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Abstract Number: 1653

Efficacy and Safety of Romilkimab in Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Randomized, Double-Blind, Placebo-Controlled, 24-week, Proof of Concept Study

Yannick Allanore1, Christopher Denton 2, Dinesh Khanna 3, Christina Soubrane 4, Corinne Esperet 4, Frederic Marrache 4, Raphael Bejuit 4, Amel Lahmar 5 and Peter Wung 5, 1Dept. of Rheumatology A, Descartes University, APHP, Cochin Hospital, Paris, France, Paris, France, 2University College London Division of Medicine, Centre for Rheumatology and Connective Tissue Diseases, London, UK, London, United Kingdom, 3Department of Medicine, University of Michigan, Ann Arbor, Michigan, USA, Ann Arbor, 4Sanofi, Chilly Mazarin, France, 5Sanofi, Bridgewater, NJ

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: systemic sclerosis and clinical trials

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Session Information

Date: Monday, November 11, 2019

Session Title: Systemic Sclerosis & Related Disorders – Clinical Poster II

Session Type: Poster Session (Monday)

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

Background/Purpose: Systemic sclerosis (SSc) is a progressive, multi-organ disease with limited treatment options. Interleukin-4 (IL-4) and IL-13 have been implicated in the general fibrotic pathway and pathogenesis of SSc and are promising targets. Romilkimab (RKB) is an engineered humanized bispecific immunoglobulin-G4 antibody that binds and neutralizes both IL-4/IL-13. We report a Phase IIa randomized, double-blind, placebo-controlled trial (NCT02921971, Sanofi funded) employing RKB in SSc.

Methods: Patients with dcSSc (disease duration ≤36 months, mRSS 10-35) with or without immunosuppressive background therapy were randomized (1:1) to subcutaneous RKB 200mg or placebo (PBO) for 24 weeks and stratified based upon history of SSc-ILD. The primary endpoint was mean change in mRSS from baseline to Week 24 and FVC/DLco and HAQ-DI served as secondary endpoints. All analyses employed a 1-sided p-value < 0.05 as reaching statistical significance.

Results: Ninety-seven patients with similar baseline characteristics between arms (Table 1), including the use of background therapy (PBO 59.2% vs. RKB 52.1%) were randomized. Six (12.2%) and 4 (8.3%) patients discontinued study treatment early in the PBO and RKB arms, respectively. The primary endpoint showed an absolute change in mRSS of -2.45 (0.85) and -4.76 (0.86) for the PBO and RKB groups, respectively with a difference of -2.31 (1.21) favoring RKB (p-value = 0.029) (Table 2). Subgroup analysis based upon stratification criteria did not yield a significant difference (interaction p-value=0.731). Subgroup analysis based on background therapy showed a similar treatment effect with a placebo subtracted difference in mRSS of -2.69 (1.83) and -2.38 (1.59) (Table 2), suggesting an additive effect between background therapy and RKB. Secondary endpoints did not show a statistically significant difference between RKB vs. PBO arms, although there was numerically less decline in FVC with RKB (Table 2). Exploratory endpoints suggested possible effect of RKB on overall pain, Raynaud’s, digital ulcers, and EQ-5D-5L (Table 2). Adverse events (AE) were balanced between the two groups (PBO 83.7% and RKB 83.3%). There were 5 and 4 patients with serious AEs in the PBO and RKB arms, respectively. One death occurred in each arm (PBO – cardiomyopathy, RKB – scleroderma renal crisis).

Conclusion: Patients with dcSSc who were treated with RKB showed a statistically significant reduction in mRSS compared to those receiving placebo. None of the secondary outcomes were met, although RKB was associated with a smaller decline in FVC than placebo. Romilkimab was well tolerated with no major safety concerns.


SAR156597_ACT14604 Results_abstract 24MAY2019_Final Draft_Post Internal Publication Review Table 01

Table 1. Baseline Characteristics


SAR156597_ACT14604 Results_abstract 24MAY2019_Final Draft_Post Internal Publication Review Table 02

Table 2. Outcome Measures


Disclosure: Y. Allanore, Actelion, 2, 5, Alpine, 2, 5, Bayer, 2, 5, BMS, 2, 5, Boehringer Ingelheim, 2, 5, Bristol Myers Squibb, 5, Bristol-Myers Squibb, 2, 5, Genentech Roche, 2, 5, Inventiva, 2, 5, Italfarmaco, 2, 5, Sanofi, 2, 5, Servier, 2, 5; C. Denton, Actelion, 5, Actelion Pharmaceuticals, 5, Actelion, GlaxoSmithKline, Bayer, Sanofi, lnventiva, Boehringer Ingelheim, Roche, Bristol Myers Squibb, CSL Behring, UCB, Leadiant Biosciences, 5, Bayer, 5, Boehringer Ingelheim, 5, Bristol Myers Squibb, 5, Bristol-Myers Squibb, 5, Corbus Pharmaceuticals, 5, CSL Behring, 2, 5, GlaxoSmithKline, 2, 5, Inventiva, 2, 5, Leadiant Biosciences, 2, 5, lnventiva, 5, Pfizer, 5, Roche, 5, Sanofi, 5, UCB, 5; D. Khanna, Acceleron, 5, 8, Acceleron Pharma, 5, Actelion, 5, 8, Actelion Pharmaceuticals, 5, Astra Zeneca, 5, Bayer, 2, 5, 8, Behring, 5, Blade, 5, Blade Therapeutics, 5, 8, Blade therapeutics, 5, BMS, 2, 5, 8, Boehringer Ingelham, 5, Boehringer Ingelheim, 5, 8, Boehringer-Ingelheim, 5, Bristol Myers Squibb, 2, 5, Bristol-Myers Squibb, 2, 5, Celegene, 5, Celgene, 5, 8, ChemomAB, 5, ChemomAb, 5, CiviBioPharma, Inc., 3, Corbus, 5, Corobus, 5, Corpus, 5, CSL Behring, 5, 8, Curizon, 5, Curzion, 5, Cytori, 5, 8, Eicos, 4, Eicos Sciences, 4, Eicos Sciences, Inc, 4, Eicos Sciences, Inc/ CiviBioPharma, Inc, 1, 4, Eicos Sciences, Inc/ CiviBioPharma, Inc., 1, Eicos, Inc, 4, Eicos, Inc., 5, 8, Eicos, INC., 4, Galapagos, 5, Genentech, 5, Genentech/Roche, 5, GlaxoSmithKline, 5, GSK, 5, Horizon, 2, 5, Mitsubishi Tanabe Pharma, 5, Mitsubishi Tanabe Pharma Dev America, 5, Mitsubishi Tanabe Pharma Development America, 5, Mitsubishi Tanabi, 5, NIH K24 and R01, 2, NIH / NIAMS K24 AR-063120, 2, NIH/NIAMS R01& K24, 2, Pfizer, 2, 5, Sanofi, 5, Sanofi Aventis, 5, Sanofi-Aventis, 5, 8, Sanofi-Aventis/Genzyme, 5, UCB, 5, UCB Pharma, 5; C. Soubrane, Sanofi, 3; C. Esperet, Sanofi, 3; F. Marrache, Sanofi, 3; R. Bejuit, Sanofi, 3; A. Lahmar, Sanofi, 3; P. Wung, Sanofi, 3.

To cite this abstract in AMA style:

Allanore Y, Denton C, Khanna D, Soubrane C, Esperet C, Marrache F, Bejuit R, Lahmar A, Wung P. Efficacy and Safety of Romilkimab in Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Randomized, Double-Blind, Placebo-Controlled, 24-week, Proof of Concept Study [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-romilkimab-in-diffuse-cutaneous-systemic-sclerosis-dcssc-a-randomized-double-blind-placebo-controlled-24-week-proof-of-concept-study/. Accessed January 27, 2023.
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