Ankylosing Spondylitis (AS) Patients on Adalimumab Show Sustained Improvement in Health-Related Quality of Life (HRQOL): 104-Week Results from ATLAS

Purpose: AS is a chronic, inflammatory, progressive disease with considerable impact on patient functional status and well-being. This study evaluated the improvement in HRQOL in patients with active AS treated with adalimumab for 104 weeks (wks).
Methods: The Adalimumab Trial Evaluating Long-term Efficacy and Safety in AS (ATLAS) is a Phase III study involving patients with active AS who had an inadequate response to at least one NSAID or DMARD. Patients were randomized to either adalimumab 40 mg every other wk or placebo for 24 wks, with a 236-wk open-label extension period. HRQOL was assessed by the Short Form-36 (SF-36) Health Survey (including a Physical Component Summary [PCS]) and the AS Quality of Life (ASQOL), a validated, disease-specific questionnaire. SF-36 scores range from 0-100, with higher scores indicating better health. ASQOL scores range from 0-18, with lower scores indicating better health. The minimum clinically important difference (MCID) was defined as a 3 point change for SF-36 PCS, and a -1.8 point change for ASQOL.
Results: A total of 315 patients (adalimumab, n=208; placebo, n=107) were enrolled. At baseline, adalimumab and placebo arms had comparable demographics and disease activity. HRQOL measured by SF-36 PCS and ASQOL showed statistically significant improvement compared with placebo at Wks 12 and 24. This benefit was sustained through 104 wks of adalimumab treatment (table), with 79% and 80% of patients achieving an MCID for SF-36 and ASQOL, respectively. Mean Change in HEOR PROs Through 104 Weeks of Adalimumab Treatment

Mean Change in HEOR PROs Through 104 Weeks of Adalimumab Treatment

	At Week 12†	At Week 24†	After 52 Weeks n/311	After 52 Weeks‡ [95% CI]	After 104 Weeks n/311	After 104 Weeks‡ [95% CI]
SF-36 PCS
Placebo (N=107)	1.55	1.85	µ	µ	µ	µ
Adalimumab (N=208)	6.93***	7.44***	n=278	9.1 [7.9 to 10.2]	n=214	11.1 [9.7 to 12.4]
ASQOL
Placebo (N=107)	-0.95	-1.06	µ	µ	µ	µ
Adalimumab (N=208)	-3.15***	-3.58***	n=281	-4.3 [-4.8 to -3.8]	n=218	-5.3 [-5.9 to -4.7]

†LOCF. ***P=0.001. ‡Observed. µAll patients on adalimumab after Week 24. Conclusion: These results showed that AS patients treated with adalimumab reported statistically significant and clinically meaningful improvements in physical health status and overall AS-specific HRQOL at Weeks 12 and 24 that were maintained through 104 weeks of treatment.

  D. van der Heijde, Abbott, Amgen, Centocor, Schering-Plough, Wyeth, 5; M.P. Luo, Abbott, 3; A. Kivitz, Abbott, 2; Abbott, 8; M.H. Schiff, Abbott, Amgen, Angiotech, Aventis, BMS, Centocor, Genentech, Hoffman-LaRoche, IDEC, Novartis, Merck, Wyeth-Ayerst, 5; Abbott, Amgen, Angiotech, Aventis, BMS, Centocor, Merck, Wyeth-Ayerst, 2; Abbott, Amgen, Aventis, BMS, Merck, Wyeth-Ayerst, 8; J. Sieper, Abbott, Schering-Plough/Centocor, Wyeth, 2; Abbott, Pfizer, Schering-Plough/Centocor, Wyeth, 5; Abbott, Pfizer, Schering-Plough/Centocor, Wyeth, 8; B.A. Dijkmans, Abbott, 5; J. Braun, Abbott, Amgen, Centocor, JBraun, Schering-Plough, Wyeth, 2; Abbott, Amgen, Centocor, JBraun, Schering-Plough, Wyeth, 5; M. Dougados, Abbott, 2; Abbott, 5; Abbott, 8; P. Wordsworth, Abbott, 5; R. Wong, Abbott, 1; Abbott, 3; H. Kupper, Abbott, 1; Abbott, 3; J. Davis for the ATLAS Study Group, Abbott, Amgen, Centocor, 8.