Discussion
inflammation, TEAEs, T2T disease, RA, CCP-positive
INFLAMMATION, DISEASE, REMISSION
The ABC study compared the effectiveness of the T2T disease management strategy with RC among adult RA patients with moderate to severe disease activity who initiated treatment with SC abatacept. Over the course of 1 year, approximately 40% of patients managed according to either strategy achieved sustained LDA, as defined by CDAI ≤ 10, with a comparable time to achievement of this outcome in both treatment groups. Similar proportions of patients in the T2T and RC groups achieved LDA, remission, and improved physical function, as assessed by various clinical and PRO measures. No differences were observed in the likelihood of achieving these outcomes between the regimens, with the exception of patients managed per T2T who had 1.3 times higher odds of achieving CDAI LDA. Time to achieve SDAI remission was significantly shorter in the T2T group compared with RC and although no statistically significant differences were observed in the time to achieve other clinical and PRO measures, a trend toward a more rapid response in CDAI LDA and remission, DAS28-CRP remission, and HAQ-DI MCID, but not RAPID3 LDA and remission, was noted in the T2T group compared with RC. Previous studies have suggested that RAPID3 alone may not be sufficient to follow long-term disease activity in patients with RA in clinical practice and that it may capture aspects of RA other than inflammation [The T2T strategy is the preferred RA management regimen as opposed to usual care [Despite a comparable number of changes in RA medications between treatment groups in the current analysis, physicians employing RC tended to adjust the use of MTX more frequently than those following T2T, who in turn were more likely to modify NSAIDs or discontinue abatacept presumably to switch to a different bDMARD. These treatment differences may have impacted patient outcomes, possibly accounting for the similarities between the regimens. Additionally, the T2T strategy is known to be more effective than RC in early RA [Overall, SC abatacept was found to be safe and well-tolerated, with no new safety concerns identified, consistent with the known abatacept safety profile. Over half of all patients experienced TEAEs, the majority of which were mild, with approximately 10% experiencing serious AEs.The present study had some limitations. Enrollment of physicians who were already applying the T2T approach in their medical practice could lead to selection bias. Physicians were informed of the objectives of the study, though not the specific T2T plan to be followed, potentially influencing their therapeutic approach during the study. Further, since treatment adjustments were not necessarily made using disease activity as an outcome measure, each investigator may have used a different target definition, therefore it is not possible to assess the impact of T2T education on disease management. Information on the intensity of the treatment prior to study enrollment, including management approach was not examined. Given that data were collected as per usual care, there was considerable missing data for some variables, such as anti-CCP status. At the time of study design, the relationship between response to abatacept and seropositivity was not documented; therefore, this data was not mandated in the protocol. Furthermore, this test is not universally reimbursed in some provincial healthcare systems. It would, however, be assumed that many RF-positive patients were also CCP-positive and that due to randomization, the rates of positivity should be similar in the two treatment groups. Strengths of the present study include the real-world clinical setting, minimal exclusion criteria, and no intervention in patient management other than the provision of T2T training in the T2T group, rendering results with high external validity. Several validated clinical and PRO measures were utilized allowing for consistent assessment of disease outcomes.