<p>Remicade^® (infliximab): 20 years of contributions to science and medicine</p>

Abstract

On August 24, 1998, Remicade ® (infliximab), the first tumor necrosis factor-α (TNF) inhibitor, received its initial marketing approval from the US Food and Drug Administration for the treatment of Crohn’s disease. Subsequently, Remicade was approved in another five adult and two pediatric indications both in the USA and across the globe. In the 20 years since this first approval, Remicade has made several important contributions to the advancement of science and medicine: 1) clinical trials with Remicade established the proof of concept that targeted therapy can be effective in immune-mediated inflammatory diseases; 2) as the first monoclonal antibody approved for use in a chronic condition, Remicade helped in identifying methods of administering large, foreign proteins repeatedly while limiting the body’s immune response to them; 3) the need to establish Remicade’s safety profile required developing new methods and setting new standards for postmarketing safety studies, specifically in the real-world setting, in terms of approach, size, and duration of follow-up; 4) the study of Remicade has improved our understanding of TNF’s role in the immune system, as well as our understanding of the pathophysiology of a range of diseases characterized by chronic inflammation; and 5) Remicade and other TNF inhibitors have transformed treatment practices in these chronic inflammatory diseases: remission has become a realistic goal of therapy and long-term disability resulting from structural damage can be prevented. This paper reviews how, over the course of its development and 20 years of use in clinical practice, Remicade was able to make these contributions.

Autoimmune Hepatitis—Immunologically Triggered Liver Pathogenesis—Diagnostic and Therapeutic Strategies

“…Infliximab is a humanized chimeric monoclonal antibody directed against the proinflammatory cytokine tumor necrosis factor alpha (TNF-a). Since its FDA approval more than 20 years ago, Infliximab has made substantial contribution in the treatment of different chronic autoimmune diseases including AIH [133]. Its clinical use, however, is limited to some small retrospective studies where it was mainly used as a salvage therapy in AIH patients [129, 134].…”

Repositioning of Immunomodulators: A Ray of Hope for Alzheimer’s Disease?

“…Infliximab is a monoclonal antibody against TNF-α approved for treatment of rheumatoid arthritis, Crohn's disease and other immune-mediated inflammatory disorders (Melsheimer et al, 2019).…”

Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54–78 Data From a Randomized, Double-Blind, Phase III Trial

“…The chimeric monoclonal antibody infliximab (Remicade ® ; Janssen Biotech, Horsham, PA, USA; Janssen Biologics B.V., Leiden, the Netherlands) is a tumor necrosis factor (TNF)-α inhibitor approved for the treatment of a range of immune-related inflammatory diseases [1][2][3]. In the two decades since the initial licensing of infliximab, its efficacy and safety have been well-established in diverse patient populations [4][5][6][7][8]. However, high direct costs, constrained healthcare budgets, and stringent reimbursement criteria mean that access to biologic drugs such as infliximab may be limited for some patients for whom this treatment is recommended [9].…”