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  1. H. Nabi1,2,
  2. M. L. Hetland1,2,
  3. A. G. Loft3,4,
  4. O. Hendricks5,6,
  5. D. Jensen7,8,
  6. J. K. Pedersen9,
  7. S. A. Just9,
  8. K. Danebod10,
  9. H. L. Munk11,
  10. S. Kristensen12,
  11. N. Manilo13,
  12. A. Colic14,
  13. A. Linauskas15,
  14. P. H. Thygesen16,
  15. L. B. Christensen7,
  16. M. Høgberget Kalisz7,
  17. N. Lomborg17,
  18. J. Grydehøj18,
  19. J. Raun19,
  20. R. Ahmed10,
  21. F. Mehnert4,
  22. N. Steen Krogh20,
  23. B. Glintborg1,2
  1. 1Rigshospitalet - Glostrup, DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Glostrup, Denmark
  2. 2University of Copenhagen, Department of Clinical medicine, Copenhagen, Denmark
  3. 3Aarhus University Hospital, Department of Rheumatology, Aarhus, Denmark
  4. 4Aarhus University, Department of Clinical Medicine, Aarhus, Denmark
  5. 5University Hospital of Southern Denmark, Danish Hospital for Rheumatic Diseases, Sønderborg, Denmark
  6. 6University of Southern Denmark, Department of Regional Health Research, Odense, Denmark
  7. 7Gentofte and Herlev Hospital, Department of Rheumatology, Gentofte, Denmark
  8. 8Rønne Hospital, Department of Internal Medicine, Rønne, Denmark
  9. 9Svendborg Hospital, Rheumatology Section, Department of Medicine M, Svendborg, Denmark
  10. 10Copenhagen University Hospital Rigshospitalet, Department of Rheumatology, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Glostrup, Denmark
  11. 11Odense University Hospital, Department of Rheumatology, Odense, Denmark
  12. 12Aalborg University Hospital, Department of Rheumatology, Aalborg, Denmark
  13. 13Frederiksberg Hospital, Department of Rheumatology, Frederiksberg, Denmark
  14. 14Zealand University Hospital, Department of Rheumatology, Køge, Denmark
  15. 15North Denmark Regional Hospital, Department of Rheumatology, Hjørring, Denmark
  16. 16Slagelse Hospital, Department of Rheumatology, Slagelse, Denmark
  17. 17Vejle Hospital Lillebælt, Department of Rheumatology, Vejle, Denmark
  18. 18Holstebro Hospital, Department of Rheumatology, Holstebro, Denmark
  19. 19Sygehus Lillebælt, Department of Rheumatology, Fredericia, Kolding, Denmark
  20. 20Zitelab ApS, Zitelab, Copenhagen, Denmark


Background In routine care, biosimilar-to-biosimilar infliximab switching may occur to save costs (=non-medical switching). Previous studies have investigated the efficacy and safety of switches from originator infliximab to a corresponding biosimilar in patients with inflammatory rheumatic diseases (1). However, the outcomes after switching from one infliximab biosimilar to a second infliximab biosimilar remain scarcely investigated.

Denmark has recently conducted a nationwide mandatory infliximab biosimilar-to-biosimilar switch.

Objectives To investigate the effectiveness of infliximab biosimilar-to-biosimilar switch (CTP-13 to GP1111) among patients with RA, PsA and AxSpA, including patients who had previously switched from originator (originator-experienced) to CT-P13 as well as patients who were originator-naïve.

Methods Observational cohort study based on DANBIO registry (for clinical data upon switch =baseline) linked with national patient registries (to identify prior comorbidities). Patients with RA, PsA or AxSpA who performed a biosimilar-to-biosimilar switch from CT-P13 to GP1111 between April 1st 2019 and February 1st 2020 were included. Patient were divided into two groups: originator-naïve and originator-experienced. Main outcomes in the two groups were one-year GP1111 treatment retention (Kaplan Meier “drug survival curves”) and changes in disease activity 4 months before versus 4 months after switch in individual patients. Also, factors associated with GP1111 treatment retention for both groups combined were explored with Cox proportional hazard regression analyses, stratified by diagnosis (univariate-, age-and gender adjusted and fully adjusted). Analyses were adjusted for relevant clinical factors (for details: see Table 1)

Table 1.

Baseline variables associated with GP1111 withdrawal (RA shown below, similar findings for PsA and AxSpA)

Results In total, 1,605 patients underwent an infliximab biosimilar-to-biosimilar switch and were included; 1,171 were originator-naïve and 434 were originator-experienced, 685 RA/314 PsA/606 AxSpA, median disease duration was 9 years, 42% were in DAS28/ASDAS remission at the time of switch.

At one year, 83% (95% CI 81-85) of the originator-naive and 92% (95% CI 90-95) of the originator-experienced switchers maintained GP1111 treatment (Figure 1). Changes in disease activity 4 months pre- and post-switch were close to zero for all disease activity measures (e.g. DAS28, ASDAS, VAS pain, not shown).

The risk of GP1111 withdrawal was lower in originator-experienced compared to originator-naïve patients in patients with RA and PsA: HR 0.4 (95% CI 0.2-0.9, p-value 0.01) and HR 0.1 (0.1-0.6, p=0.01), but not significantly for AxSpA 0.56 (0.27-1.13, p=0.1). Across all indications, lower disease activity at baseline (DAS28/ASDAS remission) was associated with higher retention (Table 1).

Conclusion Biosimilar-to-biosimilar infliximab switch was effective and well-tolerated in >1,500 real-world patients. Retention was higher in originator-experienced switchers and patients, who were in remission at the time of the switch, suggesting retention to be more affected by patient-related than drug-related factors.

References [1]Glintborg et al, ARD, 2017; 76: 1426–1431

Acknowledgements We thank departments reporting to the DANBIO registry.

Disclosure of Interests Hafsah Nabi Grant/research support from: Research grant from Sandoz, who had no influence on the analysis, interpretation and presentation of data., Merete L. Hetland Speakers bureau: Biogen, Celltrion, Janssen Biologics B.V, MSD, Pfizer, Samsung Biopis, Consultant of: Biogen, Celltrion, Janssen Biologics B.V, MSD, Pfizer,

Samsung Biopis, Grant/research support from: AbbVie, Biogen, BMS, Eli Lilly Denmark A/S,

Lundbeck Fond, Pfizer, Roche, Sandoz, Novartis, Anne Gitte Loft Paid instructor for: AbbVie, Eli Lilly Denmark A/S, Janssen- Cilag A/S, MSD, Novartis, Pfizer, UCB, Consultant of: AbbVie, Eli Lilly Denmark A/S, Janssen-Cilag

A/S, MSD, Novartis, Pfizer, UCB, Grant/research support from: Novartis, Oliver Hendricks Speakers bureau: AbbVie, Pfizer, Novartis, Dorte Jensen: None declared, Jens Kristian Pedersen: None declared, Søren Andreas Just: None declared, Kamilla Danebod: None declared, Heidi Lausten Munk: None declared, Salome Kristensen: None declared, Natalia Manilo: None declared, Ada Colic: None declared, Asta Linauskas: None declared, Pia Høger Thygesen: None declared, Louise Brot Christensen: None declared, Maren Høgberget Kalisz: None declared, Niels Lomborg: None declared, Jolanta Grydehøj: None declared, Johnny Raun: None declared, Rabiah Ahmed: None declared, Frank Mehnert: None declared, Niels Steen Krogh: None declared, Bente Glintborg Grant/research support from: BMS, Pfizer, Sandoz.

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