THU0210 Safety, tolerability and efficacy of subcutaneous tocilizumab administered as monotherapy or in combination with csdmards in rheumatoid arthritis: results from the oscar study
Authors: M. Safy, M.J. De Hair, M.E. Borm, M.R. Kok
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Efficacy and safety of intravenously (IV) administered tocilizumab (TCZ) in rheumatoid arthritis (RA) has been shown. Recently, efficacy and safety was confirmed for subcutaneous (SC) administration of TCZ.<sup>1</sup> The possible effects of SC TCZ upon tapering of GCs/NSAIDs has not been investigated. <h3>Objectives</h3> First, to establish the safety and efficacy of SC TCZ monotherapy or in combination with csDMARDs in DMARD-IR RA. Second, to assess GC/NSAID dose reduction and/or discontinuation under SC TCZ treatment. <h3>Methods</h3> The OSCAR study was a Dutch multicenter, open-label, single arm phase IV study within the phase 4 TOZURA program.<sup>1</sup> RA patients with an inadequate response (IR) to csDMARDS and 1 bDMARD were treated with weekly SC injections of TCZ monotherapy or in combination with csDMARDs up to 24 weeks. From week 16 onwards dose reduction and/or discontinuation of glucocorticoids (GC) and NSAIDs was allowed. Primary endpoints were occurrence of adverse events (AEs), serious AEs (SAEs) and AEs of special interest (AESI). Secondary endpoints were time to GC/NSAID dose reduction and/or discontinuation, and DAS28 (remission), ACR 50 response, EULAR response, SDAI, CDAI and HAQ-DI. Occurrence of AEs was analysed using descriptive statistics. Changes over time in efficacy endpoints and response rates were analysed using Wilcoxon test. <h3>Results</h3> Of the 150 patients 121 (81%) patients completed the treatment period. In 91% of the patients there was ≥1 AE, in 9% an SAE, and in 4% an AESI. Most AEs were mild or moderate in intensity and resolved without sequelae. Permanent TCZ treatment discontinuations due to AEs occurred in 7% of the 150 patients; of these, five patients were prematurely withdrawn from the study due to AEs. From week 16 onwards, 8 (5.3%) and 13 (8.7%) patients discontinued or reduced (for any reason) the dose of NSAIDs or GCs, respectively. Between weeks 16 and 20, 2 (1.3%) patients discontinued or reduced the dose of NSAIDs due to safety and other reasons. The dose of GCs was discontinued or reduced in 3 patients (2.0%) between weeks 16 and 20, and in another 3 between weeks 20 and 24 (2,0%), in all 6 patients mainly due to safety reasons (1.3%), while NSAIDs dosage remained stable. The safety profile observed in this trial was in line with the known TCZ safety profile. Efficacy parameters improved over time for all of the endpoints. A selection of these results is shown in table 1. The median time of follow-up of the studied population was 822 days, IQR 429–727 days. <h3>Conclusions</h3> The OSCAR study showed that SC TCZ is safe, well-tolerated and effective in RA patients with an inadequate response to csDMARDS and max 1 bDMARD. Importantly, a subset of patients could reduce GC and/or NSAID use during SC TCZ treatment. These findings support the notion that SC TCZ can be safely used in clinical practice. <h3>Reference</h3> [1] Choy E, et al. Rheumatology2017. doi:10.1093/rheumatology/kex443 <h3>Disclosure of Interest</h3> M. Safy Grant/research support from: AZ studentship grant, M. De Hair: None declared, M. Borm Employee of: Roche Nederland BV., M. Kok Consultant for: Roche B.V.