Physical function, disease activity, and health-related quality-of-life outcomes after 3 years of adalimumab treatment in patients with ankylosing spondylitis.
BACKGROUND
We evaluated the three-year impact of adalimumab on patient-reported physical function and health-related quality-of-life (HRQOL) outcomes in patients with active ankylosing spondylitis (AS).


METHODS
The Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS (ATLAS) is an ongoing five-year study that included an initial 24-week, randomized, placebo-controlled, double-blind period, followed by open-label extension treatment with adalimumab. Clinical and HRQOL data collected for up to three years from ATLAS were used for these analyses. Patients were randomized to receive adalimumab 40 mg or placebo by subcutaneous injection every other week. Physical function was assessed by the Bath AS Functional Index (BASFI), as well as by the Short Form 36 (SF-36) Health Survey Physical Component Summary (PCS) and Physical Function subscale scores. HRQOL was assessed using the AS Quality of Life (ASQOL) questionnaire. Disease activity was assessed by the Bath AS Disease Activity Index (BASDAI).


RESULTS
Of 315 patients enrolled in ATLAS, 288 (91%) participated in an open-label adalimumab treatment extension and 82% provided three-year outcome data. During the 24-week double-blind phase, adalimumab-treated patients experienced significant improvement compared with placebo-treated patients in the BASDAI (P < 0.001), BASFI (P < 0.001), ASQOL (P < 0.001), and both the SF-36 PCS (P < 0.001) and Physical Function subscale (P < 0.001) scores, but not the SF-36 Mental Component Summary score (P = 0.181) and Mental Health subscale scores (P = 0.551). Mean changes from baseline through three years of adalimumab treatment were statistically significant for the BASDAI (change score: -3.9, P < 0.001), BASFI (change score: -29.6, P < 0.001), SF-36 PCS (change score: 11.6, P < 0.001), and Physical Function (change score: 23.3, P < 0.001). Comparable results were observed for the other SF-36 scores and for the ASQOL (all P < 0.001).


CONCLUSIONS
Adalimumab significantly improved disease activity, patient-reported physical function, and HRQOL. These benefits were maintained over three years of treatment in patients with AS.
van der Heijde
Désirée M
DM
Department of Rheumatology, Leiden University Medical Center, Leiden, Leiden, The Netherlands. d.vanderheijde@kpnplanet.nl
Revicki
Dennis A
DA
Gooch
Katherine L
KL
Wong
Robert L
RL
Kupper
Hartmut
H
Harnam
Neesha
N
Thompson
Chris
C
Sieper
Joachim
J
D000068879:Adalimumab; D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D011788:Quality of Life; D012720:Severity of Illness Index; D013167:Spondylitis, Ankylosing / Q000188:drug therapy* / Q000523:psychology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D000068879:Adalimumab
Arthritis Rheum. 2005 Aug 15;53(4):494-501
16082640
Ann Rheum Dis. 2009 Jun;68(6):922-9
18701556
J Rheumatol. 2006 Mar;33(3):558-61
16463437
Rheumatology (Oxford). 2007 Mar;46(3):439-41
17255137
Arthritis Rheum. 2000 Jul;43(7):1478-87
10902749
Ann Rheum Dis. 2004 Dec;63(12):1605-10
15547084
J Rheumatol. 2005 Jan;32(1):80-5
15630730
J Rheumatol. 1994 Dec;21(12):2286-91
7699630
Ann Rheum Dis. 2006 Dec;65(12):1572-7
16968715
Arthritis Rheum. 2006 Jul;54(7):2136-46
16802350
Rheumatology (Oxford). 2002 Nov;41(11):1295-302
12422003
J Clin Epidemiol. 2008 Feb;61(2):102-9
18177782
Arthritis Rheum. 2002 Dec 15;47(6):582-7
12522830
Rheumatol Int. 2003 May;23(3):121-6
12739042
Arthritis Rheum. 2006 Oct 15;55(5):812-6
17013842
Arthritis Rheum. 2005 Dec 15;53(6):856-63
16342093
Rheumatology (Oxford). 2007 Jun;46(6):999-1004
17389658
Rheum Dis Clin North Am. 1998 Nov;24(4):815-27, x
9891712
J Rheumatol. 1999 Sep;26(9):1959-63
10493677
Rheumatol Int. 2007 May;27(7):605-11
17103172
J Rheumatol. 2008 Jul;35(7):1346-53
18484692
Joint Bone Spine. 2007 May;74(3):254-8
17387031
Rheumatology (Oxford). 2006 Dec;45(12):1566-9
16705043
Lancet. 2007 Apr 21;369(9570):1379-1390
17448825
Ann Rheum Dis. 2007 Jun;66(6):771-7
17213254
Semin Arthritis Rheum. 1993 Apr;22(5):319-34
8511596
J Rheumatol. 1994 Dec;21(12):2281-5
7699629
Arthritis Rheum. 2008 Sep 15;59(9):1270-8
18759257
Ann Rheum Dis. 2005 Nov;64(11):1568-75
15829577
Med Care. 1989 Mar;27(3 Suppl):S178-89
2646488
Ann Rheum Dis. 2005 Jan;64(1):124-6
15608310
Arthritis Rheum. 2005 Apr;52(4):1205-15
15818702
J Rheumatol. 2007 Mar;34(3):510-5
17299842
Ann Rheum Dis. 2003 Jan;62(1):20-6
12480664
Arthritis Rheum. 2006 Feb;54(2):678-81
16447247
Arthritis Rheum. 2007 Aug 15;57(6):1050-7
17665483
Rheumatology (Oxford). 2005 May;44(5):670-6
15757965
Arthritis Rheum. 1984 Apr;27(4):361-8
6231933
J Rheumatol. 2003 Apr;30(4):764-73
12672197
Arthritis Rheum. 2005 Feb;52(2):582-91
15692973
Rheumatology (Oxford). 2005 Mar;44(3):342-8
15561737
J Rheumatol. 2008 Apr;35(4):662-7
18278836
J Rheumatol. 2000 Mar;27(3):613-22
10743798
Arthritis Res Ther. 2005;7(3):R439-44
15899030
Arthritis Rheum. 2004 Jun 15;51(3):316-20
15188313