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• ACTEMRA/RoACTEMRA demonstrated a rapid, potent and comprehensive effect on RA in different patient populations
  • Patients on monotherapy who were MTX-naїve or MTX-free for the previous
    6 months (the AMBITION study).
  • Patients with an inadequate response to DMARDs (OPTION, TOWARD and LITHE studies).
  • Patients with an inadequate response to anti-TNFs (RADIATE).
• In all five Phase III studies, patients treated with ACTEMRA/RoACTEMRA 8 mg/kg had significantly higher ACR20, 50 and 70 response rates at 6 months compared with the control group.
  • In AMBITION, superiority of ACTEMRA/RoACTEMRA 8 mg/kg was demonstrated against the active comparator, MTX.
• The treatment effect was similar in patients independent of rheumatoid factor status, age, gender, race, number of prior treatments or disease status.

Rapid onset of action in RA with increasing efficacy over time

• Efficacy was apparent as early as Week 2 with ACTEMRA/RoACTEMRA and the magnitude of response continued to improve with duration of treatment.
  • Durable responses were seen for over 3 years in the ongoing open-label extension studies.
• After 2 years of treatment with ACTEMRA/RoACTEMRA plus MTX, 14% of patients achieved a major clinical response (maintenance of an ACR70 response for 24 weeks or more).

Significant improvements in all components of the ACR response

• In RA patients treated with ACTEMRA/RoACTEMRA 8 mg/kg, significant improvements were noted on all individual components of the ACR response, including:
  • tender and swollen joint counts
  • patient and physician global assessment
  • disability index scores
  • pain assessment
  • C-reactive protein (CRP) level
  compared with patients receiving placebo plus MTX or other DMARDs in all studies.

Significantly higher RA remission rates (DAS28 <2.6)

• Patients in all five studies had a mean disease activity score (DAS28) of 6.5–6.8 at baseline.
• Significant reduction in DAS28 from baseline (mean improvement) of 3.1–3.4 was observed in ACTEMRA/RoACTEMRA-treated patients compared with control patients (1.3–2.1).
• The proportion of patients achieving DAS28 clinical remission (DAS28 <2.6) was significantly higher in patients receiving ACTEMRA/RoACTEMRA (28–34%) compared with control patients (1-12%) at 24 weeks. In the LITHE study 65% of patients achieved a DAS28 <2.6 at Week 104 compared to 48% at 52 weeks and 33% of patients at Week 24.

Robust inhibition of progression of joint damage over 52 weeks

• In the LITHE study, which had co-primary endpoints at Week 52 of prevention of joint damage and improvement in physical function, inhibition of joint structural damage was shown with significantly less radiographic progression in patients receiving ACTEMRA/RoACTEMRA compared with control. The inhibition of progression of structural joint damage in ACTEMRA/RoACTEMRA plus MTX-treated patients was maintained in the second year of treatment during the open-label extension. (see LITHE study results).

Reference:
RoACTEMRA® (tocilizumab) Summary of Product Characteristics. Roche Registration Limited. June 2010.