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Abstract Number: 970

Efficacy and Safety of Sarilumab in Combination with Csdmards in Patients with Active Rheumatoid Arthritis Who Were Inadequate Responders or Intolerant of Anti–TNF-α Therapy: Results from a Phase 3 Study

Roy Fleischmann1, Geraldo Castelar-Pinheiro2, Jan Brzezicki3, Pawel Hrycaj4, Yong Lin5, Janet van Adelsberg6, Neil Graham7, Hubert van Hoogstraten5, Deborah Bauer5 and Gerd Burmester8, 1University of Texas Southwestern Medical Center, Dallas, TX, 2Discipline of Rheumatology, Rio de Janeiro State University, Rio de Janeiro, Brazil, 3Centrum Kliniczno-Badawcze, Elblag, Poland, 4Poznan University of Medical Sciences, Poznan, Poland, 5Sanofi, Bridgewater, NJ, 6Clinical Science, Regeneron Pharmaceutials, Inc., Tarrytown, NY, 7Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 8Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: Biologic agents, Clinical trials and rheumatoid arthritis, DMARDs, treatment

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Session Information

Date: Sunday, November 8, 2015

Session Title: Rheumatoid Arthritis-Small Molecules, Biologics and Gene Therapy I: Biologics

Session Type: ACR Concurrent Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose: The investigational agent
sarilumab is a human mAb directed against the IL-6 receptor. The phase 3
MOBILITY study (NCT01061736) evaluated the efficacy and safety of Sarilumab in
combination with MTX in RA patients with inadequate response to MTX.1
The objectives of the phase 3 TARGET study were to evaluate efficacy and safety
of addition of sarilumab to non-biologic DMARD(s) (csDMARDs) in patients (pts)
with active RA.

Methods: Adults with active, moderate-to-severe
RA with inadequate response or intolerance to ≥1 TNF inhibitor(s) were
randomized to placebo (Pbo) (n=181), sarilumab 150 mg q2w (n=181), or sarilumab
200 mg q2w (n=184) subcutaneously + background csDMARD(s) for 24 wks of
treatment in a double-blind fashion. Pts who did not respond adequately to
treatment, starting at wk 12, were rescued with sarilumab 200 mg q2w. Coprimary
endpoints were proportion of pts achieving ACR20 response at wk 24 (nonresponder
imputation) and change from baseline in HAQ-DI at wk 12 (before rescue for
inadequate response). Pts were stratified by region and number of previous
anti-TNFs.

Results: Baseline demographic and disease
characteristics (intention-to-treat population, n=546) were balanced among
treatment groups. A significantly greater proportion of pts receiving either dose
of sarilumab achieved ACR20 responses and significantly improved HAQ-DI scores (Table).
Similar observations were made in the proportion of ACR50, ACR70, and HAQ-DI responders
(HAQ-DI ≥0.22 improvement) at wk 24. 

 

 

Placebo + csDMARD

(n=181)

Sarilumab

150 mg q2w + csDMARD (n=181)

Sarilumab

200 mg q2w + csDMARD

(n=184)

Primary endpoints

ACR20 at week 24, %

34

56

61

     P value vs placebo

 

<0.0001

<0.0001

Change from baseline in HAQ-DI at week 12, mean (SD)

-0.29 (0.54)

-0.50 (0.64)

-0.49 (0.56)

     P value vs placebo

 

0.0007

0.0004

Other endpoints

ACR50 at week 24, %

18

37a

41a

ACR70 at week 24, %

7

20b

16b

HAQ-DI ≥0.22 at week 24, %

35

48b

56a

q2w, every 2 wks; SD, standard deviation. aP<0.0001 vs placebo. bP<0.025 vs placebo (to adjust for multiplicity, P values <0.025 are considered statistically significant).

Treatment-emergent adverse events (TEAEs; safety population,
n=546) were more frequent in sarilumab groups (66% and 65% in sarilumab 150 mg
q2w and 200 mg q2w vs 50% in Pbo). Although incidence of SAEs was higher than Pbo
(3.3%) in the sarilumab 200-mg q2w group (5.4%), they were similar to Pbo in
the 150-mg q2w group (3.3%). Infection was the most frequently reported SAE.
The most frequent events leading to treatment discontinuation were infection
and low absolute neutrophil count (ANC). ANC <1.0 Giga/L was observed in
9.8% of pts in the sarilumab 200-mg q2w group, 7.7% in the sarilumab 150-mg q2w
group, and 0.6% in the Pbo group and was not associated with serious infection.
Laboratory abnormalities included elevations in lipids and transaminases. One
death due to a car accident occurred in the Pbo group.

Conclusion: In this phase 3 study, sarilumab
demonstrated efficacy in pts with active RA who were inadequate responders or intolerant
of anti-TNFs, as evidenced by improvements vs Pbo in signs and symptoms of RA and
in physical function. TEAEs leading to treatment discontinuation were more
frequent in the sarilumab-treated groups. SAEs were more frequent in the
sarilumab 200-mg q2w group. Laboratory findings were consistent with IL-6
blockade and observations from the MOBILITY study.

1. Genovese et al. Arthritis Rheumatol. 2015;67:1424-1437.


Disclosure: R. Fleischmann, Abbvie, 2,Amgen, 2,Ardea, 2,AstraZeneca, 2,Bristol-Myers Squibb, 2,Celgene, 2,GlaxoSmithKline, 2,Janssen Pharmaceutica Product, L.P., 2,Eli Lilly and Company, 2,Merck Pharmaceuticals, 2,Pfizer Inc, 2,Resolve, 2,Roche Pharmaceuticals, 2,Sanofi-Aventis Pharmaceutical, 2,UCB, 2,AbbVie, 5,Akros, 5,Amgen, 5,AstraZeneca, 5,Bristol-Myers Squibb, 5,Celgene, 5,Janssen Pharmaceutica Product, L.P., 5,Eli Lilly and Company, 5,Pfizer Inc, 5,Roche Pharmaceuticals, 5,UCB, 5; G. Castelar-Pinheiro, Abbvie, 5,AstraZeneca, 5,GlaxoSmithKline, 5,Hospira, 5,Janssen Pharmaceutica Product, L.P., 5,Pfizer Inc, 5,RuiYi, 5,Sanofi-Aventis Pharmaceutical, 5; J. Brzezicki, None; P. Hrycaj, None; Y. Lin, Sanofi-Aventis Pharmaceutical, 3,Sanofi-Aventis Pharmaceutical, 1,Celgene, 1; J. van Adelsberg, Regeneron, 3,Regeneron, 1; N. Graham, Regeneron, 3,Regeneron, 1; H. van Hoogstraten, Sanofi-Aventis Pharmaceutical, 3,Sanofi-Aventis Pharmaceutical, 1; D. Bauer, Sanofi-Aventis Pharmaceutical, 3; G. Burmester, Abbvie, 2,Pfizer Inc, 2,UCB, 2,Roche Pharmaceuticals, 2,Abbvie, 5,Bristol-Myers Squibb, 5,Pfizer Inc, 5,Merck Human Health, 5,MedImmune, 5,UCB, 5,Roche Pharmaceuticals, 5,Abbvie, 8,Bristol-Myers Squibb, 8,Pfizer Inc, 8,Merck Human Health, 8,UCB, 8,Roche Pharmaceuticals, 8.

To cite this abstract in AMA style:

Fleischmann R, Castelar-Pinheiro G, Brzezicki J, Hrycaj P, Lin Y, van Adelsberg J, Graham N, van Hoogstraten H, Bauer D, Burmester G. Efficacy and Safety of Sarilumab in Combination with Csdmards in Patients with Active Rheumatoid Arthritis Who Were Inadequate Responders or Intolerant of Anti–TNF-α Therapy: Results from a Phase 3 Study [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-sarilumab-in-combination-with-csdmards-in-patients-with-active-rheumatoid-arthritis-who-were-inadequate-responders-or-intolerant-of-antiaetnf-i%c2%b1-therapy-results-f/. Accessed June 1, 2023.
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