Rheumatoid arthritis (RA) is a chronic disease that affects mainly small joints from hands and feet. The aims of this study were to analyze the prevalence of foot involvement in a sample of Brazilian RA patients and to explore the influence of disease variables such as inflammatory activity, serological, and epidemiological profile in this type of involvement. One hundred RA patients and 100 healthy controls paired for gender, age, and body mass index answered the FFI-BR (Foot Functional Index-Brazilian version) that evaluates foot function. RA patients had epidemiological and clinical data collection upon direct questioning and chart review. C-reactive protein (CRP), ESR (erythrocyte sedimentation rate), and DAS28-ESR were used to measure disease activity. In the RA sample, 98% had foot pain versus 76% in the controls (p < 0.0001; OR = 15.4; 95% CI = 3.4-67.5); 96% had some difficulty in function versus 66% of controls (p < 0.0001; OR = 12.3; 95% CI = 4.1-36.5); and 73% had some incapacity versus 20% of controls (p < 0.0001; OR = 10.8; 95% CI = 5.5-20.9). Values of FFI-BR showed correlation with ESR (p = 0.006), CRP (p = 0.01), and DAS28-ESR (p < 0.0001). No association between FFI-BR total score and gender, ethnic background, positive rheumatoid factor, tobacco exposure, and any of used medications was found (all p = ns). The majority of RA patients suffers from foot problems and was associated with inflammatory biomarkers. The control of inflammatory activity may help in the treatment of this problem.

Rheumatoid arthritis (RA) is a chronic, progressive inflammatory disease that can cause limitations and difficulties in activities of daily living (ADLs), due to pain, gait impairment and difficulties with self-care. 1 Damage to the ankles and feet occurs in 85% to 100% of these patients and contributes greatly to their loss of quality of life. 2 Typically, foot involvement indicates more aggressive disease and requires more than just pharmacological care. 3 Studying functional disability of the feet is important because, in addition to causing the abovementioned limitations, this form of disability has been correlated with higher risk of falls due to stiffness, pain, muscle weakness and balance disorders, which increases mortality, health resource utilization and loss of patients' work capacity. 4,5 Although RA patients frequently complain about their feet, such complaints are often overlooked by healthcare professionals. Specific instruments for foot health assessment, including the Brazilian versions of the Foot Health Status Questionnaire (FHSQ-BR) and the Foot Function Index (FFI-BR), measure the day-today impact of involvement of the feet in RA. These instruments provide data that help in understanding the repercussions of this involvement and the respective therapeutic indications. This can improve the quality of life of the individuals affected. 3 OBJECTIVE The objectives of the present study were to assess the disability that originated through foot involvement among RA patients, as indicated using the FFI-BR and FHSQ-BR questionnaires, and to evaluate the influence of inflammatory activity on the dysfunction of foot joints.

BackgroundWhile dramatic progress has been made in this decade with treatments for rheumatoid arthritis (RA), such as methotrexate (MTX) and biological agents, concern about the safety, including the occurrence of malignancy, of these highly effective drugs still exists in daily clinical practice. There has not been an evident association between the use of biological agents and the occurrence of malignancy in most reports from clinical trials1 and observational studies2, although MTX use might be associated with the development of malignant lymphoma, called MTX-associated lymphoproliferative disorder3, in patients with RA. In an analysis of risk factors for overall and site-specific malignancies in Japanese patients with RA, higher disease activity was identified to be a risk factor for overall malignancies (hazard ratio [HR] 1.10, 95% CI 1.02–1.19), suggesting that tight control of RA disease activity would reduce the occurrence of malignancies in patients with RA4. However, the risk of malignancies with RA treatments including MTX and biological agents was not assessed in that analysis.ObjectivesWe investigated the association between the occurrence of malignancies (overall and malignant lymphoma) and drug use (MTX and biological agents) in a large observational cohort of Japanese patients with RA over a long-term period.MethodsAmong Japanese patients with RA enrolled in the Institute of Rheumatology, Rheumatoid Arthritis (IORRA) cohort from April 2000 to September 2013, data for all malignancies were extracted from patients' self-reports and confirmed by medical records. Data for malignancies occurring in patients who dropped out of the IORRA study during the subsequent three months were also collected from medical information from affiliated hospitals. We analysed whether MTX and biological agents were risk factors for overall malignancy and malignant lymphoma using a marginal structural Cox proportional hazards model5 adjusted for age, gender, smoking history, body mass index, RA disease duration, rheumatoid factor positivity and disease activity (28-joint disease activity score).ResultsAmong 11,106 Japanese patients with RA representing 68,483 person-years, 507 overall malignancies, including 68 malignant lymphomas, were confirmed. Neither MTX nor biological agent use was a significant risk factor for overall malignancy, with an HR (95% CI) of 1.18 (0.77–1.81) and 1.01 (0.65–1.57), respectively, or for malignant lymphoma, with an HR (95% CI) of 1.17 (0.55–2.48) and 1.26 (0.43–3.64), respectively.ConclusionsThe use of MTX and biological agents was not significantly associated with the occurrence of overall malignancy or malignant lymphoma during long-term longitudinal observation of Japanese patients with RA.References Moulis G, et al. PLoS One. 2012;7:e48991.Mariette X, et al. Ann Rheum Dis. 2011;70:1895–904.Kameda T, et al. Arthritis Care Res (Hoboken). 2014;66:1302–9.Sugimoto N, et al. EULAR Congress 2016;FRI0143.Choi HK, et al. Lancet. 2002;359:1173–7. Disclosure of InterestN. Sugimoto Speakers bureau: T...

Background:Rheumatoid arthritis (RA) patients can experience various comorbidities1. The incidence of diabetes mellitus (DM) is reported higher in patients with RA2 and comorbid DM is likely to affect treatment outcomes3 and then healthcare resource uses, however, no previous study has not focused on it.Objectives:To evaluate medical costs and resource use in patients starting treatment for RA with and without DM using a large claims database in Japan.Methods:We used a large Japanese administrative claims database constructed by the Japan Medical Data Center (JMDC)4. Patients with the International Classification of Diseases 10th revision (ICD-10) codes for RA who started medication with disease-modifying antirheumatic drugs (DMARDs) after 6 months without them in the period from 1/1/2012 to 12/31/2017 and who were observable for 12 months as a follow-up period were enrolled. These patients were categorized as DM or non-DM group with ICD-10 codes for DM plus use of antidiabetic drugs in 6 months before starting DMARDs (baseline period). To adjust baseline characteristics between the 2 groups, they were matched by sex, age, Charlson Comorbidity Index (CCI) except for DM, months from the first RA codes to starting DMARDs, and medications. The primary endpoint was mean medical cost per patient in the 12-month follow-up period. Costs in JPY were converted into EUR (1 EUR = 125 JPY in 2020). Costs for drugs, treatments, and materials and their subcategories were evaluated both with and without DM-specific costs. The secondary endpoints were the proportions of patients using the subcategories of each resource.Results:Patients of 161 for the DM group and 2,974 for the non-DM group were eligible, and 109 patients were matched from each group. The medians of age and CCI were 59 years and 2.0 in both groups and no significant difference was observed in all baseline characteristics used for matching between the groups. Total mean costs were significantly higher in the DM group (DM, 5,331 EUR, non-DM 3,200 EUR; P< 0.05). After excluding DM-specific costs, drug costs were significantly higher in the DM group than in the non-DM group (DM 1,883 EUR, non-DM 896 EUR; P < 0.05), especially costs for biological DMARDs (DM 1,156 EUR, non-DM 292 EUR; P < 0.05), mainly because a higher proportion of patients used these drugs in the DM group (Table 1). Treatment costs (DM 2,380 EUR, non-DM 2,133 EUR) and material costs (DM 74 EUR, non-DM 149 EUR) were not different between the groups, but only costs for examinations were significantly higher in the DM group (DM 970 EUR, non-DM 779 EUR; P < 0.05).Table 1.Number and proportion of patients who used drugsType of drugDrug use, n (%)DM (N = 109)Non-DM (N = 109)P-valuecsDMARDsTotal109 (100.0)109 (100.0)1.000Methotrexate101 (92.7)102 (93.6)1.000Others46 (42.2)51 (46.8)0.583bDMARDsTotal16 (14.7)6 (5.5)0.041TNFi11 (10.1)4 (3.7)0.118IL6i6 (5.5)2 (1.8)0.219T-cell4 (3.7)0 (0.0)0.125tsDMARDs0 (0.0)0 (0.0)1.000CSs65 (59.6)62 (56.9)0.711AnalgesicsTotal103 (94.5)96 (88.1)0.167Acetaminophen24 (22.0)23 (21.1)1.000Acetaminophen /Opioids10 (9.2)6 (5.5)0.454NSAIDs102 (93.6)93 (85.3)0.093Opioids0 (0.0)4 (3.7)0.125Others25 (22.9)17 (15.6)0.185bDMARDs=biological disease-modifying antirheumatic drugs; CSs=corticosteroids; csDMARDs=conventional synthetic disease-modifying antirheumatic drugs; DM=diabetes mellitus; IL6i=interleukin-6 inhibitor; NSAID=non-steroidal anti-inflammatory drug; T-cell=selective T-cell co-stimulation modulator; TNFi=tumor necrosis factor α inhibitor; tsDMARDs=targeted synthetic disease-modifying antirheumatic drugs; P-values were calculated using McNemar testConclusion:Medical costs for RA were higher in the DM group than in the non-DM group because of more prevalent use of biological DMARDs in the DM group.References:[1]Gabriel SE et al., Arthritis Res Ther. 2009;11(3):229.[2]Giacomelli R et al., Expert Rev Clin Immunol. 2016;12(8):849-55.[3]Crepaldi G et al., PLoS One. 2016;11(1):e0146991.[4]JMDC claims database, Tokyo, Japan.Disclosure of Interests:Eiichi Tanaka Speakers bureau: AbbVie GK, Asahi Kasei Pharma Corporation, Astellas Pharma Inc, Ayumi Pharmaceutical Corporation, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., GlaxoSmithKline K.K., Kyowa Pharma Chemical Co., Ltd., Janssen Pharmaceutical K.K., Mochida Pharmaceutical Co., Ltd., Pfizer, Takeda Pharmaceutical Co., Ltd, and Teijin Pharma Ltd., Eisuke Inoue Speakers bureau: Pfizer Japan, Bristol-Myers Squibb K.K., Ryoko Sakai Speakers bureau: Bristol Myers Squibb Co., Ltd., Grant/research support from: Tokyo Women’s Medical University (TWMU), particularly the Division of Multidisciplinary Management of Rheumatic Diseases, Department of Rheumatology, has received unrestricted research grants from Ayumi Pharmaceutical Co.; Chugai Pharmaceutical Co., Ltd.; Eisai Co., Ltd., Nippon Kayaku Co., Ltd.; Taisho Toyama Pharmaceutical Co., Ltd.; Takeda Pharmaceutical Co., Ltd.; Mitsubishi Tanabe Pharma Co.; and Teijin Pharma Ltd., with which TWMU paid the salaries of RS., Iwasaki Katsuhiko: None declared, Ayako Shoji: None declared, masayoshi harigai Speakers bureau: AbbVie GK, Ayumi Pharmaceutical Corporation, Bristol-Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Pfizer Japan Inc., and Takeda Pharmaceutical Co., Ltd., Consultant of: AbbVie GK, Bristol-Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., and Gilead Sciences Inc., Grant/research support from: AbbVie GK, and Asahi Kasei Corp., Astellas Pharma Inc., Ayumi Pharmaceutical Corporation, Bristol-Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd. Daiichi-Sankyo, Inc., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Corporation., Nippon Kayaku Co., Ltd., Taisho Pharmaceutical Co., Ltd., and Takeda Pharmaceutical Co., Ltd.

Background Patients with rheumatoid arthritis (RA) in clinical remission may still have evidence of synovitis detectable by ultrasonography (US), which is associated with structural damage. It has been reported that positive power Doppler (PD) activity is still detectable by US in metacarpophalangeal joints and wrist of dominant hand even in patients in clinical remission defined by more stringent criteria (1). Objectives To assessed the presence of residual synovitis with PD activity in any peripheral joints of interest detected by US in RA patients achieving clinical remission in daily clinical setting. Methods Any peripheral joints including bilateral wrist, finger, glenohumeral, knee, ankle and metatarsophalangeal joints were scanned by US in daily outpatient clinic when confirmation of physical examination was needed, within eight weeks after clinical evaluation such as joint counts, inflammatory markers, composite disease activity scores, and physical function. Clinically obvious swollen or non-swollen joints were excluded for US examination. Among the patients, those who achieved clinical remission defined by DAS28 or new ACR/EULAR definitions were retrospectively collected from IORRA database of Tokyo Women’s Medical University, and the frequency of positive intra-capsular PD signal was evaluated. Results US scan of at least one joint was performed in 92 patients (female 78%, median age 57.6 year and duration 5.0 year) and numbers (%) of patients fulfilling remission in DAS28, CDAI, SDAI or Boolean definition were 46 (50.0), 20 (21.7), 23 (25.0) and 20 (21.7), respectively. Positive PD signal was present in 24/46, 11/20, 11/23 and 12/20 patients, in which PD activity was even detected in joints that the physician assumed to be non-swollen among 7/46, 2/20, 2/23 and 3/20 patients regarding 28 joints, and in 11/46, 5/20, 6/23 and 6/20 patients when including bilateral feet, respectively. Conclusions Imaging assessment on even selected joints of interested would be advisable when strictly targeting remission. References Saleem B, Brown AK, Keen H, Nizam S, Freeston J, Wakefield R, Karim Z, Quinn M, Hensor E, Conaghan PG, Emery P. Should imaging be a component of rheumatoid arthritis remission criteria? A comparison between traditional and modified composite remission scores and imaging assessments. Ann Rheum Dis 2011; 70: 792-798. Disclosure of Interest Y. Seto: None Declared, E. Inoue: None Declared, A. Taniguchi: None Declared, S. Momohara: None Declared, H. Yamanaka Grant/Research support from: IORRA study is supported from 40 pharmaceutical companies; Asahikasei Kuraray Medical Co.,Ltd., Abbott Japan Co.,Ltd., Asahikasei Pharma Corporation, AstellasPharma Inc., AstraZeneca K.K., Bristol-Myers Squibb, Chugai Pharmaceutical Co.,Ltd., Daiichi Fine Chemical Co.,Ltd., Daiichi Sankyo Co.,Ltd., Dainippon Sumitomo Pharma Co.,Ltd., Eisai Co.,Ltd., GlaxoSmithKline K.K., Hisamitsu Pharmaceutical Co.,Inc., Janssen Pharmaceutical K.K., Japan Tobacco Inc., Kaken Pharmaceutical Co.,Ltd., Kissei Pharmaceutical C...