Objectives In 2018, a nationwide mandatory switch from originator to biosimilar adalimumab was conducted in Denmark. The available biosimilar was GP2017 (Hyrimoz) in Eastern regions and SB5 (Imraldi) in Western regions. We aimed to assess the comparative effectiveness of GP2017 versus SB5 in patients with rheumatoid arthritis (RA)/psoriatic arthritis (PsA)/axial spondyloarthritis (AxSpA).
Methods Observational cohort study based on the DANBIO registry with geographical cluster pseudo-randomisation, analysed by emulating a randomised clinical trial. Main outcome was adjusted 1-year treatment retention (Cox regression). Furthermore, 6 months’ remission rates (logistic regression), reasons for withdrawal and back-switching to originator were investigated (overall and stratified by indication).
Results Overall, of 1570 eligible patients, 1318 switched and were included (467 RA/321 PsA/530 AxSpA); 623 (47%) switched to GP2017, 695 (53%) to SB5. Baseline characteristics of the two clusters were largely similar, but some differences in registration practice were observed. The combined 1-year retention rate for the two biosimilars was 89.5%. Compared with SB5, estimated risk of withdrawal for GP2017 was lower (HR 0.60; 95% CI 0.42 to 0.86) and 6 months’ remission rate was higher (OR 1.72; 95% CI 1.25 to 2.37). Stratified analyses gave similar results (statistically significant for RA). During 1 year, 8.5% and 12.9% withdrew GP2017 and SB5, respectively (primarily lack of effect and adverse events), of whom 48 patients (3.6%) back-switched.
Conclusion This head-to-head comparison of GP2017 versus SB5 following a mandatory switch from the originator indicated differences in effectiveness in routine care. This may reflect a true difference, but other explanations, for example, differences in excipients, differences between clusters and residual confounding cannot be ruled out.
- biosimilar pharmaceuticals
Data availability statement
All data relevant to the study are included in the article or uploaded as supplementary information.
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Handling editor Josef S Smolen
MLH and BG shared last authorship and contributed equally to the paper.
Correction notice This article has been corrected since it published Online First. The author, Dorte Vendelbo Jensen, has been added.
Contributors Study conception and design: HN, SG, BG and MLH. Acquisition of data: HN, SG, BG, MLH, FM and NSK. Statistical analysis: HN, SG, BG and MLH. All authors contributed to the interpretation of the data. HN, SG, BG and MLH wrote the manuscript. All authors critically revised the manuscript. All authors revised and approved the final manuscript to be published.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests AGL: AbbVie, Eli Lilly Denmark A/S, Janssen-Cilag A/S, MSD, Novartis, Pfizer, UCB teaching or consultancy fees. OH: AbbVie, Pfizer, Novartis. MLH: AbbVie, Biogen, BMS, Celtrion, Eli Lilly Denmark A/S, Janssen Biologics BV, Lundbeck Fonden, MSD, Pfizer, Roche, Samsung Bioepis, Sandoz. Furthermore, chair of the steering committee of the Danish Rheumatology Quality Registry (DANBIO), which receives public funding from the hospital owners and funding from pharmaceutical companies. Co-chair EuroSpA, which generates real-world evidence of treatment of psoriatic arthritis and axial spondyloarthritis based on secondary data and is partly funded by Novartis. BG: BMS, Pfizer, Sandoz (research grants).
Provenance and peer review Not commissioned; externally peer reviewed.
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