Abstract
BackgroundTo assess the risks of malignancies, infections and autoimmune diseases in patients with rheumatoid arthritis (RA) treated with abatacept compared with other biologic (b) disease-modifying antirheumatic drugs (DMARDs) or conventional synthetic (cs)DMARDs, in a US-wide observational RA cohortMethodsData were reviewed from patients (≥ 18 years) with RA who were registered with FORWARD, the National Databank for Rheumatic Diseases, and who initiated abatacept, other bDMARDs or csDMARDs between 2005 and 2015. Patients who switched treatment during the study could be allocated to more than one group. The incidence rates (IRs) by treatment were calculated for malignancies, hospitalized infections and autoimmune diseases identified by six monthly questionnaires and medical records. The hazard ratios (HRs) (95% confidence intervals [CIs]) for all outcomes with abatacept compared with other bDMARDs or csDMARDs were determined using marginal structural models adjusted for clinical confounders.ResultsIn the study sample, 1496 initiated abatacept, 3490 initiated another bDMARD and 1520 initiated a csDMARD. The risk of malignancies with abatacept was not statistically significant versus other bDMARDs (HR [95% CI)] 1.89 [0.93, 3.84]) or versus csDMARDs (HR [95% CI] 0.93 [0.20, 4.27]). Patients receiving abatacept versus other bDMARDs were at a lower risk of hospitalized infections (HR [95% CI] 0.37 [0.18, 0.75]); the risk versus csDMARDs was lower with wide CIs (HR [95% CI] 0.31 [0.09, 1.05]). The relative risks for psoriasis were similar between treatment groups (HR [95% CI] 1.46 [0.76, 2.81] and HR [95% CI] 2.05 [0.59, 7.16] for abatacept versus other bDMARDs and versus csDMARDS, respectively). The IR (95% CI) of severe infusion/injection reactions was lower with abatacept compared with other bDMARDs (1.57 [1.11, 2.17] vs 2.31 [1.87, 2.82] per 100 patient-years, respectively).ConclusionsIn this analysis, abatacept was well tolerated and did not result in an overall increased risk of malignancies, infections or autoimmune diseases compared with other bDMARDs or csDMARDs.
Highlights
To assess the risks of malignancies, infections and autoimmune diseases in patients with rheumatoid arthritis (RA) treated with abatacept compared with other biologic (b) disease-modifying antirheumatic drugs (DMARDs) or conventional syntheticDMARDs, in a US-wide observational RA cohort
Outcomes In the fully adjusted marginal structural models (MSMs), there were no differences in the risks of malignancies with abatacept relative to other Biologic DMARDs (bDMARDs) or to csDMARDs (Fig. 1)
Abatacept treatment was associated with a lower risk of all hospitalized infections compared with other bDMARDs, and with a lower risk compared with csDMARDs (0.31 [0.09, 1.05])
Summary
To assess the risks of malignancies, infections and autoimmune diseases in patients with rheumatoid arthritis (RA) treated with abatacept compared with other biologic (b) disease-modifying antirheumatic drugs (DMARDs) or conventional synthetic (cs)DMARDs, in a US-wide observational RA cohort. The relevance of these findings to the longer-term use of abatacept in clinical practice may be limited by the stringent patient inclusion criteria, short follow-up periods and limited power restraints for the detection of adverse events (AEs) in RCTs. Data from observational studies can supplement RCT safety data to broaden the understanding of the risks associated with abatacept treatment over time in a typically heterogeneous, clinical RA population. Observational findings for the safety of abatacept are mostly derived from biologic- or abatacept-specific registries of administrative or pharmacy data Analyses of these data have generated conflicting results, possibly due to considerable variations in factors such as study population, comparators, outcome definitions, confounders and AEs [18,19,20,21,22,23,24,25]. Comparative data for the risk of SIs with abatacept versus other bDMARDs are conflicting [19, 20, 22, 25, 29], and there are no data directly comparing the risk of SIs with abatacept versus csDMARDs [19, 25]
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