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Observational Study
. 2022 Aug 30;61(9):3596-3605.
doi: 10.1093/rheumatology/keab933.

Comparison of treatment retention of originator vs biosimilar products in clinical rheumatology practice in Sweden

Daniela Di Giuseppe  1 , Ulf Lindstrom  2 , Hannah Bower  1 , Bénédicte Delcoigne  1 , Thomas Frisell  1 , Katerina Chatzidionysiou  3 , Christopher Sjöwall  4 , Elisabet Lindqvist  5 , Johan Askling  1
Affiliations
Observational Study

Comparison of treatment retention of originator vs biosimilar products in clinical rheumatology practice in Sweden

Daniela Di Giuseppe et al. Rheumatology (Oxford). .

Abstract

Objectives: To compare treatment retention between biosimilars and their originator products among first starters (etanercept, infliximab, adalimumab and rituximab), as well as after non-medical switch.

Methods: Patients with rheumatic diseases starting, for the first time, an originator or biosimilar etanercept, infliximab, adalimumab or rituximab were identified in the national Swedish Rheumatology Quality Register. Moreover, patients switching from an originator to its biosimilar were identified and individually matched to patients continuing on the originator. One-year treatment retention was calculated and hazard ratios (HR) for discontinuation with 95% CIs were estimated, adjusting for comorbidities and socio-economic factors.

Results: In total, 21 443 first treatment courses were identified. The proportion of patients still on the drug at 1 year and the HR for discontinuation revealed no differences across adalimumab (Humira, Imraldi, Amgevita and Hyrimoz) nor across rituximab products (Mabthera, Ritemvia/Truxima and Rixathon). The proportions on the drug at 1 year were similar for Benepali (77%) and Enbrel (75%) and the adjusted HR for Benepali compared with Enbrel was 0.91 (95% CI 0.83, 0.99). For infliximab, the proportion still on the drug at 1 year was 67% for Remicade and 66% for Remsima/Inflectra and the HR compared with Remicade was 1.16 (95% CI 1.02, 1.33). Among 2925 patients switching from an originator drug to one of its biosimilars, we noted no statistically significant or clinically relevant differences in drug survival compared with those who remained on originator therapy.

Conclusion: This large observational study supports the equivalence of biologic DMARD biosimilar products and originators when used in routine rheumatology care.

Keywords: bDMARDs; biosimilar; retention; rheumatic diseases.

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Figures

<sc>Fig</sc>. 1
Fig. 1
Treatment retention for first starters of each bDMARD using Kaplan–Meier estimation
<sc>Fig</sc>. 2
Fig. 2
Crude 1 year retention rate and adjusted HR of discontinuation for originators and biosimilars HR <1 represents a lower discontinuation rate for the biosimilar compared with the originator. *HR for Flixabi not estimated due to <10 discontinuation events. The adjusted HR is adjusted for age, sex, indication, disease duration, line of treatment, year of start of treatment, region, education, concomitant use of csDMARDs and a comorbidity score based on the sum of comorbidities among malignancy, chronic obstructive and interstitial lung disease, heart failure, diabetes, myocardial infarction, kidney, prosthesis and infection.
<sc>Fig</sc>. 3
Fig. 3
Crude 1 year retention and adjusted HR of discontinuation following a non-medical switch to a biosimilar compared with matched controls continuing on the originator HR <1 represents a lower discontinuation rate for the biosimilar compared with the originator. *HR for Amgevita, Rixathon and Ritemvia/Truxima not estimated due to <10 discontinuation events. HR for Hyrimoz based on a model with only age, sex, indication, line of treatment, duration and concomitant csDMARD.
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