ACTEMRA/RoACTEMRA is the only biologic that in monotherapy shows superiority over MTX in ACR20, ACR50 and ACR70 responses at 6 months
AMBITION: ACTEMRA/RoACTEMRA Monotherapy in RA
The AMBITION trial enrolled patients who had not been treated with MTX within 6 months prior to randomisation and who had not discontinued previous MTX treatment as a result of clinically important toxic effects or lack of response. The majority (67%) of patients were naïve to MTX and biologic therapy. Patients with prior MTX use had discontinued MTX because of intolerance or desire to become pregnant. Doses of 8 mg/kg of ACTEMRA/ RoACTEMRA were given every 4 weeks as monotherapy. The comparator group was weekly MTX (dose titrated from 7.5 mg to a maximum of 20 mg weekly over an 8-week period). At the end of the 24-week study period, patients who met the inclusion criteria could continue in an ongoing, long-term, open-label follow-up study.
Demographics and disease characteristics were similar between the ACTEMRA/RoACTEMRA and MTX groups at baseline.
| MTX n=284 |
ACTEMRA/ RoACTEMRA 8 mg/kg n=286 |
|
|---|---|---|
| Patient population | ||
| Female, % | 79 | 83 |
| Age, years | 50.0 (12.9) | 50.7 (13.1) |
| RA duration, years | 6.2 (7.8) | 6.4 (7.9) |
| Number of DMARDs/anti-TNFs used before study | 1.1 (1.4) | 1.2 (1.3) |
| MTX-naïve, % | 67 | 67 |
| Disease activity | ||
| Swollen joint count | 19.2 (10.6) | 19.1 (11.0) |
| Tender joint count | 31.1 (14.1) | 31.8 (14.8) |
| Health Assessment Questionnaire − Disability Index (HAQ–DI) | 1.5 (0.6) | 1.6 (0.7) |
| CRP (mg/dl) | 3.1 (3.4) | 3.0 (3.3) |
| DAS28 | 6.8 (0.9) | 6.8 (1.0) |
| Haemoglobin | 44 | 38 |
|
* Values are for the per-protocol population (all patients in the ITT population who received more than two-thirds of the study treatments and did not change concomitant corticosteroids or non-steroidal anti-inflammatory drugs) Data are mean (SD) except where indicated. LLN=lower limit of normal; the LLN for men is 13.0 g/dl and for women (non-pregnant) is 12.0 g/dl |
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ACTEMRA/RoACTEMRA monotherapy was clinically superior to MTX monotherapy, and safe and well-tolerated in patients with RA who were MTX-naive and/or had not failed previous MTX or biologic treatment.
Detailed results of the AMBITION study can be found in the Efficacy and Safety and Tolerability sections of the website.
Reference:
Jones G, et al. Ann Rheum Dis 2010; 69:88-96.
Figures and tables reproduced with permission from BMJ Publishing Group Ltd © 2010.