THU0215 Efficacy of sarilumab in patients with rheumatoid arthritis with and without previous response to tocilizumab
Authors: P. Verschueren, P. Emery, H. van Hoogstraten, Q. Dong, E.K. Mangan, A. den Broeder
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Sarilumab is an IL-6R inhibitor recently approved for the treatment of rheumatoid arthritis (RA). To help clinical decision making, we studied the response rate on open-label sarilumab treatment in patients previously treated with tocilizumab, the other IL-6R inhibitor approved for RA. In the ASCERTAIN trial (NCT01768572), patients were randomised 1:1:2 to 24 weeks of sarilumab 150 mg sc every 2 weeks (q2w; n=49), sarilumab 200 mg sc q2w (n=51), or tocilizumab 4 mg/kg iv q4w (n=102) increased to 8 mg/kg at investigator's discretion if clinically indicated as per the US label; each added to conventional synthetic disease-modifying antirheumatic drug (csDMARD) background therapy. Patients who completed ASCERTAIN were eligible to enrol in an open-label extension study of sarilumab 200 mg sc q2w (EXTEND, NCT01146652), with csDMARDs as specified in the previous study. <h3>Objectives</h3> To examine outcomes for patients who switched from tocilizumab in ASCERTAIN to open-label sarilumab in EXTEND. <h3>Methods</h3> In this post-hoc analysis, patients were recorded as responders or non-responders at the end of ASCERTAIN and at Weeks 12 and 24 of EXTEND according to each of: clinical disease activity index (CDAI)≤2.8, CDAI≤10.0, disease activity score (DAS)−28 CRP &lt;2.6, DAS-28 CRP &lt;3.2, and American College of Rheumatology (ACR)20/50/70 response criteria. <h3>Results</h3> A total of 168 patients entered EXTEND from ASCERTAIN, of whom 93 had been in the tocilizumab group (last tocilizumab dose 4 mg/kg in 37 patients and 8 mg/kg in 56 patients). After switch to sarilumab, response was achieved in an additional number of patients who were non-responders on tocilizumab at the end of ASCERTAIN (table 1). The reverse, response loss in tocilizumab responders, was infrequent. Patients who switched from tocilizumab 4 mg/kg or 8 mg/kg achieved similar response rates. <h3>Conclusions</h3> These results may indicate that clinical improvements can be attained in a relevant proportion of tocilizumab non-responders with switch to sarilumab, irrespective of previous tocilizumab dose, and the majority of patients responding to tocilizumab maintain response when switching to sarilumab. <h3>Acknowledgements</h3> Study sponsored by Sanofi and Regeneron Pharmaceuticals, Inc, who also funded medical writing support provided by Matt Lewis, Adelphi Group. <h3>Disclosure of Interest</h3> P. Verschueren Grant/research support from: Pfizer chair for early RA management KU Leuven, Consultant for: AbbVie, Bristol-Myers Squibb, Eli Lilly, Nordic Pharma, Merck Sharpe and Dohme, Pfizer, Roche, Sanofi and UCB, Paid instructor for: Pfizer, Sanofi, P. Emery Grant/research support from: AbbVie, Bristol-Myers Squibb, Pfizer, Merck Sharpe and Dohme and Roche, Consultant for: Bristol-Myers Squibb, AbbVie, Pfizer, Merck Sharpe and Dohme, Novartis, Roche and UCB, H. van Hoogstraten Shareholder of: Sanofi, Novartis, Employee of: Sanofi, Q. Dong Employee of: Sanofi, E. Mangan Shareholder of: Regeneron, Pfizer, Employee of: Regeneron, A. den Broeder Grant/research support from: Grant from Dutch Arthritis Association, and from CZ and MENZIS, two Dutch Healthcare Insurance companies, Consultant for: Boehringer Ingelheim, Amgen, Employee of: Sint Maartenskliniek the Netherlands