Switching to Biosimilar SDZ-ADL in Patients with
Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week
Efficacy, Safety and Immunogenicity Results From the Phase III,
Randomized, Double-Blind ADMYRA Study

J 2020

Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study

WILAND, P., S. JEKA, Eva DOKOUPILOVÁ, J. BRANDT-JURGENS, J. M. M. LIMON et. al.

Základní údaje

Originální název

Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study

Autoři

WILAND, P. (garant), S. JEKA, Eva DOKOUPILOVÁ (203 Česká republika, domácí), J. BRANDT-JURGENS, J. M. M. LIMON, M. C. MOREIRA, R. V. CABELLO, J. JAUCH-LEMBACH, A. THAKUR, H. HALIDUOLA, I. BRUECKMANN a N. B. GAYLIS

Vydání

BIODRUGS, NORTHCOTE, ADIS INT LTD, 2020, 1173-8804

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30104 Pharmacology and pharmacy

Stát vydavatele

Nový Zéland

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 5.807

Kód RIV

RIV/00216224:14160/20:00118262

Organizační jednotka

Farmaceutická fakulta

DOI

http://dx.doi.org/10.1007/s40259-020-00447-6

UT WoS

000585016900001

Klíčová slova anglicky

COLLEGE-OF-RHEUMATOLOGY; DISEASE-ACTIVITY SCORE; PROPOSED ADALIMUMAB; CRITERIA; GP2017; PSORIASIS

Štítky

rivok, ÚFT

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 25. 2. 2021 08:24, Mgr. Hana Hurtová

Anotace

V originále

Background Sandoz adalimumab SDZ-ADL (GP-2017) is an approved adalimumab biosimilar with similar efficacy and comparable safety and immunogenicity to reference adalimumab (ref-ADL) as confirmed by analytical, pharmacokinetic and confirmatory studies. ADMYRA, a phase III double-blind study, was conducted with an aim to generate efficacy, safety and immunogenicity comparability data in patients with moderate-to-severe rheumatoid arthritis (RA) having inadequate response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX). The study also evaluated an aspect of 'switching' reference product to the biosimilar in terms of efficacy, safety and immunogenicity up to Week 48. Methods Eligible patients (N = 353) were randomized 1:1 to receive subcutaneous (sc) SDZ-ADL 40 mg (n = 177) or ref-ADL (n = 176) every other week from Week 0 to Week 24. At Week 24, all patients with at least a moderate response by Disease Activity Score-28 including high-sensitivity C-reactive protein (DAS28-CRP) in the SDZ-ADL group continued SDZ-ADL (n = 159), and in the ref-ADL group were switched to SDZ-ADL (n = 166), treated for up to 46 weeks. The primary endpoint was change in DAS28-CRP from baseline at Week 12. Other efficacy endpoints included proportion of patients with European League Against Rheumatism (EULAR) response, EULAR remission, Boolean remission, safety and immunogenicity. Results The DAS28-CRP score changes from baseline at Week 12 were similar between SDZ-ADL (- 2.16) and ref-ADL (- 2.18) with a mean difference (95% CI) of 0.02 (- 0.24 to 0.27), which was within the pre-specified equivalence margin of +/- 0.6. After switching treatment from ref-ADL to SDZ-ADL, the mean DAS28-CRP change was similar between the SDZ-ADL and 'ref-ADL/switched SDZ-ADL' group (- 3.09 vs - 3.05). The proportion of patients with good/moderate EULAR response was 69.2%/29.0% in the SDZ-ADL group and 68.0%/29.6% in the 'ref-ADL/switched SDZ-ADL' group. The proportion of patients in EULAR remission was 51.4% and 54.4% and in Boolean remission was 16.8% and 21.6% for SDZ-ADL and 'ref-ADL/switched SDZ-ADL' groups, respectively. The secondary endpoints were similar across the treatment groups. The incidence of adverse events (AEs) and injection-site reactions were low and similar between SDZ-ADL and 'ref-ADL/switched SDZ-ADL' groups (AEs 70.6% vs 68.8%, injection-site reactions 4.0% vs 6.3%), and most of these patients experienced AEs of mild or moderate severity. Antidrug antibodies were detected in 24.2% and 25.6% of patients treated with SDZ-ADL and 'ref-ADL/switched SDZ-ADL', respectively, from baseline to Week 48, of which 72.5% in SDZ-ADL and 79.1% in 'ref-ADL/switched SDZ-ADL' groups were neutralizing. Conclusions In patients with moderate-to-severe RA who had an inadequate response to DMARDs, SDZ-ADL demonstrated a similar efficacy and a comparable safety and immunogenicity profile to ref-ADL. Efficacy was sustained after switching from ref-ADL to SDZ-ADL with no impact on safety (NCT02744755).

Citovat

WILAND, P., S. JEKA, Eva DOKOUPILOVÁ, J. BRANDT-JURGENS, J. M. M. LIMON, M. C. MOREIRA, R. V. CABELLO, J. JAUCH-LEMBACH, A. THAKUR, H. HALIDUOLA, I. BRUECKMANN a N. B. GAYLIS. Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study. BIODRUGS. NORTHCOTE: ADIS INT LTD, 2020, roč. 34, č. 6, s. 809-823. ISSN 1173-8804. Dostupné z: https://dx.doi.org/10.1007/s40259-020-00447-6.

@article{1746199,
   author = {Wiland, P. and Jeka, S. and Dokoupilová, Eva and BrandtandJurgens, J. and Limon, J. M. M. and Moreira, M. C. and Cabello, R. V. and JauchandLembach, J. and Thakur, A. and Haliduola, H. and Brueckmann, I. and Gaylis, N. B.},
   article_location = {NORTHCOTE},
   article_number = {6},
   doi = {http://dx.doi.org/10.1007/s40259-020-00447-6},
   keywords = {COLLEGE-OF-RHEUMATOLOGY; DISEASE-ACTIVITY SCORE; PROPOSED ADALIMUMAB; CRITERIA; GP2017; PSORIASIS},
   language = {eng},
   issn = {1173-8804},
   journal = {BIODRUGS},
   title = {Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study},
   url = {https://pubmed.ncbi.nlm.nih.gov/33119861/},
   volume = {34},
   year = {2020}
}

TY  - JOUR
ID  - 1746199
AU  - Wiland, P. - Jeka, S. - Dokoupilová, Eva - Brandt-Jurgens, J. - Limon, J. M. M. - Moreira, M. C. - Cabello, R. V. - Jauch-Lembach, J. - Thakur, A. - Haliduola, H. - Brueckmann, I. - Gaylis, N. B.
PY  - 2020
TI  - Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study
JF  - BIODRUGS
VL  - 34
IS  - 6
SP  - 809-823
EP  - 809-823
PB  - ADIS INT LTD
SN  - 11738804
KW  - COLLEGE-OF-RHEUMATOLOGY
KW  - DISEASE-ACTIVITY SCORE
KW  - PROPOSED ADALIMUMAB
KW  - CRITERIA
KW  - GP2017
KW  - PSORIASIS
UR  - https://pubmed.ncbi.nlm.nih.gov/33119861/
N2  - Background Sandoz adalimumab SDZ-ADL (GP-2017) is an approved adalimumab biosimilar with similar efficacy and comparable safety and immunogenicity to reference adalimumab (ref-ADL) as confirmed by analytical, pharmacokinetic and confirmatory studies. ADMYRA, a phase III double-blind study, was conducted with an aim to generate efficacy, safety and immunogenicity comparability data in patients with moderate-to-severe rheumatoid arthritis (RA) having inadequate response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX). The study also evaluated an aspect of 'switching' reference product to the biosimilar in terms of efficacy, safety and immunogenicity up to Week 48. Methods Eligible patients (N = 353) were randomized 1:1 to receive subcutaneous (sc) SDZ-ADL 40 mg (n = 177) or ref-ADL (n = 176) every other week from Week 0 to Week 24. At Week 24, all patients with at least a moderate response by Disease Activity Score-28 including high-sensitivity C-reactive protein (DAS28-CRP) in the SDZ-ADL group continued SDZ-ADL (n = 159), and in the ref-ADL group were switched to SDZ-ADL (n = 166), treated for up to 46 weeks. The primary endpoint was change in DAS28-CRP from baseline at Week 12. Other efficacy endpoints included proportion of patients with European League Against Rheumatism (EULAR) response, EULAR remission, Boolean remission, safety and immunogenicity. Results The DAS28-CRP score changes from baseline at Week 12 were similar between SDZ-ADL (- 2.16) and ref-ADL (- 2.18) with a mean difference (95% CI) of 0.02 (- 0.24 to 0.27), which was within the pre-specified equivalence margin of +/- 0.6. After switching treatment from ref-ADL to SDZ-ADL, the mean DAS28-CRP change was similar between the SDZ-ADL and 'ref-ADL/switched SDZ-ADL' group (- 3.09 vs - 3.05). The proportion of patients with good/moderate EULAR response was 69.2%/29.0% in the SDZ-ADL group and 68.0%/29.6% in the 'ref-ADL/switched SDZ-ADL' group. The proportion of patients in EULAR remission was 51.4% and 54.4% and in Boolean remission was 16.8% and 21.6% for SDZ-ADL and 'ref-ADL/switched SDZ-ADL' groups, respectively. The secondary endpoints were similar across the treatment groups. The incidence of adverse events (AEs) and injection-site reactions were low and similar between SDZ-ADL and 'ref-ADL/switched SDZ-ADL' groups (AEs 70.6% vs 68.8%, injection-site reactions 4.0% vs 6.3%), and most of these patients experienced AEs of mild or moderate severity. Antidrug antibodies were detected in 24.2% and 25.6% of patients treated with SDZ-ADL and 'ref-ADL/switched SDZ-ADL', respectively, from baseline to Week 48, of which 72.5% in SDZ-ADL and 79.1% in 'ref-ADL/switched SDZ-ADL' groups were neutralizing. Conclusions In patients with moderate-to-severe RA who had an inadequate response to DMARDs, SDZ-ADL demonstrated a similar efficacy and a comparable safety and immunogenicity profile to ref-ADL. Efficacy was sustained after switching from ref-ADL to SDZ-ADL with no impact on safety (NCT02744755).
ER  -

WILAND, P., S. JEKA, Eva DOKOUPILOVÁ, J. BRANDT-JURGENS, J. M. M. LIMON, M. C. MOREIRA, R. V. CABELLO, J. JAUCH-LEMBACH, A. THAKUR, H. HALIDUOLA, I. BRUECKMANN a N. B. GAYLIS. Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study. \textit{BIODRUGS}. NORTHCOTE: ADIS INT LTD, 2020, roč.~34, č.~6, s.~809-823. ISSN~1173-8804. Dostupné z: https://dx.doi.org/10.1007/s40259-020-00447-6.

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