Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis

Papp, Kim; Bachelez, Hervé; Costanzo, Antonio; Foley, Pat; Gooderham, Melinda; Kaur, Primal; Philipp, Sandra; Spelman, Lynda; Zhang, N; Strober, Bruce

doi:10.1111/bjd.15857

Cited by 73 publications

(66 citation statements)

References 20 publications

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“…The PASI 75 response rates observed in this study are higher than those seen in previous phase III adalimumab trials; however, they are in line with more recent studies, which may reflect the improved standard of care for patients with psoriasis. In AURIEL‐PsO, the proportion of patients with moderate disease was 70·0%, compared with previous studies ranging from 18·6% to 65·5% .…”

Section: Discussionsupporting

confidence: 87%

“…In AURIEL‐PsO, the proportion of patients with moderate disease was 70·0%, compared with previous studies ranging from 18·6% to 65·5% . Previous studies with greater proportions of patients with moderate psoriasis also showed higher response rates . In addition, patients with psoriasis with a higher BMI have previously been shown to be less responsive to adalimumab or to discontinue earlier .…”

Section: Discussionmentioning

confidence: 77%

“…34,35 Previous studies with greater proportions of patients with moderate psoriasis also showed higher response rates. 35,36 In addition, patients with psoriasis with a higher BMI have previously been shown to be less responsive to adalimumab 31 or to discontinue earlier. 37 Therefore, the exclusion criteria in this study were designed to reduce the number of patients with a high body weight in order to increase the sensitivity of the population to show any differences between treatment arms.…”

Section: Discussionmentioning

confidence: 99%

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AURIEL ‐PsO: a randomized, double‐blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB 11022 to reference adalimumab in patients with moderate‐to‐severe chronic plaque‐type psoriasis

Hercogová

Papp

Chyrok³

et al. 2019

Br J Dermatol

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Summary Background MSB11022 is a proposed adalimumab biosimilar. Objectives To compare the efficacy, safety and immunogenicity of MSB11022 with reference adalimumab. Methods AURIEL‐PsO was a double‐blind randomized controlled equivalence trial, in which patients with moderate‐to‐severe chronic plaque‐type psoriasis were randomized 1 : 1 to MSB11022 or reference adalimumab. The primary end point was ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) at week 16, with a prespecified equivalence interval of ± 18%. Patients with a ≥50% improvement in PASI at week 16 were eligible to enter a double‐blind extension period: patients receiving MSB11022 continued treatment, and patients receiving reference adalimumab were rerandomized 1 : 1 either to continue reference adalimumab or to switch to MSB11022. Other efficacy end points and safety, immunogenicity and pharmacokinetic parameters were evaluated at scheduled visits up to weeks 52 (efficacy and immunogenicity), 54 and 66 (safety). Results In total, 443 patients were randomized. The difference in PASI 75 response rates at week 16 between the treatment arms was −1·9%, and the 95% confidence interval (−7·8% to 4·1%) was within the prespecified equivalence interval. No notable difference in the incidence of treatment‐emergent adverse events was observed between treatment arms up to the end of the trial, and no new safety signals were observed. Following treatment switch at week 16, no clinically meaningful differences in safety or immunogenicity were seen between treatment arms through to the end of the observation period. Conclusions Therapeutic equivalence between MSB11022 and reference adalimumab was demonstrated. AURIEL‐PsO provides evidence to support the similarity of both products with regard to efficacy, safety and immunogenicity. What's already known about this topic? Adalimumab is a fully human antitumour necrosis factor‐α monoclonal antibody, indicated for the treatment of multiple inflammatory disorders, including psoriasis, psoriatic arthritis, rheumatoid arthritis, inflammatory bowel diseases and ankylosing spondylitis. MSB11022 is a proposed adalimumab biosimilar that has shown structural and functional similarity to the reference product in an extensive analytical comparability exercise. MSB11022 has demonstrated bioequivalence and comparable safety and immunogenicity profiles in a phase I study in healthy volunteers. What does this study add? This phase III study confirmed equivalent efficacy for MSB11022 and reference adalimumab in patients without any immunomodulation comedication in moderate‐to‐severe chronic plaque‐type psoriasis at week 16. The efficacy, safety and immunogenicity of MSB11022 and reference adalimumab were similar over the respective observation periods (week 52 for efficacy and immunogenicity, week 66 for safety). A switch from reference adalimumab to MSB11022 at week 16 did not impact efficacy, safety or immunogenicity.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionmentioning

confidence: 77%

Section: Discussionmentioning

confidence: 99%

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AURIEL ‐PsO: a randomized, double‐blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB 11022 to reference adalimumab in patients with moderate‐to‐severe chronic plaque‐type psoriasis

Hercogová

Papp

Chyrok³

et al. 2019

Br J Dermatol

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“…In open-label extensions of the PLANETAS study and the PLANETRA study, transitioning to the biosimilar infliximab-dyyb (CT-P13) after 54 weeks of treatment with reference infliximab did not result in a loss of efficacy or an increase in adverse events or immunogenicity (33,46). Comparable results have been observed in the open-label extensions of other studies (47,48), as well as in postmarketing observational studies (36,43,(49)(50)(51)(52)(53)(54)(55)(56).…”

Section: Extrapolation Of Indications Switching and Substitution Anmentioning

confidence: 85%

The Science Behind Biosimilars

Bridges

White

Worthing

et al. 2018

Arthritis & Rheumatology

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“…Evidence of equivalence between ABP 501 and reference adalimumab sourced from 3 RCTs: a phase 1, single-dose study in 501 healthy adults and 2 phase 3, randomized, double-blind studies, performed in patients with moderate to severe plaque psoriasis and moderate to severe RA, respectively. Both studies have demonstrated that ABP501 is similar to adalimumab in clinical efficacy, safety and immunogenicity [39][40][41][42].…”

Section: Adalimumab Biosimilarsmentioning

confidence: 99%

Biosimilars: A Review of Published Randomized Control Trials Comparing Biosimilars with their Reference Products

Olteanu¹,

Constantin²,

Zota³

2018

Adv Tech Biol Med

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Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis

Abstract: ABP 501 and adalimumab have similar clinical efficacy, safety and immunogenicity profiles over 52 weeks, including after single transition, in this patient population.

Cited by 73 publications

References 20 publications

AURIEL ‐PsO: a randomized, double‐blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB 11022 to reference adalimumab in patients with moderate‐to‐severe chronic plaque‐type psoriasis

AURIEL ‐PsO: a randomized, double‐blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB 11022 to reference adalimumab in patients with moderate‐to‐severe chronic plaque‐type psoriasis

The Science Behind Biosimilars

Biosimilars: A Review of Published Randomized Control Trials Comparing Biosimilars with their Reference Products

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