ABATACEPT INDUCES SUSTAINED IMPROVEMENTS IN HEALTH-RELATED QUALITY OF LIFE, SLEEP QUALITY AND FATIGUE OVER 3 YEARS IN RHEUMATOID ARTHRITIS PATIENTS WITH INADEQUATE METHOTREXATE RESPONSES

P. Emery, A. Russell , G. Tate , A. Filipowicz-Sosnowska , Y. Zhou , Z. Ge , T. Li , R. Westhovens Department of Rheumatology and Rehabilitation, University of Leeds, Leeds, United Kingdom, University of Alberta Hospital, Edmonton, Canada, Organizacion Medica de Investigacion, Buenos Aires, Argentina, Department of Rheumatology, Institute of Rheumatology, Warsaw, Poland, Bristol-Myers Squibb, Princeton, United States, Department of Rheumatology, Universitaire Ziekenhuizen Leuven, Leuven, BelgiumObjectives: Therapies for rheumatoid arthritis (RA) should improve each aspect of health-related quality of life (HRQoL) that is significantly impacted by RA. Improvements in QoL associated with abatacept were examined in the Phase III AIM (Abatacept in Inadequate responders to Methotrexate [MTX]) trial and in a similar patient population treated with abatacept for 3 years as part of a Phase II trial.Methods: Both trials had a 1-year, double-blind, placebo-controlled phase. Also presented are data from 2-years of an open-label long-term extension of the Phase II trial. Both studies evaluated a fixed dose of abatacept (∼10 mg/kg) plus background MTX in patients with active RA despite MTX treatment. HRQoL was assessed using the Short Form 36 (SF-36) including four physical domains (physical function, role-physical, bodily pain, general health) and four mental domains (vitality, social function, role-emotional, mental health) and physical and mental component summaries (MCS and PCS, respectively). Sleep quality was assessed in the AIM trial using the Medical Outcomes Study Sleep Module (MOS-Sleep) and fatigue was measured using a 100 mm fatigue Visual Analog Scale (VAS).Results: In AIM, 433 vs. 219 patients were randomized to abatacept vs. placebo treatment, with 385 (88.9%) of the abatacept group and 162 (74.0%) of the placebo group completing 1 year. In the Phase II trial, 84 abatacept-treated patients (73%) entered the LTE. In AIM, abatacept-treated patients demonstrated both clinically meaningful (change of ≥3 points) and statistically significant improvements in all eight subscales and both MCS and PCS of the SF-36 (vs. placebo). Clinically meaningful improvements were sustained through 3 years in the Phase II trial. Abatacept significantly improved sleep quality and reduced fatigue (Table) and was generally safe and well tolerated. Table Mean improvement Phase III AIM trial Phase II trial 6 mo 1 yr 1 yr* 2 yrs 3 yrs Abatacept Placebo Abatacept Placebo Abatacept Abatacept Abatacept SF-36 PCS (SE) 8.8 (0.4)† 4.8 (0.6) 9.1 (0.4)† 5.0 (0.6) 9.7 (1.1) 9.2 (1.2) 9.3 (1.2) SF-36 MCS (SE) 6.2 (0.5)‡ 3.8 (0.7) 6.9 (0.5)‡ 4.7 (0.7) 6.1 (1.2) 4.6 (1.3) 4.0 (1.2) Pain: % (SE) improvement 42.5 (5.3)† 3.5 (7.4) 50.5 (4.0)† 8.0 (5.7) 52.4 (5.7) 50.2 (6.6) 55.6 (5.3) MOS-sleep (SE) –10.2 (0.7) –7.8 (1.0) –10.4 (0.7)‡ –6.8 (1.0) – – – Fatigue (SE) –25.3 (1.2)† –17.2 (1.8) –26.5 (1.2)† –16.4 (1.7) – – – *Blinded, placebo-controlled phase; †p<0.001, ‡p<0.05, all vs. placebo *Blinded, placebo-controlled phase; †p<0.001, ‡p<0.05, all vs. placeboConclusion: In AIM, abatacept-treated patients experienced improved HRQoL, as demonstrated by improved sleep quality, reduced pain and fatigue and significant, clinically meaningful improvements in all eight domains of the SF-36 and MCS and PCS. Similar improvements in Phase II were sustained through 3 years, demonstrating the consistent patient-centered benefits of abatacept.Citation: Ann Rheum Dis, volume 64, supplement III, year 2005, page 403Session: Health services, economics and outcome research 1