Search

Introduction/objectives Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by ongoing inflammation and degradation of synovial joints. The oral JAK inhibitor, upadacitinib, is approved for RA. We conducted an integrated safety analysis of upadacitinib 15 mg once daily (QD) in patients from Latin America (LATAM) versus the rest of the world (RoW). Methods Treatment-emergent adverse events (AEs) and laboratory data from six phase 3, randomized controlled trials, adjusted for upadacitinib 15 mg QD use in RA, were analyzed. Results Overall, 3209 patients received upadacitinib 15 mg QD for 7024 patient-years (PY). LATAM patients (n = 725) had a mean upadacitinib exposure of 1518 PY. Baseline characteristics were generally similar between LATAM and RoW populations. AE rates (including serious/opportunistic infections, tuberculosis, and herpes zoster) and deaths were comparable between populations. LATAM patients had lower serious AE rates per 100 PY (9.4 vs 14.0 E/100 PY) and discontinuation-related AEs (3.9 vs 6.0 E/100 PY) versus RoW. Rates of cardiovascular events were low (≤ 0.5 E/100 PY) and similar between populations. Malignancies, excluding non-melanoma skin cancer, were less common in the LATAM population versus RoW (0.2 vs 1.0 E/100 PY). Laboratory abnormalities were similar between populations, with decreases in hemoglobin, lymphocyte, and neutrophil counts, and elevations in liver enzymes and creatine phosphokinase. Mean change from baseline in low- and high-density lipoprotein cholesterol was generally comparable between LATAM and RoW populations. Conclusion Upadacitinib 15 mg QD demonstrated a consistent safety profile across LATAM and RoW patient populations, with no new safety risks observed. Trial registration numbers SELECT-EARLY, NCT02706873; SELECT-NEXT, NCT02675426; SELECT-COMPARE, NCT02629159; SELECT-MONOTHERAPY, NCT02706951; SELECT-BEYOND, NCT02706847; SELECT-CHOICE, NCT03086343. Key Points• This study assessed the safety of upadacitinib 15 mg in patients with rheumatoid arthritis from Latin America compared with patients from the rest of the world participating in the SELECT phase 3 program.• Safety was generally similar between the two groups, including serious and opportunistic infections, tuberculosis, herpes zoster, and cardiovascular events. Malignancy, major adverse cardiovascular events, and venous thromboembolic events were infrequent in the Latin American patients.• Consistent with the known safety profile of upadacitinib, serious infections, herpes zoster, and laboratory abnormalities were the most common safety events in the Latin American population.

Although telemedicine use has been under discussion for decades, this topic has gained unprecedented importance during the COVID-19 pandemic. The Rheumatoid Arthritis Disease Activity Index (RADAI) is a user-friendly tool, fully self-administered, to assess rheumatoid arthritis (RA) disease activity. The aim of this study was to compare the performance of RADAI with other disease activity indices, functional status, and inflammatory markers in a large cohort of RA patients.We assessed the concurrent validity of RADAI against Clinical Disease Activity Index (CDAI), Disease Activity Score in 28 Joints-C-reactive protein, Disease Activity Score in 28 Joints-erythrocyte sedimentation rate, Simplified Disease Activity Index, and physician assessment of disease activity and the correlation of RADAI with Health Assessment Questionnaire-Disability Index and inflammatory markers at the REAL Study baseline. We also evaluated the correlation of the change in RADAI and the change in CDAI over a 6-month follow-up.From the 1115 patients included in the REAL Study, 1113 had RADAI scores in the first assessment. At baseline, correlations between RADAI and other disease activity indices were strong, ranging from 0.64 (comparison with physician assessment) to 0.79 (comparison with CDAI). Correlation between the change in RADAI score over the 6 months of follow-up and the change in CDAI score over the same period was moderate/strong for the overall group and within the stratified analyses.The strong correlation of RADAI with other well-established tools for disease activity measurement reassures its use with RA patients' follow-up, especially in this new era of telemedicine.

AIM This study assessed the efficacy and safety of upadacitinib (UPA), in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), in Chinese, Brazilian, and South Korean patients with active rheumatoid arthritis (RA) and an inadequate response (IR) to csDMARDs. METHODS Patients on stable csDMARDs were randomized (1:1) to once-daily UPA 15 mg or matching placebo (PBO) for a 12-week, double-blind period. The primary endpoint was the proportion of patients achieving ≥20% improvement in American College of Rheumatology criteria (ACR20) at week 12. RESULTS In total, 338 patients were randomized and treated, of whom 310 (91.7%) completed the double-blind phase. The study met the primary endpoint of ACR20 at week 12 for UPA 15 mg vs PBO (71.6% vs 31.4%, P

BackgroundRheumatoid arthritis (RA) is a common autoimmune systemic inflammatory disease. In addition to joint involvement, RA patients frequently have other comorbidities, such as cardiovascular diseases. Drugs used for RA treatment may increase or decrease the risk of a cardiovascular event. This study aims to analyze cardiovascular risk comorbidities in patients with RA and the correlation with the use of anti-rheumatic drugs.MethodsCross-sectional study conducted based on the real-life rheumatoid arthritis study database – REAL, a prospective observational cohort study. Associations between the use of anti-rheumatic drugs and the presence of comorbidities were represented by their prevalence ratio and evaluated using the Chi-square or Fisher’s Exact tests.ResultsWe assessed 1116 patients, 89.4% women, mean age of 55.15 years and predominance of seropositive disease. 63.3% had some cardiovascular comorbidity, predominantly hypertension (49.9%). The use of glucocorticoids was observed in 47.4% of patients and there was a significant tendency of lower use of these drugs in the presence of dyslipidemia (PR: 0.790;p = 0.007). We observed that the presence of cardiovascular comorbidities was associated with higher use of bDMARDs (PR:1.147;p = 0.003).ConclusionsThe presence of cardiovascular risk comorbidities was confirmed to be higher in RA patients. Different treatment strategies using less glucocorticoids in the presence of dyslipidemia and more common use of bDMARDs in patients with cardiovascular comorbidities suggest that rheumatologists are aware of the potential influence of the DMARDs in the risk of cardiovascular event. Reinforcing these results, we highlight the need for a better baseline assessment to guide the choice of anti-rheumatic drugs in RA patients who have comorbidities.

Background In Brazil, socioeconomic differences in the incidence of rheumatoid arthritis (RA) have been demonstrated, which are important in the formulation of hypotheses regarding the association between environmental factors, lifestyle and the risk of disease development. This study examines how the socioeconomic condition of the patient with RA in Brazil, assessed according to social class, educational level, employment situation and use of caregivers, affects the times between the beginning of symptoms and diagnosis and the beginning of the use of disease-modifying antirheumatic drugs, as well as the presence of erosive disease and functional status. Methods This work is part of a multicentric study called REAL - Rheumatoid Arthritis in Real Life in Brazil, which is a prospective observational cohort study. Results As described in the REAL study, we included a total of 1115 patients. It was noted that patients with an educational classification of up to second grade incomplete presented with erosion percentages above those with a higher grade complete. Patients with caregivers presented a higher percentage of erosion than patients without caregivers. We verified that patients from economic classes above B2 presented fewer occurrences of erosion than those from classes C2, D-E. We also analyzed the average time differences from the beginning of symptoms and diagnosis and the beginning of treatment, according to academic level, erosion and economic classification. Patients with first grade complete showed an HAQ-DI averages higher than those with second grade complete. The patients who had employment showed lower HAQ-DI averages than patients who were not employed. The patients with erosion showed an HAQ-DI value higher than those without erosion. Patients with caregivers showed an HAQ-DI average higher than that of without caregivers. Conclusion This study showed that the therapeutic window of RA is not being reached, and therefore we should have a policy to expand and ensure access to public health for all patients, especially those with lower levels of education and income. Trial registration This study was approved by the National Commission of Ethics in Research.

Objective Our objective was to evaluate the long-term efficacy, safety, and immunogenicity of the infliximab biosimilar, PF-06438179/GP1111 (PF-SZ-IFX), in patients with rheumatoid arthritis (RA) who continued biosimilar treatment throughout 78 weeks or who switched from reference infliximab (Remicade®) sourced from the EU (IFX-EU) at week 30 or week 54 in the REFLECTIONS B537-02 study. Methods In this phase III, double-blind, active-controlled study, patients with moderate-to-severe active RA were initially randomized to PF-SZ-IFX or IFX-EU, each with methotrexate (treatment period [TP] 1; N = 650). At week 30, patients receiving PF-SZ-IFX continued PF-SZ-IFX; patients receiving IFX-EU were re-randomized to continue IFX-EU or switch to PF-SZ-IFX (TP2; n = 566). From weeks 54 to 78, all patients received open-label treatment with PF-SZ-IFX (TP3; n = 505). Efficacy, safety, and immunogenicity data were analyzed during TP3. Results Efficacy was sustained and comparable across groups at week 78, with American College of Rheumatology criteria for ≥ 20% clinical improvement response rates of 75.9% (biosimilar group), 77.8% (week 30 switch group), and 68.3% (week 54 switch group). The incidence of treatment-emergent adverse events was 28.9%, 29.4%, and 30.2%, respectively. The proportion of patients who were antidrug antibody (ADA) positive and neutralizing antibody positive (as a percentage of ADA-positive patients) was stable and comparable between groups. Conclusions Results to week 78 continue to support the efficacy, safety, and immunogenicity of PF-SZ-IFX in patients with moderate-to-severe active RA. There were no clinically meaningful differences between groups, independent of a single treatment transition from IFX-EU to PF-SZ-IFX at week 30 or week 54. Trial Registration Number NCT02222493. Electronic supplementary material The online version of this article (10.1007/s40259-019-00403-z) contains supplementary material, which is available to authorized users.

Background:Rheumatoid arthritis (RA) is associated with high frequency of comorbidities and increased risk of polypharmacy. Although there is a great potential for complications, there is a gap in literature on polypharmacy in patients with rheumatic arthritis.Objective:To evaluate the prevalence and factors associated with polypharmacy in a population in a real-life setting.Methods:A cross-sectional multicenter study was conducted in Brazil. Patients underwent clinical evaluation and medical records analysis. Polypharmacy was considered as a dependent variable. To test independent variables, we used Poisson regression.Results:We evaluated 792 patients (89% female, median age 56.6 years). Median duration of disease was 12.7 years, 78.73% had a positive rheumatoid factor. The median of disease activity score-28 was 3.5 (disease with mild activity), median of the clinical disease activity index score was 9, and median of health assessment questionnaire-disability index was 0.875; 47% used corticosteroids, 9.1% used nonsteroidal anti-inflammatory drugs, 90.9% used synthetic disease-modifying antirheumatic drugs, 35.7% used biologic disease-modifying antirheumatic drugs (DMARDs). In total, 537 (67.9%) patients used 5 or more drugs. Polypharmacy showed a relationship with a number of comorbidities and use of specific drugs (corticosteroids, methotrexate, and biological DMARDs).Conclusion:We found a high prevalence of polypharmacy (67.9%) in RA. Solutions to management this problem should be stimulated.

Objectives To compare the efficacy and safety of a new formulation of a fixed dose combination of glucosamine sulfate (GS; 1500 mg) and bovine chondroitin sulfate (CS; 1200 mg) versus the reference product (RP) in patients with knee osteoarthritis (OA). Methods In this multicenter, randomized, single-blind trial, 627 patients with knee osteoarthritis (OA)—Kellgren-Lawrence grades 2 or 3 and mean score ≥ 40 mm in the WOMAC pain subscale—were randomized to receive GS/CS or the RP for 24 weeks. The primary efficacy endpoint was the absolute change in WOMAC pain subscale score. The secondary endpoints included the following: WOMAC total and subscale scores, overall assessment of the disease by the patient and the investigator, SF-12 score, OMERACT-OARSI response rate to the treatment, and rescue medication use. Results Mean reductions of WOMAC pain score were − 35.1 (sd = 23.2) mm in the GS/CS group and − 36.5 (sd = 24.9) mm in the RP group. The difference between the adjusted means of both treatments confirmed the non-inferiority of GS/CS versus the RP. Improvement was observed in pain, stiffness, physical function and total WOMAC score, as well as in overall OA assessment by the patient and the investigator for both groups. No improvement was observed in SF-12. The rate of OMERACT-OARSI responders was 89.4% in GS/CS group and 87.9% in the RP group. Headache and changes in glucose tolerance were the most frequent treatment-related adverse events. Conclusions The new formulation of a fixed-dose combination of glucosamine sulfate and bovine chondroitin sulfate was non-inferior to the RP in symptomatic treatment of knee OA, with a high responder rate and good tolerability profile. Trial registration ClinicalTrials.gov; Registration number NCT02830919; Date of registration: July 13, 2016; First randomization date: December 05, 2016).

The Brazilian guidelines for prevention and treatment of glucocorticoid-induced osteoporosis were updated and important topics were included such as assessment of risk fracture using FRAX Brazil, use of denosumab, and also recommendations for the use of glucocorticoid pulse therapy and inhaled glucocortiocoid. Glucocorticoids (GCs) are used in almost all medical specialties and the incidences of vertebral/nonvertebral fractures range from 30 to 50% in individuals treated with GCs for over 3 months. Thus, osteoporosis and frailty fractures should be prevented and treated in patients initiating treatment or already being treated with GCs. The Committee for Osteoporosis and Bone Metabolic Disorders of the Brazilian Society of Rheumatology (BSR) established in 2012 the Brazilian Guidelines for glucocorticoid-induced osteoporosis (GIO). Herein, we provide a comprehensive update of the original guidelines based on improved available scientific evidence and/or expert experience. From March to June 2020, the Osteoporosis Committee of the BRS had meetings to update the questions presented in the first consensus (2012). Thus, twenty-six questions considered essential for the preparation of the recommendations were selected. A systematic literature review based on real-life scenarios was undertaken to answer the proposed questions. The MEDLINE, EMBASE, and SCOPUS databases were searched using specific search keywords. Based on the review and expert opinion, the recommendations were updated for each of the 26 questions. We included 48 new bibliographic references that became available after the date of the publication of the first version of the consensus. We updated the Brazilian guidelines for the prevention/treatment of GIO. New topics were added in this update, such as the assessment of risk fracture using FRAX Brazil, the use of denosumab, and approaches for the treatment of children and adolescents. Furthermore, we included recommendations for the use of inhaled GCs and GC pulse therapy in clinical settings.

Objective To evaluate the effect of upadacitinib (UPA) monotherapy vs MTX on patient-reported outcomes (PROs) in patients with RA who were MTX-naïve or who had an inadequate response to MTX (MTX-IR). Methods PROs from the SELECT-EARLY and SELECT-MONOTHERAPY randomized controlled trials were evaluated at Weeks 2 and 12/14. Patients were ≥18 years of age with RA symptoms for ≥6 weeks (SELECT-EARLY, MTX-naïve) or diagnosed RA for ≥3 months (SELECT-MONOTHERAPY, MTX-IR) and received UPA monotherapy (15 or 30 mg) or MTX. PROs included Patient Global Assessment of Disease Activity (PtGA), pain visual analogue scale, HAQ Disability Index (HAQ-DI), morning stiffness duration/severity, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (SELECT-EARLY), health-related quality of life (HRQOL) by the 36-iem Short Form Health Survey and Work Productivity and Activity Impairment (WPAI; SELECT-EARLY). Least square mean (LSM) changes and proportions of patients reporting improvements greater than or equal to the minimum clinically important differences and normative values were determined. Results In 945 MTX-naïve and 648 MTX-IR patients, UPA monotherapy (15 mg, 30 mg) vs MTX resulted in greater reported LSM changes from baseline at Weeks 12/14 in PtGA, pain, HAQ-DI, morning stiffness duration/severity, FACIT-F (SELECT-EARLY), HRQOL and WPAI (SELECT-EARLY). These changes were statistically significant with both doses of UPA vs MTX at Weeks 12/14 in both RCTs. Improvements were reported as early as week 2. Compared with MTX, more UPA-treated MTX-naïve and MTX-IR patients reported improvements greater than or equal to the minimum clinically important differences and scores greater than or equal to normative values. Conclusion Among MTX-naïve and MTX-IR patients with active RA, UPA monotherapy at 15 or 30 mg for 12/14 weeks resulted in statistically significant and clinically meaningful improvements in pain, physical function, morning stiffness, HRQOL and WPAI compared with MTX alone. Clinical trial registration number SELECT-EARLY (NCT02706873) and SELECT-MONOTHERAPY (NCT02706951) are registered with ClinicalTrials.gov.

Background This double-blind, active-controlled, randomized, multinational study evaluated the efficacy, safety, pharmacokinetics (PK), and immunogenicity of PF-06438179/GP1111 (IxifiTM/Zessly®), an infliximab biosimilar, vs infliximab (Remicade®) reference product sourced from the European Union (infliximab-EU) in biologic-naïve patients with moderate to severe active rheumatoid arthritis (RA) despite methotrexate therapy. This paper reports results from the initial 30-week treatment period. Methods Patients (N = 650) were stratified by geographic region and randomized 1:1 to PF-06438179/GP1111 or infliximab-EU (3 mg/kg intravenous at weeks 0, 2, and 6, then every 8 weeks). Dose escalation to 5 mg/kg was allowed starting at week 14 for patients with inadequate RA response. The primary endpoint was American College of Rheumatology criteria for ≥ 20% clinical improvement (ACR20) response at week 14. Therapeutic equivalence was declared if the two-sided 95% CI for the treatment difference was within the symmetric equivalence margin of ± 13.5%. Statistical analysis was also performed with a two-sided 90% CI using an asymmetric equivalence margin (− 12.0%, 15.0%). Results Patients (80.3% female; 79.4% seropositive) had a mean RA duration of 6.9 years, and mean baseline Disease Activity Score in 28 joints, four components based on C-reactive protein was 6.0 in both arms. Week 14 ACR20 in the intention-to-treat population was 62.7% for PF-06438179/GP1111 and 64.1% for infliximab-EU. Week 14 ACR20 using nonresponder imputation was 61.1% for PF-06438179/GP1111 and 63.5% for infliximab-EU, and the 95% (− 9.92%, 5.11%) and 90% (− 8.75%, 4.02%) CIs for the treatment difference (− 2.39%) were entirely contained within the prespecified symmetric and asymmetric equivalence margins, respectively. No differences were observed between arms for secondary efficacy endpoints. Overall postdose antidrug antibody (ADA) rates through week 30 were 48.6% and 51.2% for PF-06438179/GP1111 and infliximab-EU, respectively. Efficacy and immunogenicity were similar between treatments for patients with dose escalation (at or after week 14), as well as between treatments for patients without dose escalation. Safety profiles of PF-06438179/GP1111 and infliximab-EU were similar, with no clinically meaningful differences observed between arms, including after ADA development. Serum drug concentrations were similar between arms at each time point during the initial 30-week treatment period. Conclusion PF-06438179/GP1111 and infliximab-EU demonstrated similar efficacy, safety, immunogenicity, and PK with or without dose escalation in patients with moderate to severe active RA on background methotrexate. Trial registration ClinicalTrials.gov, NCT02222493. Registered on 21 August 2014. EudraCT, 2013-004148-49. Registered on 14 July 2014. Electronic supplementary material The online version of this article (10.1186/s13075-018-1646-4) contains supplementary material, which is available to authorized users.

Background:Upadacitinib (UPA), an oral Janus kinase inhibitor, in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), showed significant improvements in clinical and functional measures compared with placebo (PBO) up to 12 weeks (wks), in patients (pts) from China, Brazil, and South Korea with rheumatoid arthritis (RA) and prior inadequate response to csDMARDs (csDMARD-IR).1Objectives:To assess the efficacy and safety of UPA up to 64 wks (long-term extension; LTE) in csDMARD-IR pts with RA from China, Brazil, and South Korea.Methods:Pts were randomized to 12 wks of blinded treatment with UPA 15 mg once daily (QD) or PBO, in combination with csDMARDs. From Wk 12 onward, pts could continue to receive open-label UPA 15 mg QD. Efficacy endpoints were analyzed by original randomized treatment group sequences over 64 wks and included American College of Rheumatology (ACR) responses, and key remission and low disease activity measures. Non-responder imputation was used to handle missing data for binary endpoints. Treatment-emergent adverse events (TEAEs) per 100 patient-years (PY) were summarized for pts receiving ≥1 dose of UPA from baseline through to Wk 64.Results:Of 338 randomized pts who received ≥1 dose of study drug, 310 (91.7%) entered the LTE and 275 (81.4%) completed 64 wks of treatment. Among those initially randomized to UPA, the proportion of pts achieving 20%/50%/70% improvement in ACR criteria, and key remission and low disease activity measures increased over 64 wks of treatment (Figure 1). Improvements from baseline in the Health Assessment Questionnaire-Disability Index and pts’ assessment of pain were observed over 64 wks of UPA treatment (data not shown). By Wk 64, efficacy results for pts who switched from PBO to UPA at Wk 12 followed a similar trajectory to those originally randomized to UPA.The observed rate of serious infections was 8.1 events/100 PY. Herpes zoster events were mostly non-serious, involving only 1 or 2 dermatomes. Most cases of hepatic disorders were Grade 1 or 2 hepatic transaminase elevations. There was 1 case of venous thromboembolic event (VTE; concurrent pulmonary embolism and deep vein thrombosis [DVT] in a patient with a history of DVT) and 3 cases of malignancy. Adjudicated major adverse cardiovascular events (Table 1) occurred in 2 pts (1 with non-fatal myocardial infarction and 1 with non-fatal stroke) who had underlying risk factors for cardiovascular disease. There were no deaths, active tuberculosis, or renal dysfunction.Conclusion:UPA 15 mg was effective in treating the signs and symptoms of RA and in improving physical function over 64 wks with no new safety signals1 in csDMARD-IR pts with RA from China, Brazil, and South Korea.References:[1]Zeng A, et al. Ann Rheum Dis 2020;79(Suppl 1):1016 [abstract SAT0160]Table 1.TEAEs at Wk 64Event (E/100 PY)UPA 15 mg(n=322; PY=334.5)Any AE421.5 (399.8–444.1) Serious AE19.1 (14.7–24.4) AE leading to discontinuation of study drug9.0 (6.1–12.8) Deathsa0AEs of special interest Serious infection8.1 (5.3–11.7) Opportunistic infection0.9 (0.2–2.6) Herpes zoster9.0 (6.1–12.8) Hepatic disorder42.2 (35.5–49.7) Gastrointestinal perforation (adjudicated)0.3 (0.0–1.7) Any malignancy (excluding NMSC)0.6 (0.1–2.2) NMSC0.3 (0.0–1.7) MACE (adjudicated)b0.6 (0.1–2.2) VTE (adjudicated)c0.3 (0.0–1.7) Anemia11.1 (7.8–15.2) Neutropenia11.7 (8.3–15.9) Lymphopenia7.8 (5.1–11.4) CPK elevation11.1 (7.8–15.2)aIncluding non-treatment-emergent deaths. bDefined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. cIncluding DVT and pulmonary embolism.AE, adverse event; CPK, creatine phosphokinase; E, events; MACE, major adverse cardiovascular event; NMSC, non-melanoma skin cancerAcknowledgements:AbbVie funded this study; contributed to its design; participated in data collection, analysis, and interpretation of the data; and in the writing, review, and approval of the abstract. No honoraria or payments were made for authorship. Yanna Song, PhD, of AbbVie provided statistical support. Medical writing support was provided by Laura Chalmers, PhD, of 2 the Nth (Cheshire, UK), and was funded by AbbVie.Disclosure of Interests:Xiaofeng Zeng: None declared, Dongbao Zhao: None declared, Sebastiao Radominski: None declared, MAURO KEISERMAN: None declared, Chang-Keun Lee: None declared, Naomi Martin Employee of: AbbVie employee and may own stock or options, Sebastian Meerwein Employee of: AbbVie employee and may own stock or options, Yunxia Sui Employee of: AbbVie employee and may own stock or options, Won Park: None declared

Objective Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We assessed tofacitinib efficacy and safety in the Latin American (LA) subpopulation of global Phase 3 and long-term extension (LTE) studies. Materials and methods Data from LA patients with RA and inadequate response to disease-modifying antirheumatic drugs (DMARDs) were pooled across five Phase 3 studies. Phase 3 patients received tofacitinib 5 or 10 mg twice daily (BID), adalimumab or placebo; patients in the single LTE study received tofacitinib 5 or 10 mg BID; treatments were administered alone or with conventional synthetic DMARDs. Efficacy was reported up to 12 months (Phase 3) and 36 months (LTE) by American College of Rheumatology (ACR) 20/50/70 response rates, Disease Activity Score (DAS)28-4(erythrocyte sedimentation rate [ESR]) and Health Assessment Questionnaire-Disability Index (HAQ-DI). Incidence rates (IRs; patients with event/100 patient-years) of adverse events (AEs) of special interest were reported. Results The Phase 3 studies randomized 496 LA patients; the LTE study enrolled 756 LA patients from Phase 2 and Phase 3. In the Phase 3 studies, patients who received tofacitinib 5 and 10 mg BID showed improvements vs placebo at Month 3 in ACR20 (68.9% and 75.7% vs 35.6%), ACR50 (45.8% and 49.7% vs 20.7%) and ACR70 (17.5% and 23.1% vs 6.9%) responses, mean change from baseline in HAQ-DI (−0.6 and −0.8 vs −0.3) and DAS28-4(ESR) score (−2.3 and −2.4 vs −1.4). The improvements were sustained up to Month 36 in the LTE study. In the Phase 3 studies, IRs with tofacitinib 5 and 10 mg BID and placebo were 7.99, 6.57 and 9.84, respectively, for SAEs, and 3.87, 5.28 and 3.26 for discontinuation due to AEs. IRs of AEs of special interest in tofacitinib-treated LA patients were similar to the global population. Conclusion In Phase 3 and LTE studies in LA patients with RA, tofacitinib demonstrated efficacy up to 36 months with a manageable safety profile up to 60 months, consistent with the overall tofacitinib study population.

Background CT-P10 is a biosimilar of innovator rituximab (RTX), a biological therapy used to treat patients with rheumatoid arthritis (RA) who have responded inadequately to anti-tumor necrosis factor agents. Objective Our objective was to compare the clinical profile of CT-P10 versus RTX in patients with RA who received up to two courses of treatment and were followed for up to 72 weeks. Methods In this multicenter double-blind phase I study, patients were randomized 2:1 to receive CT-P10 1000 mg or RTX 1000 mg at weeks 0 and 2. Based on disease activity, patients could receive a second course of treatment between weeks 24 and 48. Efficacy endpoints, including mean change from baseline in Disease Activity Score using 28 joints (DAS28), safety, immunogenicity, pharmacokinetics, and pharmacodynamics were evaluated. Results In total, 154 patients were randomized to CT-P10 or RTX (n = 103 and 51, respectively); 137 (n = 92 and 45) completed the first course of treatment, of whom 83 (n = 60 and 23) were re-treated. Improvements from baseline in all efficacy endpoints were highly similar between the CT-P10 and RTX groups over both treatment courses. At week 24 after the second course, mean change from week 0 of the first course in DAS28 erythrocyte sedimentation rate was −2.47 and −2.04 for CT-P10 and RTX, respectively, (p = 0.1866) and in DAS28 C-reactive protein was −2.32 and −2.00, respectively (p = 0.3268). The proportion of patients positive for antidrug antibodies at week 24 after the second treatment course was 20.0% and 21.7% in the CT-P10 and RTX groups, respectively. The safety profile of CT-P10 was comparable to that of RTX, and pharmacokinetic and pharmacodynamic properties were similar. Conclusions In patients with RA, efficacy, safety, and other clinical data were comparable between CT-P10 and RTX after up to two courses of treatment over 72 weeks. (ClinicalTrials.gov identifier NCT01534884). Electronic supplementary material The online version of this article (doi:10.1007/s40259-017-0232-7) contains supplementary material, which is available to authorized users.

Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint destruction. Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. This post hoc analysis assessed the safety of tofacitinib in Latin American (LA) patients with RA versus the Rest of World (RoW) population.Data were pooled from 14 clinical studies of tofacitinib: six Phase 2, six Phase 3 and two long-term extension studies. Incidence rates (IRs; patients with events/100 patient-years of treatment exposure) were calculated for safety events of special interest combined across tofacitinib doses. 95% confidence intervals (CI) for IRs were calculated using the maximum likelihood method. Descriptive comparisons were made between LA and RoW (excluding LA) populations.This analysis included data from 984 LA patients and 4687 RoW patients. IRs for safety events of special interest were generally similar between LA and RoW populations, with overlapping 95% CIs. IRs for discontinuation due to adverse events, serious infections, tuberculosis, all herpes zoster (HZ), serious HZ, malignancies (excluding non-melanoma skin cancer) and major adverse cardiovascular events were numerically lower for LA versus RoW patients; IR for mortality was numerically higher. No lymphoma was reported in the LA population versus eight cases in the RoW population. Exposure (extent and length) was lower in the LA population (2148.33 patient-years [mean = 2.18 years]) versus RoW (10515.68 patient-years [mean = 2.24 years]).This analysis of pooled data from clinical studies of tofacitinib in patients with RA demonstrates that tofacitinib has a consistent safety profile across LA and RoW patient populations.

Background Discordance between patient’s global assessment (PtGA) and physician’s global assessment (PhGA) has been described in rheumatoid arthritis (RA). Understanding the reasons for this discrepancy is important in the context of treat-to-target treatment strategy. Objective To assess the determinants of PtGA and PhGA and factors associated with discordance between them. Methods The REAL study included RA patients from Brazilian public health centers. Clinical, laboratory and outcomes measures were collected. PtGA and the PhGA were rated on a visual analog scale and analyzed. Three groups were defined: no discordance (difference between PtGA and PhGA within 3 cm), positive discordance (PtGA exceeding PhGA by >3 cm), and negative discordance (PtGA less than PhGA by >3 cm). Multivariate regression analysis was used to identify determinants of PtGA and PhGA and their discordance. Results 1115 patients (89,4% female, mean age 56.7y and median disease duration of 12.7y) were enrolled. Two factors were associated with PtGA in the final multivariate model: one point increase in the pain scale leads to an increase of 0.62 in PtGA; one point increase in HAQ increases by 9,25 points the PtGA. The factors associated with PhGA were pain scale, number of tender and swollen joints (NTJ and NSJ), positive RF, ESR, HAQ-DI and use of corticosteroids. Discordance between patient and physician was found in 30.52%: positive discordance in 24.6% and negative discordance in 5.92%. An increase of one point in the NSJ was associated with a 12% increase in the chance of negative discordance. The chance of positive discordance increased by 90% and 2% for each unit increased in HAQ-DI and pain scale respectively. Finally, the chance of positive discordance decreased by 3% for each point increased in NTJ and by 15% for each point increased in NSJ. Conclusion In one-third of the assessments, there was disagreement between PtGA and PhGA (a positive discordance was found in 80% of them). Pain and function were determinants for patients to estimate disease activity, while swollen joints was the main factor related to a worse physician’s evaluation. These data show how different can be the perspectives of patients and assistants.

Aim PF‐06438179/GP1111 (PF‐SZ‐IFX) is a biosimilar of reference infliximab (Remicade®). This analysis compared the efficacy of PF‐SZ‐IFX and reference infliximab sourced from the European Union (IFX‐EU) in patient subgroups from a randomized, comparative study of PF‐SZ‐IFX versus IFX‐EU. Methods Patients with rheumatoid arthritis were randomized 1:1 to PF‐SZ‐IFX (n = 324) or IFX‐EU (n = 326); study drug (3 mg/kg) was administered intravenously at weeks 0, 2, and 6, then every 8 weeks thereafter. Subgroup analyses of efficacy endpoints such as American College of Rheumatology criteria for ≥20% clinical improvement (ACR20), change in high‐sensitivity C‐reactive protein (hs‐CRP), and change in Disease Activity Score in 28 joints, four components based on hs‐CRP (DAS28‐CRP) at weeks 14 and 30 were performed by age, gender, race, region, immunogenicity status, and treatment history. Results Overall, ACR20 response rates as well as changes in DAS28‐CRP and hs‐CRP at week 14 were similar between PF‐SZ‐IFX and IFX‐EU within the subgroups of age, gender, race, region, treatment history, and immunogenicity status. Results to week 30 support overall similarity in efficacy between the two treatment arms in all subgroups. Conclusion Overall, PF‐SZ‐IFX and IFX‐EU were similar in efficacy within the analyzed subgroups of age, gender, race, region, treatment history, and immunogenicity status. The efficacy results from these subgroup analyses were aligned with the previously described results for the overall population up to week 30.

Background Last decades witnessed great technological advances in rheumatoid arthritis (RA) management, but their implementation in clinical practice might prove difficult. Despite the efficacy demonstrated in controlled trials this information needs to be confirmed by real life data. This study assessed real-life treatment among RA patients. Methods REAL study included Brazilian RA patients from eleven centers. Interview and medical records were performed. Continuous variables were compared using Student’s t or Mann-Whitney and categorical variables were assessed with chi-square or Fisher’s exact tests. Results 1115 patients were included, women 89.5%. Median age 56.6 years, disease duration 152.5 months; 78.7% were rheumatoid fator positive; 55.2% had erosive disease; DAS28 (disease activity index-28 joints) = 3.5, HAQ (health assessment questionnaire) =0.875. The median duration of symptoms until the start of first DMARD was 12 months. A total of 529 (47.2%) patients used corticosteroids; 1022 (90.8%) were on conventional synthetic (cs) DMARDs and 406 (36.1%) on biological (b) DMARDs. Methotrexate (MTX) was the most frequent csDMARD: 748 (66.5%) patients, followed by leflunomide (LFN), used by 381 (33.9%) of patients. MTX was associated to LFN in 142 (12.6%) patients. Only five (0.4%) patients used triple therapy (MTX + hydroxychloroquine + sulfasalazine) or sulfasalazine in monotherapy. Conclusions Despite advances in therapeutic resources, roughly half RA patients failed achieve T2T goals and 55.2% developed erosive disease. The frequent use of corticosteroids and delay in initiating DMARDs were demonstrated. Issues concerning timely access to medical care are crucial for effective management.

Background: Polypharmacy is concomitant use of five or more drugs and is usually associated with various comorbidities and advanced age. The already demonstrated consequences of polypharmacy are increased side effects, drug interactions, increased hospitalizations, drug handling difficulties, reduced adherence, and even increased mortality. Rheumatoid arthritis (RA) is a chronic systemic disease with preferential involvement between the third and fifth decades. Owing to treatment of underlying disease and comorbidities, patients with RA frequently require combined use of several drugs. Despite the possible negative consequences of polypharmacy in RA, there is a shortage of studies in literature. Objectives: Evaluate prevalence and factors associated with polypharmacy in patients with RA in a real-life setting. Methods: This is a cross-sectional part of the Rheumatoid Arthritis in Real Life (REAL) study that analyzed RA patients in a real-life context from August to October 2015 in 11 public health services in Brazil. Statistical analysis involved obtaining frequencies of the variables of interest and multiple Poisson regression analyses. Results: We evaluated 792 patients, of whom 89% were women, with median age of 56.6 years. 78.73% had a positive rheumatoid factor and 55.2% had an erosive disease. The median Disease Activity Score was 3.52, the median CDAI score was 9. Of the patients, 67.9% used 5 or more drugs as follows: mean of 2.8 and maximum of 5 drugs for RA, mean of 2.7 and maximum of 9 different types of medications for comorbidities, and mean of 5.5 and maximum of 11 drugs in total. The most commonly used drugs, besides specific drugs for underlying diseases, were vitamin D (63.8%), folic acid (61.1%), calcium (57%), and antihypertensive drugs (47%). In the multivariate analysis, the use of corticosteroids, methotrexate, and biological DMARDs and number of comorbidities (all with P Conclusion: The prevalence of polypharmacy was high (67.9%) in this population with RA, much higher than that described for elderly populations and other chronic diseases. This data can serve as an alert for this important and rarely-discussed aspect of RA. References: [1] Masnoon N, Shakib S, Kalisch-Ellett L, Caughey GE. What is polypharmacy? A systematic review of definitions. BMC Geriatrics 2017;17:230. [2] da Rocha Castelar-Pinheiro G, Vargas-Santos AB, de Albuquerque CP, Bertolo MB, Junior PL, Giorgi RDN, et al. The REAL study: a nationwide prospective study of rheumatoid arthritis in Brazil. Adv Rheumatol 2018;58:9. [3] Kim J, Parish AL. Polypharmacy and medication management in older adults. Nurs Clin North Am. 2017;52(3):457-468. [4] Abolbashari M, Macaulay TE, Whayne TF, Mukherjee D, Saha S. Polypharmacy in cardiovascular medicine: problems and promises! Cardiovasc Hematol Agents Med Chem. 2017;15(1):31-39. Disclosure of Interests: Ana Paula Gomides Grant/research support from: Has received personal support and consulting fees from Pfizer and Janssen, Consultant for: Has received personal support and consulting fees from Pfizer and Janssen, Paid instructor for: Has received personal support and consulting fees from Pfizer and Janssen, Cleandro Albuquerque Shareholder of: Has received personal fees and/or non-financial support from Pfizer, AbbVie, AstraZeneca, Janssen, Bristol-Myers Squibb, Roche, Novartis and UCB, Grant/research support from: Has received personal fees and/or non-financial support from Pfizer, AbbVie, AstraZeneca, Janssen, Bristol-Myers Squibb, Roche, Novartis and UCB, Consultant for: Has received personal fees and/or non-financial support from Pfizer, AbbVie, AstraZeneca, Janssen, Bristol-Myers Squibb, Roche, Novartis and UCB, Paid instructor for: Has received personal fees and/or non-financial support from Pfizer, AbbVie, AstraZeneca, Janssen, Bristol-Myers Squibb, Roche, Novartis and UCB, Speakers bureau: Has received personal fees and/or non-financial support from Pfizer, AbbVie, AstraZeneca, Janssen, Bristol-Myers Squibb, Roche, Novartis and UCB, Ana Beatriz Vargas-Santos Grant/research support from: Has received personal fees and/or non-financial support from Pfizer, AbbVie, AstraZeneca, Janssen, Bristol-Myers Squibb, Roche, Novartis and UCB, Claiton Brenol Shareholder of: Has participated in clinical and/or experimental studies related to this work and sponsored by AbbVie, BMS, Janssen, Pfizer and Roche; has received personal or institutional support from AbbVie, BMS, Janssen, Pfizer and Roche; has delivered speeches at events related to this work and sponsored by AbbVie, Janssen, Pfizer and Roche, Grant/research support from: Has participated in clinical and/or experimental studies related to this work and sponsored by AbbVie, BMS, Janssen, Pfizer and Roche; has received personal or institutional support from AbbVie, BMS, Janssen, Pfizer and Roche; has delivered speeches at events related to this work and sponsored by AbbVie, Janssen, Pfizer and Roche, Consultant for: Has participated in clinical and/or experimental studies related to this work and sponsored by AbbVie, BMS, Janssen, Pfizer and Roche; has received personal or institutional support from AbbVie, BMS, Janssen, Pfizer and Roche; has delivered speeches at events related to this work and sponsored by AbbVie, Janssen, Pfizer and Roche, Paid instructor for: Has participated in clinical and/or experimental studies related to this work and sponsored by AbbVie, BMS, Janssen, Pfizer and Roche; has received personal or institutional support from AbbVie, BMS, Janssen, Pfizer and Roche; has delivered speeches at events related to this work and sponsored by AbbVie, Janssen, Pfizer and Roche, Speakers bureau: Has delivered speeches at events sponsored by AbbVie, Janssen, Pfizer and Roche, Ivanio Pereira Consultant for: Has received consulting fees from Roche, Pfizer, UCB Pharma, Eli-Lilly, Abbvie and Janssen, Speakers bureau: Has received speaking fees Roche, Pfizer, UCB Pharma, Eli-Lilly, Abbvie and Janssen, Karina Bonfiglioli Speakers bureau: Has received speaking fees from Roche, Pfizer, Bristol-Myers Squibb, Abbvie and Janssen., Manoel Bertolo Speakers bureau: Has delivered speeches at events sponsored by AbbVie and Pfizer, Maria Raquel Pinto: None declared, Maria de Fatima Sauma: None declared, Paulo Louzada Jr Consultant for: Has received consulting fees from Pfizer, Rina Giorgi Consultant for: Has received consulting fees from Roche, Pfizer, Bristol-Myers Squibb, UCB, Eli-Lilly, AbbVie, Abbott and EMS, Speakers bureau: Has received speaking fees from Roche, Pfizer, Bristol-Myers Squibb, UCB, Eli-Lilly, AbbVie, Abbott and EMS, Sebastiao Radominski Consultant for: Abbvie, Celgene, Genentech/Roche, Janssen, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Genentech/Roche, Janssen, Pfizer, UCB, Licia Mota Speakers bureau: Has delivered speeches at events sponsored by AbbVie, Janssen, Pfizer, Roche and UCB., Geraldo Castelar: None declared

Background Discordance between the patient‘s global assessment of disease activity (PGA) and examiner’s global assessment (EGA) has been described in rheumatoid arthritis (RA) (1,2). Understanding the reasons for this discrepancy is essential in the context of treat-to-target treatment strategy. Objectives To assess the determinants of PGA and EGA and factors associated with discordance between them. Methods The REAL study included RA patients from Brazilian public health centers. Clinical, laboratory and outcomes measures were collected. PGA and EGA were rated on a visual analog scale and analyzed. Three groups were defined: no discordance (a difference between PGA and EGA within 3 cm), positive discordance (PGA exceeding EGA by >3 cm), and negative discordance (PGA less than EGA by >3 cm). Multivariate regression analysis was used to identify determinants of PGA and EGA and their discordance. Results 1115 patients (89,4% female, mean age 56.7y and median disease duration of 12.7y) were enrolled. Two factors were associated with PGA in the final multivariate model: one point increase in the pain scale (PS) leads to an increase of 0.62 in PGA; one point increase in HAQ increases by 9,25 points the PGA. The factors associated with EGA were: PS, number of tender and swollen joints (NTJ and NSJ), RF, ESR, HAQ and use of corticosteroids. Discordance between patient and physician was found in 30.52%: positive discordance (PD) in 24.6% and negative discordance (ND) in 5.92%. An increase of one point in the NSJ was associated with a 12% increase in the chance of ND. The chance of PD increased by 90% and 2% for each unit increased in HAQ and PS respectively. Finally, the chance of PD decreased by 3% for each point increased in NTJ and by 15% for each point increased in NSJ. Conclusion In one-third of the assessments, there was disagreement between PGA and EGA (a PD in 80% of them). Pain and function were determinants for patients to estimate disease activity, while swollen joints were the main factor related to a worse examiner’s evaluation. These data show how different can be the perspectives of patients and assistants. References [1] Smolen JS, Strand V, Koenig AS, Szumski A, Kotak S, Jones TV. Discordance between patient and physician assessments of global disease activity in rheumatoid arthritis and association with work productivity. Arthritis Res Ther. 2016; 18:114. [2] Desthieux C, Hermet A, Granger B, Fautrel B, Gossec L. Patient-physician discordance in global assessment in rheumatoid arthritis: a systematic literature review with meta-analysis. Arthritis Care Res (Hoboken). 2016; 68:1767. Disclosure of Interests Maria Fernanda Guimaraes: None declared, Maria Raquel Pinto: None declared, Gustavo Resende Grant/research support from: ABBVIE, PFIZER, Consultant for: ABBVIE, JANSSEN, NOVARTIS, Paid instructor for: Novartis, Janssen, Speakers bureau: ABBVIE, JANSSEN, NOVARTIS, PFIZER, UCB, Carla Machado: None declared, Ana Beatriz Vargas-Santos Grant/research support from: Has received personal fees and/or non-financial support from Pfizer, AbbVie, AstraZeneca, Janssen, Bristol-Myers Squibb, Roche, Novartis and UCB, Cleandro Albuquerque Shareholder of: Has received personal fees and/or non-financial support from Pfizer, AbbVie, AstraZeneca, Janssen, Bristol-Myers Squibb, Roche, Novartis and UCB, Grant/research support from: Has received personal fees and/or non-financial support from Pfizer, AbbVie, AstraZeneca, Janssen, Bristol-Myers Squibb, Roche, Novartis and UCB, Consultant for: Has received personal fees and/or non-financial support from Pfizer, AbbVie, AstraZeneca, Janssen, Bristol-Myers Squibb, Roche, Novartis and UCB, Paid instructor for: Has received personal fees and/or non-financial support from Pfizer, AbbVie, AstraZeneca, Janssen, Bristol-Myers Squibb, Roche, Novartis and UCB, Speakers bureau: Has received personal fees and/or non-financial support from Pfizer, AbbVie, AstraZeneca, Janssen, Bristol-Myers Squibb, Roche, Novartis and UCB, Manoel Bertolo Speakers bureau: Has delivered speeches at events sponsored by AbbVie and Pfizer, Paulo Louzada Jr Consultant for: Has received consulting fees from Pfizer, Rina Giorgi Consultant for: Has received consulting fees from Roche, Pfizer, Bristol-Myers Squibb, UCB, Eli-Lilly, AbbVie, Abbott and EMS, Speakers bureau: Has received speaking fees from Roche, Pfizer, Bristol-Myers Squibb, UCB, Eli-Lilly, AbbVie, Abbott and EMS, Sebastiao Radominski Consultant for: Abbvie, Celgene, Genentech/Roche, Janssen, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Genentech/Roche, Janssen, Pfizer, UCB, Karina Bonfiglioli Speakers bureau: Has received speaking fees from Roche, Pfizer, Bristol-Myers Squibb, Abbvie and Janssen., Maria de Fatima Sauma: None declared, Ivanio Pereira Consultant for: Has received consulting fees from Roche, Pfizer, UCB Pharma, Eli-Lilly, Abbvie and Janssen, Speakers bureau: Has received speaking fees Roche, Pfizer, UCB Pharma, Eli-Lilly, Abbvie and Janssen, Claiton Brenol Shareholder of: Has participated in clinical and/or experimental studies related to this work and sponsored by AbbVie, BMS, Janssen, Pfizer and Roche; has received personal or institutional support from AbbVie, BMS, Janssen, Pfizer and Roche; has delivered speeches at events related to this work and sponsored by AbbVie, Janssen, Pfizer and Roche, Grant/research support from: Has participated in clinical and/or experimental studies related to this work and sponsored by AbbVie, BMS, Janssen, Pfizer and Roche; has received personal or institutional support from AbbVie, BMS, Janssen, Pfizer and Roche; has delivered speeches at events related to this work and sponsored by AbbVie, Janssen, Pfizer and Roche, Consultant for: Has participated in clinical and/or experimental studies related to this work and sponsored by AbbVie, BMS, Janssen, Pfizer and Roche; has received personal or institutional support from AbbVie, BMS, Janssen, Pfizer and Roche; has delivered speeches at events related to this work and sponsored by AbbVie, Janssen, Pfizer and Roche, Paid instructor for: Has participated in clinical and/or experimental studies related to this work and sponsored by AbbVie, BMS, Janssen, Pfizer and Roche; has received personal or institutional support from AbbVie, BMS, Janssen, Pfizer and Roche; has delivered speeches at events related to this work and sponsored by AbbVie, Janssen, Pfizer and Roche, Speakers bureau: Has delivered speeches at events sponsored by AbbVie, Janssen, Pfizer and Roche, Licia Mota Speakers bureau: Has delivered speeches at events sponsored by AbbVie, Janssen, Pfizer, Roche and UCB., Geraldo Castelar-Pinheiro Consultant for: Has received consulting fees from AbbVie, Bristol-Myers Squibb, Eli Lilly, Glaxosmithkline, Janssen, Pfizer, Sanofi Genzyme and Roche

Background Upadacitinib (UPA), a selective JAK1 inhibitor, has shown efficacy in patients with rheumatoid arthritis (RA) when combined with methotrexate (MTX) or other conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).1,2 However, the efficacy of UPA plus MTX has not been directly compared with UPA plus other csDMARDs. Objectives To compare the efficacy of UPA in combination with MTX versus UPA in combination with other csDMARDs in patients with an inadequate response (IR) to csDMARDs (SELECT-NEXT1) or biologic DMARDs (bDMARDs; SELECT-BEYOND2). Methods 661 patients in SELECT-NEXT and 498 patients in SELECT-BEYOND received UPA 15 mg or 30 mg once daily (QD) or placebo (PBO) for 12 weeks; all patients received concomitant csDMARD(s). The primary endpoints for both studies were rates of ACR20 response and DAS28(CRP) ≤3.2. Additional endpoints included DAS28(CRP) Results In SELECT-NEXT and SELECT-BEYOND, 535 and 410 patients, respectively (∼80%), were receiving concomitant MTX (mean dose 17 mg/week), and 124 and 82 patients were receiving non-MTX csDMARDs. Demographics and disease characteristics were broadly similar between treatment groups; the majority of patients were female and of white ethnicity, and around half were using oral corticosteroids at baseline. Across all subgroups, the proportion of patients achieving efficacy outcomes was higher with both UPA doses compared with PBO (Table). There were no significant differences between efficacy outcomes with UPA in combination with MTX versus UPA in combination with non-MTX csDMARDs in either patient population. This included ACR20 response as well as low disease activity and remission defined by DAS28(CRP) and CDAI. Conclusion In this post hoc analysis, the efficacy of UPA in patients with RA appeared comparable whether administered in combination with MTX or non-MTX csDMARDs. References [1] Burmester GR, et al. Lancet 2018;391:2503–12; [2] Genovese MC, et al. Lancet 2018;391:2513–24 Acknowledgement AbbVie, Inc was the study sponsor, contributed to the study design, data collection, analysis & interpretation, and to writing, reviewing, and approval of the final version. Medical writing support was provided by John Ewbank, PhD, of 2 the Nth. Disclosure of Interests Joel Kremer Grant/research support from: AbbVie, Genentech, Lilly, Novartis, Pfizer, Consultant for: AbbVie, Amgen, BMS, Genentech, Lilly, Regeneron, Sanofi, Pfizer, Filip van den Bosch Consultant for: AbbVie, BMS, Galapagos, Janssen, Lilly, Merck, Novartis, Pfizer and UCB, Speakers bureau: AbbVie, BMS, Janssen, Lilly, Merck, Novartis, Pfizer and UCB., Andrea Rubbert-Roth Consultant for: Abbvie, Speakers bureau: AbbVie, Sebastiao C. Radominski Consultant for: AbbVie, Celgene, Genentech/Roche, Janssen, Pfizer, and UCB, Paid instructor for: AbbVie, Celgene, Genentech/Roche, Janssen, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene, Genentech/Roche, Janssen, Pfizer, and UCB, Gerd Rudiger Burmester Consultant for: Roche, Sanofi-Genzyme, Speakers bureau: Roche, Sanofi-Genzyme, Heidi Camp Shareholder of: AbbVie, Employee of: AbbVie, Sebastian Meerwein Shareholder of: AbbVie, Employee of: AbbVie Deutschland GmbH & Co. KG, Mark Howard Shareholder of: AbbVie, Employee of: AbbVie, Yanna Song Shareholder of: AbbVie, Employee of: AbbVie, Sheng Zhong Shareholder of: AbbVie, Employee of: AbbVie, Bernard Combe Consultant for: Abbvie, Bristol-Myers Squibb, Gilead, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche-Chugai, Sanofi, UCB

Background Monotherapy use of upadacitinib (UPA), a selective JAK1 inhibitor, demonstrated clinically meaningful improvement in the signs and symptoms of rheumatoid arthritis (RA) compared with methotrexate (MTX).1 To better understand the impact of UPA treatment in RA from the patient’s perspective, we examined the effect of UPA on patient-reported outcomes (PROs). Objectives To evaluate the effect of UPA monotherapy vs MTX at week 12 on PROs in SELECT-EARLY (NCT02706873), a randomised controlled trial in MTX-naive patients with moderate to severe RA. Methods Patients were randomised 1:1:1 to receive once daily UPA (15 mg or 30 mg) or weekly MTX (titrated by Week 8). PROs assessed included Patient Global Assessment of Disease Activity (PtGA) by visual analogue scale (VAS), pain by VAS, physical function by Health Assessment Questionnaire Disability Index (HAQ-DI), fatigue by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), duration and severity of morning (AM) stiffness, HRQoL by Short Form 36 (SF-36), and Work Productivity and Activity Impairment (WPAI) measure. Least square mean (LSM) changes from baseline (BL) to Week 12 were based on analysis of covariance. Percentages of patients reporting changes in PRO scores from BL to Week 12 ≥ minimum clinically important differences (MCIDs) or scores ≥ normative values (age- and gender-matched for SF-36 only) were determined for UPA and MTX groups; comparisons used chi-square tests. For each PRO, the incremental number needed to treat (NNT) to achieve clinically meaningful improvement from BL was calculated. Results Data from 945 patients (MTX: 314; UPA 15 mg: 317; UPA 30 mg: 314) were analysed. Mean age was 53 years; 76% were female; 49% had RA for Conclusion Among MTX-naive patients with active RA, treatment with UPA 15 mg or 30 mg daily for 12 weeks resulted in statistically significant and clinically meaningful improvements in physical function, pain, fatigue, AM stiffness, HRQoL, and work productivity compared with MTX. The NNTs to achieve these improvements were favourable. Reference [1] van Vollenhoven R, et al. Arthritis Rheumatol. 2018;70(S9):983, abstract 891. Acknowledgement Financial support for the study was provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the abstract. All authors contributed to the development of the publication and maintained control over the final content. Medical writing services were provided by Joann Hettasch of JK Associates Inc., a member of the Fishawack Group of Companies, and funded by AbbVie. Disclosure of Interests Vibeke Strand Consultant for: AbbVie, Amgen, Bayer, BMS, Boehringer Ingelheim, Celgene, Celltrion, CORRONA, Crescendo, EMD Serono, Genentech/Roche, GSK, Horizon, Inmedix, Janssen, Kezar, Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, Servier, UCB., Namita Tundia Shareholder of: AbbVie, Employee of: AbbVie, Sebastiao Radominski Consultant for: Abbvie, Celgene, Genentech/Roche, Janssen, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Genentech/Roche, Janssen, Pfizer, UCB, Alan Friedman Shareholder of: AbbVie, Employee of: AbbVie, Kendall Dunlap Shareholder of: AbbVie, Employee of: AbbVie, Deborah Goldschmidt Employee of: Analysis Group Inc, which received consulting fees from AbbVie for this study., Martin Bergman Shareholder of: Johnson and Johnson (parent company of Janssen), Consultant for: AbbVie, Amgen, BMS, Celgene, Genentech/Roche, Janssen, Merck, Novartis, Pfizer, and Sanofi/Regeneron, Speakers bureau: AbbVie, Amgen, BMS, Celgene, Genentech/Roche, Janssen, Merck, Novartis, Pfizer, and Sanofi/Regeneron

ObjectiveTo investigate the efficacy, safety and immunogenicity of PF-06438179/GP1111 (PF-SZ-IFX) compared with European reference infliximab (Remicade®; ref-IFX) in patients with moderate-to-severe, active rheumatoid arthritis after continued long-term use of PF-SZ-IFX, and in patients who were switched from ref-IFX to PF-SZ-IFX.MethodsREFLECTIONS B537-02 was a double-blind, active-controlled, multinational study in which patients (N=650) were initially randomised to PF-SZ-IFX or ref-IFX for 30 weeks (treatment period [TP] 1). During weeks 30–54 (TP2), the PF-SZ-IFX group (n=280) continued treatment with PF-SZ-IFX (PF-SZ-IFX/PF-SZ-IFX) and patients in the ref-IFX group (n=286) were rerandomised (1:1) to continue ref-IFX (ref-IFX/ref-IFX) (n=143) or switch to PF-SZ-IFX (ref-IFX/PF-SZ-IFX) (n=143) for a further 24 weeks. Efficacy, safety, immunogenicity and pharmacokinetics were evaluated.ResultsDuring TP2, patients in all three treatment groups continued to maintain comparable treatment response. At week 54, the American College of Rheumatology (ACR20) response rates were 71.1% (PF-SZ-IFX/PF-SZ-IFX), 64.3% (ref-IFX/ref-IFX) and 70.6% (ref-IFX/PF-SZ-IFX). Observations for other endpoints, including ACR50/70, Disease Activity Score in 28 Joints Based on High-Sensitivity C Reactive Protein(DAS28-CRP) remission, and mean change in DAS28-CRP and Health Assessment Questionnaire-Disability Index, were also comparable. Treatment-emergent adverse events were reported in 36.8% (PF-SZ-IFX/PF-SZ-IFX), 33.6% (ref-IFX/ref-IFX) and 37.8% (ref-IFX/PF-SZ-IFX) of patients; there were no clinically meaningful differences in the safety profiles between groups. The percentage of patients who were antidrug antibody-positive was generally stable through the treatment period and comparable overall between the PF-SZ-IFX/PF-SZ-IFX (52.1%; neutralising: 80.8%), ref-IFX/ref-IFX (60.1%; neutralising: 84.9%) and ref-IFX/PF-SZ-IFX (58.0%; neutralising 78.3%) groups.ConclusionsThe similar efficacy, safety and immunogenicity of PF-SZ-IFX compared with ref-IFX were maintained for up to 54 weeks and were not affected by blinded treatment switch from ref-IFX to PF-SZ-IFX at week 30.Trial registration numberNCT02222493.

Background Rheumatoid arthritis is a chronic, autoimmune disease in which treatment has evolved with a variety of therapeutic classes. Biological disease-modifying antirheumatic drugs have improved therapy; however, the continued long-term use of these drugs with sustained safety and efficacy remains a challenge. ObjectiveThe objective of this study was to analyze time of use and reasons for discontinuation of biological disease-modifying antirheumatic drugs in patients with rheumatoid arthritis.SettingIt is as part of REAL (Rheumatoid Arthritis in Real Life), a multicenter project that evaluated Brazilian patients with rheumatoid arthritis in a real-life setting. Eleven referral centers for the treatment in the public network participated in the study.MethodsWe conducted a cross-sectional analysis of data collected in the REAL study from August to October 2015 study. The patients were submitted to clinical evaluation and analysis of medical records.Results1125 patients were included (89.5% women; median age: 56.6 years; and disease time: 12.8 years). A total of 406 (36.09%) participants were on a biological disease-modifying antirheumatic drugs. Infliximab was the drug with the longest time of use (12 years). Most (64.4%) drug suspension episodes were due to inefficacy. Adalimumab and certolizumab had a greater number of suspensions due to primary inefficacy, while discontinuations for abatacept were due more to secondary inefficacy. Infliximab had fewer suspensions due to primary inefficacy and golimumab had fewer episodes of secondary inefficacy. Regarding side effects, infliximab was suspended a greater number of times because of clinical and laboratory side effects. Abatacept and adalimumab had fewer suspensions due to clinical side effects, and certolizumab, rituximab and tocilizumab had fewer laboratory adverse effects. Conclusion Among the biological disease-modifying antirheumatic drugs being used for long periods, infliximab had greater time of use. Most drug suspensions (64%) were due to primary or secondary inefficacy. Number of discontinuations due to clinical and laboratory adverse effects for each drug was analyzed, and these data should be confirmed by other real-life studies. Knowledge of what is happening in real life is essential to health professionals, who need to be aware of the most common adverse effects and to health managers, who aim for greater cost-effectiveness in the choice of medications.

Resumo A osteoporose e a principal causa de fraturas na populacao acima de 50 anos. E uma doenca silenciosa que afeta especialmente as mulheres na pos‐menopausa e idosos e tem elevada taxa de morbimortalidade. O principal objetivo do tratamento da osteoporose e a prevencao das fraturas. A identificacao dessa populacao de risco atraves do diagnostico e tratamento precoces e de fundamental importância. A ultima diretriz brasileira para tratamento da osteoporose em mulheres na pos‐menopausa foi elaborada em 2002. Desde entao foram desenvolvidas novas estrategias de diagnostico da osteoporose, bem como farmacos com novos mecanismos de acao foram adicionados ao arsenal terapeutico. A Comissao de Osteoporose e Doencas Osteometabolicas da Sociedade Brasileira de Reumatologia em conjunto com a Associacao Medica Brasileira e sociedades afins desenvolveu esta atualizacao da diretriz do tratamento da osteoporose em mulheres na pos‐menopausa de acordo com as melhores evidencias cientificas disponiveis. Esta atualizacao e destinada aos profissionais das varias especialidades medicas e da area da saude envolvidos no tratamento da osteoporose, medicos em geral e organizacoes relacionadas a saude.

ObjectiveTo demonstrate pharmacokinetic equivalence of CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA) with inadequate responses or intolerances to antitumour necrosis factor agents.MethodsIn this randomised phase I trial, patients with active RA were randomly assigned (2:1) to receive 1000 mg CT-P10 or RTX at weeks 0 and 2 (alongside continued methotrexate therapy). Primary endpoints were area under the serum concentration–time curve from time zero to last quantifiable concentration (AUC0–last) and maximum serum concentration after second infusion (Cmax). Additional pharmacokinetic parameters, efficacy, pharmacodynamics, immunogenicity and safety were also assessed. Data are reported up to week 24.Results103 patients were assigned to CT-P10 and 51 to RTX. The 90% CIs for the ratio of geometric means (CT-P10/RTX) for both primary endpoints were within the bioequivalence range of 80%–125% (AUC0–last: 97.7% (90% CI 89.2% to 107.0%); Cmax: 97.6% (90% CI 92.0% to 103.5%)). Pharmacodynamics and efficacy were comparable between groups. Antidrug antibodies were detected in 17.6% of patients in each group at week 24. CT-P10 and RTX displayed similar safety profiles.ConclusionsCT-P10 and RTX demonstrated equivalent pharmacokinetics and comparable efficacy, pharmacodynamics, immunogenicity and safety.Trial registration numberNCT01534884.

Background:Upadacitinib (UPA), an oral, selective JAK-1 inhibitor was effective in global ph 3 trials in rheumatoid arthritis (RA) patients with inadequate response (IR)/intolerance to csDMARDs and bDMARDs.Objectives:This Phase 3, randomized, double-blind, placebo (PBO)-controlled study assessed the efficacy and safety of UPA in combination with csDMARDs in csDMARD-IR patients with RA from China, Brazil, and South Korea.Methods:Patients were randomized 1:1 to receive UPA 15 mg once daily (QD) or PBO in combination with csDMARDs. The primary endpoint was ACR20 response at Week 12, using non-responder imputation.Results:338 patients were randomized, and 310 (91.7%) completed Week 12. At Week 12, statistically significantly more patients receiving UPA vs PBO achieved the primary endpoint of ACR20 (71.6% vs 31.4%, pTable 1.Efficacy endpoints at Week 12EndpointaUPA 15 mg QD (n=169)PBO(n=169)Primary endpointACR20, %71.6***31.4Secondary endpointsΔ DAS28(CRP)-2.56***-0.95Δ HAQ-DI-0.62***-0.18Δ SF-36 PCS8.93c***3.36dDAS28(CRP) ≤3.2, %46.2***13.6DAS28(CRP) 29.6***5.3CDAI ≤10, %35.5***11.2ACR50, %b40.8***8.3ACR70, %b21.3***3.6ACR20 at Week 1, %b25.4***5.9***paNRI for binary endpoints; ANCOVA with multiple imputation for DAS28(CRP) and HAQ-DI; mixed model repeated measures for other continuous endpointsbUnranked secondary endpoint.cn=143.dn=149Conclusion:Efficacy of UPA was demonstrated in this csDMARD-IR population from China, Brazil, and South Korea. The safety of UPA was comparable with the global Phase 3 program.Disclosure of Interests: :Xiaofeng Zeng Consultant of: MSD Pharmaceuticals, Dongbao Zhao: None declared, Sebastiao Radominski: None declared, MAURO KEISERMAN Speakers bureau: Pfizer, Abbott, Actelion, AstraZeneca, Amgen, Roche, Bristol Myers Squibb, and Janssen and has received clinical trial honoraria from Pfizer, Amgen, AstraZeneca, Anthera Pharmaceuticals, Bristol-Myers Squibb, Biogen Idec Inc, Celltrion Inc., Eli Lilly, Human Genome Sciences, Novartis, Roche, Sanofi, UCB Inc., Chang-Keun Lee: None declared, Sebastian Meerwein Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Jeffrey Enejosa Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Yunxia Sui Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Mohamed-Eslam Mohamed Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Won Park: None declared

ObjectivesTo evaluate the long-term efficacy and safety of canakinumab in patients with active systemic juvenile idiopathic arthritis (JIA).MethodsPatients (2–19 years) entered two phase III studies and continued in the long-term extension (LTE) study. Efficacy assessments were performed every 3 months, including adapted JIA American College of Rheumatology (aJIA-ACR) criteria, Juvenile Arthritis Disease Activity Score (JADAS) and ACR clinical remission on medication criteria (CRACR). Efficacy analyses are reported as per the intent-to-treat population.Results144 of the 177 patients (81%) enrolled in the core study entered the LTE. Overall, 75 patients (42%) completed and 102 (58%) discontinued mainly for inefficacy (63/102, 62%), with higher discontinuation rates noted in the late responders group (n=25/31, 81%) versus early responders (n=11/38, 29%). At 2 years, aJIA-ACR 50/70/90 response rates were 62%, 61% and 54%, respectively. CRACR was achieved by 20% of patients at month 6; 32% at 2 years. A JADAS low disease activity score was achieved by 49% of patients at 2 years. Efficacy results were maintained up to 5 years. Of the 128/177 (72.3%) patients on glucocorticoids, 20 (15.6%) discontinued and 28 (22%) tapered to 0.150 mg/kg/day. Seven patients discontinued canakinumab due to CR. There were 13 macrophage activation syndrome (three previously reported) and no additional deaths (three previously reported). No new safety findings were observed.ConclusionResponse to canakinumab treatment was sustained and associated with substantial glucocorticoid dose reduction or discontinuation and a relatively low retention-on-treatment rate. No new safety findings were observed on long-term use of canakinumab.Trial registration numbersNCT00886769, NCT00889863, NCT00426218 and NCT00891046.

To identify baseline predictors of remission and low disease activity (LDA) in early rheumatoid arthritis (RA) from the GLADAR (Grupo Latino Americano De estudio de la Artritis Reumatoide) cohort.Patients with 1- and 2-year follow-up visits were included. Remission and LDA were defined by DAS28-ESR ( 2.6 and ≤ 3.2, respectively). Baseline predictors examined were gender, ethnicity, age at diagnosis, socioeconomic status, symptoms' duration, DMARDs, RF, thrombocytosis, anemia, morning stiffness, DAS28-ESR (and its components), HAQ-DI, DMARDs and corticosteroid use, and Sharp-VDH score. Multivariable binary logistic regression models (excluding DAS28-ESR components to avoid over adjustment) were derived using a backward selection method (α-level set at 0.05).Four hundred ninety-eight patients were included. Remission and LDA/remission were met by 19.3% and 32.5% at the 1-year visit, respectively. For the 280 patients followed for 2 years, these outcomes were met by 24.3% and 38.9%, respectively. Predictors of remission at 1 year were a lower DAS28-ESR (OR 1.17; CI 1.07-1.27; p = 0.001) and HAQ-DI (OR 1.48; CI 1.04-2.10; p = 0.028). At 2 years, only DAS28-ESR (OR 1.40; CI 1.17-1.6; p 0.001) was a predictor. Predictors of LDA/remission at 1 year were DAS28-ESR (OR 1.42; CI 1.26-1.61; p 0.001), non-use of corticosteroid (OR 1.74; CI 1.11-2.44; p = 0.008), and male gender (OR 1.77; CI 1.2-2.63; p = 0.036). A lower baseline DAS28-ESR (OR 1.45; CI 1.23-1.70; p 0.001) was the only predictor of LDA/remission at 2 years.A lower disease activity consistently predicted remission and LDA/remission at 1 and 2 years of follow-up in early RA patients from the GLADAR cohort. Key Points • In patients with early RA, a lower disease activity at first visit is a strong clinical predictor of achieving remission and LDA subsequently. • Other clinical predictors of remission and LDA to keep in mind in these patients are male gender, non-use of corticosteroids and low disability at baseline. • Not using corticosteroids at first visit is associated with a lower disease activity and predicts LDA/remission at 1 year in these patients.

Background There are few data on the epidemiology, clinical manifestations and management of RA in Brazil, even with the recognition of the high direct, indirect and societal costs of this disease. Herein, we report the formation of the REAL - Rheumatoid Arthritis in Real Life, the first nationally representative multicenter prospective observational study in Brazil. Methods The REAL study was designed to include a total of 1300 evaluable patients from 13 tertiary care public health centers specialized in RA management and representative of 5 regions of Brazil. Each center was expected to enroll ~ 100 consecutively seen patients and follow them prospectively in a systematic protocol-driven fashion with scheduled visits at baseline, 6 and 12 months. Core clinical, laboratory and patient-reported outcomes measures were required to be collected at each visit. Results A total of 1115 patients (89.4% female, mean age of 56.7 years and median disease duration of 12.7 years) were enrolled from 11 participating centers. Almost 80% of patients were of middle-low or low socioeconomic classes. The median educational time was 8 years, with 3.23% being below literacy level. The interval between symptoms and diagnosis varied from 1 to 457 months (median 12 months). Almost half of the patients were on glucocorticoids, 96.5% on DMARDs, with 35.7% on biologics. Median HAQ-DI was 0.875, ranging from 0 to 3. Median DAS28-ESR was 3.5, with 58.7% of patients presenting moderate or high disease activity. Conclusions The first large cohort of Brazilian patients with RA in a real-life setting shows several striking differences from previously published cohorts from other countries. The long delay for diagnosis and start of DMARDs may partly explain the high frequency of erosive disease. An elevated percentage of patients on moderate or high disease activity was seen, despite of the high frequency of corticosteroid and biologics utilization. Data from this cohort may enable public health managers of developing countries better allocate the limited resources available for the care of RA patients.

Background Although Rheumatoid Arthirtis (RA) extra-articular manifestations (ExRA) occurrence have been decreasing over time, they are still a major mortality risk factor for patients, and also a challenge for rheumatologists. Objectives To determine the prevalence of ExRA in a large cohort, and its association with several clinical data. Methods A cross-sectional and observational study, based on a multi-centric database from a prospective cohort (The REAL – RA in real life in Brazil), in which 11 public rheumatology centres enrolled RA patients (1987ARA or 2010 ACR-EULAR). Data collection began in 08–2015, using a single online electronic medical record, and included demographic, socioeconomic, clinical and therapeutic characteristics. Results 1116 patients from 11 centres were included: 89% women, age [mean ±SD] 58.2±11.5 year, disease duration 14.5±12.2 year, positive Rheumatoid Factor (RF) in 77%. Regarding ExRA, 334 occurrences (detailed in table 1) were registered in 261 patients, summing for an overall prevalence of 23,4% in our cohort. Comparison among ExRA and No-ExRA groups reveals significant higher age, disease duration, Cinical Disease Activity index (CDAI), Health Assessment Questionnaire (HAQ) and Disease Activity Index (DAS 28) in ExRA group (table 2). Unexpectedly, some well–known factors associated with ExRA, such as Rheumatoid factor (RF) and tobacco use, were similar among the two groups. Conclusions ExRA still shows an expressive occurrence that should not be underestimated. Our findings reinforce that long-term disease, associated with significant disability and persistent inflammatory activity, are the key factors related to ExRA development. Early aggressive treatment with effective therapies should lower the risk and severity of ExRA. Disclosure of Interest None declared

Background Rheumatoid arthritis (RA) is associated with impairments in functionality, affecting aspects such as physical capacity, independence, mental health, social and professional life. Health Assessment Questionnaire-Disability Index (HAQ-DI) is a validated tool for assessing functional capacity in RA patients. A simple questionnaire with a score of 0 to 3 is applied, with an inverse relationship between grade and functionality. Previous studies have shown worse functional indexes in patients with high disease activity and established joint damage. Objectives To relate clinical, laboratory and therapeutic aspects with HAQ-DI in a large cohort of Brazilian patients. Methods A prospective, multicenter cohort study (“REAL” Study) involving 11 Brazilian centres specialised in the treatment of RA patients. All patients were submitted to at least 3 clinical evaluations in a 12 month period. Only patients older than 18 years and classified as RA according to 1987 (ACR) or 2010 (ACR/EULAR) criteria were evaluated. HAQ-DI was applied for assessing functional capacity, and the results were analysed for association with clinical, laboratory and therapeutic elements. Comparison between groups was performed using Mann-Whitney or Kruskal-Wallis tests. Results Overall, 1116 patients (89.43% females, mean age 58±11 years) took part in the study. Rheumatoid factor (RF) in high levels and bone erosion were both associated with higher HAQ-DI indexes (p: 0.0244 and p Conclusions In our prospective cohort, patients with high levels of RF, bone erosion, in use of any biologic DMARD or targeted-synthetic DMARD, abatacept, rituximab or tocilizumab had worse functional capacity indexes. When compared to non-use, the use of any conventional DMARD was associated with better rates of HAQ-DI. References [1] Drossaers-Bakker KW, de Buck M, van Zeben D, et al. Long-term course and outcome of functional capacity in rheumatoid arthritis: The effect of disease activity and radiologic damage over time. Arthritis Rheum1999;42:1854. [2] Scott DL, Pugner K, Kaarela K, et al. The links between joint damage and disability in rheumatoid arthritis. Rheumatology (Oxford)2000;39:122. Disclosure of Interest None declared

Background Rheumatoid arthritis (RA) is a chronic disease, characterised by inflammatory involvement of the synovial joints. The ”treat to target” concept is well established in the rheumatologic community, however, in many patients, especially in developing countries, its implementation is not feasible. Considering the high costs of treatment com of RA and the limited national epidemiological data available on this disease, we sought to describe the profile of use of biological drugs in Brazilian patients with RA to help the decision-making process by public health managers. Objectives To describe the frequency and time of use of biological drugs in Brazilian patients with rheumatoid arthritis. Methods The REAL – RA in real life in Brazil – is a multicenter prospective cohort study, with twelve-month follow-up period. To be included in this study, consecutive patients from 11 tertiary rheumatology centres had to meet the 1987 ACR or the 2010 ACR/European League Against Rheumatism (EULAR) criteria. Data were collected during routine clinical care and previous medical records were used as secondary sources. The present study present data taken from the participants’ initial assessment. This research was approved by the Ethics Committees of each centre. Results A total of 1125 patients were analysed. 89% were women with a mean age of 56.6 years. The main clinic data were: DAS 28 (median)=3.52, HAQ (median)=0.87 and CDAI (median)=9. 1022 (90.84%) used synthetic DMARDs and 406 (36.09%) biologic therapy. The frequency of use of the biologic therapy was: abatacept (73 patients/6.49%), etanercept (66/5.87%), tocilizumab (60/5.33%), adalimumab (54/4.8%), infliximab (50/4.44%), rituximab (49/4.36%), golimumab (37/3.29%), certolizumab (17, 1.51%). The time of use of the biological drugs is presented in table 1. Conclusions The therapeutic profile of this cohort of Brazilian RA patients shows some interesting results. The relatively high number of patients on biologics, compared to other studies, may be related to fact that the centres involved were reference centres, probably dealing with more difficult cases. References [1] Azevedo AB, Ferraz MB, Ciconelli RM. Indirect Costs of Rheumatoid Arthritis in Brazil. Value in Health2008;11(5):869–877. [2] Boonen A, Severens JL. The burden of illness of rheumatoid arthritis. Clin Rheumatol2011;30(Suppl 1):S3–S8. Disclosure of Interest None declared