SAT0100 ASSOCIATION BETWEEN LOW HEMOGLOBIN AND RADIOGRAPHIC PROGRESSION OVER 52 WEEKS IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULTS FROM A PHASE 3 TRIAL OF SARILUMAB

Abstract

Background:Anemia is a common comorbidity in patients with rheumatoid arthritis (RA).Objectives:Assess whether low hemoglobin (Hb) identifies a subgroup of patients at increased risk of joint damage progression, and investigate whether sarilumab modulates this risk.Methods:The 52-week, double-blind, Phase 3 MOBILITY trial (NCT01061736) in patients with active RA and inadequate response to methotrexate (n = 1197) demonstrated the tolerability and efficacy (clinical and radiographic) of subcutaneous sarilumab 150 and 200 mg every 2 weeks versus placebo, both in combination with methotrexate (MTX). In thispost hocanalysis, baseline characteristics and radiographic outcomes in MOBILITY were analyzed by baseline Hb category (low or normal) according to World Health Organization criteria, with low Hb defined as <120 g/L for women and <130 g/L for men. NominalPvalues are presented.Results:A total of 414 patients (35%) had low Hb at baseline. Patients with low Hb were more likely than patients with normal Hb to be female (86% vs 79%, respectively), Asian (14% vs 5%), younger (mean age 49 vs 51 years), and to have lower body weight (mean 69 vs 77 kg); all nominalP<0.01. Duration of RA, prior biologic use, rheumatoid factor positivity, and baseline tender and swollen joint counts were similar between patients with low and normal baseline Hb, but there was a nominally significant difference in C-reactive protein (mean 30.2 [SD 28.5] vs 17.3 [18.5] mg/L;P<0.0001). Patients with low Hb generally exhibited more joint damage progression over 52 weeks than patients with normal Hb (Table). In the sarilumab + MTX groups, joint damage progression was mitigated compared with placebo + MTX in patients with low Hb and in patients with normal Hb. Mean change from baseline in Hb at 52 weeks in the placebo + MTX, sarilumab 150 mg + MTX, and sarilumab 200 mg + MTX groups was +3.7 (SD 10.8), +14.7 (12.1), and +14.0 (10.5) g/L, respectively, in patients with low Hb at baseline, and –2.5 (9.9), +6.2 (9.3), and +8.0 (9.9) g/L in patients with normal Hb at baseline.Table.Mean change from baseline (SD) in radiographic measures of joint damagePlacebo+ MTXSarilumab 150 mg+ MTXSarilumab 200 mg+ MTXLow Hb (n = 140)Normal Hb (n = 258)Low Hb (n = 145)Normal Hb (n = 255)Low Hb (n = 129)Normal Hb (n = 270)mTSS3.75 (9.00)2.29 (6.98)1.20*** (5.58)0.73** (4.07)0.60*** (4.13)0.08*** (4.83)Joint space narrowing1.52 (3.71)1.22 (3.92)0.79* (3.17)0.30** (2.70)0.50** (2.93)0.06*** (3.33)Erosion score2.24 (6.24)1.07 (3.91)0.41*** (3.18)0.44* (2.05)0.10*** (2.13)0.02*** (2.19)NominalP*<0.05, **<0.01, ***<0.001 versus placebo by rank ANCOVA model stratified by prior biologic use and region; mTSS, modified total Sharp scoreConclusion:Overall, sarilumab slowed joint damage progression in patients with RA. Additionally, in those patients with low Hb, who may suffer greater damage than those with normal Hb, sarilumab also increased Hb.Acknowledgments:Study funding and medical writing support (Matt Lewis, PhD, of Adelphi Communications Ltd, Macclesfield, UK) were provided by Sanofi Genzyme (Cambridge, MA, USA) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA) in accordance with Good Publication Practice (GPP3) guidelines.Disclosure of Interests:Gerd Rüdiger Burmester Consultant of: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma, Speakers bureau: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma, Jean-Pierre Morello Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc., Owen Hagino Shareholder of: Sanofi, Employee of: Sanofi, Amy Praestgaard Employee of: Sanofi Genzyme, Stefano Fiore Shareholder of: Sanofi, Employee of: Sanofi, Mark C. Genovese Grant/research support from: Abbvie, Eli Lilly and Company, EMD Merck Serono, Galapagos, Genentech/Roche, Gilead Sciences, Inc., GSK, Novartis, Pfizer Inc., RPharm, Sanofi Genzyme, Consultant of: Abbvie, Eli Lilly and Company, EMD Merck Serono, Genentech/Roche, Gilead Sciences, Inc., GSK, Novartis, RPharm, Sanofi Genzyme