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certolizumab pegol (Cimzia)

Indications: - rheumatoid arthritis [2]* - ankylosing spondylitis [2]* - psoriatic arthritis [2,3]* - plaque psoriasis [4] - Crohn's disease [2] * FDA-approved indications according to [2] Contraindications: Pregnancy category: B [2] - PEGylated & unlikely to cross placenta [5] - pregnancy outcomes similar to those reported for general population [5] Dosage: - requires 2 SC injections given by a health care provider every 4 weeks Monitor: - screening for tuberculosis [2] - CBC, LFTs, serum creatinine at baseline & every 3-6 month thereafter [2] Laboratory: - certolizumab in serum/plasma (no Loinc as of Aug 2017) Mechanism of action: - Fab' segment of humanized monoclonal antibody - PEGylated to extend its half-life - inhibitor of TNF-alpha [2] Notes: Cost is about $1500 per month (same as Humira)

Interactions

drug adverse effects of immunosuppressive agents monitor with immunosuppressive agents

General

recombinant protein; chimer pharmaceutical monoclonal antibody tumor necrosis factor (TNF) inhibitor

References

  1. Prescriber's Letter 15(6): 2008 New Drug: Cimzia (Certolizumab Pegol) Detail-Document#: 240607 (subscription needed) http://www.prescribersletter.com
  2. Medical Knowledge Self Assessment Program (MKSAP) 16, 17, 18, 19. American College of Physicians, Philadelphia 2012, 2015, 2018, 2022.
  3. Cimzia (certolizumab pegol) approved by the U.S. FDA for treatment of adult patients with active psoriatic arthritis. http://www.prnewswire.com/news-releases/cimzia-certolizumab-pegol-approved-by-the-us-fda-for-treatment-of-adult-patients-with-active-psoriatic-arthritis-225778051.html
  4. Bankhead C American Academy of Dermatology Meeting Coverage 2017 Cimzia Passes Muster in Two Psoriasis Trials - Met primary efficacy goals versus placebo; third trial still to come. http://www.medpagetoday.com/MeetingCoverage/AAD/63625?xid=nl_mpt_DHE_2017-03-07&eun=g1094596d0r&pos=4 - Gottlieb AB, et al Certolizumab pegol treatment for chronic plaque psoriasis: 16-week primary results from two phase III, multicenter, randomized, placebo-controlled studies. American Academy of Dermatology (AAD) 2017; Abstract 5077.
  5. Clowse MEB, Scheuerle AE, Chambers C et al. Pregnancy outcomes after exposure to certolizumab pegol: Updated results from a pharmacovigilance safety database. Arthritis Rheumatol 2018 Sep; 70:1399-1407 PMID: 29623679
  6. Cimzia Prescribing information http://www.cimzia.com/pdf/Prescribing_Information.pdf