Adalimumab Overview

Introduction of Adalimumab

Adalimumab (trade name Humira) is a a recombinant, fully human IgG1 monoclonal antibody and subcutaneously administered biological disease modifier which targets tumor necrosis factor (TNF). The drug is produced by recombinant DNA technology in a mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps. Adalimumab is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa, juvenile idiopathic arthritis, and uveitis. It was originally launched by Abbvie in the US and approved in 2002 by the FDA. This drug is available in a prefilled syringe form and convenient pen form for subcutaneous self-administered doses. Adalimumab-adaz (Hyrimoz) is a new biosimilar to adalimumab developed by Novartis AG. It was approved by the FDA on October 31, 2008. However, due to the importance of TNF in host defense, one of the issues of major concern with all TNF-blockers, including adalimumab, is the increased risk of infections and malignancies.

Mechanism of Action of Adalimumab

Psoriasis is a chronic inflammatory immune-mediated skin disease that affects 1%-3% of general population. The disease is characterized by hyperproliferation and abnormal differentiation of keratinocytes, vascular changes in the papillary dermis, intraepidermal accumulation of neutrophils and dermal inflammation with prominent lymphocytic infiltrate. The development of psoriasis has a multifactorial nature resulting from the interaction between genetic predisposition and environmental factors. Pathogenic mechanisms are considered to be secondary to an abnormal immune response, with an aberrant regulation of both the adaptative (CD4+ Th1 lymphocytes and CD8+ type-1 T-cells) and the innate immunity (dendritic cells, macrophages, keratinocytes) resulting in a complex network of cytokines, chemokines and growth factors. The serendipitous discovery of the effectiveness of anti-TNF biologics in psoriasis has suggested the crucial role of this cytokine, which can be implicated in multiple events of psoriasis-related inflammation: attraction of leucocytes into the skin, activation of dendritic cells and T lymphocytes, release of epithelial and vascular growth factors, synthesis of cytokines, chemokines and other proinflammatory mediators via activation of NF-kappaB. The mechanism of action of adalimumab is primarily linked to the neutralization of TNF-alpha bioactivity by preventing the interaction of TNF-alpha with the cell surface TNF receptors. Through this mechanism, adalimumab inhibits several TNF-alpha-induced events, i.e., the release of serum cytokines (IL-6), acute phase reactants of inflammation, matrix metalloproteases and other markers of cartilage and synovium turnover, and the expression of adhesion molecules responsible for leukocyte migration. In addition, adalimumab lyses TNF-expressing cells in the presence of complement.

Mechanism of Action of Adalimumab

Fig 1. Mechanism of Action of Adalimumab

Table 1. Clinical Projects of Adalimumab*

NCT ID Status Conditions Lead Sponsor Update Time
NCT03221621 Recruiting Hidradenitis Suppurativa Erasmus Medical Center July 18, 2017
NCT03816397 Not yet recruiting Uveitis, JIA Nisha Acharya January 25, 2019
NCT02904902 Active, not recruiting Hidradenitis Suppurativa AbbVie September 19, 2016
NCT03357939 Active, not recruiting Pharmacokinetics, Safety, Toleratiblity and Immunogenicity Comparison Between a Biosimilar and Humira in Healthy Volunteers Shanghai Henlius Biotech November 30, 2017
NCT03172377 Recruiting Crohn Disease in Remission, Crohn Disease Radboud University June 1, 2017
NCT02762955 Active, not recruiting Psoriasis Biocad May 5, 2016
NCT03849313 Not yet recruiting Healthy Volunteers Alvotech Swiss AG February 21, 2019
NCT03306446 Recruiting CD Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives October 11, 2017
NCT02035800 Recruiting RheumatoId Arthritis Université de Sherbrooke January 14, 2014
NCT03828019 Not yet recruiting Uveitis JHSPH Center for Clinical Trials February 4, 2019
NCT01893996 Active, not recruiting Rheumatoid Arthritis, Cardiovascular Disease University of California, San Francisco July 9, 2013
NCT03311464 Recruiting Pyoderma Gangrenosum AbbVie October 17, 2017
NCT02808975 Active, not recruiting Hidradenitis Suppurativa (HS) AbbVie June 22, 2016
NCT03153319 Recruiting Mucopolysaccharidosis I, II Los Angeles Biomedical Research Institute May 15, 2017
NCT03607903 Active, not recruiting Pain, Injection Site Centre for Human Drug Research, Netherlands July 31, 2018
NCT02706704 Recruiting Uveitis, Non-Infectious Uveitis American University of Beirut Medical Center March 11, 2016
NCT02471118 Recruiting Osteoarthritis, Knee Canadian Research & Education in Arthritis June 15, 2015
NCT01716039 Active, not recruiting Ulcerative Colitis University of Western Ontario, Canada October 29, 2012
NCT02065557 Recruiting Ulcerative Colitis (UC) AbbVie February 19, 2014
NCT02632175 Enrolling by invitation Ulcerative Colitis (UC) AbbVie December 16, 2015
NCT03383263 Recruiting Polyarticular Juvenile Arthritis AbbVie December 26, 2017
NCT03823391 Not yet recruiting Rheumatoid Arthritis (RA) AbbVie January 30, 2019
NCT03561649 Recruiting Spondylitis, Ankylosing University Hospital, Grenoble June 19, 2018
NCT03017014 Recruiting Crohn's Disease AbbVie January 11, 2017
NCT03464136 Recruiting Crohn Disease Janssen Scientific Affairs, LLC March 13, 2018
NCT02332590 Active, not recruiting Rheumatoid Arthritis Sanofi January 7, 2015
NCT01848561 Recruiting Ulcerative Colitis (UC) AbbVie May 7, 2013
NCT03259074 Recruiting Ankylosing Spondylitis Novartis Pharmaceuticals August 23, 2017
NCT02745080 Active, not recruiting Psoriatic Arthritis Novartis Pharmaceuticals April 20, 2016
NCT02738125 Active, not recruiting Ulcerative Colitis (UC) AbbVie April 14, 2016
NCT03261102 Recruiting Crohn Disease, Drug Monitoring, Inflammatory Bowel Diseases waqqas.afif August 24, 2017
NCT03619876 Not yet recruiting Rheumatoid Arthritis, Myocardial Inflammation Columbia University August 8, 2018
NCT03505892 Recruiting Ankylosing Spondylitis (AS) AbbVie April 23, 2018
NCT03151551 Active, not recruiting Psoriatic Arthritis Eli Lilly and Company May 12, 2017
NCT02171429 Recruiting Ulcerative Colitis Hoffmann-La Roche June 24, 2014
NCT02163759 Recruiting Ulcerative Colitis Hoffmann-La Roche June 16, 2014
NCT03099083 Active, not recruiting Psoriasis AbbVie April 4, 2017
NCT03110094 Recruiting Rheumatoid Arthritis Rennes University Hospital April 12, 2017
NCT02916017 Active, not recruiting Uveitis AbbVie September 27, 2016
NCT03217734 Recruiting Psoriasis Jeffrey J Crowley MD July 14, 2017
NCT03789292 Recruiting Rheumatoid Arthritis Celltrion December 28, 2018
NCT02362074 Recruiting Rheumatoid Arthritis (RA) AbbVie February 12, 2015
NCT02988674 Active, not recruiting Spondylarthritis, Psoriatic Arthritis, Ankylosing Spondylitis (AS) AbbVie December 9, 2016
NCT02929251 Recruiting Uveitis, Biotherapy Assistance Publique - Hôpitaux de Paris October 11, 2016
NCT03505008 Recruiting Rheumatoid Arthritis Keio University April 20, 2018
NCT02687828 Active, not recruiting Intestinal Behcet's Disease (BD) AbbVie February 22, 2016
NCT02764762 Recruiting Crohn Disease Takeda May 6, 2016
NCT03001115 Recruiting Hidradenitis Suppurativa (HS) AbbVie December 22, 2016
NCT03339102 Recruiting Uveitis AbbVie November 13, 2017
NCT03849404 Recruiting Plaque Psoriasis Alvotech Swiss AG February 21, 2019
NCT02065570 Active, not recruiting Crohn's Disease AbbVie February 19, 2014
NCT03210259 Recruiting Psoriasis Boehringer Ingelheim July 6, 2017
NCT03155243 Active, not recruiting Uveitis AbbVie May 16, 2017
NCT02814175 Recruiting Psoriatic Arthritis AbbVie June 27, 2016
NCT02629159 Active, not recruiting Rheumatoid Arthritis AbbVie December 14, 2015
NCT03104400 Recruiting Psoriatic Arthritis AbbVie April 7, 2017
NCT03236870 Recruiting Psoriasis AbbVie August 2, 2017
NCT02130362 Active, not recruiting Crohn's Disease AbbVie May 5, 2014
NCT02878083 Recruiting ULCERATIVE COLITIS Nantes University Hospital August 25, 2016
NCT03389984 Recruiting Psoriasis Vulgaris Poitiers University Hospital January 4, 2018
NCT02506179 Recruiting Ulcerative Colitis (UC) AbbVie July 23, 2015
NCT02852694 Recruiting Crohn's Disease PIBD-Net August 2, 2016
NCT02087878 Recruiting Crohn's Disease, Ulcerative Colitis (UC), Hepatosplenic T-Cell Lymphoma AbbVie March 14, 2014
NCT02557100 Active, not recruiting Rheumatoid Arthritis Bristol-Myers Squibb September 23, 2015
NCT00783510 Active, not recruiting Juvenile Idiopathic Arthritis, JIA AbbVie October 31, 2008
NCT02896920 Active, not recruiting Hidradenitis Suppurativa (HS) AbbVie September 12, 2016
NCT02056184 Active, not recruiting Rheumatoid Arthritis, Targeted Ultrasound University of Leeds February 5, 2014
NCT03316781 Recruiting Plaque Psoriasis Shanghai Henlius Biotech October 20, 2017
NCT03180957 Recruiting Dupuytren's Disease University of Oxford June 8, 2017
NCT02871635 Active, not recruiting Crohn Disease Boehringer Ingelheim August 18, 2016
NCT03827876 Recruiting Psoriasis Psoriasis Treatment Center of Central New Jersey February 4, 2019
NCT02760407 Recruiting Rheumatoid Arthritis R-Pharm May 3, 2016
NCT03339089 Recruiting Ankylosing Spondylitis (AS), Psoriasis, Rheumatoid Arthritis (RA) AbbVie November 13, 2017
NCT02065622 Active, not recruiting Ulcerative Colitis (UC) AbbVie February 19, 2014
NCT02713295 Active, not recruiting Moderate to Severe Plaque Psoriasis AbbVie March 18, 2016
NCT03412747 Active, not recruiting Chronic Plaque Psoriasis, Moderate to Severe Plaque Psoriasis UCB Biopharma S.P.R.L. January 26, 2018
NCT02413047 Recruiting Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease Indiana University April 9, 2015
NCT02634060 Recruiting Crohn Disease, Colitis, Ulcerative Universitaire Ziekenhuizen Leuven December 17, 2015
NCT01077232 Active, not recruiting Psoriasis AbbVie (prior sponsor, Abbott) March 1, 2010
NCT01559038 Active, not recruiting Psoriatic Arthritis AbbVie (prior sponsor, Abbott) March 21, 2012
NCT02492217 Recruiting Ankylosing Spondylitis Universidade Nova de Lisboa July 8, 2015
NCT02896985 Recruiting Crohn's Disease AbbVie September 12, 2016
NCT03703817 Recruiting Rheumatoid Arthritis Pfizer October 12, 2018
NCT03248531 Active, not recruiting Hidradenitis Suppurativa UCB Biopharma S.P.R.L. August 14, 2017
NCT01387802 Active, not recruiting Ankylosing Spondylitis AbbVie (prior sponsor, Abbott) July 6, 2011
NCT02207244 Active, not recruiting Psoriasis Janssen Research & Development, LLC August 4, 2014
NCT00799877 Active, not recruiting Chronic Plaque Psoriasis AbbVie (prior sponsor, Abbott) December 1, 2008
NCT02207231 Active, not recruiting Psoriasis Janssen Research & Development, LLC August 4, 2014
NCT03220841 Recruiting Crohn Disease, Inflammatory Bowel Diseases, Stricture; Bowel St Vincent's Hospital Melbourne July 18, 2017
NCT03011268 Recruiting Colitis,Ulcerative Helse Møre og Romsdal HF January 5, 2017
NCT01698307 Active, not recruiting Crohn's Disease University of Western Ontario, Canada October 2, 2012
NCT02374021 Recruiting Arthritis, Rheumatoid Brigham and Women's Hospital February 27, 2015
NCT02456363 Recruiting Ankylosing Spondylitis Chung Shan Medical University May 28, 2015
NCT02856763 Active, not recruiting CD Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives August 5, 2016
NCT02840175 Recruiting Juvenile Idiopathic Arthritis Assistance Publique - Hôpitaux de Paris July 21, 2016
NCT02092467 Recruiting Arthritis, Rheumatoid Pfizer March 20, 2014
NCT03352622 Recruiting Pharmacological Action Universidad de Antioquia November 24, 2017
NCT01602302 Recruiting Rheumatoid Arthritis Medical University of Graz May 18, 2012
NCT01706692 Recruiting Psoriasis Swiss Dermatology Network for Targeted Therapies October 15, 2012
NCT01793519 Recruiting Rheumatoid Arthritis Georgetown University February 15, 2013
NCT01965132 Recruiting Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives October 18, 2013
NCT03808506 Not yet recruiting Ulcerative Colitis Assistance Publique - Hôpitaux de Paris January 17, 2019
NCT03833271 Recruiting Juvenile Idiopathic Arthritis Pfizer February 6, 2019
NCT02889796 Active, not recruiting Rheumatoid Arthritis Universidad de Antioquia September 7, 2016
NCT02994836 Recruiting Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis Medical University of Graz December 16, 2016
NCT03737708 Recruiting Rheumatoid Arthritis (RA) Swiss Dermatology Network for Targeted Therapies November 9, 2018
NCT02134054 Active, not recruiting Inflammatory Bowel Disease Georgetown University May 8, 2014
NCT03445845 Not yet recruiting Axial Spondyloarthritis Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives February 26, 2018
NCT03397108 Recruiting Crohn's Disease, Ulcerative Colitis, Healthy Controls Assistance Publique - Hôpitaux de Paris January 11, 2018
NCT02162472 Recruiting Psoriasis Northwestern University June 12, 2014
NCT02619552 Active, not recruiting Crohn's Disease, IBD University of Maryland December 2, 2015
NCT03759288 Recruiting Crohn's Disease, IBD Allergan November 29, 2018
NCT03100253 Recruiting Rheumatoid Arthritis Mario Negri Institute for Pharmacological Research April 4, 2017
NCT03853395 Not yet recruiting Arthritis, Rheumatoid, Psoriatic University of Manchester February 25, 2019
NCT03739853 Not yet recruiting Psoriatic Arthritis University of Oxford November 14, 2018
NCT01848028 Recruiting Psoriasis, Psoriatic-arthritis Universitätsklinikum Hamburg-Eppendorf May 7, 2013
NCT03108326 Recruiting Crohn Disease Ced Service GmbH April 11, 2017
NCT03016260 Recruiting RheumatoId Arthritis TcLand Expression S.A. January 10, 2017
NCT03056924 Recruiting Inflammatory Bowel Diseases Boston Medical Center February 17, 2017
NCT03679546 Not yet recruiting Ulcerative Colitis Rennes University Hospital September 20, 2018
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
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
NCT02914717 Active, not recruiting Ulcerative Colitis Universitaire Ziekenhuizen Leuven September 26, 2016
NCT02075697 Recruiting Psoriasis Fundación Academia Española de Dermatología March 3, 2014
NCT03580876 Recruiting Clinical Failure After Switch Védrines, Philippe, M.D. July 9, 2018
NCT03839862 Recruiting Spondyloarthropathies, Ankylosing Spondylitis Region Skane February 15, 2019
NCT02674308 Recruiting Ulcerative Colitis and Crohn's Disease Takeda February 4, 2016
NCT01506661 Active, not recruiting Rheumatoid Arthritis, Varicella Zoster Oklahoma Medical Research Foundation January 10, 2012
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
NCT02714634 Not yet recruiting Rheumatoid Arthritis, Insufficient Response to Methotrexate. University Hospital, Strasbourg, France March 21, 2016
NCT03651518 Not yet recruiting Inflammatory Disease, Autoimmune Diseases Assistance Publique - Hôpitaux de Paris August 29, 2018
NCT02829424 Recruiting Psoriasis Assistance Publique Hopitaux De Marseille July 12, 2016
NCT03710486 Recruiting Ulcerative Colitis, Crohn's Disease Takeda October 18, 2018
NCT02242474 Recruiting Rheumatoid Arthritis CHU de Quebec-Universite Laval September 17, 2014
NCT02557308 Recruiting Ankylosing Spondylitis Celltrion September 23, 2015
NCT01764321 Active, not recruiting Rheumatoid Arthritis UCB Pharma SA January 9, 2013
NCT03775824 Active, not recruiting Rheumatoid Arthritis Region Skane December 14, 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
NCT02557295 Recruiting Rheumatoid Arthritis Celltrion September 23, 2015
NCT03591770 Not yet recruiting Inflammatory Bowel Diseases Boston Medical Center July 19, 2018
NCT00508547 Recruiting Psoriasis, Arthritis, Psoriatic Janssen Scientific Affairs, LLC July 30, 2007
NCT02353780 Recruiting Rheumatoid Arthritis (RA) Dr. Larry W. Moreland February 3, 2015
NCT03006809 Recruiting Ulcerative Colitis Najwa Elnachef December 30, 2016

Table 2. Approved Drugs of Adalimumab**

INN (trade name) Therapeutic area Dose Strength Route Company Marketing start Market
Humira Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Adult Crohn’s Disease, Pediatric Crohn’s Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis Solution for injection 40MG/0.8ML Syringe AbbVie December 31, 2002 Ranibizumab Overview
Humira plaque psoriasis, rheumatoid arthritis, axial spondyloarthritis , Crohn’s disease, ulcerative colitis, polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis, hidradenitis suppurativa, non-infectious uveitis Solution for injection 40MG/0.8ML Syringe AbbVie September 8, 2003 Ranibizumab Overview

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

**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=125057

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