Background/Purpose: Abatacept (ABA) has comparable efficacy to TNF inhibitors in achieving clinical remission in rheumatoid arthritis (RA) patients. However, although clinical evidence suggests that biologic-free remission is achievable for RA patients treated with TNF inhibitors, no evidence for biologic-free remission is available for ABA. To evaluate the efficacy of ABA in terms of biologic-free remission in RA patients who achieved clinical remission with ABA.

Methods: We conducted a multi-center, non-randomized, 12-month, prospective observational study that recruited RA patients who achieved DAS28-CRP < 2.3 at the end of a Japanese phase II/III study. ABA was continued or discontinued based on the patients’ decision. During a 12 month follow-up period, ABA treatment was restarted in patients who experienced disease flare (DAS28-CRP >2.7 at two consecutive visits) or according to doctors’ decisions. The primary endpoint was the proportion of patients who maintained biologic-free remission 1 year after ABA discontinuation. DAS28-CRP and change in van der Heijde-modified Sharp Score (DTSS) were compared between the discontinuation and continuation groups.

Results: A total of 51 RA patients were enrolled in the study, of which 34 discontinued and 17 continued ABA treatment. The mean age was 57.1±11.3 and 61.4±9.4 years, mean disease duration at entry was 6.6±5.3 and 12.0±10.5 years, and mean duration of ABA treatment was 3.3±0.3 and 3.3±0.3 years for the discontinuation and continuation groups, respectively. Twelve patients (35.3%) in the discontinuation group maintained biologic-free remission for 12 months. Among the other 21 patients in the discontinuation group, 14 patients experienced disease flare, with 9 of them restarted ABA treatment. Seven patients dropped out from the study and one was excluded due to data deficiency, even though the patient discontinued ABA during the entire follow-up period (included in the analysis). The overall remission rate at month 12 for the discontinuation and continuation groups did not significantly differ (p=0.058, 23.5% and 52.9%, respectively). The least square mean (LS) means for DAS28-CRP at month 12 were 3.1 and 2.1 in the discontinuation and continuation groups, respectively, and the longitudinal profiles of the two groups were significantly different (P=0.030). DTSS of the discontinuation and continuation groups was 0.64 and 0.32, respectively, which did not statistically differ (p=0.19). The proportion of patients with non-radiological progression (DTSS≤0.5) was 52.9% and 70.6%, respectively, and no marked differences in HAQ-DI at month 12 were detected (0.68 and 0.56, respectively; p=0.46).

Conclusion: Biologic-free remission occurred in 35.3% of ABA discontinuation patients, with over 50% of both groups achieving non-radiographic progression. Moreover, functional remission was also maintained among patients in biologic-free remission compared to those in the continuation group. Our findings suggest that ABA may achieve biologic-free remission in RA patients.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/abatacept-biologic-free-remission-study-in-established-rheumatoid-arthritis-patients-orion-study/