Golimumab Overview

Introduction of Golimumab

Golimumab (brand name Simponi) is a human IgG1 monoclonal antibody derived from immunizing genetically engineered mice with human TNFα. It is a full-size antibody with a molecular mass of approximately 150 kilodaltons that exhibits multiple glycoforms. The drug binds and inhibits soluble and transmembrane human TNFα. The product was originally isolated from a hybridoma clone produced by HuMab (Medarex) transgenic mice that had been immunized with human TNFα. The golimumab-secreting clone was selected after being assayed for human light and heavy chains, and for TNFα-binding. The commercial product is produced in a recombinant cell line cultured by continuous perfusion. Golimumab was approved in the US and Canada in April 2009 as a treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. The product was developed by Centocor and Janssen Pharmaceutical KK, in collaboration with Schering-Plough and Mitsubishi Tanabe Pharma. Large, double-blind randomized controlled trials in patients with rheumatoid arthritis have shown that golimumab in combination with methotrexate was more effective than methotrexate alone. When clinically indicated, golimumab is estimated as a moderate cost-effective treatment option. National Institutes for Health and Care Excellence (NICE) stated that treatment with golimumab is not recommended for RA patients who have failed prior TNFi treatment. Unlike other TNFi treatments such as adalimumab and certolizumab pegol, there have been no reported cases of drug-induced lupus-like syndrome (DILS).

Mechanism of Action of Golimumab

Autoimmune inflammatory diseases affect approximately 7.6-9.4% of the world population, especially among the young and middle-aged women. Frequently accompanied by severe and chronic morbidity, autoimmune diseases are also leading causes of death all around world. Excessive and prolonged activation of immune cells, such as T and B lymphocytes, and overexpression of the master pro-inflammatory cytokine tumor necrosis factor alpha (TNF), together with other mediators play a central role in the pathogenesis of autoimmune inflammatory responses in rheumatoid arthritis inflammatory bowel disease, Crohn’s disease, and ankylosing spondylitis. Tumor necrosis factor (TNF), a pleiotropic cytokine mainly produced by activated macrophages, modulates a wide range of biological functions in multiple tissues and organs. Besides its effects on tumor cell death, TNF is a key mediator of both acute and chronic inflammation that serves a key role in the pathogenesis of a variety of immunological diseases. As majority of TNF-α blockers, Golimumab inhibits soluble and transmembrane forms of TNF-α binding to their specific receptors and blocking in consequence their bioactivity. Furthermore, Golimumab neither bind nor inhibit other members of TNF-α such as the lymphotoxin (TNF-β) Competing with TNF-α receptors, Golimumab regulates TNF-α pro-inflammatory cytokines essentially produced by activated macrophages. Golimumab has also the power to fix complement inducing cell lysis and to participate in immune responses implicating antibody-dependent cell cytotoxicity function. Following Golimumab therapy, numerous positive responses related to RA disease cure were obtained, such as reductions in levels of C-reactive protein (CRP), IL-6, MMP-3, ICAM-1, and VEGF.

Mechanism of Action of Golimumab

Fig 1. Mechanism of Action of Golimumab

Table 1. Clinical Projects of Golimumab*

NCT ID Status Conditions Lead Sponsor Update Time
NCT03669029 Not yet recruiting Colitis, Ulcerative Hospital de Manises September 13, 2018
NCT03182166 Recruiting Ulcerative Colitis Centre Hospitalier Universitaire de Saint Etienne June 9, 2017
NCT03733925 Recruiting Spondylitis, Ankylosing, Arthritis, Psoriatic Johnson & Johnson Private Limited November 7, 2018
NCT03298542 Recruiting Pre-Symptomatic Type 1 Diabetes Janssen Research & Development, LLC October 2, 2017
NCT02277444 Active, not recruiting Arthritis, Juvenile Janssen Research & Development, LLC October 29, 2014
NCT01900574 Active, not recruiting Colitis, Ulcerative Janssen Research & Development, LLC July 16, 2013
NCT03394586 Recruiting Ulcerative Colitis, Flare Up, Symptom University of Zurich January 9, 2018
NCT03124121 Recruiting Ulcerative Colitis Guy's and St Thomas' NHS Foundation Trust April 21, 2017
NCT03729349 Recruiting Arthritis, Rheumatoid Janssen Inc. November 2, 2018
NCT03557853 Active, not recruiting Ankylosing Spondylitis, Coxitis MSD Pharmaceuticals LLC June 15, 2018
NCT02425865 Not yet recruiting ULCERATIVE COLITIS Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives April 24, 2015
NCT02910375 Active, not recruiting Ulcerative Colitis Universitaire Ziekenhuizen Leuven September 22, 2016
NCT02728934 Active, not recruiting Arthritis, Rheumatoid Janssen Scientific Affairs, LLC April 5, 2016
NCT02846545 Active, not recruiting Diabetes Mellitus, Type 1 Janssen Research & Development, LLC July 27, 2016
NCT03596645 Recruiting Colitis, Ulcerative Janssen Research & Development, LLC July 24, 2018
NCT03773445 Recruiting Ulcerative Colitis Hospital San Carlos, Madrid December 12, 2018
NCT03632759 Recruiting Type 1 Diabetes Mellitus Carla Greenbaum, MD August 15, 2018
NCT03270501 Not yet recruiting Axial Spondyloarthritis University Ghent September 1, 2017
NCT02868398 Recruiting Ulcerative Colitis Evangelismos Hospital August 16, 2016
NCT03662542 Recruiting Colitis, Ulcerative Janssen Research & Development, LLC September 7, 2018
NCT02914717 Active, not recruiting Ulcerative Colitis Universitaire Ziekenhuizen Leuven September 26, 2016
NCT03253796 Active, not recruiting Spondyloarthritis Merck Sharp & Dohme Corp. August 18, 2017
NCT02758782 Active, not recruiting Ankylosing Spondylitis Charite University, Berlin, Germany May 2, 2016
NCT01804166 Recruiting Hepatosplenic T-Cell Lymphoma Janssen Scientific Affairs, LLC March 5, 2013
NCT02687724 Recruiting Colitis University College Dublin February 22, 2016
NCT03011268 Recruiting Colitis,Ulcerative Helse Møre og Romsdal HF January 5, 2017
NCT02935387 Recruiting Arthritis, Rheumatoid UMC Utrecht October 17, 2016
NCT01602302 Recruiting Rheumatoid Arthritis Medical University of Graz May 18, 2012
NCT02808780 Recruiting Ulcerative Colitis Janssen Biotech, Inc. June 22, 2016
NCT01965132 Recruiting Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis Seoul National University Hospital October 18, 2013
NCT03445845 Not yet recruiting Axial Spondyloarthritis Centre Hospitalier Universitaire de Saint Etienne February 26, 2018
NCT03100253 Recruiting Rheumatoid Arthritis Mario Negri Institute for Pharmacological Research April 4, 2017
NCT02456363 Recruiting Ankylosing Spondylitis Chung Shan Medical University May 28, 2015
NCT03679546 Not yet recruiting Ulcerative Colitis Rennes University Hospital September 20, 2018
NCT03016260 Recruiting RheumatoId Arthritis TcLand Expression S.A. January 10, 2017
NCT03168347 Recruiting Psoriasis Wake Forest University Health Sciences May 30, 2017
NCT03219359 Recruiting Crohn Disease Icahn School of Medicine at Mount Sinai July 17, 2017
NCT02674308 Recruiting Ulcerative Colitis and Crohn's Disease Takeda February 4, 2016
NCT02755194 Recruiting Lactation The Hospital for Sick Children April 28, 2016
NCT03710486 Recruiting Ulcerative Colitis, Crohn's Disease Takeda October 18, 2018
NCT02714634 Not yet recruiting Rheumatoid Arthritis, Insufficient Response to Methotrexate. University Hospital, Strasbourg, France March 21, 2016
NCT01764321 Active, not recruiting Rheumatoid Arthritis UCB Pharma SA January 9, 2013
NCT03775824 Active, not recruiting Rheumatoid Arthritis Region Skane December 14, 2018
NCT03591770 Not yet recruiting Inflammatory Bowel Diseases Boston Medical Center July 19, 2018
NCT02242474 Recruiting Rheumatoid Arthritis CHU de Quebec-Universite Laval September 17, 2014
NCT01848028 Recruiting Psoriasis, Psoriatic-arthritis Universitätsklinikum Hamburg-Eppendorf May 7, 2013
NCT03056924 Recruiting Inflammatory Bowel Diseases Boston Medical Center February 17, 2017

Table 2. Approved Drugs of Golimumab**

INN (trade name) Therapeutic area Dose Strength Route Company Marketing start Market
Simponi Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis Concentrate for injection 50MG Subcutaneous injection Centocor Ortho Biotech April 24, 2019 Golimumab Overview
Simponi Active rheumatoid arthritis, Active and progressive psoriatic arthritis, Axial spondyloarthritis, Moderately to severely active ulcerative colitis, Polyarticular juvenile idiopathic arthritis Solution for injection 50MG Subcutaneous injection Janssen Biologics October 1, 2009 Golimumab Overview

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

**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=125289

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