Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.


Sustained and Clinically Meaningful Improvements in Both Day- and Night-Time Aspects of HRQoL Are Observed with Abatacept Treatment in Patients with Rheumatoid Arthritis (RA) and Previous Inadequate Response to MTX: 5-Year Data from the AIM Trial.

Kremer2,  Joel, Russell3,  Anthony S., Westhovens5,  Rene, Teng1,  Julie, Rosenblatt1,  Lisa, Emery4,  Paul

Bristol-Myers Squibb, Princeton, NJ
Center for Rheumatology, Albany Medical College, Albany, NY
University of Alberta Hospital, Edmonton, AB, Canada
University of Leeds, Leeds, United Kingdom
UZ Gasthuisberg, Leuven, Belgium

Background:

RA significantly impairs patients' quality of life and limits their ability to participate in daily activities. Long-term, sustainable improvements in HRQoL are important treatment goals for this chronic disease, and capturing this information is key to improving patient care. Here we report 5-year data from the AIM trial, examining the long-term impact of abatacept across multiple day- and night-time aspects of HRQoL in patients with established RA.

Methods:

In the double-blind (DB), placebo-controlled AIM trial, patients were randomized to abatacept (~10 mg/kg) or placebo, plus methotrexate (MTX), for 1 year; patients who completed the 1-year period were eligible to enter an open-label (OL) long-term extension (LTE), during which all patients received abatacept (~10 mg/kg) plus MTX. Sleep quality (Medical Outcomes Study Sleep-Problem Index [SPI] scored 0–100) and fatigue (visual analog scale [0–100 mm]) were assessed up to Year 5 (1 year DB + 4 years OL), and activity (Activity Limitations Score, 0–30 days) up to Year 4 (1 year DB + 3 years OL). Minimal clinically important (MCI) changes in sleep, fatigue and activity were estimated at –6 units, –10 units and –4 days respectively.1,2 Data are summarized over time by original randomization group using point estimates for patients who received >=1 dose of abatacept in the LTE (as-observed data).

Results:

433 and 219 patients were randomized and treated with abatacept or placebo in the 1-year DB period; 378 and 161, respectively, entered and were treated in the LTE, of which 390 (72.4%) have completed 5 years. At baseline, the mean age of patients entering the LTE was 50.8 years, mean duration of RA was 8.5 years, and mean tender and swollen joint counts were 31.6 and 21.9, respectively; mean baseline values for sleep, fatigue and activity were similar between groups (Table). Initial improvements in HRQoL over 1-year DB treatment were greater for abatacept versus placebo (Table). Over 4–5 years' treatment, patients initially treated with abatacept sustained clinically important improvements, i.e. above the MCI threshold, in all HRQoL domains. Over time, patients who switched to abatacept plus MTX after 1 year of MTX plus placebo showed similar HRQoL improvements as those seen in patients continuously treated with abatacept.

Table. Mean changes from baseline over time in sleep problems, fatigue and activity limitations

 Year
 BL0.511.522.533.544.55
Sleep problem index (0–100): MCI is -6 units
Abatacept42.2*-10.9-10.8-11.4-10.9-12.2-11.9-12.2-11.7-11.2-10.6
Placebo43.6*-9.3-8.0-10.9-11.3-12.0-11.3-10.1-10.4-11.6-9.1
Fatigue, VAS (0–100 mm): MCI is -10 units
Abatacept63.5*-26.9-28.0-29.4-31.2-29.7-32.8-30.3-32.2-30.9-30.3
Placebo65.3*-23.6-22.6-31.1-30.0-30.6-31.3-31.2-32.6-32.3-32.0
Activity limitation, number of days of limitation (0–30): MCI is -4 days
Abatacept13.7*-8.7-9.0-9.2-9.6-9.4-10.1-10.0-9.7--
Placebo13.4*-5.6-6.4-9-8.2-9.2-8.7-8.3-10.3--
*Baseline value equals mean for subjects entering long-term extension with data available at baseline and Day 29; Data represent mean change from baseline; higher scores for all variables represent more severe impairment; BL=baseline; VAS=visual analog scale.

Conclusions:

In patients with RA and an inadequate response to MTX, abatacept provides sustained, long-term, MCI improvements across both day- and night-time measures of HRQoL, and reduces the limitation of patients' usual daily activities caused by their disease. These improvements represent tangible benefits to patients.

1.Wells, G, et al. J Rheumatol 2007;34:280-;9

2.Todd, KH, et al. Ann Emerg Med 1996;27:485-;9.

To cite this abstract, please use the following information:
Kremer, Joel, Russell, Anthony S., Westhovens, Rene, Teng, Julie, Rosenblatt, Lisa, Emery, Paul; Sustained and Clinically Meaningful Improvements in Both Day- and Night-Time Aspects of HRQoL Are Observed with Abatacept Treatment in Patients with Rheumatoid Arthritis (RA) and Previous Inadequate Response to MTX: 5-Year Data from the AIM Trial. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :1836
DOI: 10.1002/art.29601

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