Safety and Effectiveness of SB2 (Infliximab Biosimilar) in Adult Patients with Immune-Mediated Inflammatory Diseases: A Post-Marketing Surveillance in Korea

Kim, Dong Ho; Lee, Yousun; Kim, Geuntae; Kim, Sang‐Hwan; Cho, Dae H; Choi, Jeongmin; Kwon, Yong Hwan; Park, Younjin; Choi, Wooree; Park, Dong Il

doi:10.1007/s12325-022-02404-x

Cited by 3 publications

(1 citation statement)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…IFX is a human-murine chimeric monoclonal antibody that specifically blocks tumor necrosis factor-α (TNF-α) via binding to TNF-α with high affinity and inhibiting TNF-α from binding to its receptor, and therefore exhibits anti-inflammatory effects. IFX is indicated for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and Crohn’s disease ( 17 ). Besides, it is the first anti-TNF-α monoclonal antibody that has been validated for the treatments in pediatric patients ( 18 ).…”

Section: Introductionmentioning

confidence: 99%

Current knowledge of TNF-α monoclonal antibody infliximab in treating Kawasaki disease: a comprehensive review

Chen,

Liao,

Xiang

et al. 2023

Front. Immunol.

View full text Add to dashboard Cite

Kawasaki disease (KD), an autoinflammatory disease primarily affecting young children, characterized by consisting of acute systemic vasculitis and coronary artery involvement in severe cases. Intravenous immunoglobulin gamma (IVIG) combined with aspirin therapy is the first-line regimen for the prevention of coronary aneurysms in the acute phase of KD. The etiology and pathogenesis of KD are unclear, but its incidence is increasing gradually, especially in the cases of IVIG-naïve KD and refractory KD. Conventional therapies for refractory KD have unsatisfactory results. At present, infliximab (IFX), a human-murine chimeric monoclonal antibody that specifically blocks tumor necrosis factor-α (TNF-α), has made great progress in the treatment of KD. This review revealed that IFX infusion (5 mg/kg) could effectively modulate fever, reduce inflammation, improve arthritis, diminish the number of plasma exchange, decrease hospitalizations, and prevent the progression of coronary artery lesions. The adverse effects of IFX administration included skin rash, arthritis, respiratory disease, infusion reaction, hepatomegaly, and vaccination-associated complications. But the incidence of these adverse effects is low. The clear optimal application protocol of the application of IFX for either initial combination therapy or salvage therapy in KD is still under investigation. In addition, there are no effective biomarkers to predict IFX resistance. Further multicenter trials with large sample size and long-term follow-up are still needed to validate the clinical efficacy and safety of IFX for IVIG-resistant KD or refractory KD.

show abstract

Section: Introductionmentioning

confidence: 99%

Current knowledge of TNF-α monoclonal antibody infliximab in treating Kawasaki disease: a comprehensive review

Chen,

Liao,

Xiang

et al. 2023

Front. Immunol.

View full text Add to dashboard Cite

show abstract

Infliximab

2023

Reactions Weekly

View full text Add to dashboard Cite

Biosimilars approved for psoriasis treatment in Europe

Milidrag,

Lačković,

Dimić

et al. 2023

PONS

View full text Add to dashboard Cite

In recent decades, biologics have emerged as pivotal components in the therapeutic armamentarium, revolutionizing the management of various diseases, including chronic inflammatory skin disorder, the psoriasis. Biosimilars, biological formulations designed to closely mimic but not replicate existing reference biologic drugs, have heralded a seismic shift in healthcare delivery, promising equitable access to innovative therapies while fostering competition in the pharmaceutical market. The advent of biosimilars has democratized access to effective treatments, alleviating the financial burden on healthcare systems and patients alike, particularly pertinent for conditions like psoriasis, notorious for their exorbitant treatment costs. However, despite their widespread adoption and significant promise, significant challenges remain, requiring ongoing research to comprehensively examine their clinical efficacy, safety profiles, and long-term outcomes. This review aims to present all the biosimilars approved so far in Europe. Biosimilars represent a transformative force in modern healthcare, but their optimal integration requires careful monitoring, robust pharmacovigilance mechanisms, and ongoing research initiatives to ensure patient safety, build trust among healthcare providers, and maximize treatment efficacy for individuals struggling with psoriasis and other chronic diseases.

show abstract

Safety and Effectiveness of SB2 (Infliximab Biosimilar) in Adult Patients with Immune-Mediated Inflammatory Diseases: A Post-Marketing Surveillance in Korea

Cited by 3 publications

References 17 publications

Current knowledge of TNF-α monoclonal antibody infliximab in treating Kawasaki disease: a comprehensive review

Current knowledge of TNF-α monoclonal antibody infliximab in treating Kawasaki disease: a comprehensive review

Infliximab

Biosimilars approved for psoriasis treatment in Europe

Contact Info

Product

Resources

About