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Editors’ note The Editors of the 5 journals of the American College of Rheumatology and European Alliance of Associations for Rheumatology have been reminded by this editorial that ACR and EULAR have jointly agreed on various classification criteria, definitions, recommendations, or points to consider, which do not always find reflection in manuscripts submitted to the journals. Consequently, in the future, the Editors will enforce the use of the products obtained in the course of joint ACR/EULAR or EULAR/ACR activities in all respective papers. For rheumatoid arthritis this would mean use of the ACR/EULAR or EULAR/ACR classification criteria, remission definitions, recommendations on what to report in clinical trials, and others, as pertinent. The same applies to other diseases. There are valid and important reasons that these activities have been undertaken by ACR and EULAR, and therefore, the conclusions of the various task forces, which have been endorsed by ACR and EULAR, should be respected by investigators and study administrators. This does not mean other methods could not be used in a study, but at the least, the reports should address the methods agreed on by the two organisations. Maintaining uniformity across major publications regarding rheumatoid arthritis remission or other definitions not only allows for more appropriate comparison across analyses, but also enhances readers' ability to interpret results. Author instructions across the five journals will more strongly reflect this requirement. Over the last 30 years, treatment for rheumatoid arthritis (RA) has improved dramatically. By the early 2000s, disease remission had become a realistic goal, although definitions of remission varied widely, making it difficult to compare treatment strategies and gauge how often remission occurred. In 2009, the American College of Rheumatology (ACR) and the European Alliance of Associations for Rheumatology (EULAR) created a joint committee whose charge was to recommend a definition of remission. Members …

ObjectivesTo assess the risk of severe COVID-19 outcomes in patients with autoimmune rheumatic diseases (ARDs) and transplant recipients compared with matched general population comparators.DesignPopulation-based matched cohort study using administrative health data sets.SettingBritish Columbia, Canada.ParticipantsAll adults with test-positive SARS-CoV-2 infections. SARS-CoV-2-positive patients with ARDs and those with transplantation were matched to SARS-CoV-2-positive general population comparators on age (±5 years), sex, month/year of initial positive SARS-CoV-2 test and health authority.Outcome measuresCOVID-19-related hospitalisations, intensive care unit (ICU) admissions, invasive ventilation and COVID-19-specific mortality. We performed multivariable conditional logistic regression models adjusting for socioeconomic status, Charlson Comorbidity Index, hypertension, rural address and number of previous COVID-19 PCR tests.ResultsAmong 6279 patients with ARDs and 222 transplant recipients, all SARS-CoV-2 test positive, risk of hospitalisation was significantly increased among patients with ARDs (overall ARDs (adjusted OR (aOR) 1.30; 95% CI 1.19 to 1.43)); highest within ARDs: adult systemic vasculitides (aOR 2.18; 95% CI 1.17 to 4.05) and transplantation (aOR 10.56; 95% CI 6.88 to 16.22). Odds of ICU admission were significantly increased among patients with ARDs (overall ARDs (aOR 1.30; 95% CI 1.11 to 1.51)); highest within ARDs: ankylosing spondylitis (aOR 2.03; 95% CI 1.18 to 3.50) and transplantation (aOR 8.13; 95% CI 4.76 to 13.91). Odds of invasive ventilation were significantly increased among patients with ARDs (overall ARDs (aOR 1.60; 95% CI 1.27 to 2.01)); highest within ARDs: ankylosing spondylitis (aOR 2.63; 95% CI 1.14 to 6.06) and transplantation (aOR 8.64; 95% CI 3.81 to 19.61). Risk of COVID-19-specific mortality was increased among patients with ARDs (overall ARDs (aOR 1.24; 95% CI 1.05 to 1.47)); highest within ARDs: ankylosing spondylitis (aOR 2.15; 95% CI 1.02 to 4.55) and transplantation (aOR 5.48; 95% CI 2.82 to 10.63).ConclusionsThe risk of severe COVID-19 outcomes is increased in certain patient groups with ARDs or transplantation, although the magnitude differs across individual diseases. Strategies to mitigate risk, such as booster vaccination, prompt diagnosis and early intervention with available therapies, should be prioritised in these groups according to risk.

ObjectiveTo determine the prevalence of physician burnout during the pandemic and differences by gender, ethnicity or sexual orientation.Design, setting and participantsWe conducted a cross-sectional survey (August–October in 2020) of internal medicine physicians at two academic hospitals in Vancouver, Canada.Primary and secondary outcomesPhysician burnout and its components, emotional exhaustion, depersonalisation and personal accomplishment were measured using the Maslach Burnout Inventory.ResultsThe response rate was 38% (n=302/803 respondents, 49% women,). The prevalence of burnout was 68% (emotional exhaustion 63%, depersonalisation 39%) and feeling low personal accomplishment 22%. In addition, 21% reported that they were considering quitting the profession or had quit a position. Women were more likely to report emotional exhaustion (OR 2.00, 95% CI: 1.07 to 3.73, p=0.03) and feeling low personal accomplishment (OR 2.26, 95% CI: 1.09 to 4.70, p=0.03) than men. Visible ethnic minority physicians were more likely to report feeling lower personal accomplishment than white physicians (OR 1.81, 95% CI: 1.28 to 2.55, p=0.001). There was no difference in emotional exhaustion or depersonalisation by ethnicity or sexual orientation. Physicians who reported that COVID-19 affected their burnout were more likely to report any burnout (OR: 3.74, 95% CI: 1.99 to 7.01, pConclusionBurnout affects 2 out of 3 internal medicine physicians during the pandemic. Women, ethnic minority physicians and those who feel that COVID-19 affects burnout were more likely to report components of burnout. Further understanding of factors driving feelings of low personal accomplishment in women and ethnic minority physicians is needed.

Across the globe, concerns of hydroxychloroquine (HCQ) supply shortages for patients with rheumatic disease are growing,1 in part as a consequence of the immense scientific and public enthusiasm for HCQ as a potential COVID-19 therapy.2 3 However, published data on the occurrence of HCQ shortages during the COVID-19 pandemic are presently lacking. Therefore, we conducted a national survey of 531 Canadian rheumatologists between 14 and 24 April 2020. The 5-question electronic survey (French or English) included province of practice, whether respondents were concerned about HCQ shortages in their province, and whether they had been contacted by patients or pharmacies regarding difficulties renewing HCQ prescriptions during the COVID-19 pandemic. Physicians who answered ‘yes’ to the latter question were asked to estimate for how many patients this occurred. The McGill University Health Centre research ethics board approved this survey. Of 134 rheumatologists who completed the survey (25% response rate), three quarters (n=102, 76%) were concerned about HCQ shortages, while 81 (60%) had been contacted by pharmacies or patients …

ObjectiveBalanced scorecards (BSCs) were developed in the early 1990s in corporate settings as a strategic performance management tool that emphasised measurement from multiple perspectives. Since their introduction, BSCs have been adapted for a variety of industries, including to healthcare settings. The aim of this scoping review was to describe the application of BSCs in healthcare.MethodsMedline, Embase and CINHAL databases were searched using keywords and medical subject headings for ‘balanced scorecard’ and related terms from 1992 to 17/04/2020. Title and abstract screening and full text review were conducted in duplicate by two reviewers. Studies describing the development and/or implementation of a BSC in a healthcare setting were included. Data were abstracted using pilot-tested forms and reviewed for key themes and findings.Results8129 records were identified and 841 underwent a full text review. 87 articles were included. Over 26 countries were represented and the majority of BSCs were applied at a local level (54%) in hospital settings (41%). While almost all discussed Kaplan and Norton’s original BSC (97%), only 69% described alignment with a strategic plan. Patients/family members were rarely involved in development teams (3%) which typically were comprised of senior healthcare leaders/administrators. Only 21% of BSCs included perspectives using identical formatting to the original BSC description. Lessons learnt during development addressed three main themes: scorecard design, stakeholder engagement and feasibility.ConclusionsBSC frameworks have been used in various healthcare settings but frequently undergo adaptation from the original description in order to suit a specific healthcare context. Future BSCs should aim to include patients/families to promote patient-centred healthcare systems. Considering the heterogeneity evident in development approaches, methodological guidance in this area is warranted.

Background:Inflammatory arthritis (IA) predisposes patients to several chronic conditions including cardiovascular diseases (CVD), diabetes (DM), osteoporosis (OP) and infections, likely due to systemic effects of inflammation. Studies have found that patients with IA often receive suboptimal care for screening and managing these conditions.Objectives:This is the first phase of a study which will develop and pilot test automated EMR reminders for family physicians. The reminders will prompt family physicians to screen for and address risk factors for these conditions. We conducted a Delphi process to select care recommendations to be addressed by the EMR reminders.Methods:We conducted a review of current BC, Canadian and international guidelines for screening and addressing risk factors for CVD, DM, OP and infection. A list of 22 care recommendations, including their level of evidence and risks/benefits of implementation, was reviewed by a panel of six family physicians, three rheumatologists and three IA patients, in a three-round online modified Delphi process. Panelists rated each care recommendation, using 9-point scales, on 1) their clinical importance, 2) their likelihood of improving outcomes, and 3) implementation feasibility. Results were discussed in an online forum. Panelists then rated slightly revised care recommendations, modified based on feedback from the discussion. Care recommendations were retained if the median rating was ≥7 with no disagreement as defined by the RAND/UCLA Method handbook.Results:A list of 15 care recommendations was selected by the Delphi process for EMR integration, including recommendations that address CVD risk assessment (1), hypertension screening (1), DM screening (2), fracture risk assessment (1), BMD testing (1), osteoporosis prevention (1) and treatment (1) with bisphosphonates, preventing infections through immunization (2), minimizing steroids (1) and hepatitis screening (1), screening for hydroxychloroquine retinal toxicity (1), and counselling for lifestyle modifications (2). We excluded 7 recommendations which addressed lipid testing (1), BMD testing in steroid users (1), immunizations (2), weight management (1), and DMARD laboratory test monitoring (2). Recommendations were excluded on the basis of importance (1) or feasibility (6).Conclusion:The results of the Delphi process will inform the development of reminders, integrated in EMRs, that will support family physicians in their efforts to engage IA patients in addressing risk factors for chronic diseases related to inflammation. We hope to improve the prevention of these diseases, which represent an important cause of morbidity and mortality for people with inflammatory arthritis.Acknowledgements:Iman Sheriff’s work on this project was funded by the CRA summer studentship programme. Dr. Lacaille is supported by the Mary Pack Chair in Arthritis Research from UBC and The Arthritis Society of Canada. Thank you to all who participated in the Delphi survey.Disclosure of Interests:None declared

Background:According to the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2017, over 120,000 individuals currently have rheumatoid arthritis (RA) in Canada, yet a study that evaluates the combined effect of RA on the longevity and quality of life in the country is lacking.Objectives:The objectives of this study are three: 1) to describe burden of RA levels and trends from 1990-2017 using GBD data, 2) to describe age and sex differences, and 3) to compare Canada RA burden to other countries.Methods:We obtained publicly available data from GBD Study 2017 from the Institute for Health Metrics and Evaluation interactive visualization tool (http://vizhub.healthdata.org/gbd-compare). Disease burden indicators include prevalence, mortality, years of life lost (YLLs), years lived with disability (YLDs), and disability-adjusted life years (DALYs). Estimates were presented as non age-standardized and age-standardized rates per 100,000 population. GBD estimated prevalence using published literature, survey data, patient records, and health insurance claims, and mortality using cause of death ensemble modelling technique. YLLs measure premature death calculated as the sum of each death multiplied by the standard life expectancy at each age. YLDs measure amount of time in a year an individual lives with a short- or long-term health condition, calculated by combining prevalence with disability weights for each age/sex/year. DALYs were calculated as the sum of YLLs and YLDs. DALYs for Canada were compared to DALYs of countries with similar socio-demographic index (SDI) values. SDI combines income per capita, average educational attainment, and fertility rates. Data were analysed by DisMod-MR 2.1, a Bayesian meta-regression tool.Results:In Canada, RA mortality (mortality and YLLs) improved over time, with a steeper decline after the year 2002. However, the population burden of quality of life (YLDs and DALYs) increased due to increasing prevalence. The disease burden was higher in females (prevalence, mortality, YLLs, YLDs, DALYs), and DALY rates were higher among older populations. Compared to other countries, Canada had greater improvement in mortality and YLLs over time and had a lower age-standardized DALYs rate compared to countries of similar SDI values. A weak association was found between global age-standardized DALYs and SDI (R2 = 0.0138).Conclusion:RA is a major public health challenge. Canada fares better than other countries with regards to national RA burden. Early identification and management are critical to reducing the overall burden of RA in Canada, especially in women. More data from multiple provincial RA databases would increase the accuracy of our estimates for Canada.References:[1]Cross M, Smith E, Hoy D, et al. The global burden of rheumatoid arthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014;73(7):1316-1322. doi:10.1136/annrheumdis-2013-204627[2]Myasoedova E, Davis JM 3rd, Crowson CS, Gabriel SE. Epidemiology of rheumatoid arthritis: rheumatoid arthritis and mortality. Curr Rheumatol Rep. 2010;12(5):379-385. doi:10.1007/s11926-010-0117-y[3]Safiri S, Kolahi AA, Hoy D, et al. Global, regional and national burden of rheumatoid arthritis 1990-2017: a systematic analysis of the Global Burden of Disease study 2017. Ann Rheum Dis. 2019;78(11):1463-1471. doi:10.1136/annrheumdis-2019-215920Acknowledgements:Nejat Hassen is supported by a grant from the Canadian Institute of Health Research. Dr. Diane Lacaille is supported by the Mary Pack Chair in Arthritis Research from the University of British Columbia and The Arthritis Society of Canada.Disclosure of Interests:None declared

ObjectivesTo obtain stakeholder perspectives to inform the development and implementation of a rheumatoid arthritis (RA) healthcare quality measurement framework.DesignQualitative study using thematic analysis of focus groups and interviews.SettingArthritis stakeholders from across Canada including healthcare providers, persons living with RA, clinic managers and policy leaders were recruited for the focus groups and interviews.ParticipantsFifty-four stakeholders from nine provinces.InterventionsQualitative researchers led each focus group/interview using a semistructured guide; the digitally recorded data were transcribed verbatim. Two teams of two coders independently analysed the transcripts using thematic analysis.ResultsPerspectives on the use of different types of measurement frameworks in healthcare were obtained. In particular, stakeholders advocated for the use of existing healthcare frameworks over frameworks developed in the business world and adapted for healthcare. Persons living with RA were less familiar with specific measurement frameworks, however, they had used existing online public forums for rating their experience and quality of healthcare provided. They viewed a standardised framework as potentially useful for assisting with monitoring the care provided to them individually. Nine guiding principles for framework development and 13 measurement themes were identified. Perceived barriers identified included access to data and concerns about how measures in the framework were developed and used. Effective approaches to framework implementation included having sound knowledge translation strategies and involving stakeholders throughout the measurement development and reporting process. Clinical models of care and health policies conducive to outcome measurement were highlighted as drivers of successful measurement initiatives.ConclusionThese important perspectives will be used to inform a healthcare quality measurement framework for RA.

ObjectiveExcess mortality in rheumatoid arthritis (RA) is expected to have improved over time, due to improved treatment. Our objective was to evaluate secular 5-year mortality trends in RA relative to general population controls in incident RA cohorts diagnosed in 1996–2000 vs 2001–2006.MethodsWe conducted a population-based cohort study, using administrative health data, of all incident RA cases in British Columbia who first met RA criteria between January 1996 and December 2006, with general population controls matched 1:1 on gender, birth and index years. Cohorts were divided into earlier (RA onset 1996–2000) and later (2001–2006) cohorts. Physician visits and vital statistics data were obtained until December 2010. Follow-up was censored at 5 years to ensure equal follow-up in both cohorts. Mortality rates, mortality rate ratios and HRs for mortality (RA vs controls) using proportional hazard models adjusting for age, were calculated. Differences in mortality in RA versus controls between earlier and later incident cohorts were tested via interaction between RA status (case/control) and cohort (earlier/later).Results24 914 RA cases and controls experienced 2747 and 2332 deaths, respectively. Mortality risk in RA versus controls differed across incident cohorts for all-cause, cardiovascular diseases (CVD) and cancer mortality (interactions pConclusionsIn our population-based incident RA cohort, mortality compared with the general population improved over time. Increased mortality in the first 5 years was observed in people with RA onset before, but not after, 2000.

Background:Increased awareness of the efficacy of MTX in rheumatic disease is leading to more MTX use in patients from HIV endemic areas. While HIV related immunosuppression may contribute to improvement of some rheumatic diseases, immune reconstitution from highly active antiretroviral therapy (HAART) may lead to exacerbation or presentation of autoimmune disorders for which MTX therapy may be warranted. Most management guidelines for rheumatic disease do not address MTX use in the context of HIV.Objectives:To systematically review the published literature on the safety of using MTX ≤30 mg per week in HIV.Methods:We searched CINAHL, Embase, Global, MEDLINE and World of Science databases (Jan 1990 to May 2018) for terms including ‘methotrexate’ and ‘human immunodeficiency virus’. We also searched citations from review articles. Titles, abstracts or full manuscripts were screened independently by 2 reviewers to identify studies reporting HIV in patients taking MTX. Study quality was assessed using the McGill Mixed Methods Appraisal Tool (MMAT). Data was extracted on MTX and HIV adverse events (MTX toxicity, HIV viral load, CD4 count). Descriptive summaries are presented for studies providing outcomes in patients taking MTX ≤30 mg per week.Results:After removing duplicates and studies not meeting criteria or not providing sufficient information, 42 of the 2714 identified reports were included (1 clinical trial, 2 cohort, 1 cross-sectional study, 38 case reports/case series). Most reports (81%) originated from USA or Europe. Study quality was generally good with most studies fulfilling 50-100% of MMAT criteria. The randomized controlled trial (USA) assessing MTX on atherosclerotic disease in HIV showed that adverse events were more common in MTX versus placebo (12.8% vs 5.6%, p non-inferiority Conclusion:There remains limited data on the safety of low dose MTX in HIV. Surveillance for HIV is warranted for individuals on MTX who are at risk for acquiring HIV. Caution and careful monitoring for MTX toxicity, opportunistic infections and HIV state is suggested if MTX is used in the setting of HIV particularly if combined with other immunosuppression.References:[1] Clin Infectious Disease 2019:68[2] J Rheumatology 2014:41[3] Arthritis and Rheumatism 2003:49[4] Medicine 2017:96Acknowledgments :Funding from International League Against RheumatismMcGill University Global Health Scholar AwardsDisclosure of Interests:Alize Gunay: None declared, Anna Davidson: None declared, Ines Colmegna: None declared, Diane Lacaille: None declared, Hal Loewen: None declared, Michele Meltzer: None declared, Yewondwossen Mengistu: None declared, Rosie Scuccimarri: None declared, Zenebe Yirsaw: None declared, Sasha Bernatsky: None declared, Carol Hitchon Grant/research support from: UCB Canada; Pfizer Canada

Background:Arthritis often leads to presenteeism (decreased at-work productivity), missed days from work and permanent work disability, leading to reduced quality of life and high costs to individuals and society. Yet, health services addressing the employment needs of people with arthritis are lacking.Objectives:We evaluated the effectiveness of the Making-it-WorkTM(MiW) program, an online self-management program developed to help people with inflammatory arthritis (IA) deal with employment issues.Methods:A multi-center RCT evaluated the effectiveness of MiW at improving presenteeism and preventing work cessation (WC) over two years. Participants were recruited from rheumatologist practices, consumer organizations and arthritis programs, in three Canadian provinces. Eligibility criteria: diagnosis of IA, employed, age 18-59, and concerned about ability to work. Participants were randomized 1:1 to MiW or usual care plus printed material on workplace tips. MiW consists of five online self-learning modules and group meetings, and individual vocational counselling and ergonomic consultations. Questionnaires were administered every 6 months. Outcomes were presenteeism [Rheumatoid Arthritis Work Instability Scale (RA-WIS)], time to WC ≥ 6 months, and time to WC ≥ 2 months (secondary outcome). Baseline characteristics (age, gender, ethnicity, occupation, education, disease duration and self-employment) were collected. Intention-to-treat (ITT) longitudinal analysis of RA-WIS using linear mixed effect regression models with 2-year comparison as primary endpoint and survival analysis for time to WC using Kaplan-Meier and Cox Proportional Hazard models were performed. Robustness analyses were conducted by using various missing values imputation methods like last observation carried forward, imputation using worse possible outcomes and model-based multiple imputations; using square root transformation of RA-WIS outcome; and adjusting for baseline covariates. SAS version 9.4 was used.Results:A total of 564 participants were recruited, with 478 (84.75%) completing 2-year follow-up. Baseline characteristics were similar between groups. Mean RA-WIS scores were significantly lower in the intervention group from 6 months onwards, with the greatest difference observed at 2 years (-1.78, 95%CI: -2.7, -0.9, p < .0001), yielding a standardized effect size of 32%. Satisfactory robustness was observed. Work cessation occurred less often in intervention than control groups, but only reached statistical significance for WC ≥ 2 months (WC ≥ 6 months: 31 versus 44 events, aHR 0.70, 95%CI: 0.44, 1.11, p = 0.13; WC ≥ 2 months: 39 versus 61 events, aHR: 0.65, 95%CI: 0.43, 0.98, p = 0.04).Conclusion:Results of the RCT reveal the program was effective at improving presenteeism and preventing short-term WC. Effectiveness at preventing long-term work disability will be assessed at 5 years. This program fills one of the most important and costly unmet needs for people with inflammatory arthritis.References:[1]Carruthers EC, Rogers P, Backman CL, et al. “Employment and arthritis: making it work” a randomized controlled trial evaluating an online program to help people with inflammatory arthritis maintain employment (study protocol).BMC Med Inform Decis Mak. 2014;14:59. Published 2014 Jul 21. doi:10.1186/1472-6947-14-59Disclosure of Interests:Andre Luquini: None declared, Yufei Zheng: None declared, Hui Xie: None declared, Catherine Backman: None declared, Pamela Rogers: None declared, Alex Kwok: None declared, Astrid Knight: None declared, Monique Gignac: None declared, Dianne Mosher: None declared, Linda Li: None declared, John Esdaile: None declared, Carter Thorne Consultant of: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Diane Lacaille: None declared

Background:Increased awareness of the importance of MTX in rheumatic disease is leading to more MTX use in patients from TB-endemic areas. Current management guidelines for rheumatic disease address TB in the context of biologics but not MTX use.Objectives:To systematically review the published literature on TB rates with MTX ≤30 mg per week.Methods:We searched CINAHL, Embase, Global, MEDLINE and World of Science databases (Jan 1990 to May 2018) for terms including ‘methotrexate’ and ‘tuberculosis’. We also searched citations from review articles. Titles, abstracts or full manuscripts of the 4707 reports identified were screened independently by 2 reviewers to identify studies reporting TB in patients taking MTX. Study quality was assessed using the McGill Mixed Methods Appraisal Tool (MMAT). Data was extracted on TB incidence (new TB diagnosis vs reactivation of latent TB), and outcomes (pulmonary, dissemination, death) and safety of isoniazid, INH. Descriptive summaries are presented on studies providing outcomes in patients taking MTX ≤30 mg per week.Results:After removing duplicates and studies not meeting criteria or providing sufficient information, 31 studies were included (8 cohort, 7 case-control, 1 clinical trial, 15 case reports/case series). Only 27% of articles reported data from low to moderate human development index countries. Studies were of moderate quality. Seven case control studies were heterogeneous but most demonstrated a modest increased risk of TB with MTX (Table). Five cohort studies reported TB incidence rates in rheumatic disease (treated with MTX +/- biologics) ranging from 102-367.9/100,000 patient-years. These rates were generally higher than comparator general population rates. Two cohort studies of MTX in RA (without biologic) reported cumulative TB incidence in Maldova (12 TB cases in 44 RA patients, 27%) and in China (9/114, 7.9%). Other cohort studies generated rates of overt infection (143/100,000 patient years in Spain, higher if co-prescribed with corticosteroids and other immunosuppressants in South Africa), and latent TB rates detection (16/922 RA screened, 1.7%, in Canada). When reported, rates of extra-pulmonary TB were higher than comparator general population rates. One clinical trial (China), 2 cohorts (Japan, USA) and 2 case-series (Belgium, USA) evaluated safety of INH and MTX. Isoniazid-related hepatotoxicity and neutropenia were generally more common when taken with MTX, but were usually reversible.Conclusion:Despite a paucity of high-quality data, this review confirms that TB screening and clinical surveillance are needed in patients from TB-endemic areas who are prescribed MTX, particularly with co-administration of corticosteroids or other immunosuppressants. Isoniazid, if monitored, appears safe and prevents TB reactivation.References:Table .Case control studiesRegion (Year)DiagnosisTB with MTXTB without MTXOdds RatioMexico(1999)Mixed (4 RA)1/65/752.76Japan(2004)RA3/4717/1540.56Canada(2009)RA29/48321/10463.12Brazil(2010)Lupus2/31/57112Taiwan(2012)Psoriasis33/144464/23411.2Taiwan(2015)JIA4/3574/10262.90South Africa (2017)RA0/1340/18NAJIA=juvenile idiopathic arthritisAcknowledgments:Funded by the International League Against Rheumatism and McGill University Global Health Scholar AwardsDisclosure of Interests:Anna Davidson: None declared, Alize Gunay: None declared, Ines Colmegna: None declared, Diane Lacaille: None declared, Hal Loewen: None declared, Michele Meltzer: None declared, Rosie Scuccimarri: None declared, Yewondwossen Mengistu: None declared, Sasha Bernatsky: None declared, Carol Hitchon Grant/research support from: UCB Canada; Pfizer Canada

Objective: To determine the magnitude of the risk of incident cardiovascular disease (CVD; fatal and non-fatal), including acute myocardial infarction (MI), cerebrovascular accidents (CVA) and congestive heart failure (CHF), in patients with rheumatoid arthritis (RA) compared to the general population through a meta- analysis of controlled observational studies. Methods: The authors searched the Medline, Embase, LILACS and Cochrane databases from their inception to June 2011. Observational studies meeting the following criteria were included: (1) prespecified RA criteria; (2) predefined CVD criteria for incident CVD (MI, CVA or CHF); (3) a comparison group; and (4) RR estimates, 95% CI or data for calculating them. The authors calculated the pooled RR using the random-effects model and tested for heterogeneity using the bootstrap version of the Q statistic. Results: Fourteen studies comprising 41 490 patients met the inclusion criteria. Overall, there was a 48% increased risk of incident CVD in patients with RA (pooled RR 1.48 (95% CI 1.36 to 1.62)). The risks of MI and CVA were increased by 68% (pooled RR 1.68 (95% CI 1.40 to 2.03)) and 41% (pooled RR 1.41 (95% CI 1.14 to 1.74)). The risk of CHF was assessed in only one study (RR 1.87 (95% CI 1.47 to 2.39)). Significant heterogeneity existed in all main analyses. Subgroup analyses showed that inception cohort studies were the only group that did not show a significantly increased risk of CVD (pooled RR 1.12 (95% CI 0.97 to 1.65)). Conclusions: Published data indicate that the risk of incident CVD is increased by 48% in patients with RA compared to the general population. Sample and cohort type influenced the estimates of RR.

ObjectivesTo determine the effect of glucocorticoids (GC) on the risk of cerebrovascular accidents (CVA) in patients with rheumatoid arthritis (RA).MethodsA population-based cohort study was carried out using administrative health data on 7051 individuals with RA onset between 1997 and 2001 and no exposure to GC before RA onset. Follow-up was until 2006. GC exposure was defined in four ways: current use (yes/no), current dose (mg/day), cumulative dose (grams) and cumulative duration of use (years). All were used as time-dependent variables updated monthly. CVA were ascertained using hospitalisation and vital statistics data. Transient ischaemic attacks were not considered as CVA. Cox regression models adjusting for demographics, cardiovascular drug use, propensity scores and RA characteristics were used.ResultsThe mean age of the cohort was 56 years and 66% were women. Over 6 years' mean follow-up (43 355 person-years), 178 incident CVA cases were identified. GC current use was not associated with a significant increase in the risk of CVA (HR=1.41, 95% CI 0.84 to 2.37). Similarly, the models that accounted for daily dose (HR=1.07, 95% CI 0.94 to 1.21 for each 5 mg increase in the daily dose), cumulative duration of use (HR=1.1, 95% CI 0.94 to 1.32 for each year accumulated in the past) and total cumulative dose (HR=1.04, 95% CI 0.99 to 1.08 per gram accumulated in the past) were also not significantly associated with CVA.ConclusionsThis large population-based study indicates that GC use is not associated with an increased risk of CVA in cases with RA.

Objective: To provide context for the malignancy experience in the rheumatoid arthritis (RA) abatacept clinical development programme (CDP) by performing comparisons with similar RA patients and the general population. Methods: Malignancy outcomes included total malignancy (excluding non-melanoma skin cancer (NMSC)), breast, colorectal, lung cancers and lymphoma. Comparisons were made between the observed incidence in patients within the abatacept CDP and RA patients on disease-modifying antirheumatic drugs (DMARD) identified from five data sources: the population-based British Columbia RA Cohort, the Norfolk Arthritis Register, the National Data Bank for Rheumatic Diseases, the Sweden Early RA Register and the General Practice Research Database. Age and sex-adjusted incidence rates (IR) and standardised incidence ratios (SIR) were used to compare events in the abatacept trials with the RA DMARD cohorts and the general population. Results: A total of 4134 RA patients treated with abatacept in seven trials and 41 529 DMARD-treated RA patients in the five observational cohorts was identified for study inclusion. In the abatacept-treated patients, the 51 malignancies (excluding NMSC), seven cases of breast, two cases of colorectal, 13 cases of lung cancer and five cases of lymphoma observed were not greater than the range of expected cases from the five RA cohorts. The SIR comparing RA patients with the general population were consistent with those reported in the literature. Conclusions: The IR of total malignancy (excluding NMSC), breast, colorectal, lung cancers and lymphoma in the abatacept CDP were consistent with those in a comparable RA population. These data suggest no new safety signals with respect to malignancies, which will continue to be monitored.

Background Early DMARD use in RA may prevent damage and possibly, need for joint replacement. Objectives To assess joint replacements within incident RA patients in Quebec, Canada, and potential associations with early DMARD use. Methods A cohort of incident RA patients was identified from Quebec9s physician billing and hospitalization databases from 2002-2008; all patients covered by the provincial drug insurance for the duration of the study were included in analyses. We used Cox regression with time-dependent variables for: 1) methotrexate (MTX) use, 2) other non-biologic DMARDs and 3) anti-tumor necrosis factor (TNF) agents. Models were adjusted for baseline sociodemographic characteristics, co-morbidity including pre-existing osteoarthritis, and prior health service use, and for time-dependent variables reflecting cumulative use of other drugs (COXIBs, NSAIDs, and systemic steroids) and time-dependent indicators of disease severity (extra-articular RA features and number of rheumatology visits). The outcome (any joint replacement) was defined using procedure codes. Results During follow-up, 321 joint replacements occurred among 5,199 incident RA patients observed for a total of 19,693 years (1.6 events/100 person-years). The best-fitting models relied on cumulative duration of MTX and cumulative duration of non-MTX traditional DMARD use in the first year after RA diagnosis. Controlling for anti-TNF exposure, joint replacement rates throughout follow-up appeared to be significantly lower with greater cumulative MTX and with greater cumulative non-MTX traditional DMARD use in the first year of RA (Hazard ratio, HR=0.95 per month of MTX use, 95% Confidence Interval, CI 0.91-0.98; HR=0.93 per month of use of non-MTX traditional DMARDs, 95% CI 0.90-0.97). However, patients receiving both MTX and non-MTX traditional DMARDs, concurrently or sequentially, within the first year after RA onset, had a significantly higher risk of joint replacement than those who used only one of the two drug classes within the first year. We could not establish independent effects for anti-TNF agents. Conclusions Higher cumulative use of MTX and higher cumulative use of non-MTX traditional DMARDs within the first year after RA diagnosis appeared to be associated with fewer joint replacements. This may be consistent with joint-sparing effects of aggressive, early use of these drugs, though a causal link cannot be established with these observational data. The increased joint replacement risk in patients taking both MTX and other DMARDS, concurrently or sequentially, in the first year, suggests potential confounding by indication, as patients taking multiple drugs may have more severe disease, and greater risk for joint damage. References Gramling A, O9Dell JR (2012). Initial management of rheumatoid arthritis. Rheum. Dis. Clin. North Am. 38 (2): 311–25. Acknowledgements Canadian Institutes for Health Research/Drug Safety and Effectiveness Network (CIHR/DSEN) Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.3061

Background While it is well known that patients with ankylosing spondyltis (AS) experience restrictions in worker participation, information regarding participation in other social roles is lacking. Objectives To assess and understand social role participation in patients with AS in comparison with a healthy control group using the social role participation questionnaire (SRPQ). Methods In a cross-sectional study, subjects completed the SRPQ, which assesses the influence of health on the perceived importance of 11 diverse social roles (e.g., hobbies, traveling, relationships, employment) and one global participation question, as well as the satisfaction with the role performance. All items were rated on a 5 point likert scale ranging from 1= not important /not at all satisfied to 5= very important/very satisfied. From these scores the importance satsifaction gap was calculated (importance minus satisfaction with the role performance), indicating the discordance between role salience and role performance. Results A total of 246 AS patients (mean age 51 ± 12 years; 62% males; mean disease duration of 17 ± 12 years) and 510 healthy controls (mean age 42 ± 15 years; 70% males) were included. The mean scores of importance and satisfaction with the role performance of the global participation question were 4.3 ± 0.8 and 3.0 ± 1.0, respectively for patients and 4.0 ± 0.9 and 3.6 ± 0.9, respectively for controls and were significantly different between groups for both measures P < 0.001. The difference of the importance-satisfaction gaps between patients and controls accros social roles varied between 0 and 1.1. [Figure 1][1] illustrates the gaps for patients and controls for all social roles seperately. ![Figure][2] Conclusions In comparison with a healthy population, patients with AS report larger importance-satisfaction gaps except for the social role of paid work. Future studies should explore the reasons for the difference in the gap between patients and controls as well as the contribution of the concept of the importance-satisfaction gap on the satisfaction with life. Disclosure of Interest S. van Genderen: None Declared, G. Plasqui: None Declared, P. Jacobs: None Declared, L. Heuft: None Declared, J. Luime: None Declared, A. Spoorenberg: None Declared, S. Arends: None Declared, M. Gignac: None Declared, D. Lacaille: None Declared, D. van der Heijde: None Declared, R. Landewe: None Declared, A. Boonen Grant/research support from: MSD, Pfizer, Amgen, Abbott, Consultant for: Pfizer, Speakers bureau: Pfizer, UCB [1]: #F1 [2]: pending:yes

Background RA related health resource use and direct costs may be influenced by prevalence, disease management, and available medications, and understanding trends is crucial for policy makers. Previous costing studies in RA have been limited by unrepresentative RA populations, small numbers, lack of costing data and relatively short follow-up. Objectives To determine the trend in components of resource utilization in a large, representative, RA cohort based on administrative health data. Methods RA patients were identified for each fiscal year from 1996/97 to 2004/05 if they had at least two rheumatologist visits with an RA diagnosis, one in the study year and another in a span from the previous to the following year, using administrative health data from British Columbia. The costs of drugs, physician visits and hospitalizations were calculated from administrative data records using standard procedures and inflated to 2005 Canadian dollars. Results The number of patients identified increased steadily from 6,525 in 1996/97 to 10,068 in 2004/05. A total of 22,756 individuals with RA provided 71,200 person-years of follow-up. While annual total costs for this RA cohort increased from $13.5M in 1996 to $33.0M in 2004/05, the annual cost per person year increased from $2,077 to $3,289 (Figure 1). The proportion of costs attributable to hospitalizations markedly decreased (from 59.4% to 21.1% of the total per person annual cost), while since 2001 the proportion of costs attributable to medications has increased, predominantly through biologics which have grown from 17.4% to 48.4% of the total costs. Conclusions The type of resources consuming health care dollars has changed dramatically. We are currently in the process of extending this analysis to 2010 data. As decisions are made on future management and policy strategies, understanding causal relationships between components, for example whether increased biologic use has led to reduced hospitalisations will be crucial and is the subject of future research. Disclosure of Interest None Declared