Obesity is a risk factor for poor response to treatment in early rheumatoid arthritis: a NORD-STAR study

Abstract

Objective This report from the NORD-STAR (Nordic Rheumatic Diseases Strategy Trials and Registries) trial aimed to determine if obesity is associated with response to conventional and biological antirheumatic treatment in early rheumatoid arthritis (RA). Methods This report included 793 participants with untreated early RA from the randomised, longitudinal NORD-STAR trial, all of whom had their body mass index (BMI) assessed at baseline. Obesity was defined as BMI ≥30 kg/m2. All participants were randomised 1:1:1:1 to one of four treatment arms: active conventional treatment, certolizumab-pegol, abatacept and tocilizumab. Clinical and laboratory measurements were performed at baseline and at 8, 12, 24 and 48-week follow-up. The primary endpoint for this report was response to treatment based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) remission and Disease Activity Score with 28 joints using C-reactive protein (DAS28-CRP) <2.6 stratified by BMI. Results Out of 793 people included in the present report, 161 (20%) had obesity at baseline. During follow-up, participants with baseline obesity had higher disease activity compared with those with lower BMI, despite having similar disease activity at baseline. In survival analyses, obesity was associated with a lower likelihood of achieving response to treatment during follow-up for up to 48 weeks (CDAI remission, HR 0.84, 95% CI 0.67 to 1.05; SDAI, HR 0.77, 95% CI 0.62 to 0.97; DAS28-CRP <2.6, HR 0.78, 95% CI 0.64 to 0.95). The effect of obesity on response to treatment was not influenced by the treatment arms. Conclusion In people with untreated early RA followed up for up to 48 weeks, obesity was associated with a lower likelihood of good treatment response, irrespective of the type of randomised treatment received. Trial registration number [NCT01491815][1]. Data are available upon reasonable request. Data are available on reasonable request. Nordic Rheumatic Diseases Strategy Trials and Registries (NORD-STAR) data will not be shared publicly. Access to the NORD-STAR data is organised according to a strict data access procedure. For all types of access, a research proposal must be submitted for evaluation by the NORD-STAR Steering Committee. The evaluation is performed to align the goals of the researchers with the goals of NORD-STAR (which are in turn aligned with the informed consent form signed by NORD-STAR participants). Further information on NORD-STAR data can be obtained by contacting the NORD-STAR Steering Committee (mail to nordstar@ki.se). [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01491815&atom=%2Frmdopen%2F10%2F2%2Fe004227.atom