Certolizumab pegol for the treatment of psoriatic arthritis and plaque psoriasis

ABSTRACT

Introduction: Certolizumab pegol (CZP) is an Fc-free PEGylated TNF-α inhibitor approved for the treatment of psoriatic arthritis (PsA) and plaque psoriasis in many countries. It demonstrated favorable results in PsA in terms of improvement in peripheral arthritis, dactylitis, and enthesitis in a phase III trial (RAPID-PSA) and in real-life experiences. Recently, three phase III randomized clinical trials (CIMPASI-1, CIMPASI-2, CIMPACT) showed significant and sustained improvements in signs and symptoms of moderate-to-severe plaque psoriasis as well as in quality of life parameters as compared to placebo and etanercept.

Areas covered: We reviewed the structure and the mechanism of action of CZP, and critically analyzed data from clinical trials and real-life, concerning its efficacy and safety in all aspects of the psoriatic disease. We designed a comprehensive literature search on this topic, by a review of published articles in indexed international journals up until 31 July 2019.

Expert opinion: CZP demonstrated positive results in several domains of psoriatic disease, also in patients previously exposed to other TNF-α inhibitors and in patients receiving re-treatment after treatment interruption. The peculiar chemical structure, along with its well-established efficacy and safety, support CZP as the drug of choice in specific subgroups of patients with psoriatic disease, in particular patients with comorbidities and pregnant or breastfeeding female patients.

KEYWORDS:

• Certolizumab pegol
• plaque psoriasis
• psoriatic arthritis
• psoriatic disease
• tumor necrosis factor alpha inhibitors

Article highlights

• CZP is an Fc-free PEGylated anti-tumor necrosis factor biologic, thus not able to activate antibody-dependent cell-mediated or complement-dependent cytotoxicity.

• CZP received approval for the treatment of PsA in Europe in 2009 and in the USA in 2013 and, recently, in 2018, for moderate-to-severe plaque psoriasis in Europe and the USA.

• CZP demonstrated favorable results in psoriatic arthritis (PsA) improving peripheral arthritis, dactylitis, enthesitis, nail disease, and quality of life in a phase III trial (RAPID-PSA) and in real-life experiences.

• Promising results on the efficacy of CZP in moderate-to-severe chronic plaque psoriasis were obtained in a phase II trial and later confirmed in three phase III trials (CIMPASI-1, CIMPASI-2, CIMPACT).

• Both CZP regimens (400 mg or 200 mg every 2 weeks) improved psoriasis signs and symptoms in the short-term, with a greater efficacy for the higher dose, and were associated with the sustained response through week 48.

• CZP efficacy was also observed in psoriasis patients previously exposed to TNF inhibitors and in patients receiving re-treatment for loss of response after drug withdrawal.

• Safety profile in PsA and in psoriasis patients was consistent with other anti-TNFα drugs and with that reported for CZP treatment in other indications.

• Accumulating evidences support CZP as the drug of choice in specific subgroups of patients with the psoriatic disease (e.g. patients with comorbidities, pregnant or breastfeeding female patients).

Declaration of interest

M Esposito has served as a speaker and advisory board member for Eli Lilly, Novartis, Janssen, Sandoz, Sanofi-Genzyme, UCB. F Carubbi has served as a speaker and advisory board member for Abbvie, Celgene, UCB. A Giunta has served on advisory board, received honoraria for lectures and research grants from Amgen, Biogen, Eli Lilly, Pfizer, Sandoz. A Alunno has served as a speaker and advisory board member for Eli Lilly. R Giacomelli has served on the advisory board, received honoraria for lectures and research grants from Abbvie, Janssen, Novartis, Pfizer, Roche, Sanofi-Genzyme. MC Fargnoli has served on advisory board, received honoraria for lectures and research grants from Almirall, Celgene, Eli Lilly, Galderma, Janssen, Leo Pharma, Medac Pharma, Mylan, Novartis, Pfizer, Roche, Sanofi, UCB, Sun pharma, Pierre Fabre. The authors have no other 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 apart from those disclosed.

Reviewer disclosures

A peer reviewer on this manuscript his disclosed research funds from: Abbvie, Boehringer Ingelheim, Celgene, Eli Lilly, Incyte, Janssen/Johnson & Johnson, Leo Pharmaceuticals, Medimmune/Astra Zeneca, Novartis, Pfizer, Sciderm, Valeant, and ViDac, and is also a consultant for Allergan, Aqua, Boehringer-Ingelheim, LEO Pharma, Menlo, Mitsubishi, Promius and Theravance. Another peer reviewer on this manuscript his disclosed research, speaking and/or consulting support from Galderma, GSK/Stiefel, Almirall, Alvotech, Leo Pharma, BMS, Boehringer Ingelheim, Mylan, Celgene, Pfizer, Ortho Dermatology, Abbvie, Samsung, Janssen, Lilly, Menlo, Merck, Novartis, Regeneron, Sanofi, Novan, Qurient, National Biological Corporation, Caremark, Advance Medical, Sun Pharma, Suncare Research, Informa, UpToDate and National Psoriasis Foundation; they also declare affiliations with and interest in www.DrScore.com and Causa Research (a company dedicated to enhancing patients’ adherence to treatment). Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.