Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Switching Patients (pts) with Rheumatoid Arthritis (RA) from Intravenous (IV) to Subcutaneous (SC) Abatacept Is Well Tolerated and Sustains Previously Established Efficacy.
Keystone9, Edward C., Kremer6, Joel M., Russell7, Anthony S., Box1, Jane H., Abud-Mendoza5, Carlos, Elizondo4, Mario Alberto Garza, Luo2, Allison
Box Arthritis and Rheumatology of the Carolinas, Charlotte, NC
Bristol-Myers Squibb, Princeton, NJ
Bristol-Myers Squibb, Braine-l'Alleud, Belgium
Faculty of Medicine, Universidad Autónoma de Nuevo León, Monterrey, NL, Mexico
Regional Unit of Rheumatology, Faculty of Medicine and Central Hospital, University of San Luis Potosí, San Luis Potosi, Mexico
The Center for Rheumatology, Albany, NY
University of Alberta, Edmonton, AB, Canada
University of Cincinnati College of Medicine, Cincinnati, OH
University of Toronto and Mount Sinai Hospital, Toronto, ON, Canada
IV abatacept is effective and well tolerated in pts with RA1,2. For some pts, the flexibility and convenience of self-administered treatment is desirable. Here, we evaluate the safety, immunogenicity and maintenance of efficacy in pts who switched from long-term IV abatacept to SC abatacept formulation.
This was an open-label, single-arm trial. Consenting and eligible pts completing ~5 years of the AIM (Abatacept in Inadequate Responders to Methotrexate)1 or ATTAIN (Abatacept Trial in Treatment of Anti-TNF INadequate Responders)2 IV abatacept trials were enrolled and self-administered SC abatacept 125 mg/week via ready-to-use, prefilled syringes (no IV loading months, clinically indicated adjustments were allowed. Safety for the first 3 months administered). Initially, pts were maintained on the same stable doses of corticosteroids, DMARDs and analgesics received during the IV trials; after 3 after switching from IV abatacept was the primary endpoint, reported in all pts who received >=1 dose of SC abatacept. Immunogenicity, reported up to Month 3, was assessed by ELISA and electrochemiluminesence (ECL). Proportions of pts achieving Low Disease Activity State (LDAS; DAS28 [CRP]<=3.2) and DAS28-defined remission (DAS28 [CRP] <2.6) are reported over 1 year. Data are as-observed for patients with available data at the visit of interest.
In total, 123 pts entered the study (AIM, n=71; ATTAIN, n=52); mean age was 54.3 years, mean DAS28 was 3.4 and mean tender and swollen joint counts were 8.9 and 4.8, respectively. At Month 3, 120 (97.6%) pts were ongoing; no pts discontinued due to lack of efficacy. By Month 3, adverse events (AEs) were reported in 49 (39.8%) pts overall. One pt (0.8%) discontinued due to an AE (musculoskeletal pain, unlikely related to treatment) and one pt (0.8%) experienced a serious AE (worsening RA, unrelated to treatment). Two (1.6%) pts had local injection site reactions (erythema, pain); both were mild in intensity. Overall, 8/122 (6.6%) pts had a positive abatacept-induced antibody response by ELISA; six of those eight had a positive response before enrollment. No pt had a positive response based on ECL. The proportions of pts (95% CI) achieving LDAS and remission was sustained after switching from IV to SC abatacept (N=123); LDAS: Day 1, 43.4% (34.652.2); Month 3, 54.6% (45.763.6); Year 1, 51.3% (42.160.5). Remission is shown in Figure 1.
These data demonstrate that switching pts from IV to SC abatacept is well tolerated, with few and mild local injection site reactions, and is associated with low immunogenicity. Furthermore, efficacy was sustained and not compromised following the switch.
To cite this abstract, please use the following information:
Keystone, Edward C., Kremer, Joel M., Russell, Anthony S., Box, Jane H., Abud-Mendoza, Carlos, Elizondo, Mario Alberto Garza, et al; Switching Patients (pts) with Rheumatoid Arthritis (RA) from Intravenous (IV) to Subcutaneous (SC) Abatacept Is Well Tolerated and Sustains Previously Established Efficacy. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :416