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, Piotr; Jeka, Sławomir; Dokoupilová, Eva; Brandt‐Jürgens, Jan; Limón, Juan Manuel Miranda; Moreira, Miguel Cantalejo; Cabello, Raúl Veiga; Jauch-Lembach, Julia; Thakur, Anjali; Haliduola, Halimu N.; Brueckmann, Ines; Gaylis, Norman

doi:10.1007/s40259-020-00447-6

Cited by 31 publications

(70 citation statements)

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“…Previous studies demonstrated that GP2017 and Humira have identical amino acid sequences, indistinguishable secondary and tertiary structures, the same level of post-translational modifications, and a functional and pharmacological similarity to the reference drug (20,21). Wiland et al (22,23) conducted a phase III trial including 353 moderate-to-severe RA patients with inadequate response to disease modifying anti-rheumatic drugs. Patients were on a stable dose of MTX with biologics.…”

Section: Gp2017 (Hyrimoz/hefya/halimatoz)mentioning

confidence: 99%

Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

Lin

et al. 2021

Front. Immunol.

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Adalimumab, as a TNF inhibitor biologic for the treatment of rheumatoid arthritis, is one of the top-selling drugs worldwide. As its various patents have gradually expired, experiments on its biosimilars are constantly being implemented. In this review, we summarized clinical trials of seven biosimilars currently approved by the FDA and/or EMA for the treatment of rheumatoid arthritis, namely: ABP 501 (Amjevita/Amgevita/Solymbic), BI 695501 (Cyltezo), SB5 (Imraldi/Hadlima), GP2017 (Hyrimoz/Hefiya/Halimatoz), MSB11022 (Idacio), FKB327 (Hulio), and PF-06410293 (Abrilada). Overall, these biosimilars showed similar efficacy, safety, and immunogenicity to adalimumab. All biosimilar switching trials indicated that switching from adalimumab to a biosimilar does not have a significant impact on efficacy, safety, and immunogenicity.

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Section: Gp2017 (Hyrimoz/hefya/halimatoz)mentioning

confidence: 99%

Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

Lin

et al. 2021

Front. Immunol.

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“…S1b). A total of 325 (92.1%) patients entered SP2 and 303 (85.8%) completed the study [ 24 ]. The SP1 and SP2 sets included 353 and 325 patients, respectively.…”

Section: Resultsmentioning

confidence: 99%

“…HRQoL is reportedly impaired in IMIDs, including RA, PsA, and PsO [ 1 – 3 ]; PROs are therefore gaining considerable interest as they provide valuable evidence to inform clinical decision–making, pharmaceutical labeling claims, and health policies [ 10 – 13 ]. The primary results of the ADACCESS and ADMYRA studies demonstrated equivalent efficacy between SDZ-ADL and ref-ADL in patients with PsO [ 23 ] and RA [ 24 ], respectively. Results from the PROs assessed in the two studies confirm that both treatments lead to comparable improvements in HRQoL across the three diseases, PsO, PsA, and RA.…”

Section: Discussionmentioning

confidence: 99%

“…The study design and patient populations of the ADACCESS and ADMYRA studies have been reported previously [ 23 , 24 ]. ADACCESS was a randomized, double-blinded, multicenter, phase III confirmatory study in patients with plaque PsO.…”

Section: Methodsmentioning

confidence: 99%

“…In addition, switching between SDZ-ADL and ref-ADL up to four times had no impact on efficacy, safety, or immunogenicity [ 23 ]. Another study (ADMYRA) in patients with moderate-to-severe RA also demonstrated equivalent efficacy of SDZ-ADL and ref-ADL, with a sustained and comparable efficacy after switching patients from ref-ADL to SDZ-ADL [ 24 ]. One of the objectives of these two studies was to compare QoL improvements in patients treated with SDZ-ADL versus ref-ADL.…”

Section: Introductionmentioning

confidence: 99%

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Treatment with SDZ-ADL, an Adalimumab Biosimilar, in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis: Results of Patient-Reported Outcome Measures from Two Phase III Studies (ADMYRA and ADACCESS)

et al. 2021

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Background SDZ-ADL (GP2017; Sandoz GmbH, Austria) is an EMA-/FDA-approved adalimumab biosimilar. The effect of SDZ-ADL on quality of life (QoL) and patient-reported outcomes (PROs) was assessed as part of two phase III studies, one in patients with moderate‐to‐severe chronic plaque psoriasis (PsO; ADACCESS) and the other in patients with rheumatoid arthritis (RA; ADMYRA). Additionally, ADACCESS included patients with psoriatic arthritis (PsA). Methods ADACCESS included 465 patients with PsO, whereas ADMYRA included 353 patients with RA. Both studies evaluated and confirmed equivalent efficacy, similar safety, and immunogenicity of SDZ-ADL with reference adalimumab (ref-ADL). A third of patients underwent multiple (four) treatment switches between study treatments starting at Week 17 (ADACCESS); all patients switched from ref-ADL to SDZ-ADL at Week 24 (ADMYRA). Assessed PROs included Dermatology Life Quality Index (DLQI) and EuroQol five-dimension health status questionnaire (EQ-5D-5L) in ADACCESS, Functional Assessment of Chronic Illness Therapy–Fatigue Scale (FACIT-Fatigue) score in ADMYRA, and Health Assessment Questionnaire–Disability Index (HAQ-DI) in both studies. Results In both studies, baseline scores for all PRO assessments were comparable between the two treatment groups. In ADACCESS, mean DLQI decreased from baseline in both groups, and the mean (standard deviation [SD]) percent reductions from baseline in DLQI were comparable between groups at Week 17 (SDZ-ADL, − 64.5 [80.3]; ref-ADL, − 70.6 [41.7]), which were sustained after the switch at Week 51 (‘continued SDZ-ADL,’ − 79.7 [36.2]; ‘continued ref-ADL,’ − 80.8 [44.6]; ‘switched to SDZ-ADL,’ − 70.7 [32.2]; ‘switched to ref-ADL,’ − 69.3 [49.6]). In ADACCESS, the proportion of patients with an EQ-5D-5L score of 1 (no problems) increased from baseline for all five dimensions in all treatment groups and was comparable between treatment groups at Week 51. In ADACCESS, in patients with PsA at baseline, mean (SD) HAQ-DI scores decreased from baseline in both treatment groups, and scores were comparable between groups at Week 17 (SDZ-ADL, 0.5 [0.6]; ref-ADL, 0.5 [0.6]) and after switching at Week 51 (‘continued SDZ-ADL,’ 0.4 [0.5]; ‘continued ref-ADL,’ 0.4 [0.6]; ‘switched to SDZ-ADL,’ 0.5 [0.8]; ‘switched to ref-ADL,’ 0.7 [0.6]). In ADMYRA, proportion of patients achieving HAQ-DI in the normal range (≤ 0.5) was comparable between treatment groups at Week 24 (SDZ-ADL, 37.8%; ref-ADL, 36.3%) and after switching at Week 48 (‘SDZ-ADL,’ 41.6%; ‘ref-ADL/switched to SDZ-ADL,’ 40.0%). In ADMYRA, mean FACIT-Fatigue scores increased from baseline in both treatment groups. At Week 24, mean (SD) percent change from baseline in the FACIT-Fatigue scores was 75.4 (135.5) in SDZ-ADL and 73.0 (96.3) in ref-ADL groups; the scores were sustained after switching at Week 48. Conclusion Treatment with SDZ-ADL and ref-ADL resulted in comparable improvements in PROs as well as ...

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Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis

et al. 2023

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ImportanceBiosimilar drugs are potentially lower-cost versions of biologics that may improve access to therapy. However, there is a lack of adequate systematic reviews demonstrating equivalence between these drugs for the treatment of rheumatoid arthritis (RA).ObjectivesTo assess the efficacy, safety, and immunogenicity associated with biosimilars of adalimumab, etanercept, and infliximab compared with their reference biologics in patients with RA.Data SourcesMEDLINE via PubMed, Embase, Cochrane Central Register of Controlled Trials, and LILACS databases were searched from inception to September 2021.Study SelectionHead-to-head randomized clinical trials (RCTs) of biosimilars of adalimumab, etanercept, and infliximab and their biologic reference drugs for RA were assessed.Data Extraction and SynthesisTwo authors independently abstracted all data. Meta-analysis was conducted with bayesian random effects using relative risks (RRs) for binary outcomes and standardized mean differences (SMDs) for continuous outcomes, with 95% credible intervals (CrIs) and trial sequential analysis. Specific domains were assessed for the risk of bias in equivalence and noninferiority trials. This study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline.Main Outcomes and MeasuresEquivalence was tested using prespecified margins for the American College of Rheumatology criteria, with at least 20% improvement in the core set measures (ACR20) (ie, RR, 0.94 to 1.06), and for the Health Assessment Questionnaire–Disability Index (HAQ-DI) (ie, SMD, −0.22 to 0.22). Secondary outcomes included 14 items measuring safety and immunogenicity.ResultsA total of 25 head-to-head trials provided data on 10 642 randomized patients with moderate to severe RA. Biosimilars met equivalence with reference biologics in terms of ACR20 response (24 RCTs with 10 259 patients; RR, 1.01; 95% CrI, 0.98 to 1.04; τ2 = 0.000) and change of HAQ-DI scores (14 RCTs with 5579 patients; SMD, −0.04; 95% CrI, −0.11 to 0.02; τ2 = 0.002) considering prespecified margins of equivalence. Trial sequential analysis found evidence for equivalence for ACR20 since 2017 and HAQ-DI since 2016. Overall, biosimilars were associated with similar safety and immunogenicity profiles compared with reference biologics.Conclusion and RelevanceIn this systematic review and meta-analysis, biosimilars of adalimumab, infliximab, and etanercept were associated with clinically equivalent treatment effects compared with their reference biologics for the treatment of RA.

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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

Cited by 31 publications

References 27 publications

Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

Treatment with SDZ-ADL, an Adalimumab Biosimilar, in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis: Results of Patient-Reported Outcome Measures from Two Phase III Studies (ADMYRA and ADACCESS)

Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis

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