| Drug Name |
Certolizumab pegol |
| Drug ID |
BADD_D00416 |
| Description |
Certolizumab pegol is a pegylated monoclonal antibody against the tumor necrosis factor-alpha (TNF-alpha).[A176585] It is formed with a humanized Fab fragment of 50 kDa, from an IgG 1 isotype, fused to a 40 kDa polyethylene glycol moiety replacing the Fc antibody region. The absence of the Fc region was ideated to prevent complement fixation and antibody-mediated cytotoxicity as well as to markedly increase its half-life.[A176606]
Certolizumab does not require glycosylation for active function and hence, its production is significantly more affordable when compared to other existing TNF-alpha therapies as it can be done directly in bacterial hosts such as _E. coli_.[A176606] It was developed and manufactured by UCB Pharma, first FDA approved in 2008[L4894] and updated for a new indication on March 28, 2019.[L5819] |
| Indications and Usage |
Certolizumab pegol has been approved for several different conditions listed below:
- Symptomatic management of Chron's disease patients and for the maintenance of clinical response in patients with moderate to severe disease with inadequate response to conventional therapy.
- Treatment of adult patients with moderate to severely active rheumatoid arthritis.
- Treatment of adult patients with active psoriatic arthritis.
- Treatment of adult patients with active ankylosing spondylitis.
- Treatment of adult patients with moderate-to-severe plaque psoriasis that are candidates for systemic therapy or phototherapy.[FDA label]
- Treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation.[L5819]
In Canada, certolizumab pegol is additionally approved in combination with [methotrexate] for the symptomatic treatment, including major clinical response, and for the reduction of joint damage in adult patients with moderately to severely active rheumatoid arthritis and psoriatic arthritis.[L5825]
Inflammation is a biological response against a potential threat. This response can be normal but in certain conditions, the immune system can attack the body's normal cells or tissues which causes an abnormal inflammation.[L5840] TNF-alpha has been identified as a key regulator of the inflammatory response. The signaling cascades of this inflammatory mediator can produce a wide range of reactions including cell death, survival, differentiation, proliferation and migration.[A176660] |
| Marketing Status |
approved |
| ATC Code |
L04AB05 |
| DrugBank ID |
DB08904
|
| KEGG ID |
D03441
|
| MeSH ID |
D000068582
|
| PubChem ID |
Not Available
|
| TTD Drug ID |
Not Available
|
| NDC Product Code |
50474-700; 49187-0228; 28877-7100; 68225-045; 28877-7300; 50474-710 |
| UNII |
UMD07X179E
|
| Synonyms |
Certolizumab Pegol | Cimzia | CDP870 | CDP 870 |
