KEVZARA EFFICACY

Head-to-Head
Monotherapy and OLE

Head-to-Head Monotherapy and OLE

RELEVANT TRIALS: MONARCH, MONARCH OPEN-LABEL EXTENSION

Pivotal Trial Study Designs

MONARCH and MONARCH OLE data are not included in the KEVZARA US full Prescribing Information.

MONOTHERAPY

GREATER IMPROVEMENT IN DISEASE ACTIVITY vs ADALIMUMAB

KEVZARA monotherapy was superior to adalimumab monotherapy in meeting primary endpoint of mean change from baseline to week 24 in DAS28-ESR.1

Participants saw 49% greater improvement in DAS28-ESR than adalimumab at week 24

greater improvement in DAS28-ESR
than adalimumab at week 241

MONARCH (MTX-IR)
change in das28-esr
at week 241
KEVZARA® (sarilumab) monotherapy had greater improvement in DAS28-ESR than adalimumab at week 24
  • *Difference: -1.08 (95% CI: -1.36 to -0.79).

DAS28-ESR=Disease Activity Score-28 Erythrocyte Sedimentation Rate; MTX-IR=methotrexate inadequate response; LS=least squares; SE=standard error; q2w=once every 2 weeks.

At week 24, more than 3x as many  KEVZARA® (sarilumab) patients achieved low disease activity (DAS28-ESR) vs adalimumab monotherapy

KEVZARA patients achieved low disease activity (DAS28-ESR <2.6) vs adalimumab monotherapy
(26.6% vs 7.0%; P<0.0001)1

IMPROVED PHYSICAL FUNCTION vs ADALIMUMAB

Significantly greater improvements in HAQ-DI were achieved with KEVZARA monotherapy vs adalimumab monotherapy at 24 weeks.1

MONOTHERAPY

Participants saw 42% greater improvement in HAQ-DI vs adalimumab at week 24

greater improvement in HAQ-DI
vs adalimumab at week 241

MONARCH (MTX-IR)
Change from baseline in HAQ-DI
at week 241
KEVZARA® (sarilumab) monotherapy resulted in higher improved physical function than adalimumab at week 24
  • HAQ-DI=Health Assessment Questionnaire-Disability Index; MTX-IR=methotrexate inadequate response; LS=least squares; q2w=once every 2 weeks.

PROVIDED GREATER CLINICAL
RESPONSE vs ADALIMUMAB

Significantly more patients achieved ACR responses with KEVZARA monotherapy vs adalimumab monotherapy through week 24.1

MONARCH:(MTX-IR)
ACR Responses at week 241
More patients achieved ACR responses with KEVZARA® (sarilumab) monotherapy through week 24
  • *P<0.01.
  • ACR20=American College of Rheumatology 20% improvement criteria; MTX-IR=methotrexate inadequate response; q2w=once every 2 weeks.
More patients achieved greated control of disease activity
with KEVZARA vs adalimumab1

Long-Term Monotherapy

Given the limitations and context described above, caution should be used in interpreting 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.

Please see Study Context and Limitations above for more information.

MONARCH OPEN-LABEL EXTENSION DATA: INTERPRET WITH CAUTION
CHANGE IN Disease Activity

mean change from
baseline in DAS28-ESR1-3
Mean change from baseline in DAS28-ESR with KEVZARA® (sarilumab) through 48 weeks
  • DAS28-ESR=Disease Activity Score-28 Erythrocyte Sedimentation Rate; SE=standard error; q2w=once every 2 weeks.

Changes in disease activity were measured in both patients who continued treatment with KEVZARA monotherapy and in those who switched treatment from adalimumab to KEVZARA

MONARCH OPEN-LABEL EXTENSION DATA: INTERPRET WITH CAUTION
IMPROVEMENT IN PHYSICAL FUNCTION

Mean haq-di over time2,3
Mean HAQ-DI over time with KEVZARA® (sarilumab) through 48 weeks
  • HAQ-DI=Health Assessment Questionnaire-Disability Index; SE=standard error; q2w=once every 2 weeks.

MONARCH OPEN-LABEL EXTENSION DATA: INTERPRET WITH CAUTION
OBSERVED ACR clinical response

ACR20/50/70 at weeks 0 and 48
IN OPEN-LABEL EXTENSION (OLE)2
Observed ACR clinical response with KEVZARA® (sarilumab) through 48 weeks
  • *ACR response is based on change from original study baseline and not OLE baseline.

ACR20=American College of Rheumatology 20% improvement criteria; q2w=once every 2 weeks.

Clinical response (ACR20/50/70) was measured in both patients who continued treatment with KEVZARA monotherapy and in those who switched treatment from adalimumab to KEVZARA

References:

  • Burmester GR, Lin Y, Patel R, et al. Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial. Ann Rheum Dis. 2017;76(5):840-847.
  • Burmester GR, Strand V, Rubbert-Roth A, et al. Safety and efficacy of switching from adalimumab to sarilumab in patients with rheumatoid arthritis in the ongoing MONARCH open-label extension. RMD Open. 2019;5(2):e001017. doi: 10.1136/rmdopen-2019-001017.
  • Data on file, Sanofi/Regeneron. Burmester poster SAT0183. June 2018.