Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comparative Study
. 2020 Jan;6(1):e001145.
doi: 10.1136/rmdopen-2019-001145.

Eligibility criteria for biologic disease-modifying antirheumatic drugs in axial spondyloarthritis: going beyond BASDAI

Jose Marona  1   2 , Alexandre Sepriano  2   3 , Santiago Rodrigues-Manica  1   2 , Fernando Pimentel-Santos  1   2 , Ana Filipa Mourão  1   2 , Nélia Gouveia  2 , Jaime Cunha Branco  1   2 , Helena Santos  4 , Elsa Vieira-Sousa  5   6 , Filipe Vinagre  7 , João Tavares-Costa  8 , João Rovisco  9   10 , Miguel Bernardes  11 , Nathalie Madeira  4 , Rita Cruz-Machado  5   6 , Raquel Roque  7 , Joana Leite Silva  8 , Mary Lucy Marques  9 , Raquel Miriam Ferreira  11 , Sofia Ramiro  12   3   13
Affiliations
Comparative Study

Eligibility criteria for biologic disease-modifying antirheumatic drugs in axial spondyloarthritis: going beyond BASDAI

Jose Marona et al. RMD Open. 2020 Jan.

Abstract

Objectives: To compare definitions of high disease activity of the Ankylosing Spondylitis Disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in selecting patients for treatment with biologic disease-modifying antirheumatic drugs (bDMARDs).

Methods: Patients from Rheumatic Diseases Portuguese Register (Reuma.pt) with a clinical diagnosis of axial spondyloarthritis (axSpA) were included. Four subgroups (cross-tabulation between ASDAS (≥2.1) and BASDAI (≥4) definitions of high disease activity) were compared regarding baseline characteristics and response to bDMARDs at 3 and 6 months estimated in multivariable regression models.

Results: Of the 594 patients included, the majority (82%) had both BASDAI≥4 and ASDAS ≥2.1. The frequency of ASDAS ≥2.1, if BASDAI<4 was much larger than the opposite (ie, ASDAS <2.1, if BASDAI≥4): 62% vs 0.8%. Compared to patients fulfilling both definitions, those with ASDAS ≥2.1 only were more likely to be male (77% vs 51%), human leucocyte antigen B27 positive (79% vs 65%) and have a higher C reactive protein (2.9 (SD 3.5) vs 2.1 (2.9)). Among bDMARD-treated patients (n=359), responses across subgroups were globally overlapping, except for the most 'stringent' outcomes. Patients captured only by ASDAS responded better compared to patients fulfilling both definitions (eg, ASDAS inactive disease at 3 months: 61% vs 25% and at 6 months: 42% vs 25%).

Conclusion: The ASDAS definition of high disease activity is more inclusive than the BASDAI definition in selecting patients with axSpA for bDMARD treatment. The additionally 'captured' patients respond better and have higher likelihood of predictors thereof. These results support using ASDAS≥2.1 as a criterion for treatment decisions.

Keywords: DMARDs (biologic); disease activity; spondyloarthritis.

PubMed Disclaimer

Conflict of interest statement

Competing interests: AS received speaker fees from Novartis. FPS received speaker/consultancy/research fees from AbbVie, Novartis, MSD, Eli Lilly, Janssen-Cilag, Pfizer, Biogen, Vitória, Roche, Menarini, AlfaSigma, UCB and Medac. HS received speaker/consultancy fees from AbbVie, Eli Lilly, Janssen-Cilag, Novartis and Pfizer. JTC received speaker/consultancy fees from AbbVie, Amgen, Eli Lilly, Janssen-Cilag, MSD, Novartis, Pfizer and UCB. MB received consultancy fees from AbbVie, Amgen, Eli Lilly, Novartis, Pfizer, Janssen-Cilag, Glaxosmithkline, Biogen. Speaker fee: Janssen-Cilag. SR received speaker/consultancy fees from AbbVie, Eli Lilly, MSD, Novartis, Pfizer and Sanofi.

Figures

Figure 1
Figure 1
Flow chart representing sample selection based on inclusion/exclusion criteria and type of analysis. * ASAS20, ASAS40, ASAS PR, ASDAS CII, ASDAS MI, ASDAS ID and BASDAI 50 response. ASAS, Assessment of SpondyloArthritis international Society; ASDAS, Ankylosing Spondylitis Disease Activity Score; ASDAS CII, ASDAS clinically important improvement; ASDAS ID, ASDAS inactive disease; ASDAS MI, ASDAS major improvement; axSpA, axial spondyloarthritis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; bDMARD, biologic disease-modifying antirheumatic drugs.
See this image and copyright information in PMC

References

    1. Garrett S, Jenkinson T, Kennedy LG, et al. . A new approach to defining disease status in ankylosing spondylitis: the Bath ankylosing spondylitis disease activity index. J Rheumatol 1994;21:2286–91. - PubMed
    1. Pham T, Landewé R, van der Linden S, et al. . An international study on starting tumour necrosis factor-blocking agents in ankylosing spondylitis. Ann Rheum Dis 2006;65:1620–5. 10.1136/ard.2005.042630 - DOI - PMC - PubMed
    1. Machado P, van der Heijde D. How to measure disease activity in axial spondyloarthritis? Curr Opin Rheumatol 2011;23:339–45. 10.1097/BOR.0b013e3283470f23 - DOI - PubMed
    1. Machado P, Landewe R. Spondyloarthritis: is it time to replace BASDAI with ASDAS? Nat Rev Rheumatol 2013;9:388–90. - PubMed
    1. Lukas C, Landewé R, Sieper J, et al. . Development of an ASAS-endorsed disease activity score (ASDAS) in patients with ankylosing spondylitis. Ann Rheum Dis 2009;68:18–24. 10.1136/ard.2008.094870 - DOI - PubMed

Publication types

Substances