Evaluation of the patient acceptable symptom state as an outcome measure in patients with ankylosing spondylitis: data from a randomized controlled trial.
OBJECTIVE
To evaluate the feasibility/acceptability, reliability, external validity, and discriminant capacity of the Patient Acceptable Symptom State (PASS) concept in patients with active ankylosing spondylitis (AS).


METHODS
PASS was assessed by asking patients to respond yes or no to a single question: "Considering all the different ways your disease is affecting you, if you would stay in this state for the next months, do you consider that your current state is satisfactory?" during the 24-week, randomized (2:1 ratio), double-blind, placebo-controlled portion of an adalimumab study of 315 patients.


RESULTS
PASS reliability was high (kappa = 0.86) in patients with stable disease. Significantly more patients who answered yes to PASS than patients who answered no to PASS were responders based on the ASsessment in Ankylosing Spondylitis (ASAS) International Working Group criteria for 20% improvement (75% who answered yes versus 29% who answered no), the ASAS criteria for 40% improvement (61% versus 16%), the ASAS partial remission criteria (37% versus 3%), and > or =50% improvement on the Bath Ankylosing Spondylitis Disease Activity Index (65% versus 19%; P < 0.001 for all comparisons), demonstrating external validity of the PASS concept. More adalimumab-treated than placebo-treated patients achieved PASS at week 12 (42.3% versus 22.4%; P < 0.001), and more adalimumab-treated than placebo-treated patients achieved sustained PASS through week 20 (34.6% versus 12.3%; P < 0.001), indicating excellent discriminant capacity.


CONCLUSIONS
PASS is a feasible, acceptable, reliable, and valid assessment of satisfactory health state in patients with AS.
Dougados
Maxime
M
Hôpital Cochin and University of Paris, Paris, France.
Luo
Michelle P
MP
Maksymowych
Walter P
WP
Chmiel
Joseph J
JJ
Chen
Naijun
N
Wong
Robert L
RL
Davis
John C
JC
van der Heijde
Désirée
D
D000068879:Adalimumab; D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*; D011795:Surveys and Questionnaires
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D000068879:Adalimumab