TY - JOUR
T1 - Comparative effectiveness of two adalimumab biosimilars in 1318 real-world patients with inflammatory rheumatic disease mandated to switch from originator adalimumab
T2 - nationwide observational study emulating a randomised clinical trial
AU - Nabi, Hafsah
AU - Georgiadis, Stylianos
AU - Loft, Anne Gitte
AU - Hendricks, Oliver
AU - Jensen, Dorte Vendelbo
AU - Andersen, Marlene
AU - Chrysidis, Stavros
AU - Colic, Ada
AU - Danebod, Kamilla
AU - Hussein, Mohamad Redha
AU - Kalisz, Maren Høgberget
AU - Kristensen, Salome
AU - Lomborg, Niels
AU - Manilo, Natalia
AU - Munk, Heidi Lausten
AU - Pedersen, Jens Kristian
AU - Raun, Johnny Lillelund
AU - Mehnert, Frank
AU - Krogh, Niels Steen
AU - Hetland, Merete Lund
AU - Glintborg, Bente
N1 - © Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.
COPECARE
PY - 2021/11
Y1 - 2021/11
N2 - OBJECTIVES: In 2018, a nationwide mandatory switch from originator to biosimilar adalimumab was conducted in Denmark. The available biosimilar was GP2017 (Hyrimoz) in Eastern regions and SB5 (Imraldi) in Western regions. We aimed to assess the comparative effectiveness of GP2017 versus SB5 in patients with rheumatoid arthritis (RA)/psoriatic arthritis (PsA)/axial spondyloarthritis (AxSpA).METHODS: Observational cohort study based on the DANBIO registry with geographical cluster pseudo-randomisation, analysed by emulating a randomised clinical trial. Main outcome was adjusted 1-year treatment retention (Cox regression). Furthermore, 6 months' remission rates (logistic regression), reasons for withdrawal and back-switching to originator were investigated (overall and stratified by indication).RESULTS: Overall, of 1570 eligible patients, 1318 switched and were included (467 RA/321 PsA/530 AxSpA); 623 (47%) switched to GP2017, 695 (53%) to SB5. Baseline characteristics of the two clusters were largely similar, but some differences in registration practice were observed. The combined 1-year retention rate for the two biosimilars was 89.5%. Compared with SB5, estimated risk of withdrawal for GP2017 was lower (HR 0.60; 95% CI 0.42 to 0.86) and 6 months' remission rate was higher (OR 1.72; 95% CI 1.25 to 2.37). Stratified analyses gave similar results (statistically significant for RA). During 1 year, 8.5% and 12.9% withdrew GP2017 and SB5, respectively (primarily lack of effect and adverse events), of whom 48 patients (3.6%) back-switched.CONCLUSION: This head-to-head comparison of GP2017 versus SB5 following a mandatory switch from the originator indicated differences in effectiveness in routine care. This may reflect a true difference, but other explanations, for example, differences in excipients, differences between clusters and residual confounding cannot be ruled out.
AB - OBJECTIVES: In 2018, a nationwide mandatory switch from originator to biosimilar adalimumab was conducted in Denmark. The available biosimilar was GP2017 (Hyrimoz) in Eastern regions and SB5 (Imraldi) in Western regions. We aimed to assess the comparative effectiveness of GP2017 versus SB5 in patients with rheumatoid arthritis (RA)/psoriatic arthritis (PsA)/axial spondyloarthritis (AxSpA).METHODS: Observational cohort study based on the DANBIO registry with geographical cluster pseudo-randomisation, analysed by emulating a randomised clinical trial. Main outcome was adjusted 1-year treatment retention (Cox regression). Furthermore, 6 months' remission rates (logistic regression), reasons for withdrawal and back-switching to originator were investigated (overall and stratified by indication).RESULTS: Overall, of 1570 eligible patients, 1318 switched and were included (467 RA/321 PsA/530 AxSpA); 623 (47%) switched to GP2017, 695 (53%) to SB5. Baseline characteristics of the two clusters were largely similar, but some differences in registration practice were observed. The combined 1-year retention rate for the two biosimilars was 89.5%. Compared with SB5, estimated risk of withdrawal for GP2017 was lower (HR 0.60; 95% CI 0.42 to 0.86) and 6 months' remission rate was higher (OR 1.72; 95% CI 1.25 to 2.37). Stratified analyses gave similar results (statistically significant for RA). During 1 year, 8.5% and 12.9% withdrew GP2017 and SB5, respectively (primarily lack of effect and adverse events), of whom 48 patients (3.6%) back-switched.CONCLUSION: This head-to-head comparison of GP2017 versus SB5 following a mandatory switch from the originator indicated differences in effectiveness in routine care. This may reflect a true difference, but other explanations, for example, differences in excipients, differences between clusters and residual confounding cannot be ruled out.
KW - Adalimumab/therapeutic use
KW - Adult
KW - Aged
KW - Antirheumatic Agents/therapeutic use
KW - Arthritis, Psoriatic/drug therapy
KW - Arthritis, Rheumatoid/drug therapy
KW - Biosimilar Pharmaceuticals/therapeutic use
KW - Cohort Studies
KW - Comparative Effectiveness Research
KW - Denmark
KW - Drug Substitution
KW - Female
KW - Humans
KW - Logistic Models
KW - Male
KW - Medication Adherence
KW - Middle Aged
KW - Proportional Hazards Models
KW - Registries
KW - Spondylarthropathies/drug therapy
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=85105744780&partnerID=8YFLogxK
U2 - 10.1136/annrheumdis-2021-219951
DO - 10.1136/annrheumdis-2021-219951
M3 - Journal article
C2 - 33926921
SN - 0003-4967
VL - 80
SP - 1400
EP - 1409
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
IS - 11
ER -