gms | German Medical Science

Background: ACTION (NCT02109666) was a 2-year, international, observational study of patients with moderate-to-severe RA who initiated IV abatacept in routine clinical practice. Previous findings showed discontinuation in biologic-naïve patients was higher in Germany versus other countries [1]. In this analysis, outcomes in biologic-naïve patients in the German cohort were compared with pooled data from biologic-naïve patients enrolled in other countries.

Methods: Baseline characteristics, crude abatacept retention rates and clinical outcomes at 2 years were compared in biologic-naïve patients in the German versus pooled cohort from other participating countries.

Results: In the German cohort, 677/680 (99.6%) patients enrolled were evaluable: 171/677 (25.3%) were biologic naïve. At baseline, a greater proportion of biologic-naïve patients in the German versus other countries cohort (n=502), respectively, were RF positive (76.1% vs 70.4%), had a greater number of mean (SD) prior conventional synthetic DMARDs (1.41 [1.03] vs 1.01 [0.94]), had ≥1 co-morbidity (83.0% vs 74.9%) and received abatacept monotherapy (27.5% vs 12.9%). Overall crude abatacept retention rate at 2 years among biologic-naïve patients was lower in the German versus other countries cohort (42.1% vs 58.7%; log-rank test p<0.001, Figure 1 [Fig. 1]). Discontinuation rates in biologic-naïve patients in the German versus other countries cohort, respectively, were higher for intolerance or safety (23/69 [33.3%] vs 19/128 [14.8%]) than for inefficacy (37/69 [53.6%] vs 84/128 [65.6%]). At 2 years, good/moderate EULAR response rates in biologic-naïve patients were lower in the German versus other countries cohort (85.4% vs 92.2%). The proportion of biologic-naïve patients achieving low disease activity or remission at 2 years also tended to be lower in the German versus other countries cohort. Abatacept was well tolerated and the safety profile was consistent with previous published data, with no new safety signals.

Conclusion: At 2 years, biologic-naïve patients in the German cohort had a lower overall abatacept retention rate and a lower good/moderate EULAR response rate than those in the other countries cohort. These findings could reflect cohort differences in baseline characteristics or greater access to biologic DMARDs in Germany versus other countries.