Certolizumab pegol for the treatment of psoriatic arthritis

Abstract

Certolizumab pegol (CZP) is a TNF-α inhibitor approved for the treatment of psoriatic arthritis in 38 countries, including many European countries and the USA. It is a pegylated humanized anti-TNF-α antigen-binding fragment, administered subcutaneously. As other TNF-α antibodies, CZP binds to and neutralizes both soluble and membrane TNF-α. In contrast to whole antibodies and etanercept, CZP does not activate antibody-dependent cell-mediated cytotoxicity or complement-dependent cytotoxicity, as it does not have an Fc piece. CZP showed efficacy in improving skin scores and patient reported outcomes in a Phase II study of 176 adults with moderate-to-severe plaque psoriasis. In a Phase III study of CZP in 409 psoriatic arthritis patients, CZP treatment resulted in improvements in peripheral arthritis, as well as dactylitis, enthesitis, nail disease and quality of life. The safety profile of CZP appears to be similar to that of other TNF-α inhibitor.

Keywords:

• biologic agents
• certolizumab pegol
• psoriatic arthritis
• tumor necrosis factor alpha inhibitors

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Erratum

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Psoriatic arthritis (PsA) is a heterogeneous disease with various manifestations, including peripheral arthritis, enthesitis, dactylitis, axial arthritis, skin and nail psoriasis and other manifestations.

• Current treatment options of PsA include disease modifying drugs, other oral agents and biologic agents.

• Certolizumab pegol (CZP) is one of the TNF-α inhibitors (TNFi) approved for the treatment of PsA in 38 countries worldwide (through 2014), including the EU and the USA.

• CZP is a recombinant, humanized anti-TNF-α antigen-binding fragment (it lacks an Fc region), that is administered subcutaneously.

• CZP resulted in rapid improvements in peripheral arthritis, as well as dactylitis, enthesitis, nail disease and quality of life in PsA patients in Phase III study; CZP may also have benefits in home and work productivity in PsA patients.

• CZP efficacy was observed even in patients with prior TNFi exposure.

• The safety profile of CZP in PsA patients is similar to RA and to that of other TNFi.

• Due to the lack of Fc region, CZP crosses placenta differently from the whole antibodies, such as infliximab and adalimumab, and its use might be safe in pregnancy.