ACTEMRA/RoACTEMRA in combination with
DMARDs is effective in reducing signs and
symptoms in DMARD-IR patients
Proven Efficacy in RA Patients with an Inadequate Response to DMARDs: The TOWARD Study
ACR response rates were higher with ACTEMRA/RoACTEMRA versus placebo, regardless of the background DMARDs selected
- Compared with controls treated with placebo plus DMARDs, patients in the ACTEMRA/RoACTEMRA 8 mg/kg plus DMARDs arm had superior ACR20, 50 and 70 responses (p<0.0001 for each), and more patients achieved DAS28 remission at 24 weeks (p<0.0001).
- As early as Week 2, 64% of patients in the ACTEMRA/RoACTEMRA group had achieved a good or moderate EULAR response, compared with 18% of the control group (p<0.0001).
| Parameter | Placebo plus DMARD† n=413 |
ACTEMRA/ RoACTEMRA 8 mg/kg plus DMARD† n=803 |
|---|---|---|
| ACR20 (primary endpoint) | 24 | 61*** |
| ACR50 | 9 | 38*** |
| ACR70 | 3 | 21*** |
| DAS28 remission | 3 | 30*** |
| Mean change in CRP level, mg/dl | –0.27 | –2.20*** |
| Mean change in haemoglobin level, g/dl | –0.13 | 0.98*** |
| Change from baseline in HAQ–DI score of ≥0.3 | 34 | 60 |
| Mean change in HAQ–DI score | –0.2 | –0.5*** |
| Mean change in FACIT-Fatigue score | 3.6 | 8.0*** |
|
† Most patients (77% in the ACTEMRA/RoACTEMRA group and 75% in the placebo group) received just one background DMARD. **P<0.01; ***P<0.0001 vs. control group. Data are percentage of patients except where indicated. |
||
- Notably, ACTEMRA/RoACTEMRA in combination with any of the study DMARDs resulted in a higher proportion of ACR20 responders than did placebo plus DMARDs.
- Differences in response rates were apparent even when two background DMARDs were used (a subgroup of 234 patients), with 66% of patients in the ACTEMRA/RoACTEMRA group achieving an ACR20 response at Week 24, compared with 29% in the placebo group.
- ACTEMRA plus MTX reduced systemic inflammation and reversed chronic anaemia in patients with RA.
- CRP levels were normalised in patients in the ACTEMRA/RoACTEMRA 8 mg/kg plus DMARDs arm within 2 weeks of the first infusion and remained low throughout the study.
- By Week 24, there was a significant increase from baseline in mean haemoglobin levels in those treated with ACTEMRA/RoACTEMRA; in contrast, there was essentially no change in haemoglobin levels in those who received placebo.
- Patients in the ACTEMRA/RoACTEMRA 8 mg/kg arm also showed significant improvements in physical function (measured by HAQ-DI score) and fatigue (measured by FACIT-Fatigue score).
- In addition, mean improvements from baseline in SF-36 scores were higher in the ACTEMRA/RoACTEMRA group than in the control group at Week 24 for both physical and mental components (p<0.0001 for both).
The design of the TOWARD study and a summary of baseline characteristics of participants can be found in the Phase III Trials section 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