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
-

Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)

First Posted Date
2009-02-16
Last Posted Date
2017-04-12
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
158
Registration Number
NCT00844805

Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315)

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2009-01-30
Last Posted Date
2017-04-12
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
39
Registration Number
NCT00833053

The HAM Infliximab Study

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2009-01-15
Last Posted Date
2013-04-15
Lead Sponsor
Imperial College London
Target Recruit Count
3
Registration Number
NCT00823641
Locations
🇬🇧

Imperial College Healthcare NHS Trust, London, United Kingdom

A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab

First Posted Date
2008-12-15
Last Posted Date
2020-11-06
Lead Sponsor
Genentech, Inc.
Target Recruit Count
28
Registration Number
NCT00808210
Locations
🇺🇸

Ohio State Univ Med Center, Columbus, Ohio, United States

🇺🇸

Ctr for Inflammatory Disease, Nashville, Tennessee, United States

🇺🇸

Phillip A Waller MD, PA, Houston, Texas, United States

and more 49 locations

Study to Assess the Safety and Efficacy of Infliximab to Treat Hidradenitis Suppurtativa

First Posted Date
2008-11-21
Last Posted Date
2008-11-24
Lead Sponsor
Florida Academic Dermatology Centers
Target Recruit Count
38
Registration Number
NCT00795574
Locations
🇺🇸

Florida Academic Dermatology Center, Miami, Florida, United States

Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease

First Posted Date
2008-11-14
Last Posted Date
2016-11-02
Lead Sponsor
University Hospitals Cleveland Medical Center
Target Recruit Count
2
Registration Number
NCT00791557
Locations
🇺🇸

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-09-26
Last Posted Date
2014-11-24
Lead Sponsor
University of California, San Diego
Target Recruit Count
196
Registration Number
NCT00760435
Locations
🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

🇺🇸

University of California, San Diego, La Jolla, California, United States

A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)

Completed
Conditions
Interventions
First Posted Date
2008-08-26
Last Posted Date
2017-01-04
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
363
Registration Number
NCT00741104

Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED)

Completed
Conditions
Interventions
First Posted Date
2008-07-29
Last Posted Date
2015-09-04
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
33
Registration Number
NCT00724243
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