Trial reportRheumatology (Oxford, England)2015
Maintenance of improvement in spinal mobility, physical function and quality of life in patients with ankylosing spondylitis after 5 years in a clinical trial of adalimumab.
Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph
Trial report in Rheumatology (Oxford, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00085644 (A Phase 3 Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis), which is not on this map. Cited by 24 papers, 3 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 3 pooled it
3.1field-weighted citation impact, top 9% of its field
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3 Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis
Who cites it
24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 55 citations in OpenAlex.
- Guideline
- An Overview of Adalimumab Therapy for Ankylosing Spondylitis.Current rheumatology reviews · 2024Pooled it
- Smoking quantity determines disease activity and function in Chinese patients with ankylosing spondylitis.Clinical rheumatology · 2018Pooled it
- Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpA.Rheumatology (Oxford, England) · 2017Trial
- Clinical performance of the ASAS health index in chinese patients with ankylosing spondylitis and its influencing factors.Clinical rheumatology · 2024Article
- Review
- Clinically relevant differences in spinal mobility related to daytime performance in patients with axial spondyloarthritis.RMD open · 2024Observational
- Satisfaction with Social Roles and Physical Function in Immune-mediated Inflammatory Diseases: A Cross-Sectional Study.Reviews on recent clinical trials · 2022Article
- Delayed treatment with a tumor necrosis factor alpha blocker associated with worse outcomes in patients with spondyloarthritis: data from the Czech National Registry ATTRA.Therapeutic advances in musculoskeletal disease · 2022Article
- Sustained clinical response and safety of etanercept in patients with early axial spondyloarthritis: 10-year results of the ESTHER trial.Therapeutic advances in musculoskeletal disease · 2021Article
- Observational
- Effectiveness of Global Postural Reeducation in Ankylosing Spondylitis: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2020Article
- Frequency of peripheral diseases in Korean patients with ankylosing spondylitis and the effectiveness of adalimumab.International journal of rheumatic diseases · 2020Observational
- Treat to Target in Axial Spondyloarthritis: Pros, Cons, and Future Directions.Rheumatic diseases clinics of North America · 2020Review
- The Efficacy and Safety of Simple-Needling Therapy for Treating Ankylosing Spondylitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Evidence-based complementary and alternative medicine : eCAM · 2020Review
- Targeting inflammatory pathways in axial spondyloarthritis.Arthritis research & therapy · 2019Review
- Similar alteration for mental and physical aspects in health-related quality of life over 5 to 8 years in 1347 patients with early arthritis and early inflammatory back pain.Arthritis research & therapy · 2019Observational
- Effectiveness of Subcutaneous Tumor Necrosis Factor Inhibitors in Patients With Ankylosing Spondylitis: A Real-World Prospective Observational Cohort Study in China.Frontiers in pharmacology · 2019Article
- Comparative effectiveness of secukinumab and adalimumab in ankylosing spondylitis as assessed by matching-adjusted indirect comparison.European journal of rheumatology · 2018Article
- Impact of adalimumab on clinical outcomes, healthcare resource utilization, and sick leave in patients with ankylosing spondylitis: an observational study from five Central and Eastern European countries.Drugs in context · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 5 institutions in 4 countries.
Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA mail@dvanderheijde.nl.
Maxime BrebanDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
Dale HalterDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
Gino DiVittorioDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
Johan BrattDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
Fabrizio CantiniDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
Sonja KaryDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
Aileen L PanganDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
Hartmut KupperDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
Suchitrita S RathmannDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
Joachim SieperDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
Phillip J MeaseDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
Assistance Publique – Hôpitaux de Paris · FRSwedish Medical Center · USAbbVie (United States) · USKarolinska University Hospital · SELeiden University Medical Center · NL
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveChronic pain and progressive loss of physical function with AS may adversely affect health-related quality of life (HRQoL). The objective of this study was to assess the 5-year data regarding spinal mobility, physical function and HRQoL in patients with AS who participated in the Adalimumab Trial Evaluating Long-term Efficacy and Safety for AS (ATLAS) study.
methodsPatients received blinded adalimumab 40 mg or placebo every other week for 24 weeks, then open-label adalimumab for up to 5 years. Spinal mobility was evaluated using linear BASMI (BASMIlin). BASDAI, total back pain, CRP, BASFI, Short Form-36 and AS quality of life (ASQoL) were also assessed. Correlations between BASMIlin and clinical, functional and ASQoL outcomes after 12 weeks and after 5years of adalimumab exposure were evaluated using Spearman's rank correlation. Associations were further analysed using multivariate regression.
resultsThree hundred and eleven patients received ≥1 dose of adalimumab; 125 of the 208 patients originally randomized to adalimumab received treatment for 5 years. Improvements in BASMIlin were sustained through 5 years, with a mean change of -0.6 from baseline in the population who completed 5 years of treatment with adalimumab. Improvements in disease activity, physical function and ASQoL were also sustained through 5 years. BASMIlin was significantly correlated with all evaluated clinical outcomes (P < 0.001). The highest correlation was with BASFI at 12 weeks (r = 0.52) and at 5 years (r = 0.65). Multivariate regression analysis confirmed this association (P < 0.001).
conclusionTreatment with adalimumab for up to 5 years demonstrated sustained benefits in spinal mobility, disease activity, physical function and HRQoL in patients with active AS. Spinal mobility was significantly associated with short- and long-term physical function in these patients.
trial registrationClinicaltrials.gov; https://clinicaltrials.gov/NCT00085644.
Indexed as
AdalimumabAdultAntibodies, Monoclonal, HumanizedAntirheumatic AgentsDose-Response Relationship, DrugFemaleFollow-Up StudiesHumansLongitudinal StudiesMaleMiddle AgedMotor ActivityOutcome Assessment, Health CareQuality of LifeRange of Motion, ArticularSeverity of Illness IndexAdalimumabAntibodies, Monoclonal, HumanizedAntirheumatic AgentsTumor Necrosis Factor-alphaankylosing spondylitisanti-TNF drugshealth-related quality of lifephysical functionspinal mobility
Identifiers
What OpenQuestion holds
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LicenceCC BY-NC
Read underepoch 390
Registered trials
NCT00085644ClinicalTrials.gov
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.