RHEUMATOLOGY Letters to the Editor Rheumatology 2017;56:660–661 doi:10.1093/rheumatology/kew460 Advance Access publication 30 December 2016 Rheumatology key message L ET T E R . Socio-economic status is under-reported in randomized controlled trials of biologic DMARDs in RA. SIR, randomized control trials (RCTs) show that biologic DMARDs (bDMARDs) robustly decrease disease activity, retard radiographic progression and improve functional outcomes in RA [1]. It is also well established that lower socio-economic status (SES) is associated with both an increased risk of developing RA and with poorer patient outcomes [2–4]. RA patients with low SES have higher levels of disease activity, worse physical and mental health and reduced quality of life compared with those with high SES [4–7]. Given this, SES is an important potential confounder in RA clinical trials and may impact both the clinical outcomes and generalizability of the findings. We reviewed the reporting of SES in 100 recent consecutive RA bDMARD RCTs published in leading general medicine and rheumatology journals. The journals included the New England Journal of Medicine (14 RCTs), Lancet (12), BMJ (2), Annals of the Rheumatic Diseases (25), Arthritis and Rheumatology (25), Arthritis Care and Research (6), Arthritis Research and Therapy (6) and The Journal of Rheumatology (10). We extracted data from eight journals, with 28 studies from general medical journals and 72 studies from rheumatology journals, using methodology from a previous study [8]. Direct measures of SES were extracted from the reported baseline demographics, including occupational group, employment status, income, educational attainment, area-based and occupation-based SES measures and the indirect SES measures of ethnicity, language, weight or BMI and smoking. Publication year and location of study were recorded and used as comparative factors. The reporting of SES characteristics of participants in recent RA bDMARD RCTs was very limited (Table 1). Direct SES measures of employment status, income and educational attainment were recorded in 2, 2 and 1%, respectively, of the published RA bDMARD trials. The remaining three direct measures of SES were not reported in any of the trials reviewed. Ethnicity, considered to be an indirect measure of SES, was reported in just over half of the trials (54%), while smoking and weight/BMI were measured in 4 and 36% of the trials. The three studies that Measures of SES Reported measure, % Employment status Income Educational attainment Occupational group Area-based SES measures Occupation-based SES measures Ethnicitya Languagea Smokinga Weight/BMIa 2 2 1 0 0 0 54 0 4 36 aSES indirect factor. SES: socioeconomic status. reported direct measures of SES were single-country studies. More multinational studies (70%; n = 39/56) reported at least one measure of direct or indirect SES than singlecountry studies (45%, n = 13/29). The reporting of indirect or direct SES was not correlated with publication year or journal. We have demonstrated that SES was under-reported in recent bDMARD RA clinical trials. Given the known association between low SES and disease activity and outcomes in RA, understanding the SES status of the population included in trials is important for generalizability of the results. Additionally, indirect SES factors, such as smoking and weight, were not reported in proportion to their likely role in RA disease outcomes. Without adequate reporting of SES in trial participants, the representation of low SES is unknown. Although further research is required to examine the relationships between SES and RA outcomes, we suggest that increased reporting of SES in RA bDMARD clinical trials would improve the capacity of clinicians to assess the applicability of trial results in everyday clinical practice. Acknowledgements H.C. was supported by a University of Queensland School of Medicine Summer Research Scholarship and H.B. is supported by an National Health and Medical Research Council Translating Research into Practice Fellowship. Funding: No specific funding was received from any bodies in the public, commercial or not-for-profit sectors to carry out the work described in this manuscript. Disclosure statement: H.B. has received speaker honoraria from Bristol-Myers Squibb, Union Chimique Belge and ! The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com Downloaded from https://academic.oup.com/rheumatology/article-abstract/56/4/660/2763344 by guest on 25 May 2020 Under-reporting of socio-economic status in randomized control trials of biologic diseasemodifying anti-rheumatic drugs in rheumatoid arthritis TABLE 1 Reporting on measures of socio-economic status Letters to the Editor Janssen and research grant funding from UCB and AbbVie. All other authors have declared no conflicts of interest. Hedva Chiu1, Samantha Hollingworth2, Mieke Van Driel1, Parker Magin3 and Helen Benham1 Rheumatology 2017;56:661–663 doi:10.1093/rheumatology/kew493 Advance Access publication 29 January 2017 Pregnancy outcomes in women with rheumatoid arthritis ever treated with rituximab 1 School of Medicine, University of Queensland, Herston, School of Pharmacy, University of Queensland, Brisbane, QLD and 3Discipline of General Practice, University of Newcastle, Callaghan, NSW, Australia Revised version accepted 16 November 2016 Correspondence to: Helen Benham, School of Medicine, University of Queensland, Translational Research Institute, 37 Kent Street, Woolloongabba, QLD 4012, Australia. E-mail: h.benham@uq.edu.au Rheumatology key message 2 1 Nam JL, Ramiro S, Gaujoux-Viala C et al. Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2013 update of the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis 2014;73:516–28. 2 Bengtsson C, Nordmark B, Klareskog L et al. Socioeconomic status and the risk of developing rheumatoid arthritis: results from the Swedish EIRA study. Ann Rheum Dis 2005;64:1588–94. 3 Pedersen M, Jacobsen S, Klarlund M et al. Socioeconomic status and risk of rheumatoid arthritis: a Danish case-control study. J Rheumatol 2006;33:1069–74. 4 Jacobi C, Mol G, Boshuizen H et al. Impact of socioeconomic status on the course of rheumatoid arthritis and on related use of health care services. Arthritis Rheum 2003;49:567–73. 5 Molina E, Del Rincon I, Restrepo JF et al. Association of socioeconomic status with treatment delays, disease activity, joint damage, and disability in rheumatoid arthritis. Arthritis Care Res 2015;67:940–6. 6 Jiang X, Sandberg M, Saevarsdottir S et al. Higher education is associated with a better rheumatoid arthritis outcome concerning for pain and function but not disease activity: results from the EIRA cohort and Swedish rheumatology register. Arthritis Res Ther 2015;17:317. 7 Margaretten M, Barton J, Julian L et al. Socioeconomic determinants of disability and depression in patients with rheumatoid arthritis. Arthritis Care Res 2011;63:240–6. 8 Magin P, Victoire A, Zhen XM et al. Under-reporting of socioeconomic status of patients in stroke trials: adherence to CONSORT principles. Stroke 2013;44:2920–2. Rates of live births were reassuring in women with RA exposed to rituximab before conception. SIR, In women with RA, information concerning the exposure risk to rituximab (RTX) during pregnancy is limited. RTX, an mAb, can cross the placenta from the second trimester, has a long half-life, estimated to be between 18 and 23 days, and lymphocyte depletion is variable and possibly longstanding. Hence, the current Summary of Product Characteristics states that women should take contraception during RTX treatment and for 12 months after finishing RTX treatment [1]. In this analysis, we summarize the pregnancy outcomes of women with RA receiving RTX before or during pregnancy in the British Society for Rheumatology Biologics Register in RA (BSRBR-RA). This register systematically captures information on RA patients exposed to biologic therapy to monitor long-term safety [2]. The North-West MultiCentre Research Ethics Committee granted Ethical approval for the BSRBR-RA. Patients gave informed written consent. This study did not require additional approval or consent. Following the report of a pregnancy, additional data are collected via a pregnancy event proforma, including information on exposure to medications, on pregnancy outcome and on complications/congenital malformations. We included all patients with a reported pregnancy up to 18 December 2015 exposed to RTX at any point before pregnancy end and divided exposure into the following three groups: exposed within 6 months before conception, between 6 and 12 months before conception, and longer than 12 months before conception. A total of 32 pregnancies (including 1 twin pregnancy) in 23 women were reported (Table 1). The mean (range) age at conception was 34 (20–41) years. No women received RTX during pregnancy. Of 27 known pregnancy outcomes, 21 (66%) were live births, 2 (6%) stillborn, 3 (9%) miscarriages and 2 (6%) terminations. The median (range) gestational length of live births (available for 18 pregnancies) was 38 (29–42) weeks. Preterm delivery, defined as gestation <37 weeks, occurred in 4/18 (22%). Unfortunately, no data on immunoglobulin levels or lymphocyte counts in either mothers or newborns were recorded in the BSRBR-RA. Ten women reported RTX exposure 6 months before conception [median (range) time of exposure was 3 (1–5) months], with the outcome known in 9, as follows: 6 live births, 1 stillbirth after 27 weeks (placental insufficiency), 1 miscarriage and 1 termination after 5 weeks. Four (40%) women were receiving MTX at conception. The woman who miscarried received MTX until ! The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com Downloaded from https://academic.oup.com/rheumatology/article-abstract/56/4/660/2763344 by guest on 25 May 2020 References .