Adalimumab Biosimilar-to-biosimilar Switch in Patients with Inflammatory Rheumatic Diseases – Real-world Evidence from the Nationwide Danish Registry, DANBIO

Kasper Yde Jensen¹, Hafsah Nabi², Dorte Vendelbo Jensen³, Jens Pedersen⁴, Oliver Hendricks⁵, Anne Gitte Loft⁶, Ada Colic⁷, Kamilla Danebod³, Salome Kristensen⁸, Heidi Munk⁹, Niels Lomborg¹⁰, Natalia Manilo¹¹, Stavros Chrysidis¹², Søren Just¹³, Asta Linauskas¹⁴, Pil Højgaard¹⁵, Pia Høger Thygesen¹⁶, Malene Kildemand¹⁷, Rene Drage Oestgaard¹⁸, Merete Hetland¹⁹ and Bente Glintborg²⁰, ¹Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark, ²DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Copenhagen, Denmark, Glostrup, Denmark, ³Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Glostrup, Denmark, ⁴Department of Rheumatology C, Research Unit, Odense University Hospital and Department of Clinical Research, University of Southern Denmark, Odense, Denmark, ⁵Danish Hospital For Rheumatic Diseases, Sønderborg, Denmark, ⁶Department of Rheumatology, Aarhus University Hospital and Aarhus University, Aarhus, Denmark, ⁷Department of Rheumatology, Zealand University Hospital, Koege, Denmark, ⁸Centre of Rheumatic Research Aalborg, Department of Rheumatology and Aalborg University Hospital and Department of Clinical Medicine, Aalborg University, Aalborg, Denmark, ⁹Department of Rheumatology, Odense University Hospital, Odense, Denmark and Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark, ¹⁰Department of Rheumatology, Vejle Hospital Lillebælt, Odense C, Denmark, ¹¹Department of Rheumatology, Frederiksberg Hospital, Copenhagen, Denmark, ¹²Department of Rheumatology, University Hospital of Southern Denmark, Esbjerg, Denmark, ¹³Medicinsk Afdeling Svendborg Sygehus OUH, Odense, Denmark, ¹⁴Department of Rheumatology, North Denmark Regional Hospital, Hjoerring, Denmark and Department of Clinical Medicine, Aalborg University, Aalborg, Denmark, ¹⁵Department of Internal Medicine 2; Rheumatology, Holbæk Sygehus, Holbæk, Denmark and Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Frederiksberg Hospital, Copenhagen, Denmark, ¹⁶Department of Rheumatology, Slagelse Hospital, Slagelse, Denmark, ¹⁷Department of Rheumatology, Odense University Hospital, Svendborg, Denmark, ¹⁸Department of Medicine, Goedstrup Regional Hospital and Diagnostic Center, Silkeborg Regional Hospital, Silkeborg, Denmark, ¹⁹DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet and University of Copenhagen, Copenhagen, Denmark, Glostrup, Denmark, ²⁰DANBIO, Rigshospitalet Glostrup and University of Copenhagen, Virum, Denmark

Meeting: ACR Convergence 2024

Keywords: Disease Activity, Disease-Modifying Antirheumatic Drugs (Dmards), Epidemiology, registry, risk assessment

Session Information

Date: Sunday, November 17, 2024

Title: Epidemiology & Public Health Poster II

Session Type: Poster Session B

Session Time: 10:30AM-12:30PM

Background/Purpose: In Denmark, mandatory switches between originators and corresponding biosimilar products have been performed for economic reasons for nearly a decade (1). Starting in January 2021, a biosimilar-to-biosimilar adalimumab switch from SB5 (Imraldi®) to GP2017 (Hyrimoz®) was performed in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). A subgroup of patients had previously made an additional adalimumab switch, from the originator (Humira®) to SB5 (November 2018). Evidence regarding biosimilar-to-biosimilar switch effects is scarce.
This study aims to explore GP2017 treatment retention following the SB5 switch in Danish patients with RA, PsA and axSpA, and the influence of previous originator adalimumab (ADAo) treatment history.

Methods: Observational cohort study based on prospectively registered data in the nationwide registry DANBIO (2). Patients with RA, PsA and axSpA who switched from SB5 to GP2017 in the time period January 1st 2021-June 30th 2021 were identified. Characteristics at GP2017 treatment start (baseline) were described. Follow-up was until one year after baseline, death or last visit in DANBIO, whichever came first. Flare rates 6 months before versus after the switch (RA and PsA: ΔDAS28 >1.2, axSpA: ΔASDAS >1.3) were inspected. One-year GP2017 retention was estimated with Kaplan-Meier curves (log-rank tests) according to previous ADAo treatment (yes/no). We performed Cox regression analyses stratified by diagnosis to identify characteristics associated with treatment retention. The analyses were adjusted for sex, baseline age, disease activity, patient global score on a VAS, disease duration, concomitant methotrexate, and previous ADAo history.

Results: Overall, 1233 patients (454 RA, 296 PsA, 483 axSpA) were included. At time of switch, patients with ADAo treatment history were older, had longer disease duration and lower disease activity than patients not previously treated with ADAo, while use of methotrexate was comparable for all diagnoses (Table 1).
Similar flare rates were observed for all diagnoses before versus after switch (details not shown).
Patients previously treated with ADAo had higher GP2017 one-year retention rate than patients with no ADAo treatment history (93% and 89%, Figure 2). Stratified by diagnosis, this difference was only significant for RA (log rank test, p=0.028, details not shown).
In Cox regression analyses, higher treatment retention rates were associated with methotrexate use (only RA) and male sex (PsA and axSpA), whereas there was no impact of ADAo history (Figure 2).

Conclusion: This nationwide observational study describes stable treatment outcomes following a mandatory switch from the adalimumab biosimilar SB5 to GP2017 – with GP2017 one-year retention rates of nearly 90% and unaffected flare rates. The impact of adalimumab originator treatment history was minor. These results support the use of biosimilar adalimumab in routine care.

References

Nabi H, Hetland ML, Glintborg B et al. ARD 2021
Ibfelt EH, et al. Clin Epidemiol. 2017

*MH and BG are shared last author.

Acknowledgements

Contributors to the DANBIO registry. Niels Steen Krogh, Zitelab, for datamanagement.

Figure 1 – GP2017 treatment retention following SB5 switch, stratified by previous ADAo treatment history, Kaplan-Meier analysis

Figure 2. One-year GP2017 treatment retention, results of COX regression analyses with Hazard ratios and Forest plots

Disclosures: K. Jensen: None; H. Nabi: AbbVie/Abbott, 5, Sandoz, 5; D. Jensen: None; J. Pedersen: None; O. Hendricks: None; A. Loft: None; A. Colic: Eli Lilly, 1, Janssen, 5, Novartis, 1, Synteos, 5; K. Danebod: None; S. Kristensen: None; H. Munk: None; N. Lomborg: None; N. Manilo: None; S. Chrysidis: None; S. Just: None; A. Linauskas: None; P. Højgaard: None; P. Thygesen: Boehringer-Ingelheim, 5; M. Kildemand: None; R. Oestgaard: None; M. Hetland: AbbVie/Abbott, 5, 12, Paid to my institution, no personal fee, Bristol-Myers Squibb(BMS), 5, 12, Paid to my institution, no personal fee, Eli Lilly, 5, 12, Paid to my institution, no personal fee, Medac, 6, 12, Paid to my institution, no personal fee, Merck/MSD, 5, 12, Paid to my institution, no personal fee, Novartis, 5, 6, Pfizer, 5, 6, 12, Paid to my institution, no personal fee, Sandoz, 5, 6, 12, Paid to my institution, no personal fee, UCB, 6, 12, Paid to my institution, no personal fee; B. Glintborg: AbbVie/Abbott, 5, Bristol-Myers Squibb(BMS), 5, Pfizer, 5, Sandoz, 5.

To cite this abstract in AMA style:

Jensen K, Nabi H, Jensen D, Pedersen J, Hendricks O, Loft A, Colic A, Danebod K, Kristensen S, Munk H, Lomborg N, Manilo N, Chrysidis S, Just S, Linauskas A, Højgaard P, Thygesen P, Kildemand M, Oestgaard R, Hetland M, Glintborg B. Adalimumab Biosimilar-to-biosimilar Switch in Patients with Inflammatory Rheumatic Diseases – Real-world Evidence from the Nationwide Danish Registry, DANBIO [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/adalimumab-biosimilar-to-biosimilar-switch-in-patients-with-inflammatory-rheumatic-diseases-real-world-evidence-from-the-nationwide-danish-registry-danbio/. Accessed .

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