KEVZARA EFFICACY

Clinical Remission Data

Clinical Remission Data

Relevant Trials: MOBILITY, TARGET, Combination Therapy Open-Label Extension (OLE)

PIVOTAL TRIAL STUDY DESIGNS

CLINICAL REMISSION DATA (DAS28-CRP <2.6) WITH KEVZARA

Significantly more patients achieved DAS28-CRP <2.6 with KEVZARA 200 mg + MTX in MOBILITY and KEVZARA 200 mg + DMARD(s) in TARGET

REMISSION Data (DAS28-CRP <2.6) at week 24: Mobility1,2
Disease activity response at week 24 in MOBILITY (MTX-IR) as a result of KEVZARA® (sarilumab) treatment
REMISSION DATA (DAS28-CRP <2.6) at week 24: Target2,3
Disease activity response at week 24 in TARGET (TNF-IR) as a result of KEVZARA® (sarilumab) treatment

Measures of remission do not imply drug-free remission or complete absence of disease.

  • DAS28-CRP=disease activity score 28-C-reactive protein; MTX=methotrexate; MTX-IR=methotrexate inadequate response; TNF-IR=tumor necrosis factor inhibitor inadequate response or intolerant; q2w=once every 2 weeks; DMARDs=disease-modifying antirheumatic drugs.

CLINICAL REMISSION DATA (SDAI ≤3.3/CDAI ≤2.8) WITH KEVZARA

KEVZARA 200 mg + MTX showed improvement in CDAI remission compared to placebo + MTX in MOBILITY (MTX-IR)

Remission DATA at week 24: Mobility1,4
Remission rate at week 24 in MOBILITY (MTX-IR) as a result of KEVZARA® (sarilumab) treatment
Remission at week 24: Target4,5
Remission rate at week 24 in TARGET (TNF-IR) as a result of KEVZARA® (sarilumab) treatment

Measures of remission do not imply drug-free remission or complete absence of disease.

  • SDAI=Simple Disease Activity Index; CDAI=Clinical Disease Activity Index; MTX=methotrexate; MTX-IR=methotrexate inadequate response; TNF-IR=tumor necrosis factor inhibitor inadequate response or intolerant; q2w=once every 2 weeks; DMARDs=disease-modifying antirheumatic drugs.

LONG-TERM COMBINATION THERAPY

Given the limitations and context described above, caution should be used in interpreting open-label extension (OLE) data. There are limitations associated with open-label study design, including decreasing sample size and potential continued involvement of responders and attrition of non-responders. Data presented are descriptive in nature and no statistical comparisons are made.

OPEN-LABEL EXTENSION DATA: INTERPRET WITH CAUTION

CLINICAL REMISSION DATA (SDAI ≤3.3/CDAI ≤2.8) OVER 4 YEARS

REMISSION DATA: SDAI ≤3.3/CDAI ≤2.84,6
Remission rates in DAS28-CRP observed KEVZARA® (sarilumab) in the open-label extension at 216 weeks and at 244 weeks
REMISSION DATA: SDAI ≤3.3/CDAI ≤2.84,6
Disease activities in DAS28-CRP observed KEVZARA® (sarilumab) in the open-label extension at week 216 and week 244

Measures of remission do not imply drug-free remission or complete absence of disease.

  • SDAI=Simple Disease Activity Index; CDAI=Clinical Disease Activity Index; MTX-IR=methotrexate inadequate response; TNF-IR=tumor necrosis factor inhibitor inadequate response or intolerant; MTX=methotrexate; q2w=once every 2 weeks; DMARDs=disease-modifying antirheumatic drugs.

OPEN-LABEL EXTENSION DATA: INTERPRET WITH CAUTION

CLINICAL REMISSION DATA (DAS28-CRP <2.6) OVER 4 YEARS

REMISSION DATA: DAS28-CRP <2.67
Disease activity in DAS28-CRP observed KEVZARA® (sarilumab) in the open-label extension at 244 weeks
REMISSION DATA: DAS28-CRP <2.66
Disease activity in DAS28-CRP observed KEVZARA® (sarilumab) in the open-label extension at week 144

Measures of remission do not imply drug-free remission or complete absence of disease.

  • DAS28-CRP=disease activity score 28-C-reactive protein; MTX-IR=methotrexate inadequate response; TNF-IR=tumor necrosis factor inhibitor inadequate response or intolerant; MTX=methotrexate; q2w=once every 2 weeks; DMARDs=disease-modifying antirheumatic drugs.

References:

  • 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.
  • KEVZARA [prescribing information]. Bridgewater, NJ: Sanofi/Regeneron Pharmaceuticals, Inc.
  • 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.
  • Data on file, Sanofi/Regeneron. Integrated summary. October 25, 2019.
  • Data on file, Sanofi/Regeneron. TARGET CSR data. August 2019.
  • Data on file, Sanofi/Regeneron. EULAR poster SAT0172. June 2018.
  • Genovese MC, van der Heijde D, Lin Y, et al. Long-term safety and efficacy of sarilumab plus methotrexate on disease activity, physical function and radiographic progression: 5 years of sarilumab plus methotrexate treatment. RMD Open. 2019;5(2):e000887. doi:10.1136/rmdopen-2018-000887.