title: Certolizumab pegol in rheumatoid arthritis: current update.
abstract: BACKGROUND
  The development of TNF-α inhibitors (TNF-is) represents a major advancement in the treatment of rheumatoid arthritis (RA). Currently, there are five agents licensed for moderate-to-severely active RA. Certolizumab pegol (CZP) is a novel PEGylated, constant fragment-free TNF-i therapy, which is the focus of this review.
  
  
  METHODS
  Data from Phase III randomised controlled trials in terms of clinical efficacy, radiographic progression, patient-reported outcomes and safety profile are reviewed. These include long-term data from open-label extension studies.
  
  
  CONCLUSIONS
  The advantages of CZP include rapid reduction of disease activity, low rates of injection-site reaction and may be safe for use in pregnancy. The long-term data strengthen the position of CZP for use either as monotherapy or preferably in combination with disease modifying anti-rheumatic drugs (DMARDs), in moderate-to-severely active RA, comparable to other TNF-is. Notably, prolonged CZP exposure is not associated with increased risk of severe infection compared to general population, contrasting with preliminary analysis of short-term data. Over the next few years, evidence will be available on the use of CZP in combination with methotrexate for remission induction in DMARD-naïve patients, biomarkers and the development and licensing of TNF-i biosimilars.
authors.affiliation: University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine , Chapel Allerton Hospital, Chapeltown Road, Leeds, LS7 4SA , UK +44 113 3924884 ; +44 113 3924991 ; p.emery@leeds.ac.uk.
authors.forename: Marie
authors.initials: M
authors.lastname: Fechtenbaum
authors.forename: Md Yuzaiful
authors.initials: MY
authors.lastname: Md Yusof
authors.forename: Paul
authors.initials: P
authors.lastname: Emery
mesh_terms: D000818:Animals; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D000068582:Certolizumab Pegol; D004359:Drug Therapy, Combination; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors / Q000378:metabolism
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D007140:Immunoglobulin Fab Fragments; D014409:Tumor Necrosis Factor-alpha; D011092:Polyethylene Glycols; D000068582:Certolizumab Pegol
keywords: PEGylation; anti-TNF; biological therapy; certolizumab; rheumatoid arthritis