Factors associated with treatment discontinuation and age-stratified safety of abatacept in Japanese patients with rheumatoid arthritis: 5-year results of the ORIGAMI study.

OBJECTIVE

We investigated the factors associated with treatment discontinuation and safety of abatacept treatment up to 5 years as the first-line biologic in Japanese patients with rheumatoid arthritis (RA) of moderate disease activity (MDA).

METHODS

We analyzed 5-year data from the Orencia® Registry in Geographically Assembled Multicenter Investigation (ORIGAMI) study (UMIN000021263). We examined the factors associated with treatment discontinuation, overall and age-stratified safety, and effectiveness.

RESULTS

Among 279 analyzed patients, the cumulative incidence (95% CI) of discontinuation was 0.210 (0.158-0.262) for insufficient effectiveness and 0.266 (0.208-0.323) for adverse events (AEs). Older age (subdistribution hazard ratio [95% CI] 0.970 [0.946-0.995]; P = .018) and anti-citrullinated peptide antibody-positive status (0.284 [0.140-0.575]; P < .001) were associated with lower risk of discontinuation due to insufficient effectiveness. Presence of comorbidities was associated with greater risk of discontinuation due to AEs. The frequencies of AEs and adverse drug reactions remained stable or decreased over time. The safety was consistent with prior analyses of ORIGAMI and comparable among three age groups (<65, ≥65 to <75, and ≥75 years).

CONCLUSIONS

Five-year results of the ORIGAMI study provide further evidence supporting the factors associated with long-term treatment continuation and safety of subcutaneous abatacept in patients with RA of MDA.