Loet XL et al. - These findings indicate that interleukin-1 receptor antagonist anakinra 100 mg/day in combination with DMARD therapy safely improved functional status in patients with active RA Methods
Study to assess changes in functional status in RA pts receiving the anakinra in addition to a DMARD
Adult pts with RA receiving methotrexate, sulfasalazine, or hydroxychloroquine for ≥3 mos were given anakinra 100 mgx1/d for 36 wks
The primary objective was to evaluate changes from baseline to week 36 in the HAQ disability index and subscales
Changes in the DAS28, proportion of pts meeting EULAR response criteria, and the safety of each combination regimen were also assessed
Results
1207 pts, received ≥1 dose of anakinra were included in the efficacy and safety analyses
A significant change in the HAQ disability index was observed; no differences were seen among the 3 DMARD groups
A clinically meaningful improvement in HAQ was observed in 51% of pts
Mean improvement in DAS28 was 1.5, and 64% of pts achieved a good or moderate EULAR response score
Injection site reaction was the most frequently reported AE
The incidence of infections most commonly respiratory infection, was similar across treatment groups
No notable changes were observed in laboratory findings and vital signs