TY - JOUR
T1 - Infliximab biosimilar-to-biosimilar switching in patients with inflammatory rheumatic disease
T2 - clinical outcomes in real-world patients from the DANBIO registry
AU - Nabi, Hafsah
AU - Hendricks, Oliver
AU - Jensen, Dorte Vendelbo
AU - Loft, Anne Gitte
AU - Pedersen, Jens Kristian
AU - Just, Søren Andreas
AU - Danebod, Kamilla
AU - Munk, Heidi Lausten
AU - Kristensen, Salome
AU - Manilo, Natalia
AU - Colic, Ada
AU - Linauskas, Asta
AU - Thygesen, Pia Høger
AU - Christensen, Louise Brot
AU - Kalisz, Maren Høgberget
AU - Lomborg, Niels
AU - Chrysidis, Stavros
AU - Raun, Johnny Lillelund
AU - Andersen, Marlene
AU - Mehnert, Frank
AU - Krogh, Niels Steen
AU - Hetland, Merete Lund
AU - Glintborg, Bente
N1 - COPECARE
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2022/11
Y1 - 2022/11
N2 - 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.
AB - 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.
KW - Humans
KW - Biosimilar Pharmaceuticals/therapeutic use
KW - Infliximab/therapeutic use
KW - Arthritis, Psoriatic/diagnosis
KW - Treatment Outcome
KW - Arthritis, Rheumatoid/diagnosis
KW - Registries
UR - http://www.scopus.com/inward/record.url?scp=85142939150&partnerID=8YFLogxK
U2 - 10.1136/rmdopen-2022-002560
DO - 10.1136/rmdopen-2022-002560
M3 - Journal article
C2 - 36418087
SN - 2056-5933
VL - 8
JO - RMD Open
JF - RMD Open
IS - 2
M1 - 002560
ER -