Robust efficacy in patients with prior history of inadequate response1
With KEVZARA 150 mg + DMARD (TARGET), 56%† of patients achieved ACR20 response, 37%† achieved ACR50 response, and 20%|| achieved ACR70 response week 24 (n=181)
With KEVZARA 150 mg + MTX (MOBILITY), 58%† of patients achieved ACR20 response, 37%† achieved ACR50 response, and 20%† achieved ACR70 response at week 24 (n=400)
*After week 12 in TARGET and week 16 in MOBILITY, patients with an inadequate response could have been treated with open-label KEVZARA 200 mg every 2 weeks. †P<0.0001; ‡P<0.01; §DMARDs in TARGET include MTX, sulfasalazine, leflunomide, and/or hydroxychloroquine; ||P<0.001.
Efficacy and Safety Studied in TNF-IR and MTX-IR Patients
TNF-IR=tumor necrosis factor inhibitor inadequate response or intolerant; MTX-IR=methotrexate inadequate response; q2w=once every 2 weeks; HAQ-DI=Health Assessment Questionnaire-Disability Index.
References: 1. KEVZARA [prescribing information]. Bridgewater, NJ: Sanofi/Regeneron Pharmaceuticals, Inc. 2. Data on file. Sanofi/Regeneron. Integrated summary. April 1, 2017. 3. Fleischmann R, van Adelsberg J, Lin Y, et al. Sarilumab and non-biologic disease-modifying antirheumatic drugs in patients with active RA and inadequate response or intolerance to TNF inhibitors. Arthritis Rheumatol. 2017;69(2):277-290. 4. Genovese MC, Fleischmann R, Kivitz AJ, et al. Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a phase III study. Arthritis Rheumatol. 2015;67(6):1424-1437.
from baseline with
KEVZARA 200 mg + DMARD
compared to 39% reduction with
placebo + DMARD
from baseline with
KEVZARA 200 mg + DMARD
A 70% reduction in tender joints
compared to 59% reduction with
placebo + DMARD
A 73% reduction in swollen joints
compared to 63% reduction with
placebo + DMARD
levels from baseline with
KEVZARA 200 mg + DMARD
compared to 25% reduction with
placebo + DMARD
With KEVZARA 150 mg + DMARD, reduction from baseline was 69% in tender and 72% in swollen joints, 49% in pain, and 87% in median CRP
As early as 2 weeks after the first dose, KEVZARA normalized CRP levels (<10 mg/L) in patients with elevated CRP1,5
with KEVZARA 200 mg + MTX
compared to 18% response with
placebo + MTX
with KEVZARA 200 mg + MTX
compared to 9% response with
placebo + MTX
*P<0.0001, P value is for descriptive purposes only and is not adjusted for multiplicity.
KEVZARA 200 mg + MTX provided an absolute difference of 2.52 units (CI: -3.38, -1.66) in mean ΔmTSS relative to placebo + MTX
68%* greater inhibition of joint damage progression with KEVZARA 150 mg + MTX at week 52 relative to placebo + MTX1
KEVZARA 150 mg + MTX provided an absolute difference of 1.88 units in mean mTSS relative to placebo + MTX
KEVZARA 200 mg + MTX significantly inhibited the progression of joint damage1
Week 52 analysis employs linear extrapolation method to impute missing or postrescue data.
*Based on post hoc comparisons of mean change in mTSS per treatment group.
CI=confidence interval.
Change from baseline with KEVZARA 150 mg + DMARD vs placebo + DMARD -0.50 and -0.29, respectively
Change from baseline with KEVZARA 150 mg + MTX vs placebo + MTX -0.54 and -0.30, respectively
In MOBILITY, patients maintained clinically meaningful improvement in physical function through week 523*
At week 52, KEVZARA 200 mg +
MTX: 48% (190/399) | Placebo + MTX 26% (104/398)
*Minimal clinically important difference. HAQ-DI change from baseline ≥0.3 units.1
TARGET Study Design: A 24-week, randomized, double-blind, parallel group, placebo-controlled, multicenter study (N=546) assessing the efficacy and safety of KEVZARA 200 mg and 150 mg added to nonbiologic DMARD in patients with moderate to severe active RA (≥6 months duration) with inadequate response and/or intolerance to 1 or more TNF antagonists, when administered with background nonbiologic DMARD. Primary endpoints were reduction of signs and symptoms (ACR20) at 24 weeks and change from baseline in HAQ-DI at 12 weeks. After week 12 in TARGET, patients with an inadequate response could have been treated with open-label KEVZARA 200 mg every 2 weeks.
MOBILITY Study Design: A 52-week, randomized, double-blind, placebo-controlled, multicenter study (N=1197) assessing the efficacy and safety of KEVZARA 200 mg + MTX and 150 mg + MTX in patients with moderate to severe active RA (duration of ≥3 months) who had been on MTX 10 to 25 mg/week ≥6 weeks. Primary endpoints were reduction of signs and symptoms (ACR20) at 24 weeks, change in van der Heijde mTSS at 52 weeks, and change from baseline in HAQ-DI at 16 weeks. After week 16 in MOBILITY, patients with an inadequate response could have been treated with open-label KEVZARA 200 mg every 2 weeks.
References: 1. KEVZARA [prescribing information]. Bridgewater, NJ: Sanofi/Regeneron Pharmaceuticals, Inc; 2. Fleischmann R, van Adelsberg J, Lin Y, et al. Sarilumab and nonbiologic disease-modifying antirheumatic drugs in patients with active rheumatoid arthritis and inadequate response or intolerance to tumor necrosis factor inhibitors. Arthritis Rheumatol. 2017;69(2):277-290. 3. Genovese MC, Fleischmann R, Kivitz AJ, et al. Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a phase III study. Arthritis Rheumatol. 2015;67(6):1424-1437. 4. Data on file, Sanofi/Regeneron. Integrated summary. April 1, 2017. 5. Center for Devices and Radiological Health. Guidance for industry and FDA staff: review criteria for assessment of c-reactive protein (CRP), high sensitivity c-reactive protein (hsCRP) and cardiac c-reactive protein (cCRP) assays. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm071017.pdf. Accessed October 18, 2017.
