Safety and efficacy of BI 695501 versus adalimumab reference product in patients with advanced Crohn's disease (VOLTAIRE-CD): a multicentre, randomised, double-blind, phase 3 trial

Hanauer, Stephen B.; Liedert, Bernd; Balser, Sigrid; Brockstedt, Ekkehard; Moschetti, Viktoria; Schreiber, Stefan

doi:10.1016/s2468-1253(21)00252-1

Cited by 29 publications

(23 citation statements)

References 27 publications

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“…The above studies demonstrated similar safety profiles between adalimumab-adbm and adalimumab-RP, with no new safety information identified, compared with original adalimumab trials. 11,16-20,22 Equivalence studies did not find immunogenicity profile differences between adalimumab-RP and adalimumab-adbm, and switching from adalimumab-RP to adalimumab-adbm did not affect immunogenicity. 11,16-20,22 The most common adverse reactions to adalimumab-adbm reported in phase 3 studies included infections (eg, upper respiratory tract infections) and injection site reactions.…”

Section: Safety Considerationsmentioning

confidence: 89%

“…11,16-20,22 Equivalence studies did not find immunogenicity profile differences between adalimumab-RP and adalimumab-adbm, and switching from adalimumab-RP to adalimumab-adbm did not affect immunogenicity. 11,16-20,22 The most common adverse reactions to adalimumab-adbm reported in phase 3 studies included infections (eg, upper respiratory tract infections) and injection site reactions. Interestingly, most phase 3 studies found increased treatment-related AE with adalimumab-RP compared with adalimumab-adbm.…”

Section: Safety Considerationsmentioning

confidence: 89%

“…The efficacy and safety of adalimumab-adbm for patients with moderate to severe Crohn’s disease were evaluated in a phase 3, multicenter, double-blind, randomized, parallel-group, active comparator trial referenced as VOLTAIRE-CD. 18 Adults (18-80 years old) with moderate to severe Crohn’s disease (defined by the Crohn’s disease Activity Index [CDAI] score of 220-450) with confirmed evidence of mucosal ulceration for longer than 4 months per endoscopy or radiologic evidence and considered to be TNF-naïve or with secondary loss of response to infliximab were included. Participants were excluded if they had received any biological treatment within 6 months prior to screening, required continued use of any medication considered likely to interfere with the safe conduct of the trial, or required budesonide and prednisone 4 weeks prior to randomization.…”

Section: Clinical Trials—efficacy and Safetymentioning

confidence: 99%

“…However, the studies were not powered to determine statistical significance of this finding and the rates of serious AEs were overall similar between adalimumab-RP and adalimumab-adbm. 11,[16][17][18][19][20]22 Recommended monitoring parameters for adalimumab-adbm are listed in Table 1. 11,23,24…”

Section: Safety Considerationsmentioning

confidence: 99%

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Adalimumab-Adbm: The First Interchangeable Biosimilar for the Treatment of Inflammatory Diseases

et al. 2022

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Objective The objective of the study was to review the pharmacologic and clinical profile of adalimumab-adbm (BI 695501), the first interchangeable biosimilar for treatment of inflammatory diseases. Data Sources A PubMed search was conducted from inception to December 2021 using the keywords BI 695501 and adalimumab-adbm. Information was also obtained from published abstracts and package inserts. Study Selection and Data Extraction Phase 1, 2 and 3 studies plus relevant literature on adalimumab-adbm pharmacologic and clinical profile were reviewed. Data Synthesis: Adalimumab-adbm approval was based on a series of phase 3 VOLTAIRE trials, which evaluated the biosimilar’s efficacy and safety in the treatment of moderate to severe Crohn’s disease, rheumatoid arthritis, and psoriasis. Interchangeability status was granted based on data from the VOLTAIRE-X trial. The VOLTAIRE and VOLTAIRE-X studies demonstrated comparable efficacy and safety between adalimumab-adbm and reference adalimumab. Common adverse events included infections and injection site reactions. Similar to reference adalimumab, adalimumab-adbm contains black box warnings related to serious infections and malignancy. Relevance to Patient Care and Clinical Practice Adalimumab-adbm is the first interchangeable biosimilar to be approved for inflammatory diseases and has the potential to improve patient access to treatment while decreasing medication-related costs. However, it will not be commercially available for patient use until 2023 and its adoption into clinical practice may face potential barriers seen with other biosimilars. Conclusion As an interchangeable biosimilar with comparable efficacy and safety to reference adalimumab, adalimumab-adbm is an important advance toward cost-effective management of inflammatory diseases.

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Section: Safety Considerationsmentioning

confidence: 89%

Section: Safety Considerationsmentioning

confidence: 89%

Section: Clinical Trials—efficacy and Safetymentioning

confidence: 99%

Section: Safety Considerationsmentioning

confidence: 99%

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Adalimumab-Adbm: The First Interchangeable Biosimilar for the Treatment of Inflammatory Diseases

et al. 2022

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“…Current data suggest that infliximab and adalimumab biosimilars share immunodominant epitopes and exhibit similar immunogenicity with the originators [ 41 - 43 ]. Switching from infliximab originator to biosimilar, both single and multiple switches, does not seem to raise any efficacy and safety issues or immunogenicity concerns [ 44 , 45 ].…”

Section: Biosimilarsmentioning

confidence: 99%

The efficacy of immunomodulators in the prevention and suppression of anti-drug antibodies to anti-tumor necrosis factor therapy in inflammatory bowel disease

Fousekis

Papamichael

Kourtis

et al. 2021

aog

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The development of biological agents against tumor necrosis factor (TNF) has revolutionized the management of inflammatory bowel disease (IBD), frequently achieving induction and maintenance of remission in both ulcerative colitis and Crohn’s disease. However, a loss of response due to the development of anti-drug antibodies (ADA) is seen annually in approximately 20% of IBD patients receiving anti-TNF therapy. Current evidence suggests that the use of immunomodulators (IMM), such as thiopurines (azathioprine and 6-mercaptopurine) or methotrexate, may prevent or suppress ADA formation. In this article, we present a comprehensive review of the available literature regarding the efficacy of IMM in the prevention and suppression of ADA development to anti-TNF therapy in patients with IBD.

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Consistent efficacy outcomes between phase 2 and phase 3 trials in Crohn’s disease or ulcerative colitis in adults: a meta-analysis

Wan,

Jiang,

Zhou

et al. 2024

Inflamm. Res.

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Safety and efficacy of BI 695501 versus adalimumab reference product in patients with advanced Crohn's disease (VOLTAIRE-CD): a multicentre, randomised, double-blind, phase 3 trial

Cited by 29 publications

References 27 publications

Adalimumab-Adbm: The First Interchangeable Biosimilar for the Treatment of Inflammatory Diseases

Adalimumab-Adbm: The First Interchangeable Biosimilar for the Treatment of Inflammatory Diseases

The efficacy of immunomodulators in the prevention and suppression of anti-drug antibodies to anti-tumor necrosis factor therapy in inflammatory bowel disease

Consistent efficacy outcomes between phase 2 and phase 3 trials in Crohn’s disease or ulcerative colitis in adults: a meta-analysis

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