Objective

To report the tolerability and effectiveness of certolizumab pegol (CZP) for the treatment of patients with active rheumatoid arthritis (RA) in a routine clinical practice setting.

Methods

F alpha sT (NCT01069419) was a non-interventional, observational 104-week (wk) study performed at 163 sites in Germany. RA patients were treated according to the treating physician's discretion. Clinical remission (DAS28-CRP<2.6) at wk 104 was the primary endpoint of the study. Remission data based on ESR (DAS28-ESR<2.6) were also assessed. Secondary endpoints included the effect of CZP treatment on pain, physical function and disease activity. Safety data were collected at all study visits.

Results

1,117 patients were enrolled in the F alpha sT study (78% female, mean age: 55 years). Rapid responses were observed at wk 6 (18.7% and 12.9% patients in DAS28-CRP and DAS28-ESR remission, respectively) with improvements sustained over 2 years (20.0% and 13.9% patients achieved DAS28-CRP and DAS28-ESR remission, respectively at wk 104). Anti-TNF naive patients exhibited greater improvements than anti-TNF experienced patients (mean DAS28-ESR change from baseline [CfB] -1.3, -1.5 and -1.7 for patients with >= 2, 1 and no anti-TNFs, respectively at wk104). Improvements were reported in all secondary endpoint measures. 1,111 patients were exposed to CZP for a total of 1,538 patient-years during the study. 2,000 treatment-emergent adverse events (TEAEs) were reported in 745 patients (67.1%); 9 (0.8%) experienced TEAEs with fatal outcome.

Conclusion

CZP demonstrated efficacy and safety outcomes reflective of those observed in trial settings. Rapid reductions in disease activity and improvements in physical function were maintained up to wk 104.