The study is a Phase III double-blind placebo-controlled trial.
Rapid response rates following treatment with certolizumab pegol were achieved across various clinical response measures, including good/moderate EULAR response rates at weeks 6 and 12 (67.4% and 77.6% respectively versus 27.0% and 29.1% for placebo) based on this post hoc analysis.
Similarly, ACR20 rates were 51.3% and 63.8% in patients treated with certolizumab pegol versus 18.2% and 18.3% for placebo at week 6 and 12 respectively.
Using the disease activity score, DAS28[ESR] = 1.2 responder definition, a higher proportion of patients treated with certolizumab pegol (75.8%) responded at week 12 compared to placebo (27.5%).
Results suggest that a higher proportion of patients treated with certolizumab pegol who responded at week 12, achieved DAS28 low disease activity (LDA) at 52 weeks compared with patients who did not (37.2% versus 6.1%).
Patients who responded at week 12 also experienced less radiographic progression than those who did not.
The majority of patients (approximately 75%) who responded at week 12 had a clinical response at week 6.
These patients reported further improved outcomes such as pain, physical function and fatigue, a greater response in terms of ACR20, 50 and 70 measures as well as higher rates of DAS28 LDA and remission, relative to those who showed response at week 12.