Abstract
Management guidelines assume that results from clinical trials can be generalised, although seldom is data available to test this assumption. We aimed to determine the proportion of patients commencing tumour necrosis factor inhibition (TNFi) who would have been eligible for relevant clinical trials, and whether treatment response differs between these groups and the trials themselves. The British Society for Rheumatology Biologics Register for Ankylosing Spondylitis (BSRBR-AS) recruited a real-world cohort of TNFi-naïve spondyloarthritis patients with data collection from clinical records and patient questionnaires. Participant characteristics were extracted from trials identified from a recent Health Technology Assessment of TNFi for ankylosing spondylitis/non-radiographic axial spondyloarthritis. Descriptive statistics were used to determine the differences, including treatment response, between BSRBR-AS participants who would/would not have been eligible for the clinical trials and with trial participants. Among 2420 BSRBR-AS participants, those commencing TNFi (34%) had shorter symptom duration (15 vs 22 years) but more active disease (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 6.4 vs 4.0; Bath Ankylosing Spondylitis Disease Functional Index (BASFI) 6.2 vs 3.8). Of those commencing TNFi, 41% met eligibility criteria for ≥1 of fourteen relevant trials; they reported higher disease activity (BASDAI 6.9 vs 6.1) and poorer function (BASFI 6.6 vs 6.0). 61.7% of trial participants reported a positive treatment response, vs 51.3% of BSRBR-AS patients (difference: 10.4%; 95% CI 4.4% to 16.5%). Potential eligibility for trials did not influence treatment response (difference 2.0%; -9.4% to 13.4%). Fewer patients in the real world respond to TNFi than is reported in the trial literature. This has important implications for the generalisability of trial results, and the cost-effectiveness of TNFi agents.
Original language | English |
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Pages (from-to) | 914-919 |
Number of pages | 6 |
Journal | Annals of the Rheumatic Diseases |
Volume | 79 |
Issue number | 7 |
Early online date | 23 Apr 2020 |
DOIs | |
Publication status | Published - Jul 2020 |
Bibliographical note
Funding This work was supported by the British Society for Rheumatology (BSR) who funded the BSRBR-AS. The BSR received funding for this from Pfizer, AbbVie and UCB. These companies receive advance copies of manuscripts for comments but have no input in to the topics for analysis in the register nor the work involved in undertaking analysis. Analysis of data was supported by the Versus Arthritis/Medical Research Council Centre for Musculoskeletal Health and Work (grant number 20665).Keywords
- ankylosing spondylitis
- anti-TNF
- epidemiology
- spondyloarthritis
- BSR
- ANKYLOSING-SPONDYLITIS
- BATH
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Gary Macfarlane
- School of Medicine, Medical Sciences & Nutrition, Applied Health Sciences - Clinical Chair in Epidemiology
- School of Medicine, Medical Sciences & Nutrition, MRC/Versus Arthritis Centre for Musculoskeletal Health and Work
- School of Medicine, Medical Sciences & Nutrition, Aberdeen Centre for Arthritis and Musculoskeletal Health (ACAMH)
- School of Medicine, Medical Sciences & Nutrition, Epidemiology Group
Person: Clinical Academic