Abstract 696: Liquid Formulation Certolizumab Pegol with Methotrexate Decreases Progression of Structural Joint Damage in Rheumatoid Arthritis Patients: The RAPID 2 Study
Authors
RB Landewé, V Strand, J Smolen, D van der Heijde
Methods
RAPID 2 was a 24-week study in which patients on background MRX also received 1 of 2 CZP dose regimens of a liquid formulation (400 mg baseline and Weeks 2 and 4, then 200 mg or 400 mg q 2 weeks) or placebo, in a 2:2:1 ratio. Patients who failed to achieve an ACR20 response at both Weeks 12 and 14 could withdraw at Week 16 and enter open-label follow-up. Radiographic progression was assessed using van der Heijde modified Total Sharp Score (mTSS), erosion score (ES), and joint space narrowing (JSN) at baseline and Week 24, or at withdrawal. For withdrawals, linear extrapolation was used to estimate radiographic progression.
Results
619 patients were randomized (mean age 51.9 years, mean disease duration 6.16 years, 81.5% female, mean DAS28 6.8). Patients on placebo, CZP 200 mg, or 400 mg every 2 weeks had a mean mTSS at baseline of 47.2, 40.2, and 48.2 Sharp units, and mean estimated yearly progression of 9.3, 7.5 and 8.2 Sharp units/year, respectively. 79.5% in the placebo group compared with 19.7% in the CZP groups entered open-label treatment after 16 weeks due to lack of efficacy. The change in mTSS from baseline was significantly lower in patients receiving CZP + MTX compared with those receiving placebo + MTX at 24 weeks. Mean change from baseline in mTSS in the 400 mg group of -0.4 Sharp units (95% CI: -0.7, -0.1) was suggesting repair. There were no significant differences between the 2 CZP groups.
Comparison of radiographic disease progression at Week 24 |
|||
|
Placebo |
CZP 200 mg |
CZP 400 mg |
Change from Baseline: |
|||
mTSS |
|
|
|
Mean (SD) |
1.2 (4.1) |
0.2 (2.7)** |
-0.4 (2.1)* |
ES |
|
||
Mean (SD) |
0.7 (2.6) |
0.1 (2.0) °° |
-0.3 (1.8)* |
JSN |
|
||
Mean (SD) |
0.5 (2.3) |
0.1 (1.4) ° |
-0.1 (1.0) ° |
P values vs placebo: * p <0.001, ** p = 0.003, ° p = 0.004, °° p = 0.005 |
|||
Conclusion
A liquid formulation of CZP 200 or 400 mg every 2 weeks, added to MTX, was significantly more effective in decreasing progression of structural joint damage compared with placebo + MTX, over 24 weeks of treatment.
