SAT0169 No evidence that concomitant glucocorticoid therapy affects efficacy and safety of tocilizumab monotherapy in rheumatoid arthritis clinical trials
Authors: M. Safy, J. W. G. Jacobs, M. Edwardes, J. Pei, M. De Hair, X. Teitsma, P. Welsing, M. Borm, Y. Luder, J. Van Laar, A. Pethö-Schramm, J. W. J. Bijlsma
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background:</h3> For rheumatoid arthritis (RA) patients included in clinical trials, background treatment with glucocorticoids (GCs) is quite common (40–60%), but their potential contribution to efficacy and safety of the disease modifying anti-rheumatic drug (DMARD) tested in that trial has rarely been evaluated. <h3>Objectives:</h3> To establish whether a stable GC dose at baseline and during the study contributed to the efficacy and safety of TCZ monotherapy initiated in RA patients in 4 TCZ RCTs. In addition, to investigate the same issue in the comparator arms of these trials, in which adalimumab (ADA) or methotrexate (MTX) was initiated. <h3>Methods:</h3> Data from 4 randomized controlled double-blind trials (AMBITION, ACT-RAY, ADACTA and FUNCTION) with TCZ monotherapy arms was analysed in this post hoc analysis [1–4]. Study participants were MTX-naïve, intolerant or had an inadequate response to conventional synthetic DMARDs (csDMARD-IR). Because of differences between the studies in region, and baseline RA duration and disease severity, analyses were done separately for each study. Stable GC dose at baseline was allowed and was to be continued unchanged during the first 24 weeks. Analyses of covariance (ANCOVA) of change from baseline to Week 24 in CDAI and DAS28 and logistic regression analyses at Week 24 for CDAI remission and ACR50 were performed. Repeated measures analyses using all visits up to week 24 were also done. Incidence rates of serious adverse events (SAEs) were assessed by GC use. <h3>Results:</h3> Baseline characteristics were mostly comparable between GC users and non-GC users in each treatment arm for each study. The adjusted differences (95% CIs) of CDAI change at week 24 between GC and non-GC users in TCZ arms of AMBITION, FUNCTION, ACT-RAY and ADACTA were -1.4 (-4.8, 2.1), 0.8 (-2.5, 4.1), 1.2 (-4.0, 6.3) and -4.2 (-9.7, 1.4), respectively (table 1). CDAI remission rates, ACR50 response rates and DAS28 score changes at 24 weeks neither were significantly different between GC users and non-GC users in the TCZ arms, nor in the MTX and ADA arms (table 1). Repeated measures analyses to week 24 showed no significant differences in DAS28 or CDAI. Statistically significant predictors for the various clinical outcomes included baseline CDAI, baseline DAS28, age, sex, RA duration and region. A numerically higher but not significantly different SAE rate was seen in the GC-arms of all four trials, compared to the non-GC-arms. <h3>Conclusions:</h3> No evidence was found that GC treatment at baseline and continued at a stable dose affects either clinical efficacy or safety over 24 weeks of TCZ, MTX, or ADA monotherapy initiated at baseline in RA clinical trials. <h3>References</h3> [1]Jones G, et al. Ann Rheum Dis2010;69:88–96. [2]Dougados M, et al. Ann Rheum Dis2013;72:43–50. [3]Gabay C, et al. Lancet2013;381:1541–50 [4]Burmester GR, et al. Ann Rheum Dis2017;76:1279–84. <h3>Disclosure of Interest:</h3> M. Safy Grant/research support from: Research grant from AZ, J. Jacobs: None declared, M. Edwardes Employee of: Everest Clinical Research, Canada, J. Pei Employee of: US Medical Affairs, Immunology, Genentech, Inc., M. De Hair: None declared, X. Teitsma: None declared, P. Welsing: None declared, M. Borm Employee of: employee of Roche Nederland BV., Y. Luder Employee of: 4 F Hoffmann-La Roche, Basel, Switzerland, J. Van Laar Consultant for: Arthrogen, MSD, Pfizer, Eli Lilly, and BMS and research grants from Astra Zeneca, Roche-Genentech., A. Pethö-Schramm Employee of: F Hoffmann-La Roche, J. Bijlsma Consultant for: Grants and fees from Roche, AbbVie, Bristol-Myers Squibb, Merck Sharp &amp; Dohme, Pfizer, and UCB