Infliximab biosimilar-to-biosimilar switching in patients with inflammatory rheumatic disease: clinical outcomes in real-world patients from the DANBIO registry
Bente Glintborg,
Anne Gitte Loft,
Asta Linauskas,
Kamilla Danebod,
Dorte Vendelbo Jensen,
Stavros Chrysidis,
Salome Kristensen,
Johnny Lillelund Raun,
Natalia Manilo,
Frank Mehnert,
Niels Steen Krogh,
Ada Colic,
Heidi Lausten Munk,
Hafsah Nabi,
Marlene Andersen,
Maren Høgberget Kalisz,
Niels Lomborg,
Pia Høger Thygesen,
Louise Brot Christensen
Affiliations
Bente Glintborg
Faculty of Health and Medical Sciences, University of Copenhagen, Kobenhavn, Denmark
Anne Gitte Loft
7 Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark
Asta Linauskas
17 Department of Rheumatology, North Denmark Regional Hospital, Hjørring, Denmark
Kamilla Danebod
12 Department of Rheumatology, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Glostrup, Denmark
Dorte Vendelbo Jensen
5 Department of Rheumatology, Gentofte and Herlev Hospital, Copenhagen University Hospital, Gentofte, Denmark
Stavros Chrysidis
21 Department of Rheumatology, Esbjerg Hospital, Esbjerg, Denmark
Salome Kristensen
14 Department of Rheumatology, Aalborg University Hospital, Aalborg, Denmark
Johnny Lillelund Raun
22 Department of Rheumatology, Hospital Lillebælt, Fredericia, Kolding, Denmark
Natalia Manilo
15 Department of Rheumatology, Frederiksberg Hospital, Copenhagen, Denmark
Frank Mehnert
24 Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark
Niels Steen Krogh
25 Zitelab Aps, Copenhagen, Denmark
Ada Colic
16 Department of Rheumatology, Zealand University Hospital, Køge, Denmark
Heidi Lausten Munk
13 Department of Rheumatology, Odense University Hospital, Odense C, Denmark
Hafsah Nabi
1 DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet, Glostrup, Denmark
Marlene Andersen
23 Department of Rheumatology, North Denmark Regional Hospital, Hjorring, Nordjylland, Denmark
Maren Høgberget Kalisz
5 Department of Rheumatology, Gentofte and Herlev Hospital, Copenhagen University Hospital, Gentofte, Denmark
Niels Lomborg
20 Department of Rheumatology, Vejle Hospital Lillebælt, Vejle, Denmark
Pia Høger Thygesen
19 Department of Rheumatology, Slagelse Hospital, Slagelse, Denmark
Louise Brot Christensen
5 Department of Rheumatology, Gentofte and Herlev Hospital, Copenhagen University Hospital, Gentofte, Denmark
Objective Successful uptake of biosimilars in rheumatology is limited by lack of real-world evidence regarding effectiveness of biosimilar-to-biosimilar switching. We investigated infliximab biosimilars CT-P13-to-GP1111 switching among patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA).Methods Observational cohort study from the DANBIO registry. Patients were classified as originator-naïve or originator-experienced. Retention rates of 1-year GP1111 treatment were explored (Kaplan-Meier). We identified baseline factors (at the time of switch) associated with withdrawal of GP1111 (multivariable Cox-regression analyses with HRs including originator treatment history). Changes in subjective and objective measures of disease activity 4 months before and after the switch were assessed in individual patients.Results Of 1605 patients (685 RA, 314 PsA and 606 AxSpA, median disease duration was 9 years, 37% in Clinical Disease Activity Index/Ankylosing Spondylitis Disease Activity Score remission), 1171 were originator-naïve. Retention rates at 1-year were 83% (95% CI: 81% to 85%) and 92% (95% CI: 90% to 95%) for the originator-naïve and originator-experienced, respectively. GP1111 retention rates were higher in originator-experienced compared to originator-naïve with RA (HR=0.4 (95% CI: 0.2 to 0.7)) and PsA (HR=0.2 (95% CI: 0.1 to 0.8)), but not significantly for AxSpA: HR=0.6 (95% CI: 0.3 to 1.2). Lower disease activity was associated with higher retention. Changes in disease activity preswitch and postswitch were close to zero.Conclusion This real-world observational study of more than 1600 patients with inflammatory arthritis showed high 1-year retention following a nationwide infliximab biosimilar-to-biosimilar switch. Retention was higher in originator-experienced and in patients with low disease activity, suggesting outcomes to be affected by patient-related rather than drug-related factors.
