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OBJECTIVES: To explore antinuclear autoantibody (ANA) and anti-double-stranded DNA (anti-dsDNA) autoantibody development during abatacept and tumour necrosis factor inhibitor (TNFi) treatment, and effects of switching from TNFi to abatacept in ANA/anti-dsDNA autoantibody-positive patients.
METHODS: This was a post hoc analysis of biologic-naïve patients with active RA in ATTEST and AMPLE. In AMPLE, patients received subcutaneous abatacept or adalimumab (2 years). In ATTEST, patients received intravenous abatacept or infliximab (1 year), or placebo (6 months) then abatacept (6 months); at 1 year, all patients could receive abatacept (open-label long-term extension). Serum ANA/anti-dsDNA autoantibody levels were measured at baseline, Month 6 (ATTEST only), Years 1 and 2.
RESULTS: At baseline, 25.7 and 0.9% (AMPLE), and 21.6 and 8.4% of patients (ATTEST) were ANA/anti-dsDNA autoantibody positive, respectively. More baseline ANA/anti-dsDNA autoantibody-negative patients became positive during TNFi than abatacept treatment. In ATTEST (TNFi group), 48.5% (48/99; ANA) and 48.3% (57/118; anti-dsDNA) of patients seroconverted to positive status by Year 1, falling to 22.4% (22/98 ANA) and 13.3% (15/113; anti-dsDNA) by Year 2 after switching to abatacept. Of ANA/anti-dsDNA autoantibody-positive patients at Year 1, 41.9% and 68.9%, were negative at Year 2.
CONCLUSIONS: ANA/anti-dsDNA seroconversion was more frequent with TNFi than abatacept therapy; TNFi-associated seroconversion decreased after switching from TNFi to abatacept.
OBJECTIVES: This double-blind trial evaluated the efficacy and safety of abatacept or infliximab vs placebo. The primary objective of this study was to evaluate the mean change from baseline in Disease Activity Score (based on erythrocyte sedimentation rates; DAS28 (ESR)) for the abatacept vs placebo groups at day 197.
METHODS: Patients with rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX) were randomised 3:3:2 to abatacept ( approximately 10 mg/kg every 4 weeks, n = 156), infliximab (3 mg/kg every 8 weeks, n = 165), or placebo (every 4 weeks, n = 110) and background MTX. Safety and efficacy were assessed throughout the study.
RESULTS: Similar patient demographics and clinical characteristics were present at baseline between groups, with mean scores of approximately 1.7 for HAQ-DI and 6.8 for DAS28 (ESR). At 6 months, mean changes in DAS28 (ESR) were significantly greater for abatacept vs placebo (-2.53 vs -1.48, p<0.001) and infliximab vs placebo (-2.25 vs -1.48, p<0.001). For abatacept vs infliximab treatment at day 365, reductions in the DAS28 (ESR) were -2.88 vs -2.25. At day 365, the following response rates were observed for abatacept and infliximab, respectively: American College of Rheumatology (ACR) 20, 72.4 and 55.8%; ACR 50, 45.5 and 36.4%; ACR 70, 26.3 and 20.6%; low disease activity score (LDAS), 35.3 and 22.4%; DAS28-defined remission, 18.7 and 12.2%; good European League Against Rheumatism (EULAR) responses, 32.0 and 18.5%; and Health Assessment Questionnaire Disability Index (HAQ-DI), 57.7 and 52.7%. Mean changes in physical component summary (PCS) were 9.5 and 7.6, and mental component summary (MCS) were 6.0 and 4.0, for abatacept and infliximab, respectively. Over 1 year, adverse events (AEs) (89.1 vs 93.3%), serious AEs (SAEs) (9.6 vs 18.2%), serious infections (1.9 vs 8.5%) and discontinuations due to AEs (3.2 vs 7.3%) and SAEs (2.6 vs 3.6%) were lower with abatacept than infliximab.
CONCLUSIONS: In this study, abatacept and infliximab (3 mg/kg every 8 weeks) demonstrated similar efficacy. Overall, abatacept had a relatively more acceptable safety and tolerability profile, with fewer SAEs, serious infections, acute infusional events and discontinuations due to AEs than the infliximab group.
TRIAL REGISTRATION NUMBER: NCT00095147.
This article is not included in any systematic review
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The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.
To explore antinuclear autoantibody (ANA) and anti-double-stranded DNA (anti-dsDNA) autoantibody development during abatacept and tumour necrosis factor inhibitor (TNFi) treatment, and effects of switching from TNFi to abatacept in ANA/anti-dsDNA autoantibody-positive patients.
METHODS:
This was a post hoc analysis of biologic-naïve patients with active RA in ATTEST and AMPLE. In AMPLE, patients received subcutaneous abatacept or adalimumab (2 years). In ATTEST, patients received intravenous abatacept or infliximab (1 year), or placebo (6 months) then abatacept (6 months); at 1 year, all patients could receive abatacept (open-label long-term extension). Serum ANA/anti-dsDNA autoantibody levels were measured at baseline, Month 6 (ATTEST only), Years 1 and 2.
RESULTS:
At baseline, 25.7 and 0.9% (AMPLE), and 21.6 and 8.4% of patients (ATTEST) were ANA/anti-dsDNA autoantibody positive, respectively. More baseline ANA/anti-dsDNA autoantibody-negative patients became positive during TNFi than abatacept treatment. In ATTEST (TNFi group), 48.5% (48/99; ANA) and 48.3% (57/118; anti-dsDNA) of patients seroconverted to positive status by Year 1, falling to 22.4% (22/98 ANA) and 13.3% (15/113; anti-dsDNA) by Year 2 after switching to abatacept. Of ANA/anti-dsDNA autoantibody-positive patients at Year 1, 41.9% and 68.9%, were negative at Year 2.
CONCLUSIONS:
ANA/anti-dsDNA seroconversion was more frequent with TNFi than abatacept therapy; TNFi-associated seroconversion decreased after switching from TNFi to abatacept.
