Objective To assess safety, immunogenicity and efficacy in rheumatoid arthritis (RA) patients switched from long-term intravenous to subcutaneous (SC) abatacept.
Methods In this phase IIIb, open-label, single-arm trial, patients who completed ≥4 years of intravenous abatacept (in long-term extensions of two phase III studies) were enrolled to receive SC abatacept (125 mg/week). The primary objective was safety during the first 3 months after switching from intravenous therapy.
Results 123 patients entered the study (mean Disease Activity Score 28 (based on C reactive protein) and HAQ-DI of 3.4 and 0.94, respectively). At month 3, 120 (97.6%) patients were continuing to receive SC abatacept; no patients discontinued due to lack of efficacy. Adverse events (AEs) were reported in 49 (39.8%) patients through month 3. One patient (0.8%) discontinued due to an AE and one patient (0.8%) experienced a serious AE. Two (1.6%) patients had SC injection site reactions (erythema, pain), both with mild intensity. Clinical efficacy was maintained throughout. Limited impact on immunogenicity was observed when switching routes of administration.
Conclusion These data demonstrate that patients can switch from long-term monthly intravenous abatacept to a weekly fixed dose of 125 mg SC abatacept with no increased safety concerns. This study further supports SC abatacept as an alternative treatment option for patients with RA.
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Funding This study was sponsored, and editorial support funded, by Bristol-Myers Squibb.
Competing interests ECK has received consulting fees from Abbott Laboratories', AstraZeneca Pharma, Biotest, Bristol-Myers Squibb Company, Centocor, Inc, F Hoffmann-La Roche Inc, Genentech Inc, Merck, Nycomed, Pfizer Pharmaceuticals and UCB; has received research grants from Abbott Laboratories, Amgen Inc, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb, Centocor, Inc, F Hoffmann-LaRoche Inc, Genzyme, Merck, Novartis Pharmaceuticals, Pfizer Pharmaceuticals and UCB; and has participated in speakers' bureau for Abbott Laboratories, Bristol-Myers Squibb, Hoffmann-La Roche Inc, Merck, Pfizer Pharmaceuticals and UCB. JMK has received consulting fees from Abbott Laboratories, Amgen Inc, Bristol-Myers Squibb, Centocor Ortho Biotech Inc, Genentech, Genentech and Biogen IDEC Inc, Merck Pharmaceuticals, Ortho Biotech Products L P, Pfizer Inc, Roche and UCB, Inc; has received research grants from Abbott Laboratories, Amgen Inc, Bristol-Myers Squibb, Centocor Ortho Biotech Inc, Genentech, Genentech and Biogen IDEC Inc, Human Genome Sciences, Inc, Merck Pharmaceuticals, Ortho Biotech Products LP, Pfizer Inc, Roche, Roche Diagnostics and UCB, Inc; has participated in speakers' bureau for Genentech, Genentech and Biogen IDEC Inc, and Roche; and has stock holdings in CORRONA. AR has received consulting fees and honoraria from Bristol-Myers Squibb, GlaxoSmithKline and Pfizer Inc, and has participated in speakers' bureau for Bristol-Myers Squibb, GlaxoSmithKline and Pfizer Inc. JB has received consulting fees from Bristol-Myers Squibb, has participated in a speakers' bureau for Bristol-Myers Squibb, and is the owner of Box Arthritis and Rheumatology of the Carolinas PLLC. CA-M and MGE have nothing to disclose. ML has received research grants from Bristol-Myers Squibb. AL, ID and RS are full-time employees of, and stock-holders in, Bristol-Myers Squibb. RA and SG were full-time employees of, and stock-holders in, Bristol-Myers Squibb, when this study was carried out.
Patient consent Freely given written informed consent was obtained from each subject, or in those situations where consent could not be given by the subject, their legally acceptable representatives, at the final quarterly dosing visit for AIM or ATTAIN prior to participation in ATTUNE, including informed consent for any screening procedures conducted to establish subject eligibility in the study
Provenance and peer review Not commissioned; externally peer reviewed
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