ACTEMRA/RoACTEMRA in combination with
DMARDs is effective in reducing signs and
symptoms in DMARD-IR patients
TOWARD: ACTEMRA/RoACTEMRA in RA Patients with DMARD failure
The TOWARD trial enrolled patients who had an inadequate response to their existing RA therapy, including one or more DMARDs (MTX, chloroquine, hydroxychloroquine, parenteral gold, sulphasalazine, azathioprine or leflunomide). ACTEMRA/RoACTEMRA 8 mg/kg or placebo were given every four weeks in combination with stable DMARDs. 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.
Baseline characteristics were well balanced between treatment groups with respect to demographics, treatment history, disease activity and laboratory parameters.
| TOWARD | ||
|---|---|---|
| ACTEMRA/ RoACTEMRA 8 mg/kg plus DMARD n=803 |
Placebo plus DMARD n=413 |
|
| Demographics and treatment history | ||
| Female, % | 81 | 84 |
| Age, years | 53 (13) | 54 (13) |
| RA duration, years | 9.8 (8.8) | 9.8 (9.1) |
| Number of DMARDs or anti-TNFs used before study | 1.6 (1.6) | 1.6 (1.6) |
| Disease activity and laboratory tests | ||
| Swollen joint count | 19.7 (11.6) | 18.7 (10.8) |
| Tender joint count | 30.1 (16.0) | 29.1 (14.8) |
| HAQ–DI | 1.5 (0.6) | 1.5 (0.6) |
| CRP, mg/dl | 2.6 (3.2) | 2.6 (4.7) |
| DAS28 | 6.7 (1.0) | 6.6 (1.0) |
|
Data are mean (SD) except where indicated. |
||
ACTEMRA/RoACTEMRA combined with one or more DMARDs was an effective and well-tolerated therapeutic approach in patients with moderate to severe active RA with an inadequate response to a DMARD.
Detailed results of the TOWARD study can be found in the Efficacy and Safety and Tolerability sections of the website.
Reference:
Genovese MC, et al. Arthritis Rheum 2008; 58:2968-2980.
Figures and tables reproduced with permission of John Wiley & Sons, Inc. © 2008