokine levels, Hatakka et al observed no significant improvement in the experimental group in HAQ, NAD and NAI, and Nenonent et al. Did not observe differences in DAS28. In the last, EC of Vaghef-Mehrabany of 2017 metabolic measures were evaluated without finding significant improvements If an improvement in insulin resistance was observed as measured by the HOMA B index in the study by Zamani et al. Conclusions Treatment with probiotics seems to be effective in controlling the inflammatory activity of rheumatoid arthritis. Disclosure of Interest None declared

AB1109 Dose de-escalation in a specialized outpatient clinic on biological therapy: cost minimization observational study

Objectives To estimate the annual cost in the use of biological therapy (BT) in patients with different rheumatic diseases when dose modifications are undertaken in daily clinical practice in a specialized outpatient clinic during 2016 and to compare the results with data obtained in 2013. Methods Design: Cost minimization observational study under conditions of clinical practice. Patients: Patients with different rheumatic diseases who come to a specialized outpatient clinic on BT in the Rheumatologic department at a tertiary Spanish hospital (with a tight follow-up) that had been treated with BT under reduced doses during 2016 were collected. Protocol: Reductions in treatment dose or dose frequency were established empirically and were carried out by their rheumatologist in those patients who were in remission (DAS 28 <2,6) for at least 6 months without steroids. Main outcome: Reduction of annual average cost in euros in BT used in patients who are in dose reduction in clinical practice in 2016. Secondary outcome:Differences in annual costs reduction in 2016 compared with 2013. The cost reduction was calculated by comparing the actual expenditure (after modifying treatment dose in clinical practice) with the theoretical costs (official price) in case you had not made the adjustment. Statistical analysis: Sample descriptive analysis. Reducing annual absolute costs and by treatment after tapering down doses in clinical practice in 2016 and the differences found between 2013 were calculated. Results During 2016, the dose of the BT of 168 patients (94 Subcutaneous BT and 74 intravenous BT) were modified in clinical practice after reaching clinical remission:mean of DAS 28 (mean±SD)=2.31±0.76 or BASDAI (mean±SD)=2.15±1.39 without radiographic progression. Most patients were women (n=113;67%)and had rheumatoid arthritis (n=103;62%) and the rest were distributed among: spondyloarthritis (n=28;17%), psoriatic arthritis (n=22;13%), juvenile idiopathic arthritis (n=10;5%) and Systemic Lupus Erithematosus (n=5;3%). No patients treated with certolizumab or anakinra was modified treatment doses. During this period, 5 patients discontinued BT (3 remissions and 2 minor adverse events). Table 1 shows the number of patients by type of BT and costs. The BT dose reduction in clinical practice during 2016 represented a saving of 676,501.67€ and a greater efficiency of treatments while in 2013, only 86 patients (30 etanercept, 15 adalimumab, 16 Infliximab (Remicade), 15 Tocilizumab IV and 55 Rituximab) had a modified dose of BT in clinical practice assuming a saving of 396,995.46€. The difference in the annual cost reductions in 2016 compared to 2013 meant a saving of 279.506,21€ more in the last year. Table 1. Conclusions In rheumatic diseases we may do a dose de-escalation of BT in patients who go into remission and therefore we could reduce the associated costs of BT and being more efficient with the treatments. We believe that it is important to create specialized outpatient clinics on BT where a tight-control management of these patients and an individualized treatment are carried out. Disclosure of Interest None declared

SAT0201 Treatment Adherence in Rheumatoid Arthritis (RA) Patients Followed in a Specific Biological Therapy Unit. a Pilot Study: Table 1.

Objectives To study the adherence to biologic therapy (BT) of patients with RA. Methods Design: Cross-sectional study. Patients: 40 RA-pts treated with BT (50% wit subcutaneously [sc] and 50% with intravenously [iv]) with or without synthetic DMARDs were consecutively recruited from a specific unit of BT. Protocol: Patients with sc BT are alternately reviewed every three months in general and specific (only BT pts) outpatient clinic. Iv BT patients are checked each time the drug is infused. At 5 days from 1st iv BT infusion or in the day that 2nd dose of sc BT is given, patients receive a call from the nurse to confirm that everything went well. Patients with sc BT have a self-injections diary and direct free telephone access to the nurse. Variables: Demographic, clinical and laboratory, therapeutic, Morisky-Green adherence questionnaire (MGAQ), control of the number of sc BT doses withdrawn from outpatient hospital pharmacy, assisting to infusions in the case of iv BT and removal of synthetic DMARDs in the drugstores using “XXI electronic prescription” (a software used to control the dispensations in the public health system in Andalusia) in the last 6 months. Outcome variables: (1) level of adherence and (2) compliance level with MGAQ. MGAQ considers that the patients are adherents when they give 3 or more responses indicative of adherence. Good drug withdrawal from hospital pharmacy or drugstore was defined as removal of >80% of the prescribed dose. Adherence to BT and synthetic DMARDs was measured independently. The degree of adhesion was classified as good (3 or 4 correct responses in MGAQ and good drug withdrawal), medium (3 or 4 good responses in MGAQ but bad drug withdrawal or vice versa) and bad (<3 good responses in MGAQ and bud drug withdrawal). Statistical analysis: Descriptive analysis of the main variables. Adherence between sc BT and iv BT was compared using T-Student. Results The main characteristics of the patients (n=40) are shown in the table. 10/40 patients were in monotherapy. 37/40 (92.5%) showed good adherence to BT, 3/40 (7.5%) moderate and bad none. There was no difference in the level of adherence to BT among sc BT and iv. BT (90% vs. 95% good adhesion; p=0.50) nor between BT alone or in combination with DMARDs (70% vs. 100% good adhesion; p=0.12). The level of adherence was good with BT in 100% of the patients and in the 70% with synthetic DMARDs.Table 1. Demographic-clinical features Variables Patients Age (years), mean (DE) 57,1 (9,3) Sex (Female), n (%) 32 (80) Race (Caucasian), n (%) 38 (95) Rheumatoid factor, n (%) 35 (87,5) Anti–cyclic citrullinated peptide, n (%) 33 (82,5) Erosions, n (%) 32 (80) DAS28 at protocol, mean (DE) 2,9 (0,9) HAQ at protocol, mean (DE) 1,1 (0,6) Delay to diagnosis (months), mean (DE) 21,9 (2,34) Disease duration (months), mean (DE) 138,8 (6,4) Conclusions Adherence to BT in RA-patients in a specific unit of BT that controls the treatment adherence is very good with the BT and good with synthetic DMARDs. Patients treated with sc or iv. BT and those with monotherapy or combination therapy are equally adherents. These data represent are only a preliminary study. Disclosure of Interest None declared

SAT0295 Measuring Microarchitecture Bone in Patients with Systemic Lupus Erythematosus. Pilot Study

Objectives To evaluate the trabecular bone score (TBS) in patients with systemic lupus erythematosus (SLE). Methods Design: Cross sectional study. Patients: we recruited 37 patients with SLE who had at least one DXA and one analysis of the trabecular microarchitecture during the follow-up. Protocol: we analysed the most recent DXA, TBS and clinical data collected from the clinical records using a predesigned questionnaire. Variables: demographic, therapeutic (including use of glucocorticoids and antiresorptives), clinical and laboratory features of SLE (including cumulative number of ACR criteria of LES, SLICC damage and SELENA-SLEDAI average of the two years prior at protocol date). Also were collected: personal and family history of fragility fractures, densitometric diagnosis (OMS) and FRAX index. Outcome variables: (1) Measurement of microarchitecture using software “Trabecular bone score -MedIMaps®” (TBS) and (2) Measurement of BMD (g/cm2) of the lumbar spine (L1 L4), proximal femur and total hip, using DXA (GE Lunar Prodigy Advance). Definitions: The cutoff points for TBS used in the study were the same proposed by the International working group of TBS users: (1) Normal microarchitecture, score>1.350; (2) microarchitecture partially degraded, score <1.350 and >1.200; and (3) microarchitecture degraded<1.200. Bone densitometry scores were classified according to OMS criteria as normal bone, osteopenia and osteoporosis at the lumbar spine (LS), femoral neck (FN) and total hip (TH). Statistical analysis: Descriptive analysis of the main variables, T-student test for the comparison of quantitative variables of groups, Fisher exact test to compare qualitative and correlation of Pearson/Spearman Rho for the quantitative variables. Results The main characteristics of the patients (n=37) are shown in the Table. Almost all of them had received hydroxychloroquine, calcium supplements and vitamin D. The majority had lumbar osteopenia (43.9%) and trabecular bone microarchitecture partially degraded (46.3%). A trend towards association between densitometric diagnosis (OMS) and the TBS LS (p=0.096) was observed, but not in the case of the BMD FN (p=0.335) or BMD TH (p=0.447).) A negative correlation between the FRAX index and the LS T-score (p=0005 r= -0.5) and FN (r= -0.7; p<0.001 was observed, but not with the TBS (Rho = -0, 3; p=0.1). No correlation between FRAX, TBS, SLEDAI and SLICC was observed. No association was observed between the uses of hydroxychloroquine, oral or intravenous glucocorticoids and the T-score or TBS.Table 1. Main characteristics of the patients (n=37). Conclusions Most patients with SLE studied in this small pilot study have some moderate bone disorder that affects both the amount of bone mass and quality of their lumbar trabecular microarchitecture. Acknowledgements SEIOMM Disclosure of Interest None declared

AB1143-HPR A Pilot Study of A Standardized Educational Programme for the Improvement of Chronic Pain and Fatigue in Systemic Lupus Erythematosus (SLE)

Objectives To evaluate the effectiveness of a standardized educational intervention to improve pain, fatigue, sleep and health-related quality of life (HRQoL) in patients with systemic lupus erythematosus. Methods Design: Open, uncontrolled intervention. Patients: 22 adults with SLE (ACR criteria) selected by simple randomization. Intervention: A nurse provides face-to-face training activities to groups. They include oral presentations and group dynamics. In the first session, 22 patients participated. Self-management aspects were tackled in the following topics: 1. What is pain? 2. Self-management: chronic pain. 3. Self-management: rest. 4. What is fatigue? 5. Self-management: fatigue. In the second session, half of patients (n=11) participated. Psychological aspects to improve the self-management of chronic pain and fatigue were worked by covering the following topics: 1. Cognitive Restructuring. 2. Breathing relaxation techniques. Variables: Outcome 1. Improvement in chronic pain at 3 months, assessed with the Brief Pain Inventory (BPI) questionnaire. Outocome 2. included changes in coping with chronic pain, using the Spanish coping questionnaire to the chronic pain (CAD), in HRQoL assessed with both the EQ-5D and the SF- 36, and in fatigue using FACIT-F/fatigue at 3 and 6 months. Other meassured variables were: changes in lupus activity (SELENA-SLEDAI) and in sleep (Oviedo questionnaire). Comorbidities were collected using the Charlson Comorbidity Index. All variables except comorbidities were collected before the intervention, at 3 months and at 6 months (only patients who attended the 2nd workshop). Statistical analysis: Descrptive of the results, Students t-distribution or Wilcoxon signed-rank test for paired samples as appropriate for quantitative variables. McNemars test on paired qualitative variables at the 3-month assessment. Repeated measures ANOVA at 0, 3 and 6 months assessments. Results A total of 22 women with SLE participated (age 46.3±11.3) with baseline SLEDAI 2.8±2, 3 months 2.73±1.52, 6 months 2.54±2.2. 77.3% had multimorbidity (≤2). Major comorbidities presented were: gastrointestinal diseases (31.8%), depression (31.8%), anxiety (22.7%), visual impairment (18.2%), obesity (13.6%), degenerative disc disease (13.6%), osteoporosis (13.6%), peripheral vascular disease (13.6%). Baseline and throughout the study, 4.5% of patients used CPAP to sleep and 40.9% used hypnotics. At 3 months, sleep (p=0.042) and coping with chronic pain (p=0.008) improved. No change observed in all other variables. At 6 months, % of relief with medication (Pillai-M. S. Bartlett trace, p=0.008) and HRQoL meassured with EQ-5D (Pillai-M. S. Bartlett trace, p=0.024) improved. We found no differences in all other variables. Conclusions The educational intervention had positive effects on pain, sleep and HRQoL in SLE patients at 3 and 6 months. Although a forgetting effect might have occurred at 6 months in some of the improvements obtained at 3 months, we cannot discard that the small size of the sample makes it harder to detect differences at 6 month. Since they are preliminary results, we expect to obtain more solid results once the study is completed. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.4668

SAT0089 Cost Minimization Observational Study after Dose Optimization in A Specialized Outpatient Clinic on Subcutaneous Biological Therapy

Objectives To estimate annual cost in the use of subcutaneous BT (scBT) in patients with rheumatic diseases when dose modifications are undertaken in daily practice in a specialized outpatient clinic of a tertiary hospital during 2013 and to compare the results with data obtained in 2012. Methods Cost minimization, cross-sectional observational study.Patients with different rheumatic diseases who are following a tight control care in a specialized scBT outpatient clinic of a tertiary Spanish hospital who have been treated with BT under conventional and modified doses during 2013 were collected.Reductions in treatment dose were made at the discretion of their physician in patients who were in remission for at least 6 months.Main outcome:Reduction of annual average cost in euros in scBT used in clinical practice in 2013. Secondary variables:demographics, type of rheumatic disease, clinical and laboratory data. The cost reduction was calculated by comparing the real expenditure (after modifying treatment dose) with the theoretical costs if he had not made the adjustment. Statistical analysis:Descriptive analysis was performed. Reducing annual absolute costs and by treatment after the adequacy of dose in 2013 and the differences found between 2012-2013 were calculated. Results A total of 204 patients were followed in the monographic scBT clinic in 2013, with 333 visits [1.58 visits/patient (min.1-max.5)]. Most patients had RA (n=123, 60.3%) and the rest were distributed among: spondyloarthritis (n=37, 17.6%), psoriatic arthritis (n=33; 16.2%), juvenile idiopathic arthritis (n=11; 5.4%) and one SAPHO (0.5%) treatments received in the outpatient clinic were:etanercept, adalimumab, golimumab, abatacept, certolizumab and anakinra. During 2013, the dose of the scBT of 43 (21.1%) patients (19 RA,6 SpA,16 PsA,2 JIA) were modified in clinical practice because they reached clinical remission:DAS28[(mean (±SD)]=2.57 (0.85) or BASDAI [(mean (±SD)]=2.67 (1.59), without radiographic progression. No patients treated with golimumab, abatacept, certolizumab or anakinra was modified treatment doses. Among the 43 patients, 28 patients were treated with Etanercept and 15 with Adalimumab. The BT dose reduction in clinical practice during 2013 represented a saving of €205,947.68 and a greater efficiency of treatments while in 2012, only 28 patients (18 etanercept and 10 adalimumab) had a modified dose of scBT in clinical practice assuming a saving of €124,120.79. Conclusions In rheumatic diseases we may adjust the dose of treatment in patients who go into remission reducing the associated costs of scBT and being more efficient with the treatments. A largest number of patients in dose reduction, during 2013, could be attributed to a tight-control management carried out since the creation of a specialized BT outpatient clinic. We believe it is important to create outpatient clinics specialized in BT where periodic assessments with close monitoring of these patients and an individualized treatment are carried out. Disclosure of Interest S. Manrique-Arija Grant/research support: Pfizer, C. Romero-Barco: None declared, M. Ordoñez-Cañizares: None declared, I. Ureña: None declared, L. Cano: None declared, F. Jimenez-Nuñez: None declared, L. Nieves-Martin: None declared, N. Mena-Vazquez: None declared, M. Irigoyen: None declared, A. Ponce: None declared, V. Coret: None declared, M. Belmonte-Lopez: None declared, M. Rodriguez: None declared, A. Fernandez-Nebro Grant/research support: Pfizer, Roche, Speakers bureau: Pfizer, Roche, Abbvie, MSD, BMS DOI 10.1136/annrheumdis-2014-eular.4525

AB1144-HPR Case Management on Frail Patients in the Rheumatology Department at the Regional University Hospital in Malaga

Objectives To determine the features of patients referred to case management and from the case management process at the Regional University Hospital in Malaga. Methods Design: Descriptive cross-sectional study. Patients: patients treated in the Rheumatology service at the Regional University Hospital in Malaga and referred to case management from April to November 2013. The case management model is created as a response to the need for greater efficiency in care management due to the new Socio-medical Syndrome situation caused by the ageing of the population, the increase of frail patients and the need for home care. The case management process begins with the rheumatologist identifying a problem to be referred to case management. The rheumatologist contacts the rheumatology nurse specialist who prepares a report and hands it over to the case management nurse of the hospital. The case management nurse of the hospital contacts the primary care center of the patient that manages the petition from the Rheumatology unit. Variables include the basic characteristics of the patients, the Barthel index that measures the dependence in activities of daily living, the main reasons for referral to case management and professionals involved in primary care. Statistical Analysis: Basic descriptive of the results, the Kolmogorov-Smirnov test for the normality of the variables. Results From April to November 2013, 16 patients (75% women) with an average age 66.5±13.35 years were referred to case management. Rheumatic diseases in patients were: rheumatoid arthritis (n=10), systemic lupus erythematosus (n=3), scleroderma (n=1), severe osteoporosis (n=1) and psoriatic arthritis (n=1). 87.5% Frail patients with a Barthel index score of severe dependence in 62.5% of cases and of total dependence in 25% of cases. 43.8% lived with relatives, 25% with a professional caregiver and 25% lived alone. The reasons for referral to case management were: domiciliary nursing (50%), professional in-home caregiving (37.5%), help from the primary care center (PCC) staff (25%), information from the primary care physician (PCP) (25%), social problems (18.8%), nursing-home PCP (6.3%). Primary care professionals involved in the care of these patients were: nurses (62.5%), PCPs (37.5%), social workers (50%), community case manager nurses (50%). In 75% of cases the PCC belonged to the districts of Malaga. Conclusions Case management is a management tool that integrates primary care and specialty care professionals optimizing resources and improving the quality of health care provided to patients in situations of dependency. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.4555

AB0583 Effectiveness and safety of short-term treatment of active rheumatoid arthritis (RA) moderate to severe with tocilizumab

Objectives To evaluate the effectiveness and safety of tocilizumab (TCZ) for the treatment of active RA in our department. Methods Type of study: Prospective cohort. Inclusion criteria: RA-patients (new ACR-EULAR criteria) who have failed to at least one anti-TNF drug. Variables and Statistic: We evaluated the monthly changes of DAS28 and HAQ during the first year of treatment with TCZ using repeated measures ANOVA and survival of TCZ over the first 2 years with survival curves of Kaplan-Meier. Safety was assessed collecting adverse events, withdrawals due to safety and deaths. Results We included 35 patients, 19 of them from clinical trials (88.6% women with a mean age of 55.3±11.1 years) with a total follow-up for 29.7 person-years, a median duration of disease of 10.0±7.3 years. Anti-CCP was positive in 22 patients (64%) and the rheumatoid factor in 31 (89%). Thirty-one (89%) had radiographic erosions and 1 patient had previous orthopedic surgery (arthroplasty of both knees). The number of previous DMARDs: 6 (17%) had received one, 11 (31%) two, 11 (31%) three, 1 (3%) four, 2 (5.7%) five, and one (3%) six DMARDs. The mean of DMARDs was 2.4±1.3 per patient. Twenty (60%) patients had taken MTX (mean dose 16.4±4.8 mg/week), 6 (17%) had received LF (mean dose 20mg/24 h) and 1 (3%) hydroxychloroquine (mean dose of 400mg/24 h). The number of previous biological therapies used was: 8 (22.9%) patients had received one, 13 (37%) two, 7 (20%) three and 6 (17%) four, which represented an average of 2, 3±1.0 per patient biologics. The DAS28 improved progressively during the first year with TCZ (F =17.8; Trace Pilai p=0.008). Although the most significant change occurred in the first month (mean difference 1.9 (95% CI =0.4 to 3.3, p=0.002, Bonferroni adjustment p=0.010) after 1 year reached an estimated mean difference of 3.1 (95% CI =1.3 to 4.8, Bonferroni adjustment p=0.002).The HAQ also improved progressively with TCZ the first 3 months (F =3.5; Trace Pilai p=0.043), but in a much slower than the DAS28 [mean difference from baseline to third month in 0.436 (95% CI = - 0056 to -0929; Bonferroni adjustment p=0.103). Twenty (57.1%) patients continued with treatment after a median of 18 months (CI 95% 11.7 to 24.2 months) which resulted in the suspension rates of 14%, 17% and 26% at 3, 6 and 12 months, respectively. The causes of withdrawal or abandonment of treatment with TCZ were: 2 (6%), infections (severe cellulitis, and conjunctivitis), 2 (6%) due to failure of efficacy, 3 (9%) for infusional reaction, 1 (3%) by asymptomatic neutropenia, 3 (9%) patient’s decision, 2 (6%) due to gastrointestinal intolerance and 1 (3%) for protocol violation. Of all dropouts, only 8 patients were withdrawn due to adverse effects (including the only serious case was a right lower limb cellulitis). Conclusions In patients with RA who have previously failed other biologic therapies, TCZ produced a rapid improvement of inflammatory activity and physical function. The rate of discontinuation due to adverse events was relatively low for this subgroup of patients (23%), and serious adverse events were unusuals. Disclosure of Interest None Declared