ABATACEPT IMPROVES FATIGUE, ACTIVITY LIMITATION AND QUALITY OF LIFE IN METHOTREXATE-NAÏVE PATIENTS WITH EARLY RA AND POOR PROGNOSTIC FACTORS

Background: In methotrexate (MTX)-naïve patients with early RA and poor prognostic factors, abatacept plus MTX provides significantly better clinical efficacy benefits versus MTX alone over 1 year. RA is associated with pain, fatigue, disability and functional loss, which can significantly impact a patient's health-related quality of life (HRQoL); here we evaluate the HRQoL benefits observed with abatacept over 1 year in this population of patients with early RA. Methods: In this 2-year double-blind, Phase IIIb study, patients with RA ≤2 years were randomized 1:1 to abatacept + MTX or placebo + MTX. Patients were MTX-naïve, RF and/or anti-CCP positive and had radiographic evidence of joint erosions. Abatacept was administered at $∼ $10 mg/kg based on weight range; MTX was initiated at 7.5 mg/week and titrated to 20 mg/week by Week 8. HRQoL was assessed using the Short Form-36 (SF-36; Physical and Mental Component Summaries [PCS and MCS]) and the fatigue 100 mm visual analog scale (100 mm VAS). Activity limitation was assessed as the number of days a patient was unable to perform usual activities due to RA in the past month. The established minimal clinically important difference (MCID) for these assessments are 3 (SF-36), -10 (fatigue) and -4 (activity limitation). LOCF analyses were performed for all assessments. Results: Overall, patients had high baseline disease activity (mean ± SD tender and swollen joints: 31.0±14.4 and 22.4±10.8, respectively, and mean DAS28 [CRP] score 6.3±1.0) with short disease duration (6.5±7.3 months, and were positive for RF (96.5%), anti-CCP (89.0%) or both (86.1%). Of the 256 and 253 patients treated with abatacept + MTX or MTX alone, 24/256 (90.6%) and 26/253 (89.7%) completed Year 1, respectively. Mean baseline values for SF-36, fatigue and activity limitation scores were comparable between the abatacept + MTX versus MTX alone groups (PCS: 30.7 vs 30.9; MCS: 40.3 vs 41.6; fatigue: 66.3 vs 64.4; activity limitation: 16.1 vs 15.1). At Year 1, improvements exceeded the MCID for all assessments, with significantly greater improvements observed in abatacept + MTX patients versus patients treated with MTX alone (Table). QoL at Year 1 by treatment group Adjusted mean change from baseline in:Abatacept+MTXMTXAdjusted difference for (N=254)(N=249)abatacept+MTX vs MTX (95% CI) SF-36 PCS (score 0-100) (SE)11.68 (0.62)9.18 (0.63)2.50 (0.77, 4.23) SF-36 MCS (score 0-100) (SE)8.15 (0.64)6.34 (0.64)1.81 (0.03, 3.60) Fatigue 100 mm VAS (score 0-100) (SE)-34.1 (1.58)-27.1 (1.59)-6.95 (-11.4, -2.54) Activity limitation score (score 0-30 days) (SE)-10.4 (0.52)-8.22 (0.52)-2.19 (-3.63, -0.74) Conclusion: In this patient population with early RA and poor prognostic factors, abatacept + MTX provides significantly greater improvements in QoL parameters compared with MTX alone. Taken together with previously reported clinical efficacy benefits, these data support the early use of abatacept in RA patients with moderate-to-severe disease. References: 1. Westhovens R, et al. Ann Rheum Dis 2009;doi:10.1136/ard.2008.101121. 2. Samsa G, et al. Pharmacoeconomics 1999;15:141-55. 3. Wells G, et al. J Rheumatol 2007;34:280-9. Disclosure of Interest: RW: BMS, Schering-Plough (SP), Consultant/Speakers Bureau; UCB, Research Grants JW: No disclosure JB: Amgen, Biogen Idec, Merck Serono, Grant Support; BMS, Grant Support/Honorarium; Crescendo Biosciences, Roche, Consultant BH: Abbott, Amgen, BMS, Roche, SP, UCB, Wyeth, Grant Support/Consultant/Speakers Bureau JCB: BMS, Employee/Shareholder/Pension AC: BMS, Employee TL: BMS, Shareholder/EmployeeCitation: Annals of the Rheumatic Diseases, volume 68, supplement 3, year 2009, page 577Session: Rheumatoid arthritis Other biologic treatment (Poster Presentations )