The minimum clinically important improvement and patient-acceptable symptom state in the BASDAI and BASFI for patients with ankylosing spondylitis

Kviatkovsky, Milla Johanna, Ramiro, Sofia, Landewe, Robert, Dougados, Maxime, Tubach, Florence, Bellamy, Nicholas, Hochberg, Marc, Ravaud, Philippe, Martin-Mola, Emilio, Awada, Hassane, Bombardier, Claire, Felson, David, Hajjaj-Hassouni, Najia, Logeart, Isabelle, Matucci-Cerinic, Marco, Van De Laar, Mart and Van Der Heijde, Désirée (2016) The minimum clinically important improvement and patient-acceptable symptom state in the BASDAI and BASFI for patients with ankylosing spondylitis. Journal of Rheumatology, 43 9: 1680-1686. doi:10.3899/jrheum.151244


Author Kviatkovsky, Milla Johanna
Ramiro, Sofia
Landewe, Robert
Dougados, Maxime
Tubach, Florence
Bellamy, Nicholas
Hochberg, Marc
Ravaud, Philippe
Martin-Mola, Emilio
Awada, Hassane
Bombardier, Claire
Felson, David
Hajjaj-Hassouni, Najia
Logeart, Isabelle
Matucci-Cerinic, Marco
Van De Laar, Mart
Van Der Heijde, Désirée
Title The minimum clinically important improvement and patient-acceptable symptom state in the BASDAI and BASFI for patients with ankylosing spondylitis
Journal name Journal of Rheumatology   Check publisher's open access policy
ISSN 1499-2752
0315-162X
Publication date 2016-09-01
Sub-type Article (original research)
DOI 10.3899/jrheum.151244
Open Access Status Not yet assessed
Volume 43
Issue 9
Start page 1680
End page 1686
Total pages 7
Place of publication Toronto, ON, Canada
Publisher Journal of Rheumatology
Language eng
Subject 2745 Rheumatology
2723 Immunology and Allergy
2403 Immunology
Abstract Objective. To establish cutoffs for the minimum clinically important improvement (MCII) and the patient-acceptable symptom state (PASS) for the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Bath Ankylosing Spondylitis Functional Index (BASFI) in patients with ankylosing spondylitis (AS). Methods. Patients with AS who started nonsteroidal antiinflammatory drugs were included. After 4 weeks, the PASS and the MCII were defined using external anchor questions (for the PASS, patients considering their condition of AS over the prior 48 h as "acceptable" forever; and for the MCII, those reporting moderate or slightly important improvement). Consistency of the MCII and PASS were tested according to HLA-B27 status, presence/absence of SpA extraarticular manifestations, age, sex, disease duration, and baseline BASDAI/BASFI score. The 75th percentile of the cumulative distribution was used to determine the MCII and PASS. Results. In total, 283 patients from a multinational cohort were included. Overall cutoffs for the PASS were 4.1 in the BASDAI and 3.8 in the BASFI. Cutoffs for the MCII were 0.7 and 0.4 for the BASDAI and BASFI, respectively. Subgroup analyses revealed that disease duration and baseline BASDAI/BASFI were significantly associated with the PASS and MCII. In a subanalysis limited to patients with active disease (baseline BASDAI ≥ 4), the MCII was 1.1 for the BASDAI and 0.6 for the BASFI. Conclusion. The conceptual viability of the PASS for the BASDAI is questionable because levels approach those required for the start of biological therapy. Because the MCII is less variable than the PASS, we propose its exclusive use, with cutoffs of 1.1/0.6 for the BASDAI/BASFI in patients with active disease. Because these values are based on a subset of the study population, we recommend confirmation in larger studies focused on patients with baseline BASDAI ≥ 4.
Formatted abstract
Objective: To establish cutoffs for the minimum clinically important improvement (MCII) and the patient-acceptable symptom state (PASS) for the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Bath Ankylosing Spondylitis Functional Index (BASFI) in patients with ankylosing spondylitis (AS).

Methods: Patients with AS who started nonsteroidal antiinflammatory drugs were included. After 4 weeks, the PASS and the MCII were defined using external anchor questions (for the PASS, patients considering their condition of AS over the prior 48 h as "acceptable" forever; and for the MCII, those reporting moderate or slightly important improvement). Consistency of the MCII and PASS were tested according to HLA-B27 status, presence/absence of SpA extraarticular manifestations, age, sex, disease duration, and baseline BASDAI/BASFI score. The 75th percentile of the cumulative distribution was used to determine the MCII and PASS.

Results: In total, 283 patients from a multinational cohort were included. Overall cutoffs for the PASS were 4.1 in the BASDAI and 3.8 in the BASFI. Cutoffs for the MCII were 0.7 and 0.4 for the BASDAI and BASFI, respectively. Subgroup analyses revealed that disease duration and baseline BASDAI/BASFI were significantly associated with the PASS and MCII. In a subanalysis limited to patients with active disease (baseline BASDAI ≥ 4), the MCII was 1.1 for the BASDAI and 0.6 for the BASFI.

Conclusion: The conceptual viability of the PASS for the BASDAI is questionable because levels approach those required for the start of biological therapy. Because the MCII is less variable than the PASS, we propose its exclusive use, with cutoffs of 1.1/0.6 for the BASDAI/BASFI in patients with active disease. Because these values are based on a subset of the study population, we recommend confirmation in larger studies focused on patients with baseline BASDAI ≥ 4.
Keyword Ankylosing spondylitis
BASDAI
BASFI
Minimum clinically important improvement
Patient-acceptable symptom state
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
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