P235 Glucocorticoid dose is progressively reduced in Patients with rheumatoid arthritis (RA) receiving sarilumab: results from the open label EXTEND study

Abstract

Abstract Background This post hoc analysis assessed changes in oral glucocorticoid (OGC) use over time in patients receiving sarilumab 200 mg (dose reduction to 150 mg for laboratory abnormalities or per investigator’s discretion) every 2 weeks (q2w) plus conventional synthetic disease-modifying antirheumatic drugs (csDMARD) in EXTEND (NCT01146652), a long-term, open-label extension (OLE) study of sarilumab in RA. Methods Patients who had completed placebo-controlled Phase 3 studies of sarilumab +csDMARD (NCT01061736 and NCT01709578) and received sarilumab in EXTEND were included. Reported total daily OGC doses were converted to prednisone equivalent daily doses (PED). Patients were grouped by PED dose at enrollment into the OLE: 0-<5, 5-<10, and ≥10 mg/day (PED <1 mg/day imputed to 0). PED doses were analyzed over 12-week intervals to Week 216. Change from baseline for average PED was tested (Wilcoxon-Pratt-Lehman). Results In total, 891/1353 patients (65.9%) had ≥1 record of OGC use. Of these, 137 (15.4%) received baseline PED of 0-<5 mg/day, 515 (57.8%) 5-<10 mg/day, and 239 (26.8%) ≥10 mg/day. Mean (±SD) PED was 6.3 (±3.1) mg/day at baseline and decreased over time (21.3% mean reduction at 4 years: nominal p < 0.0001). By Weeks 49-60, 660/776 patients (85.1%) had stable PED, 90/776 patients (11.6%) had decreased PED, and 26/776 (3.4%) had increased PED. This difference increased during follow-up: at Weeks 205-216, 109/236 patients (46.2%) had decreased PED and 18/236 (7.6%) had increased PED. Patients with PED ≥5 mg/day were more likely than patients with PED <5 mg/day to decrease their dose. Efficacy (CDAI and DAS28-CRP) was maintained with sarilumab irrespective of OGC tapering. Conclusion Long-term RA treatment with sarilumab was associated with sustained efficacy and decreased OGC dose. The proportion of patients who reduced their OGC dose increased with time and reductions were more common among patients with baseline PED ≥5 mg/day. Disclosures R. Fleischmann: Grants/research support; AbbVie, Acea, Akros, Amgen, Astra Zeneca, Bristol-Myers Squibb, Celgene, Celltrion, Centrexion, Eli Lilly, EMD Serono, Genentech, Glaxo Smith Kline, Janssen, Merck, Nektar, Novartis, Pfizer, Regeneron, Resolve, Roche. C. Selmi: Grants/research support; AbbVie, Alfa-Sigma, Biogen, Bristol-Myers Squibb, Celgene, Eli Lilly, Glaxo Smith Kline, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Roche, Sanofi-Genzyme, and UCB. M. Gonzalez-Gay: Grants/research support; AbbVie, Celgene, Eli Lilly, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Roche, Sanofi, and Sobi. H. van Hoogstraten: Corporate appointments; Employee of Sanofi. Shareholder/stock ownership; Sanofi. O. Hagino: Corporate appointments; Employee of Sanofi. Shareholder/stock ownership; Sanofi. T. Rajput: Corporate appointments; Employee of Cytel. G. St John: Corporate appointments; Employee of Regeneron Pharmacueticals Inc. Shareholder/stock ownership; Regeneron Pharmacueticals Inc. F. Buttgereit: Grants/research support; Medac, Pfizer, Roche/Chugai, and Sanofi-Genzyme. M.C. Genovese: Grants/research support; AbbVie, Astellas, Eli Lilly, EMD Serono, Galapagos, Genentech/Roche, Gilead Sciences, Inc., GlaxoSmithKline, Novartis, Pfizer, RPharm, Sanofi Genzyme, and Vertex.