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Sanofi and Regeneron Report Positive Results with Sarilumab in First Phase 3 Rheumatoid Arthritis Registration Trial
Date:11/22/2013

ent Question-Disability (HAQ-DI) at week 16. 

(3) Inhibition of progression of structural damage at Week 52, as measured by the change in the modified Van der Heijde total Sharp score (mTSS).

  • 0.25, 0.90, and 2.78 in the sarilumab 200 mg, sarilumab 150 mg, and placebo groups respectively, all in combination with MTX.
  • The group receiving the 200 mg dose of sarilumab + MTX had a reduction of approximately 90 percent in the radiographic progression assessed by the mTSS compared to the radiographic progression with placebo + MTX at week 52.
  • ACR Results at week 24 Treatment Group

    ACR20
    (%)ACR50

    (%)ACR70

    (%)200 mg sarilumab + MTX

    66*

    46*

    25*150 mg sarilumab + MTX

    58*

    37*

    20*Placebo + MTX

    33

    17

    7



    Primary Endpoint
    *p<0.0001 compared to placebo group

    In the SARIL-RA-MOBILITY trial, there was a higher incidence of treatment emergent adverse events leading to withdrawal in the sarilumab treatment groups compared to placebo (13.9 percent in 200 mg, 12.5 percent in 150 mg and 4.7 percent in placebo). 

    Infections were the most frequently reported adverse events and were reported with a higher incidence in the sarilumab groups compared to placebo, all in combination with MTX (39.6 percent for 200 mg, 40.1 percent for the 150 mg group and 31.1 percent for placebo).  The incidence of serious infections was 4.0 percent in the 200 mg + MTX group, 2.6 percent in the 150 mg + MTX group, and 2.3 percent in the placebo + MTX group.  Among patients treated with sarilumab, a dose dependent decrease in mean neutrophil counts was observed.  Serious infections were not associated with grades 3 and 4 neutropenia in this study.  Increases in mean LDL cholesterol, and transaminases were observed. &
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    SOURCE Regeneron Pharmaceuticals, Inc.
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