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In patients with limited or no MTX exposure,

ACTEMRA/RoACTEMRA is the only biologic monotherapy that shows superiority over MTX in 6-month clinical responses

Proven Efficacy as Monotherapy in RA Patients with Limited or No MTX Experience*

ACR response rates for ACTEMRA/RoACTEMRA monotherapy were superior to those for MTX monotherapy

  • ACTEMRA/RoACTEMRA is the only biologic that as monotherapy has shown superiority over MTX monotherapy in clinical endpoints comparing baseline and Week 24.
  • Analysis of ACR20 response results at Week 24 in the AMBITION study demonstrated that ACTEMRA/RoACTEMRA monotherapy was superior to MTX monotherapy (p<0.0001).
  • Efficacy was apparent as early as Week 2 with ACTEMRA/RoACTEMRA, and the rate and magnitude of clinically important improvements increased during the study.
  • ACR50 and ACR70 response rates were also significantly greater with ACTEMRA/RoACTEMRA monotherapy than with MTX monotherapy at Week 24 (p<0.01 and p<0.001, respectively).

Superior treatment responses with ACTEMRA/RoACTEMRA monotherapy vs. MTX

  • Mean changes from baseline in DAS28 were -3.3 with ACTEMRA/RoACTEMRA and -2.1 with MTX, and the proportion of patients in remission (DAS28 <2.6) at Week 24 was higher with ACTEMRA/RoACTEMRA versus MTX.

Higher remission rate with ACTEMRA/RoACTEMRA monotherapy vs. MTX

  • Mean CRP levels were within the normal range as early as Week 2 with ACTEMRA/RoACTEMRA, with persistently normal levels from Weeks 12 to 24 in more than 90% of patients.
  • Rapid improvements in haemoglobin levels were also noted, with adjusted mean changes from baseline of 1.2 g/dl with ACTEMRA/RoACTEMRA versus 0.1 g/dl with MTX at Week 24.
  • A greater improvement in physical function was reflected by the higher mean changes from baseline in health assessment questionnaire-disability index (HAQ-DI) with ACTEMRA/RoACTEMRA (-0.7 for ACTEMRA/RoACTEMRA vs. -0.5 for MTX).

The design of the AMBITION study and a summary of baseline characteristics of participants can be found in the Phase III Trials section of the website.

* MTX-naïve or MTX-free (having discontinued MTX for reasons other than lack of efficacy or toxicity) for 6 months prior to randomisation.

Reference:
Jones G, et al. Ann Rheum Dis. 2010; 69:88-96.
Figures and tables reproduced with permission from BMJ Publishing Group Ltd © 2010.