Background Certolizumab pegol (Cimzia) is a pegylated TNF inhibitor approved for the treatment of RA. Its efficacy and safety are well established from clinical trials.
Objectives To evaluate and describe the efficacy and drug survival of certolizumab pegol in real-life patients.
Methods Data from the national registry ARTIS were used for this analysis. Patients with RA, who started treatment with certolizumab pegol were identified. Clinical response was assessed by DAS28 and HAQ improvement as well as EULAR response criteria.
Results During the period from Nov 1st, 2009 until September 29th 2011, a total of 196 patients with a diagnosis of RA started treatment with certolizumab pegol. The mean (SD) age and disease duration of the patients was 56.8 (12.7) and 11.9 (10.3), respectively. 80.1% of patients were RF positive, 72.4% were female and 61.7% had concomitant DMARDs. All patients had failed conventional DMARDs and the majority had failed at least one prior biologic.
Significant reductions (mean±SD) of DAS28 from baseline (4.9±1.3, N=166) to 3 months (3.8±1.5, N=84) and 6 months (3.5±1.5, N=58) were observed (p<0.0001). Similarly HAQ was reduced from 1.2±0.7 at baseline, to 1.0±0.7 at 3 and remained stable at 6 months (p=0.002). At 3 months the percentages of EULAR Good/Moderate/No responders were 23.8/61.9/14.3% [N patients=84], and at 6 months 25.9/55.2/19% [N patients=58]. 27.4% and 31% of patients achieved DAS28<2.6 at 3 and 6 months, respectively.
During the follow-up period 32 patients (16.3%) discontinued treatment with certolizumab pegol: 15 because of lack of efficacy, 7 because of intolerance and 10 for unknown reasons. The mean (SD) time to discontinuation was 3.2 (1.8) months. 20 patients discontinued certolizumab pegol during the first 3 months. In figure 1 the drug survival of certolizumab pegol is shown.
Conclusions In this observational cohort of RA patients with long-standing and refractory disease who were treated with certolizumab pegol, 80% achieved a EULAR Good/Moderate response, and about one fourth achieved a EULAR Good response and/or a DAS28<2.6.
Disclosure of Interest None Declared
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