KEVZARA EFFICACY

LONG-TERM
COMBINATION THERAPY

References:

  • Data on file, Sanofi/Regeneron. Integrated summary. October 25, 2019.
  • 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.
  • Data on file, Sanofi/Regeneron. Number of records at baseline in analysis. October 12, 2020.

Long-Term Combination Therapy

Relevant Trials: Long-term Combination Therapy

Pivotal Trial Study Designs

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 Response Over 5 Years

pooled ACR20/50/70 Response Over Time1
KEVZARA® (sarilumab) patients with ACR20/50/70 responses over time
  • ACR20=American College of Rheumatology 20% improvement criteria; DMARDs=disease-modifying antirheumatic drugs.

OPEN-LABEL EXTENSION DATA: INTERPRET WITH CAUTION

HAQ-DI OVER 5 YEARS

Data in patients who received initial treatment with KEVZARA compared with those who initially received placebo.

MEAN HAQ-DI OVER TIME1,2*
mobility extend
Mean HAQ-DI over time with KEVZARA® (sarilumab) through year 5

This analysis has not been performed for the TNF-IR population.

  • *Mean HAQ-DI scores were calculated based on observed cases, without imputation of missing data.
  • HAQ-DI=Health Assessment Questionnaire-Disability Index; SE=standard error; MTX=methotrexate; q2w=once every 2 weeks; TNF-IR=tumor necrosis factor inhibitor inadequate response or intolerant.
HAQ-DI was measured in patients who
continued treatment with KEVZARA for up to 5 years1,2

OPEN-LABEL EXTENSION DATA: INTERPRET WITH CAUTION

INHIBITION OF RADIOGRAPHIC PROGRESSION OVER 5 YEARS

CHANGE FROM BASELINE IN RADIOGRAPHIC PROGRESSION (mTSS)2,3*
MOBILITY EXTEND
Change from baseline in radiographic progression in patients over time
  • *Radiographic progression was assessed by change from baseline in mTSS, reported using a post hoc integrated analysis of 4 separate reading campaigns. Change from baseline in mTSS was recorded in 1 campaign during the randomized controlled phase and 3 campaigns during the OLE. A post hoc integrated analysis was conducted to analyze radiographic progression based on all available campaign data.2
  • mTSS=modified total Sharp score; SE=standard error; MTX=methotrexate.
Inhibition of structural progression was measured in patients who
continued treatment with KEVZARA for up to 5 years2