Glucocorticoid Dose Is Progressively Reduced in Patients with RA Receiving Sarilumab: Results from the Open-Label EXTEND Study

Roy Fleischmann¹, Carlo Selmi ², Miguel Angel González-Gay ³, Hubert van Hoogstraten ⁴, Owen Hagino ⁴, Tejasweeni Rajput ⁵, Gregory St John ⁶, Frank Buttgereit ⁷ and Mark Genovese ⁸, ¹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ²Humanitas Research Hospital, University of Milan, Milan, Italy, ³Universidad de Cantabria and IDIVAL, Hospital Universitario Marqués de Valdecilla, Santander, Spain, ⁴Sanofi, Bridgewater, NJ, ⁵Cytel, Mumbai, India, ⁶Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁷Charité-Universitätsmedizin Berlin, Berlin, Germany, ⁸Stanford University, Stanford, CA

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: Clinical research, glucocorticoids and outcomes, rheumatoid arthritis, Rheumatoid arthritis (RA), treatment

Session Information

Date: Monday, November 11, 2019

Title: RA – Treatments Poster II: Established Treatments

Session Type: Poster Session (Monday)

Session Time: 9:00AM-11:00AM

Background/Purpose: EXTEND (NCT01146652) is a long-term, open-label extension (OLE) study of sarilumab for the treatment of RA. This post hoc analysis assessed changes in oral glucocorticoid (OGC) use over time in patients receiving sarilumab 200 mg every 2 weeks (dose reduction to 150 mg every 2 weeks was permitted to manage laboratory abnormalities or per investigator’s discretion) in combination with conventional synthetic DMARD (csDMARD) in EXTEND.

Methods: The analysis included patients who had either completed the placebo-controlled Phase 3 studies of sarilumab + csDMARD (NCT01061736 and NCT01709578) or met protocol-defined lack of efficacy after 12 weeks (NCT010709578) and were subsequently treated with sarilumab in the OLE study. Reported total daily oral doses were subsequently converted to prednisone equivalent daily doses (PED) using published conversion tables.^1,2 Patients were categorized into groups by PED dose at enrollment into the OLE: 0–< 5 mg/d, 5–< 10 mg/d and ≥10 mg/d. Patients with a baseline or post-baseline PED < 1 mg/d were imputed to 0 mg/d. PED doses were analyzed over 12-week intervals up to Week 216. Change from baseline for average PED was tested for nominal significance using a Wilcoxon-Pratt-Lehman test for non-parametric data.

Results: In the analysis population, 891/1353 patients (65.9%) had ≥1 record of OGC use. Of the patients with use of OGC, 137 (15.4%) received baseline daily PED of 0–< 5 mg, 515 (57.8%) 5–< 10 mg, and 239 (26.8%) received ≥10 mg. The mean (±SD) PED was 6.3 (±3.1) mg/d at baseline and decreased over the study period (21.3% mean reduction at 4 years; nominal P < 0.0001). During the Week 49–60 interval, 660/776 patients (85.1%) had stable PED, 90/776 patients (11.6%) had decreased PED, and 26/776 (3.4%) had increased PED (Figure). This difference increased throughout follow-up, such that 109/236 patients (46.2%) had decreased PED and 18/236 (7.6%) had increased PED by Week 205–216. When grouped by baseline PED, patients with PED ≥5 mg were more likely than patients with PED < 5 mg to decrease their dose. Baseline characteristics and efficacy by PED reduction will be presented.

Conclusion: Long-term treatment of RA with sarilumab was associated with a substantial frequency of decreased OGC dose and the proportion of patients who reduced their OGC dose increased with time. Reductions were more common among patients with baseline prednisone equivalent doses ≥5 mg/d.

Figure

Disclosure: R. Fleischmann, AbbVie, 2, 5, Acea, 2, 5, Akros, 5, Amgen, 2, 5, AstraZeneca, 2, 5, BMS, 2, 5, Bristol‐Myers Squibb, 2, 5, Bristol-Myers Squibb, 2, 5, Celgene, 2, 5, Celltrion, 5, Celtrion, 2, 5, Centrexion, 2, Eli Lilly, 2, 5, Eli Lilly and Company, 2, 5, EMD Merck-Serono, 2, 5, EMD Serono, 2, EMD-Serano, 2, EMD-Serono, 2, Genentech, 2, 5, Genetech, 2, GlaxoSmithKline, 2, 5, GSK, 2, 5, Janssen, 2, 5, Lilly, 2, 5, Merck, 2, Nektar, 2, Novartis, 2, 5, Pfizer, 2, 5, Pfizer Inc, 2, 5, Regeneron, 2, Resolve, 2, Roche, 2, Samsung, 5, Sandoz, 5, Sanofi Genzyme, 2, Sanofi‐Aventis, 2, 5, Sanofi-Aventis, 2, 5, Sanofi-Genzyme, 2, Selecta, 2, Tahio, 5, Taiho, 5, UCB, 2, 5; C. Selmi, AbbVie, 2, 5, 8, 9, Alfa-Sigma, 5, 8, 9, Biogen, 5, 8, 9, Bristol-Myers Squibb, 5, 8, 9, Celgene, 5, 8, 9, Eli-Lilly, 5, 8, 9, GlaxoSmithKline, 5, 8, 9, Janssen, 2, 5, 8, 9, Merck Sharp and Dohme, 2, 5, 8, MSD, 2, 5, 8, 9, Novartis, 2, 5, 8, 9, Pfizer, 2, 5, 8, 9, Roche, 5, 8, 9, Sanofi-Genzyme, 5, 8, 9, UCB, 5, 8, 9; M. González-Gay, AbbVie, 2, 5, 8, Abbvie, 2, 5, 8, Celgene, 5, 8, Eli Lilly, 2, 5, EliLilly, 2, 5, Jansen, 2, Janssen, 2, MSD, 2, 5, 8, Novartis, 2, 5, Pfizer, 5, 8, Roche, 2, 5, 8, Sanofi, 2, 5, 8, Sobi, 5, 8; H. van Hoogstraten, Novartis, 1, Regeneron, 1, Sanofi, 1, 3, Zambon (Dr Falk for PhD research), 2; O. Hagino, Sanofi, 1, 3, 4; T. Rajput, Cytel, 3; G. St John, Regeneron, 1, 3, 4, Regeneron Pharmaceuticals, Inc, 1, 3; F. Buttgereit, Medac, 2, 5, 8, Pfizer, 2, 5, 8, Roche, 5, Roche/Chugai, 2, 5, 8, Roche-Chugai, 2, 5, 8, Sanofi-Genzyme, 2, 5, 8; M. Genovese, AbbVie, 2, 5, Abbvie, 2, 5, AbbVie, Inc., 9, Astellas, 2, 5, Eli Lilly, 2, 5, Eli Lilly and Company, 2, 5, EMD Merck Serono, 2, 5, Galapagos, 2, 5, Galapagos NV, 2, 5, 9, Genentech/Roche, 2, 5, Gilead, 2, 5, Gilead Science, 9, Gilead Sciences, Inc., 2, 5, 9, GSK, 5, Lilly, 2, 5, 9, Novartis, 2, 5, Pfizer, 2, 5, 9, Pfizer Inc, 2, 5, Pfizer, Inc., 9, Pzier, 9, RPharm, 5, Sanofi Genzyme, 2, 5, Vertex, 2, 5.

To cite this abstract in AMA style:

Fleischmann R, Selmi C, González-Gay M, van Hoogstraten H, Hagino O, Rajput T, St John G, Buttgereit F, Genovese M. Glucocorticoid Dose Is Progressively Reduced in Patients with RA Receiving Sarilumab: Results from the Open-Label EXTEND Study [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/glucocorticoid-dose-is-progressively-reduced-in-patients-with-ra-receiving-sarilumab-results-from-the-open-label-extend-study/. Accessed .

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