Infliximab Overview

Introduction of Infliximab

Infliximab (trade name Remicade) is a tumor necrosis factor (TNF-alpha or TNF-α) blocker and a chimeric monoclonal IgG1 antibody composed of human constant (75%) and murine variable (25%) regions. It is produced by a recombinant cell line cultured by continuous perfusion and was developed by Junming Le and Jan Vilček at New York University School of Medicine and in collaboration with Centocor, (now Janssen Biotech, Inc.). Infliximab is an artificial antibody. It was originally developed in mice as a mouse antibody. Because humans have immune reactions to mouse proteins, the mouse common domains were replaced with similar human antibody domains. Infliximab was first approved by the FDA in 1998 under the market name Remicade as an intravenous injection. It is indicated for the treatment of various inflammatory disorders such as adult or pediatric Chron's disease, adult or pediatric ulcerative colitis, rheumatoid arthritis in combination with methotrexate, ankylosing spondyliti, psoriatic arthritis, and plaque psoriasis. In clinical trials, multiple infusions of infliximab displayed in a reduction of signs and symptoms of inflammatory diseases and induction of remission in patients who have had an inadequate response to alternative first-line therapies for that disorder. There are currently two biosimilars of infliximab available in the US market that demonstrate a high degree of similarity to the reference product, Remicade. They are approved for all eligible indications of the reference product. Inflectra, a first biosimilar drug product, was approved in 2016. In December 2017, Ixifi, a second biosimilar that was developed by Pfizer, was granted approval by the FDA.

Mechanism of Action of Infliximab

Crohn's disease is a lifelong inflammatory disorder characterized by the presence of inflammatory ulcerative lesions in the gastrointestinal tract. Lesions most commonly involve the large and small bowel, giving rise to symptoms of abdominal pain, weight loss, gastrointestinal haemorrhage, and fistula formation. Lesions most commonly involve the large and small bowel, giving rise to symptoms of abdominal pain, weight loss, gastrointestinal haemorrhage, and fistula formation. To date, treatment has been geared towards symptomatic relief of disease exacerbations via pharmacological interventions such as aminosalicylates, corticosteroids, immunosuppressive agents, antibiotics, and nutritional therapy. Surgery is indicated in those patients who have failed to respond to medical management, or to correct intestinal obstruction or abscesses. Surgical intervention is by no means curative, with inflammatory episodes recurring in ⩾80% of patients after intestinal resection. The inflammatory response in Crohn's disease is regulated by intercellular mediators known as cytokines. The major contributing factor to chronic local inflammation in Crohn's disease is local mucosal overproduction of proinflammatory cytokines to anti-inflammatory cytokines. Tumour necrosis factor-α (TNF-α) is one of several proinflammatory mediators, which has a central role in chronic inflammatory conditions, such as Crohn's disease, rheumatoid arthritis, and other granulomatous diseases. Its hyperactivity and enhanced signaling pathways can be observed in inflammatory diseases where it activates further pro-inflammatory cascades. Infliximab is a chimeric monoclonal antibody to TNF-α, developed as a therapeutic agent for TNF-α mediated diseases. Infliximab neutralizes the biological activity of TNF-α by binding with high affinity to the soluble (free floating in the blood) and transmembrane (located on the outer membranes of T cells and similar immune cells) forms of TNF-α and inhibits or prevents the effective binding of TNF-α with its receptors. By binding to both the soluble subunit and the membrane-bound precursor of TNF-α, infliximab disrupts the interaction of TNF-α with its receptors and may also cause lysis of cells that produce TNF-α.

Mechanism of Action of Infliximab

Fig 1. Mechanism of Action of Infliximab

Table 1. Clinical Projects of Infliximab*

NCT ID Status Conditions Lead Sponsor Update Time
NCT02987686 Recruiting Sterile Corneal Melt Centre hospitalier de l'Université de Montréal (CHUM) December 9, 2016
NCT03209232 Recruiting Ulcerative Colitis Schneider Children's Medical Center, Israel July 6, 2017
NCT02770040 Recruiting Ulcerative Colitis Austin Health May 12, 2016
NCT03393247 Recruiting Crohn Disease Sixth Affiliated Hospital, Sun Yat-sen University January 8, 2018
NCT02363738 Active, not recruiting Bipolar Depression University Health Network, Toronto February 16, 2015
NCT03704610 Not yet recruiting Extrathoracic Sarcoidosis Assistance Publique - Hôpitaux de Paris October 15, 2018
NCT03684278 Not yet recruiting Acute Pancreatitis Professor Robert Sutton September 25, 2018
NCT02638701 Not yet recruiting Aneurysm, Stroke, Vasculitis, Tumor Necrosis Factor-alpha University of California, San Francisco December 23, 2015
NCT03679546 Not yet recruiting Ulcerative Colitis Rennes University Hospital September 20, 2018
NCT02566889 Active, not recruiting Inflammatory Bowel Diseases Janssen Scientific Affairs, LLC October 2, 2015
NCT03192878 Recruiting Takayasu Arteritis Ospedale San Raffaele June 20, 2017
NCT02728934 Active, not recruiting Arthritis, Rheumatoid Janssen Scientific Affairs, LLC April 5, 2016
NCT02770794 Not yet recruiting Arthritis, Rheumatoid Chiba University May 12, 2016
NCT03765450 Not yet recruiting Ulcerative Colitis Robarts Clinical Trials Inc. December 5, 2018
NCT02847884 Recruiting Inflammatory Bowel Disease, Crohn's Disease University of Alberta July 28, 2016
NCT03308357 Not yet recruiting Inflammatory Bowel Diseases The Alfred October 12, 2017
NCT03088293 Not yet recruiting Idiopathic Refractory Scleritis Hospices Civils de Lyon March 23, 2017
NCT03348046 Recruiting Rheumatoid Arthritis Hikma Pharmaceuticals LLC November 20, 2017
NCT02332460 Active, not recruiting Chronic Inflammatory Disease Haukeland University Hospital January 6, 2015
NCT02453607 Recruiting Inflammatory Bowel Disease, Crohn's Disease Ernest Seidman May 25, 2015
NCT03704363 Recruiting Low Back Pain Oslo University Hospital October 12, 2018
NCT02799615 Active, not recruiting Colitis, Ulcerative, Bowel Diseases, Inflammatory Children's Hospital Medical Center, Cincinnati June 15, 2016
NCT02762838 Active, not recruiting Rheumatoid Arthritis Biocad May 5, 2016
NCT02136069 Recruiting Ulcerative Colitis Hoffmann-La Roche May 12, 2014
NCT02438410 Recruiting Colitis, Ulcerative, Inflammatory Bowel Disease, IBD Mayo Clinic May 8, 2015
NCT02990806 Active, not recruiting Rheumatoid Arthritis (RA) Nichi-Iko Pharmaceutical Co., Ltd. December 13, 2016
NCT03841942 Not yet recruiting Inflammatory Bowel Diseases University Hospital, Montpellier February 15, 2019
NCT02624037 Recruiting Inflammatory Bowel Disease Icahn School of Medicine at Mount Sinai December 8, 2015
NCT02177071 Recruiting Crohn's Disease Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives June 27, 2014
NCT03371095 Not yet recruiting Behcet's Disease, Vasculitis Assistance Publique - Hôpitaux de Paris December 13, 2017
NCT03221166 Recruiting Crohn Disease IRCCS Burlo Garofolo July 18, 2017
NCT02517684 Active, not recruiting Crohn's Disease Erasmus Medical Center August 7, 2015
NCT03006393 Recruiting Depression Emory University December 30, 2016
NCT03004443 Recruiting Depression Emory University December 28, 2016
NCT03818516 Not yet recruiting Schizophrenia Emory University January 28, 2019
NCT03151525 Recruiting Colitis, Ulcerative Istituto Clinico Humanitas May 12, 2017
NCT03065244 Recruiting Mucocutaneous Lymph Node Syndrome University of California, San Diego February 27, 2017
NCT03478111 Recruiting Rheumatoid Arthritis Shanghai Biomabs Pharmaceutical Co., Ltd. March 27, 2018
NCT02330458 Active, not recruiting Inflammatory Bowel Disease, Crohn's Disease Cedars-Sinai Medical Center January 5, 2015
NCT03452501 Not yet recruiting Inflammatory Bowel Diseases Including Crohn's Disease, Fistulizing Crohn's Disease and Ulcerative Colitis Hikma Pharmaceuticals LLC March 2, 2018
NCT03707535 Not yet recruiting Rheumatoid Arthritis Celltrion October 16, 2018
NCT03662919 Recruiting Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Crohn's Disease, Colitis, Ulcerative Biogen September 10, 2018
NCT03269695 Recruiting Ulcerative Colitis Pfizer September 1, 2017
NCT02413047 Recruiting Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease Indiana University April 9, 2015
NCT02868398 Recruiting Ulcerative Colitis Evangelismos Hospital August 16, 2016
NCT03074656 Recruiting Rheumatoid Arthritis, Spondyloarthritis, Ankylosing Spondylitis, Crohn Disease, Ulcerative Colitis, Psoriasis, Psoriatic Arthritis Diakonhjemmet Hospital March 9, 2017
NCT01804166 Recruiting Hepatosplenic T-Cell Lymphoma Janssen Scientific Affairs, LLC March 5, 2013
NCT02425852 Recruiting Ulcerative Colitis Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives April 24, 2015
NCT02495077 Recruiting Kidney Transplant National Institute of Allergy and Infectious Diseases (NIAID) July 13, 2015
NCT03162432 Recruiting IBD, Ulcerative Colitis, Crohn Disease Boston Children’s Hospital May 22, 2017
NCT03445624 Recruiting Inflammatory Bowel Diseases Assiut University February 26, 2018
NCT03596645 Recruiting Colitis, Ulcerative Janssen Research & Development, LLC July 24, 2018
NCT03293784 Recruiting Melanoma Institut Claudius Regaud September 26, 2017
NCT02027727 Active, not recruiting Inflammatory Bowel Diseases Cedars-Sinai Medical Center January 6, 2014
NCT03801928 Recruiting Inflammatory Bowel Disease (IBD), Crohn's Disease (CD), Ulcerative Colitis (UC) Pfizer January 14, 2019
NCT00606346 Active, not recruiting Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis, Inflammatory Bowel Diseases Janssen Biotech, Inc. February 1, 2008
NCT03011268 Recruiting Colitis,Ulcerative Helse Møre og Romsdal HF January 5, 2017
NCT03147248 Active, not recruiting Rheumatoid Arthritis Celltrion May 10, 2017
NCT02883452 Active, not recruiting Crohn's Disease, Ulcerative Colitis Celltrion August 30, 2016
NCT00508547 Recruiting Psoriasis, Arthritis, Psoriatic Janssen Scientific Affairs, LLC July 30, 2007
NCT03352622 Recruiting Pharmacological Action Universidad de Antioquia November 24, 2017
NCT01602302 Recruiting Rheumatoid Arthritis Medical University of Graz May 18, 2012
NCT02925338 Recruiting Crohn Desease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis Pfizer October 5, 2016
NCT01793519 Recruiting Rheumatoid Arthritis Georgetown University February 15, 2013
NCT01706692 Recruiting Psoriasis Swiss Dermatology Network for Targeted Therapies October 15, 2012
NCT01965132 Recruiting Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis Seoul National University Hospital October 18, 2013
NCT01917721 Recruiting Kawasaki Disease, Coronary Aneurysm Hawaii Pacific Health August 7, 2013
NCT02675153 Recruiting Crohn's Diseases The Second Hospital of Nanjing Medical University February 5, 2016
NCT03669822 Recruiting Ulcerative Colitis Johns Hopkins University September 13, 2018
NCT02994836 Recruiting Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis Fundación de Investigación Biomédica - Hospital Universitario de La Princesa December 16, 2016
NCT02134054 Active, not recruiting Inflammatory Bowel Disease Helse Stavanger HF May 8, 2014
NCT03445845 Not yet recruiting Axial Spondyloarthritis Centre Hospitalier Universitaire de Saint Etienne February 26, 2018
NCT03016260 Recruiting RheumatoId Arthritis TcLand Expression S.A. January 10, 2017
NCT03397108 Recruiting Crohn's Disease, Ulcerative Colitis, Healthy Controls The Hospital for Sick Children January 11, 2018
NCT03108326 Recruiting Crohn Disease Ced Service GmbH April 11, 2017
NCT02356445 Recruiting Sarcoidosis University of Cincinnati February 5, 2015
NCT02619552 Active, not recruiting Crohn's Disease, IBD University of Maryland December 2, 2015
NCT03100253 Recruiting Rheumatoid Arthritis Mario Negri Institute for Pharmacological Research April 4, 2017
NCT03633409 Recruiting Inflammatory Bowel Diseases University of Zurich August 16, 2018
NCT03340519 Recruiting Crohn Disease Children's Hospital Medical Center, Cincinnati November 13, 2017
NCT03819296 Not yet recruiting Cutaneous Melanoma AJCC v8, Colitis, Diarrhea, Malignant Genitourinary System Neoplasm M.D. Anderson Cancer Center January 28, 2019
NCT03769987 Recruiting Sarcoidosis University of Cincinnati December 10, 2018
NCT03358693 Recruiting Atopic Dermatitis, Psoriasis Prof. Dr. Stephan Weidinger November 30, 2017
NCT03056924 Recruiting Inflammatory Bowel Diseases Boston Medical Center February 17, 2017
NCT03494764 Recruiting Colitis, Ulcerative Dartmouth-Hitchcock Medical Center April 11, 2018
NCT02353780 Recruiting Rheumatoid Arthritis (RA) Dr. Larry W. Moreland February 3, 2015
NCT02878161 Enrolling by invitation Rheumatoid Arthritis Fen Li August 25, 2016
NCT03266471 Enrolling by invitation Inflammatory Bowel Diseases Vanderbilt University Medical Center August 30, 2017
NCT00306098 Active, not recruiting Diabetes Mellitus, Type I Rodolfo Alejandro March 22, 2006
NCT03847467 Not yet recruiting Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis Children's Hospital Medical Center, Cincinnati February 20, 2019
NCT03394586 Recruiting Ulcerative Colitis, Flare Up, Symptom University of Zurich January 9, 2018
NCT03712826 Recruiting Crohn Disease Hospices Civils de Lyon October 19, 2018
NCT02075697 Recruiting Psoriasis Fundación Academia Española de Dermatología March 3, 2014
NCT02914717 Active, not recruiting Ulcerative Colitis Universitaire Ziekenhuizen Leuven September 26, 2016
NCT03580876 Recruiting Clinical Failure After Switch Védrines, Philippe, M.D. July 9, 2018
NCT03168347 Recruiting Psoriasis Wake Forest University Health Sciences May 30, 2017
NCT03543527 Recruiting Systemic Vasculitis, Arteritis, Takayasu, Arteritis Assistance Publique - Hôpitaux de Paris June 1, 2018
NCT03839862 Recruiting Spondyloarthropathies, Ankylosing Spondylitis Region Skane February 15, 2019
NCT02674308 Recruiting Ulcerative Colitis and Crohn's Disease Takeda February 4, 2016
NCT03219359 Recruiting Crohn Disease Icahn School of Medicine at Mount Sinai July 17, 2017
NCT00085995 Recruiting Spondylitis, Ankylosing National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) June 21, 2004
NCT02755194 Recruiting Lactation The Hospital for Sick Children April 28, 2016
NCT03833310 Not yet recruiting Inflammatory Bowel Diseases Assiut University February 7, 2019
NCT02829424 Recruiting Psoriasis Assistance Publique Hopitaux De Marseille July 12, 2016
NCT03710486 Recruiting Ulcerative Colitis, Crohn's Disease Takeda October 18, 2018
NCT02229344 Active, not recruiting Colitis, Ulcerative Janssen Korea, Ltd., Korea September 1, 2014
NCT02714634 Not yet recruiting Rheumatoid Arthritis, Insufficient Response to Methotrexate. University Hospital, Strasbourg, France March 21, 2016
NCT02242474 Recruiting Rheumatoid Arthritis CHU de Quebec-Universite Laval September 17, 2014
NCT02066636 Active, not recruiting Non-Small Cell Lung Cancer (NSCLC) Bristol-Myers Squibb February 19, 2014
NCT02557308 Recruiting Ankylosing Spondylitis Celltrion September 23, 2015
NCT01862965 Active, not recruiting Chronic Graft-versus-host Disease Universitätsklinikum Hamburg-Eppendorf May 27, 2013
NCT03775824 Active, not recruiting Rheumatoid Arthritis Region Skane December 14, 2018
NCT03729674 Not yet recruiting Rheumatoid Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Crohn's Disease McGill University Health Center November 5, 2018
NCT03681652 Recruiting Crohn Disease Schneider Children's Medical Center, Israel September 24, 2018
NCT03640637 Not yet recruiting Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis Odense University Hospital August 21, 2018
NCT03088449 Active, not recruiting Crohn Disease Royal Devon and Exeter NHS Foundation Trust March 23, 2017
NCT02557295 Recruiting Rheumatoid Arthritis Celltrion September 23, 2015
NCT03112603 Recruiting Graft-versus-host Disease (GVHD) Incyte Corporation April 13, 2017
NCT03591770 Not yet recruiting Inflammatory Bowel Diseases Boston Medical Center July 19, 2018
NCT01630850 Recruiting Diabetes Mellitus, Type 1 University of Chicago June 28, 2012
NCT02596035 Active, not recruiting Renal Cell Carcinoma Bristol-Myers Squibb November 4, 2015
NCT01848028 Recruiting Psoriasis, Psoriatic-arthritis Universitätsklinikum Hamburg-Eppendorf May 7, 2013
NCT03794765 Not yet recruiting Ulcerative Colitis, Inflammatory Bowel Diseases, Acute Severe Colitis Postgraduate Institute of Medical Education and Research January 7, 2019
NCT03006809 Recruiting Ulcerative Colitis Najwa Elnachef December 30, 2016
NCT03553472 Recruiting Herpes Zoster, Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis University of Wisconsin, Madison June 12, 2018
NCT03013335 Recruiting Metastatic Renal Cell Carcinoma UNICANCER January 6, 2017

Table 2. Approved Drugs of Infliximab**

INN (trade name) Therapeutic area Dose Strength Route Company Marketing start Market
Remicade Crohn’s Disease, Pediatric Crohn’s Disease, Ulcerative Colitis, Pediatric Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis Lyophilized concentrate for injection 100MG / vial Intravenous infusion Centocor Inc August 24, 1998 Infliximab Overview
Remicade Gastroentology-Hepatology Powder for concentrate for solution for infusion 100MG / vial Intravenous infusion Centocor B.V. September 16, 2010 Infliximab Overview
Remicade Inflammatory, Antirheumatic Lyophilized concentrate for injection 100MG / vial Intravenous infusion Janssen Biotech May, 2002 Infliximab Overview

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Reference
*The table was excerpted from the following website
https://clinicaltrials.gov/ct2/results?term=Infliximab

**Information presented in the table were collected from the following website:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103772

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