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Pooled analysis of TNF inhibitor biosimilar studies comparing radiographic progression by disease activity states in rheumatoid arthritis
- Source :
- RMD Open, Vol 6, Iss 1 (2020), RMD Open
- Publication Year :
- 2020
- Publisher :
- BMJ, 2020.
-
Abstract
- ObjectiveTo evaluate the relationship between disease activity and radiographic progression in rheumatoid arthritis, three phase III studies of SB4, SB2 and SB5 (biosimilars of etanercept, infliximab and adalimumab) were pooled to assess radiographic progression by disease activity status.MethodsPatients from each study with radiographic data were pooled and grouped based on disease activity state (remission, low disease activity (LDA), moderate disease activity (MDA) and high disease activity (HDA)), determined by disease activity score based on 28-joint count (DAS28) per erythrocyte sedimentation rate, Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) at different time points. Mean change in modified Total Sharp Score (mTSS) and the proportion of radiographic non-progressors of higher disease activity groups (LDA, MDA and HDA) in reference to remission were summarised descriptively, with comparison of ORs using logistic models.Results1265 patients were included. In all treatments combined, the 1 year mean change in mTSS was 0.03, 0.4, 0.3 and 1.3 and proportion of radiographic non-progressors was 79.8%, 78.1%, 74.1% and 58.4% in the week 24/30 DAS28-determined remission, LDA, MDA and HDA groups, respectively. ORs (95% CIs) of the proportion of non-progressors were lowest in the HDA group in reference to remission (0.35 (0.23 to 0.54)), followed by MDA (0.72 (0.50 to 1.05)) and LDA (0.90 (0.55 to 1.48)) groups. Similar trends were observed when disease activity was assessed using SDAI or CDAI.ConclusionA pooled analysis of radiographic assessment data from three biosimilar studies showed that radiographic progression is small overall but increases with worse disease activity.Trial registration numbersNCT01895309, NCT01936181 and NCT02167139
- Subjects :
- Adult
Male
medicine.medical_specialty
medicine.medical_treatment
Radiography
Immunology
lcsh:Medicine
Arthritis
Rheumatoid Arthritis
DMARDs (biologic)
Severity of Illness Index
Gastroenterology
Etanercept
Arthritis, Rheumatoid
Rheumatology
Internal medicine
medicine
Adalimumab
Humans
Immunology and Allergy
skin and connective tissue diseases
Biosimilar Pharmaceuticals
Aged
medicine.diagnostic_test
business.industry
Remission Induction
lcsh:R
anti-TNF
Middle Aged
medicine.disease
Infliximab
TNF inhibitor
Logistic Models
arthritis
Antirheumatic Agents
Erythrocyte sedimentation rate
Rheumatoid arthritis
Disease Progression
Female
Tumor Necrosis Factor Inhibitors
business
medicine.drug
Subjects
Details
- ISSN :
- 20565933
- Volume :
- 6
- Database :
- OpenAIRE
- Journal :
- RMD Open
- Accession number :
- edsair.doi.dedup.....2d56d33346f578b1d2937f0b03a90260
- Full Text :
- https://doi.org/10.1136/rmdopen-2019-001096