Infliximab

Generic Name
Infliximab
Brand Names
Avsola, Flixabi, Inflectra, Remicade, Renflexis, Zessly, Remsima
Drug Type
Biotech
Chemical Formula
-
CAS Number
170277-31-3
Unique Ingredient Identifier
B72HH48FLU
Background

Infliximab 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 . Infliximab is produced by a recombinant cell line cultured by continuous perfusion. Tumor necrosis factor-alpha (TNF-α) is a key proinflammatory cytokine involved in chronic inflammatory diseases . Its hyperactivity and enhanced signalling pathways can be observed in inflammatory diseases where it activates further pro-inflammatory cascades. 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 .

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 biosilimars 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.

Indication

用于治疗:

⑴类风湿性关节炎:本品常与甲氨蝶呤合用于中重度活动性类风湿性关节炎;

⑵克罗恩病及瘘管性克罗恩病;

⑶强直性脊柱炎等自身免疫性疾病,以减轻症状和体征,改善身体机能,预防患者残疾。

⑷用于银屑病关节炎的治疗【美国FDA已批准;英国风湿病学会/英国风湿病卫生专业人员协会《BSR/BHPR—应用生物制剂治疗银屑病关节炎指南》2012版;欧洲抗风湿病联盟《EULAR—银屑病关节炎药 物治疗管理建议》2011版

】。

⑸用于6岁及以上儿童溃疡性结肠炎的治疗【美国FDA已批准;中华医学会内科学会《炎症性肠病诊断与治疗的共识意见》;中华医学会消化病学分会炎症性肠病学组《英夫利西治疗克罗恩病的推荐方案(2011年】。

Associated Conditions
Ankylosing Spondylitis (AS), Chronic Plaque Psoriasis, Fistulizing Crohn's Disease, Moderately to Severely Active Crohn's Disease, Moderately to Severely Active Rheumatoid Arthritis, Moderately to Severely Active Ulcerative Colitis, Pediatric Crohn’s Disease, Psoriatic Arthritis
Associated Therapies
-

12-Week Study Evaluating the Efficacy, Safety, and Tolerability of Adjunctive Infliximab for Bipolar I/II Depression

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-02-16
Last Posted Date
2021-07-28
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
60
Registration Number
NCT02363738
Locations
🇺🇸

VA Palo Alto Health Care System, Palo Alto, California, United States

🇨🇦

Toronto Western Hospital, Toronto, Ontario, Canada

Infliximab for Kawasaki Disease Patients Resistant to IVIG : a Multicentre, Prospective, Randomised Trial

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-11-21
Last Posted Date
2016-02-03
Lead Sponsor
Fudan University
Target Recruit Count
40
Registration Number
NCT02298062
Locations
🇨🇳

Children Hospital of Fudan University, Shanghai, Shanghai, China

An Observational Study of Infliximab in Participants Suffering From Ankylosing Spondylitis With Hip Involvement

First Posted Date
2014-11-18
Last Posted Date
2017-11-01
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
76
Registration Number
NCT02293681

A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy

First Posted Date
2014-06-27
Last Posted Date
2022-08-03
Lead Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Target Recruit Count
211
Registration Number
NCT02177071
Locations
🇦🇺

St Vincent Hospital, Melbourne, Australia

🇫🇷

Chu Clermont-Ferrand, Clermont-ferrand, Auvergne Rhone Alpes, France

🇫🇷

CHU LYON, Pierre Benite, Auvergne Rhone Alpes, France

and more 24 locations

A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors

First Posted Date
2014-05-12
Last Posted Date
2021-12-03
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
397
Registration Number
NCT02136069
Locations
🇮🇱

Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit, Tel Hashomer, Israel

🇭🇺

Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo, Budapest, Hungary

🇭🇺

Vasutegeszsegugyi Nonprofit KiemeltenKozhasznu Kft, Debrecen, Hungary

and more 116 locations

Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

First Posted Date
2014-05-07
Last Posted Date
2014-05-07
Lead Sponsor
Jagiellonian University
Target Recruit Count
100
Registration Number
NCT02132234
Locations
🇵🇱

Katedra Chorób Wewnętrznych i Medycyny Wsi, Uniwersytet Jagielloński, Krakow, Skarbowa 4, Poland

Regulatory T-cells and Crohn's Disease

Completed
Conditions
Interventions
First Posted Date
2014-02-12
Last Posted Date
2017-09-05
Lead Sponsor
Hvidovre University Hospital
Target Recruit Count
47
Registration Number
NCT02060318
Locations
🇩🇰

Hvidovre Hospital, Hvidovre, Copenhagen, Denmark

Early Serum Infliximab Levels in Severe Ulcerative Colitis.

First Posted Date
2013-10-29
Last Posted Date
2015-05-29
Lead Sponsor
University of California, San Francisco
Target Recruit Count
11
Registration Number
NCT01971814
Locations
🇺🇸

University of California at San Francisco, San Francisco, California, United States

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