Comparative effectiveness of two adalimumab biosimilars in 1318 real-world patients with inflammatory rheumatic disease mandated to switch from originator adalimumab: nationwide observational study emulating a randomised clinical trial

Abstract

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.

Adalimumab and ABP 501 in the Treatment of a Large Cohort of Patients with Inflammatory Arthritis: A Real Life Retrospective Analysis

“…Our results highlight the overall good drug persistence of ABP 501 in both inflammatory arthritides patients who are naïve and experienced to ADA. In particular, ABP 501 patients switching from originator to biosimilar showed a high retention rate that was comparable to the ones reported for other ADA biosimilars such as GP2017 and SB5 [ 17 ].…”

“…Moreover, patients switching from originator ADA to ABP 501 showed a lower risk of treatment discontinuation. Observational data on both other ADA biosimilars such as GP2017 and SB5 [ 17 , 25 ] and other TNFi biosimilars [ 26 , 27 , 28 , 29 , 30 ] showed that switching from originator to biosimilar was tolerated generally well. The only other factor associated with a negative effect on drug survival in our cohort of patients was the year of ADA prescription.…”

Effectiveness and safety of a biosimilar-to-biosimilar switch of the TNF inhibitor etanercept in patients with chronic inflammatory rheumatic diseases

“… 6 Other data from the DANBIO registry on a non-medical switch from originator to two different adalimumab (ADA) bsDMARDs (GP2017 versus SB5) also showed a high retention rate of 89.5% at year 1. 14 This head-to-head comparison of two different bsDMARD was possible because of different results of price negotiations in two regions of Denmark. Interestingly, the estimated risk of withdrawal was lower for GP2017 compared with SB5 [hazard ratio (HR): 0.60; 95% CI: 0.42 to 0.86], and the 6-month remission rate was also higher [odds ratio (OR): 1.72; 95% CI: 1.25 to 2.37].…”

Patient-Reported Outcomes in Rheumatoid Arthritis: A Key Consideration for Evaluating Biosimilar Uptake?

“… 1 , 6 , 11 , 32 Biosimilars are increasingly used in routine care of patients with RA. 33 However, the uptake of biosimilars has varied considerably between countries. 34 Randomized clinical trials (RCTs) and real-world data are crucial to improving physician and patient confidence in these medicines.…”