1312 - Effect of Adalimumab on Function, Health-Related Quality of Life, Work Productivity, and Daily Activities in Patients with Non-Radiographic Axial Spondyloarthritis

Monday, November 7, 2011: 9:00 AM-6:00 PM
Hall F2 - Poster Hall (McCormick Place West)
Walter P. Maksymowych1, Philip J. Mease2, Sumati Rao3, Aileen Pangan3, L. Steven Brown3, Vipin Arora3 and Mary A. Cifaldi3, 1University of Alberta, Edmonton, AB, 2Swedish Medical Center and University of Washington School of Medicine, Seattle, WA, 3Abbott Laboratories, Abbott Park, IL
Presentation Number: 1312

Background/Purpose: To evaluate the effect of the anti–tumor necrosis factor agent adalimumab (ADA) on physical function and health-related quality of life (HRQOL) and productivity in patients with non-radiographic axial spondyloarthritis (SpA).

Methods: Biologic-naïve patients with non-radiographic axial SpA, excluding those meeting the modified New York criteria for AS, and inadequate response to or intolerance of ≥1 nonsteroidal anti-inflammatory drug were randomized to ADA 40 mg every other week (eow) or placebo for 12 weeks of double-blind treatment (Ability 1 trial). The blinded phase was followed by a 92-week open-label phase. Function was assessed using the Health Assessment Questionnaire for Spondyloarthropathies (HAQ-S) and HRQOL using the Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) score. Productivity was assessed using the 4 components of the Work Productivity and Activity Impairment Questionnaire (WPAI). Changes from baseline to Week 12 were compared between groups using ANCOVA with adjustment for baseline scores and treatment as a factor.

Results: Analyses were conducted on the full-analysis set, a subset of the intent-to-treat population (N=91 for adalimumab; N=94 for placebo). Mean age was 38 years, 55% were women, and duration of SpA symptoms averaged 10 years. Baseline HAQ-S scores were similar between ADA- and placebo-treated patients (0.99 and 1.05, respectively) and indicated moderate impairment. For both groups, baseline SF-36 PCS scores were lower than the general US population average of 49.1 (33.9 for ADA, 33.1 for placebo). Baseline WPAI scores indicated substantial total work productivity impairment (TWPI; 46% average reduction for ADA, 49% for placebo) and total activity impairment (TAI; 57% average reduction for both ADA and placebo) due to axial SpA. ADA therapy was associated with statistically significant improvements in HAQ-S, SF-36 PCS, absenteeism, and daily nonwork activity impairment scores (TAI) compared with placebo; presenteeism and TWPI showed no significant treatment group differences (table). Improvement in SF-36 PCS met the minimum clinically important difference of 3.0.

Mean Changes From Baseline to Week 12 in Function, HRQOL, and WPAI Scores in Patients With Non-Radiographic Axial SpA

 

Placebo

(N=94)

ADA 40 mg EOW

(N=91)

P-Value

Physical Function

 

 

 

  HAQ-S

-0.1

-0.3

0.027a

HRQOL

 

 

 

  SF-36 PCS

2.0

5.5

0.001b

WPAI

 

 

 

  Absenteeism

2.3

-7.2

0.005b

  Presenteeism

-5.8

-12.3

0.07b

  TWPI

-5.7

-12.1

0.122b

  TAI

-3.6

-14.9

0.002b

aLast observation carried forward.

bAs observed.
Conclusion: Patients with non-radiographic axial SpA had substantial impairment of function, HRQOL, work productivity, and nonwork activities at baseline. After 12 weeks of therapy, the ADA group experienced clinically and statistically significant improvements in function and HRQOL and significantly less absenteeism from work and less impairment in daily nonwork activities compared with placebo.


Keywords: adalimumab, anti-TNF therapy, quality of life and spondylarthropathy

Disclosure: W. P. Maksymowych, Abbott Laboratories, 2, Abbott Laboratories, 5, Abbott Laboratories, 8 ; P. J. Mease, Abbott Immunology Pharmaceuticals, 2, Amgen, 2, Bristol Myers Squibb, 2, Novartis Pharmaceutical Corporation, 2, Centocor, Inc., 2, Genentech and Biogen IDEC Inc., 2, Lilly , 2, Pfizer Inc, 2, U C B, 2, Abbott Immunology Pharmaceuticals, 5, Amgen, 5, Bristol Myers Squibb, 5, Centocor, Inc., 5, Genentech and Biogen IDEC Inc., 5, Lilly, 5, Novartis Pharmaceutical Corporation, 5, Pfizer Inc, 5, U C B, 5, Abbott Immunology Pharmaceuticals, 8, Amgen, 8, Bristol Myers Squib, 8, Centocor, Inc., 8, Genentech and Biogen IDEC Inc., 8, Lilly, 8, Pfizer Inc, 8, U C B, 8 ; S. Rao, Abbott Laboratories, 1, Abbott Laboratories, 3 ; A. Pangan, Abbott Laboratories, 1, Abbott Laboratories, 3 ; L. S. Brown, Abbott Immunology Pharmaceuticals, 3 ; V. Arora, Abbott Laboratories, 1, Abbott Laboratories, 3 ; M. A. Cifaldi, Abbott Laboratories, 3 .