Background Therapeutic guidelines draw heavily on evidence from randomised controlled trials undertaken in well-characterised, highly-selective populations and managed in tightly-controlled settings. As such, the extent to which therapeutic efficacy in real-life populations and routine care settings is often unclear.
Objectives To assess subcutaneous (SC) abatacept (ABA) efficacy and safety in a real-life setting.
Methods This was a retrospective and single center study in which 70 patients (1987 ACR) were assessed from April 2014 to December 2014. The patients were stratified according to their treatment background: biologic-naïve, switched from IV to SC ABA administration (125mg-wk), and inadequate response to TNF inhibitor (TNF-IR). The primary and secondary endpoints were change in DAS28-CRP, and Routine Assessment of Patient Index Data (RAPID3) from baseline to 9 months, respectively. A linear mixed effects model was made to account for correlation among repeated measures. Adverse events (AEs) were assessed and recorded at each visit to the rheumatology center.
Results Baseline characteristics of patients were as follows: female gender 84.3%, mean age 54.9±10.6 years, median disease duration 12.5 (IQR 14) years, Rheumatoid Factor or Anti-Cyclic Citrullinated Peptide Antibodies seropositivity 93.8%, erosive disease 32.9%, SC ABA monotherapy 48.5%, concomitant use of methotrexate (MTX) 38.5%, mean DAS28-CRP 4.61±1.59, and mean RAPID3 15.2±7.1. Demographics and disease characteristics were similar in the three groups (including MTX use), except for baseline DAS28-CRP (p<0.0001), and RAPID3 (p=0,0009) in switch group. After 9 months of administration, the DAS28-CRP scores changed from 5.28±1.09 to 4.01±1.3 (p<0.0001, biologic-naïve group), from 3.21±1.24 to 2.8±0.87 (p<0.0001, switch IV-SC group), and from 4.6±1.83 to 3.43±1.22 (p<0.0001, TNF-IR group). The RAPID3 score change was statistically significant (p<0.0001) irrespective of group (18.5±5.6 to 12.5±6.7, 11.6±7.0 to 9.1±6.7, and 14.9±7.2 to 11.6±6.8, respectively). No patients relapsed and needed to return to the IV administration. Infections, constitutional symptoms and headache occurred in 46.9%, 40% and 38.6% of patients, respectively. Local injection-site reactions occurred in 10% of patients. Most of AEs reported were reversible and mild. There were 3 discontinuations of treatment due to inefficacy, serious AE (herpes zoster), and persistent respiratory symptoms. No deaths and malignancies were reported.
Conclusions Our results disclose an improvement in RA disease activity and physical function, during 9 months administration of SC ABA. Patients switching from IV to SC formulation of ABA had lower activity and functional impairment at baseline, and efficacy was maintained through follow-up. SC ABA demostrated a good safety profile, consistent with previously published data.
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Disclosure of Interest None declared