The DOI matches its Crossref record; 27 of the 27 references it cites were found in a registry or an index.
Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1)
Open accessAbstract
PURPOSE: To evaluate the efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis (nr-axSpA). METHODS: Patients fulfilled Assessment of Spondyloarthritis international Society (ASAS) criteria for axial spondyloarthritis, had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥ 4, total back pain score of ≥ 4 (10 cm visual analogue scale) and inadequate response, intolerance or contraindication to non-steroidal anti-inflammatory drugs (NSAIDs); patients fulfilling modified New York criteria for ankylosing spondylitis were excluded. Patients were randomised to adalimumab (N=91) or placebo (N=94). The primary endpoint was the percentage of patients achieving ASAS40 at week 12. Efficacy assessments included BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS). MRI was performed at baseline and week 12 and scored using the Spondyloarthritis Research Consortium of Canada (SPARCC) index. RESULTS: Significantly more patients in the adalimumab group achieved ASAS40 at week 12 compared with patients in the placebo group (36% vs 15%, p<0.001). Significant clinical improvements based on other ASAS responses, ASDAS and BASDAI were also detected at week 12 with adalimumab treatment, as were improvements in quality of life measures. Inflammation in the spine and sacroiliac joints on MRI significantly decreased after 12 weeks of adalimumab treatment. Shorter disease duration, younger age, elevated baseline C-reactive protein or higher SPARCC MRI sacroiliac joint scores were associated with better week 12 responses to adalimumab. The safety profile was consistent with what is known for adalimumab in ankylosing spondylitis and other diseases. CONCLUSIONS: In patients with nr-axSpA, adalimumab treatment resulted in effective control of disease activity, decreased inflammation and improved quality of life compared with placebo. Results from ABILITY-1 suggest that adalimumab has a positive benefit-risk profile in active nr-axSpA patients with inadequate response to NSAIDs.
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Cites
Evaluation of Diagnostic Criteria for Ankylosing Spondylitis
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Self-citationRudwaleit, M., Landewé, R., van der Heijde, D., Listing, J., Brandt, J., Braun, J., Burgos-Vargas, R., Collantes-Estevez, E., Davis, J., Dijkmans, B., et al. (2009) · Annals of the Rheumatic Diseases · doi:10.1136/ard.2009.108217 · Cited by 941
Self-citationvan der Heijde, D., Kivitz, A., Schiff, M. H., Sieper, J., Dijkmans, B. A. C., Braun, J., Dougados, M., Reveille, J. D., Wong, R. L., Kupper, H., et al. (2006) · Arthritis & Rheumatism · doi:10.1002/art.21913 · Cited by 872
Self-citationvan der Heijde, D., Dijkmans, B., Geusens, P., Sieper, J., DeWoody, K., Williamson, P., & Braun, J. (2005) · Arthritis & Rheumatism · doi:10.1002/art.20852 · Cited by 860
Self-citationMachado, P., Landewé, R., Lie, E., Kvien, T. K., Braun, J., Baker, D., & van der Heijde, D. (2011) · Annals of the Rheumatic Diseases · doi:10.1136/ard.2010.138594 · Cited by 805
Self-citationDavis, J. C., Van Der Heijde, D., Braun, J., Dougados, M., Cush, J., Clegg, D. O., Kivitz, A., Fleischmann, R., Inman, R., Tsuji, W., et al. (2003) · Arthritis & Rheumatism · doi:10.1002/art.11325 · Cited by 754
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ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update
Ramiro, S., Nikiphorou, E., Sepriano, A., Ortolan, A., Webers, C., Baraliakos, X., Landewé, R. B. M., Van den Bosch, F. E., Boteva, B., Bremander, A., et al. (2023) · Annals of the Rheumatic Diseases · doi:10.1136/ard-2022-223296 · Cited by 992
Self-citationMandl, P., Navarro-Compán, V, Terslev, L., Aegerter, P., van der Heijde, D., D'Agostino, M. A., Baraliakos, X., Pedersen, S. J., Jurik, A. G., Naredo, E., et al. (2015) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2014-206971 · Cited by 572
Self-citationSmolen, J. S., Braun, J., Dougados, M., Emery, P., FitzGerald, O., Helliwell, P., Kavanaugh, A., Kvien, T. K., Landewé, R., Luger, T., et al. (2014) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2013-203419 · Cited by 447
Self-citationMinozzi, S., Bonovas, S., Lytras, T., Pecoraro, V., González-Lorenzo, M., Bastiampillai, A. J., Gabrielli, E. M., Lonati, A. C., Moja, L., Cinquini, M., et al. (2016) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2016.1240783 · Cited by 308
Metadata
- Authors
- Sieper, J., van der Heijde, D., Dougados, M., Mease, P. J., Maksymowych, W. P., Brown, M. A., Arora, V., & Pangan, A. L.
- Venue
- Annals of the Rheumatic Diseases
- Publisher
- Elsevier BV
- Published
- 2013-06
- Volume
- 72
- Issue
- 6
- Pages
- 815-822
- ISSN
- 0003-4967 (ISSN-L)
- OpenAlex
- W2147791981
- Cited by
- 536
- References
- 27
- FWCI
- 37.45
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Sieper, J., van der Heijde, D., Dougados, M., Mease, P. J., Maksymowych, W. P., Brown, M. A., Arora, V., & Pangan, A. L. (2013). Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1). Annals of the Rheumatic Diseases. https://doi.org/10.1136/annrheumdis-2012-201766
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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