Background Holiday seasons can present a major problem to RA patients treated with weekly subcutaneous biologics, including subcutaneous (SC) abatacept. Therefore an evaluation into the use of IV-abatacept treatment to cover a 4 week break may present an acceptable alternative.
Objectives To study the efficacy and safety of a single intravenous (IV) course with abatacept in Patients with rheumatoid arthritis currently receiving weekly injections of SC abatacept to simulate a patient “vacation” followed by a switch back to SC abatacept.
Methods This open label, prospective, single arm 24-weeks trial recruited patients with established RA and in low disease activity (LDA) under treatment with SC abatacept for at least 3 months to receive a single dose of IV abatacept (day 0) and to be continued on SC abatacept from day 28 on (NCT01147341). DMARD- and/or biologic-inadequate responders were included and previous exposure to IV abatacept was allowed in a maximum of 50% of the patients.
Results Baseline characteristics of the 49 patients were typical for a cohort of RA patients with established disease (mean disease duration 8.31 years) in LDA under treatment. Two patients dropped out of the study (1 flare, 1 patient decision). The proportion of patients with DAS 28 ≤3.2 at day 28 was 93.9% (95%CI 83.5-97.9) at day 28, 91.7% (95%CI 80.4-96.7) at day 84 and 93.6 (95%CI 82.8-97.8) at the end of the study, day 168. This proportion remained stable throughout the entire follow up. The average DAS 28 at baseline was 1.74 (SD ±0.72) at baseline, 2.03 (SD ±1.03) at day 28, 1.86 (SD ±0.91) at day 84 and 1.96 (SD ±0.92) at the end of the study, day 168. Pre-exposure to IV abatacept and having failed MTX or anti TNF did not influence the average DAS 28 or the proportion of patients maintaining LDA. The average HAQ-DI was stable throughout the study. Adverse events occurred in 75% of subjects. Four serious adverse events (SAE) were described during the study. None of them was related to the investigational product and all SAE could be resolved during hospitalization. Discontinuation of abatacept was not necessary in these patients. There were no deaths, neoplasms, opportunistic or other serious infections.
Conclusions This prospective, open label study of abatacept shows for the first time that switching from weekly SC to IV abatacept and back after 4 weeks is an effective and safe way to bridge holidays in RA patients in LDA.
Disclosure of Interest R. Mueller Grant/research support from: The study was supported by an unrestricted research grant from BMS, M. Gengenbacher: None declared, S. Richter: None declared, J. Dudler: None declared, B. Möller: None declared, J. von Kempis Grant/research support from: The study was supported by an unrestricted research grant from BMS