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Abstract Number: 3221

Efficacy and Safety of Sarilumab Versus Adalimumab in a Phase 3, Randomized, Double-Blind, Monotherapy Study in Patients with Active Rheumatoid Arthritis with Intolerance or Inadequate Response to Methotrexate

Gerd Burmester1, Yong Lin2, Rahul Patel2, Janet van Adelsberg3, Erin Mangan3, Hubert van Hoogstraten2, Deborah Bauer2, Juan Ignacio Vargas4 and Eun Bong Lee5, 1Med. Klinik mit SP Rheumatologie und Klinische Immunologie, Charit, Berlin, Germany, 2Sanofi Genzyme, Bridgewater, NJ, 3Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 4Quantum Research, Puerto Varas, Chile, 5Seoul National University, Seoul, Korea, Republic of

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: methotrexate (MTX) and rheumatoid arthritis (RA)

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Session Information

Date: Wednesday, November 16, 2016

Session Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy V: New Biologics and Remission Induction

Session Type: ACR Concurrent Abstract Session

Session Time: 11:00AM-12:30PM

Background/Purpose: Sarilumab is a human mAb that blocks IL-6 from binding to both membrane-bound and soluble IL-6Rα. Efficacy and safety of sarilumab + non-biologic DMARDs have been demonstrated.1,2 However, 30% of patients with RA use biologics as monotherapy because of intolerance or contraindications to combination therapy.3 In this phase 3 trial, safety and efficacy of sarilumab monotherapy were compared with adalimumab monotherapy in adult patients with active RA (NCT02332590).

Methods: Adults (N=369) intolerant of, inappropriate for, or inadequate responders to MTX received subcutaneous sarilumab (200 mg every 2 weeks [q2w]) or adalimumab (40 mg q2w) monotherapy for 24 weeks in this double-blind, double-dummy superiority study. Starting at week 16, patients with inadequate response could increase to weekly adalimumab (or matching placebo). The primary endpoint, change from baseline in DAS28-ESR at week 24, was assessed using a mixed model for repeated measures analysis. Secondary endpoints, including clinical disease activity index (CDAI), were also assessed (Table).

Results: Baseline demographics and disease characteristics were generally comparable between treatment groups. At week 24, significantly greater decrease in DAS28-ESR scores, greater incidence of DAS28-ESR remission and ACR20/50/70 responses, and improvement in HAQ–Disability Index were observed with sarilumab vs adalimumab (Table); results included patients switching to weekly adalimumab. Patients in the sarilumab group were twice as likely to achieve CDAI remission at week 24 vs adalimumab (nominal P<0.05). Incidences of adverse events (AEs) (64%) and serious AEs (sarilumab, 5%; adalimumab, 7%) were similar between groups. Neutropenia and injection site reactions were more common with sarilumab; headache and worsening of RA were more common with adalimumab. Incidences of infections (sarilumab, 29%; adalimumab, 28%) and serious infections (1%) were similar between groups. Neutropenia was not associated with an increased incidence of infections. Most injection site reactions were mild; only 2 cases led to treatment discontinuation in the sarilumab group. There was 1 death in the sarilumab group, 35 days after initiating treatment, due to acute cardiac failure.

Conclusion: Sarilumab monotherapy demonstrated superiority to adalimumab monotherapy in reduction of disease activity and improvement in signs and symptoms and physical function in patients with active RA who were inappropriate candidates for continued treatment with MTX due to intolerance or inadequate response. The overall incidences of AEs and serious AEs were similar between groups, as was the rate of infections and serious infections. References: 1. Genovese et al. Arthritis Rheumatol. 2015;67:1424-1437. 2. Fleischmann et al. Presented at: ACR; November 7-11, 2015; San Francisco, CA. 3. Emery et al. Ann Rheum Dis. 2013;72:1897-1904.  

Table. Efficacy Endpoints at Week 24
 

Sarilumab

200 mg q2w

(n=184)

Adalimumab

40 mg q2w

(n=185)

P value

DAS28-ESR Mean (SD) LS mean change from baseline (SE)

3.5 (1.4)

-3.3 (0.1)

4.5 (1.4)

-2.2 (0.1)

<0.0001

<0.0001

DAS28-ESR remission, n (%)

49 (26.6)

13 (7.0)

<0.0001

ACR20 response, n (%)

132 (71.7)

108 (58.4)

0.0074

ACR50 response, n (%)

84 (45.7)

55 (29.7)

0.0017

ACR70 response, n (%)

43 (23.4)

22 (11.9)

0.0036

HAQ-DI Mean (SD) LS mean change from baseline (SE)

1.0 (0.7)

-0.6 (0.05)

1.2 (0.7)

-0.4 (0.05)

0.0074

0.0037

CDAI Mean (SD) LS mean change from baseline (SE)

13.8 (11.4)

-28.9 (0.8)

16.6 (10.4)

-25.2 (0.8)

0.0244a

0.0013a

CDAI remission, n (%)

13 (7.1)

5 (2.7)

0.0468a

CDAI, clinical disease activity index; HAQ-DI, HAQ–Disability Index; LS, least squares; q2w, every 2 weeks; SD, standard deviation; SE, standard error. aNominal P values.

 


Disclosure: G. Burmester, UCB, 2,AbbVie, BMS, Hexal, Janssen, Lilly, MSD, Medimmune, Novartis, Pfizer, Sanofi, Roche, 5,AbbVie, BMS, Hexal, MSD, Novartis, Pfizer, Roche, 8; Y. Lin, Sanofi Genzyme, 3,Sanofi Genzyme, 1; R. Patel, Sanofi Gynzyme, 1,Sanofi Genzyme, 3; J. van Adelsberg, Regeneron Pharmaceuticals, Inc., 1,Regeneron Pharmaceuticals, Inc., 3; E. Mangan, Regeneron Pharmaceuticals, Inc., 1,Regeneron Pharmaceuticals, Inc., 3; H. van Hoogstraten, Sanofi Genzyme, 1,Sanofi Genzyme, 3; D. Bauer, Sanofi Genzyme, 1,Sanofi Genzyme, 3; J. I. Vargas, Bristol-Myers Squibb, 8,Roche, Bristol-Myers Squibb, and Pfizer, 5; E. B. Lee, Pfizer Inc, 5.

To cite this abstract in AMA style:

Burmester G, Lin Y, Patel R, van Adelsberg J, Mangan E, van Hoogstraten H, Bauer D, Vargas JI, Lee EB. Efficacy and Safety of Sarilumab Versus Adalimumab in a Phase 3, Randomized, Double-Blind, Monotherapy Study in Patients with Active Rheumatoid Arthritis with Intolerance or Inadequate Response to Methotrexate [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-sarilumab-versus-adalimumab-in-a-phase-3-randomized-double-blind-monotherapy-study-in-patients-with-active-rheumatoid-arthritis-with-intolerance-or-inadequate-response-to-met/. Accessed May 17, 2022.
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