TNF-α inhibitors biosimilars as first line systemic treatment for moderate-to-severe chronic plaque psoriasis

ABSTRACT

Introduction

Biologics have revolutionized the therapy of moderate-to-severe plaque psoriasis. Despite their greater efficacy over conventional systemic therapies their high cost has represented a burden for health-care systems, which limited their use. The availability of biosimilars at low cost is changing the place in therapy of biologics for psoriasis.

Areas covered

The role of TNF- α inhibitors in the management of plaque psoriasis, their efficacy and safety profile are presented. Phase 3 clinical trials and real-life data from the use of TNF- α inhibitor biosimilars in the treatment of plaque psoriasis are also reviewed in detail. Furthermore, arguments in favor of the use of TNF- α inhibitor biosimilars as a first-line therapy in moderate-to-severe plaque psoriasis are discussed.

Expert opinion

An increasing amount of data show that biosimilars represent a safe and effective alternative to the originator biologics. In the face of ever-increasing health-care costs, switching to biosimilars and starting naïve patients on the best-value biologic can reduce expenditure for patients and payers while maintaining a high-quality care. Moreover, as the cost of biosimilars is approaching the cost of conventional systemic treatments, TNF-α inhibitors biosimilars may represent a first-line systemic treatment for psoriasis patients because they are effective and safe.

KEYWORDS:

• Biosimilars
• biologics
• plaque psoriasis
• psoriasis
• TNF-α inhibitors

Article highlights

• Psoriasis is a chronic immune-mediated disease, which affects between 2% and 3% of the general population; about 20% of psoriasis patients suffer from moderate to severe disease and, in general, require phototherapy and/or systemic treatment, not being easily managed with topical therapy alone.

• Biologics have revolutionized the therapy of moderate-to-severe plaque psoriasis. Despite their greater efficacy and safety over conventional systemic therapies their high cost has represent a burden for health-care systems, which could limit their use.

• An increasing amount of clinical trials and real-world data show that TNF-α inhibitors biosimilars represent a safe and effective alternative to the originator biologics.

• In some Countries, the cost of biosimilars is significantly reduced, and no longer represents an economic barrier.

• TNF-α inhibitors biosimilars may represent a first-line systemic treatment for patients with moderate-to-severe psoriasis offering a therapeutic option that is more effective and safer in the long term.

Declaration of interest

Gisondi P has been a consultant and/or speaker for Abbvie, Almirall, Celgene, Janssen, Leo-pharma, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Sandoz, UCB. Conti A has served as an advisory board member and consultant and has received fees, honoraria, or has participated in clinical trials for Abbvie, Eli-Lilly, Janssen Cilag, LEO-Pharma, Novartis, Pfzer, UCB Pharma, Wyeth, Sandoz, and Schering Plough. Piaserico S has been a consultant and/or speaker for Abbvie, Almirall, Celgene, Janssen, Leo-pharma, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Sandoz, UCB. De Simone C has been a consultant and/or speaker for Abbvie, Almirall, Biogen, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, Sanofi, Pfizer, UCB. Bianchi L has been a consultant and/or speaker for Abbvie, Novartis, Janssen, UCB, Amgen, Eli-Lilly, Pfizer, Sanofi. Costanzo A is supported by grants from the Ministry of Health (grant no. CO-2013-02356463), has served as an advisory board member and consultant, and has received fees and Speaker’s honoraria or has participated in clinical trials for Abbvie, Almirall, Biogen, Leo Pharma, Lilly, Janssen, Novartis, Pfizer, Sanofi Genzyme, and UCB-Pharma. Malagoli P has been a scientific consultant/speaker/clinical study investigator for AbbVie, Amgen, Biogen, Celgene, Janssen, LEO-Pharma, Eli-Lilly, and Novartis. Malara G has received honoraria as Speaker and consultant for Janssen, Sanofi, Abbvie, Eli Lilly, Novartis, Janssen, Sanofi, and Celgene. Micali G has served as an investigator for Lilly. Naldi L received honorarium as a scientific consultant from Novartis. Offidani A has been principal investigator in clinical trials and has been paid as consultant by AbbVie, Almirall, Amgen, Celgene, Eli-Lilly, Leo Pharma, Novartis, Pfizer, Regeneron, and Sanofi. Patrizi A has been a consultant and/or speaker for Abbvie, Almirall, Celgene, Genzyme, Janssen, Leo-pharma, Eli Lilly, Merck Sharp &Dohme, Novartis, Pfizer, Sandoz, Sanofi, Regeneron, Genzyme, UCB, Pierre Fabre and has been PI in many clinical trials but she did not receive personal fees from them. Prignano F has been an advisory board member and consultant and has received fees and speaker’s honoraria or has participated in clinical trials for Abbvie, Biogen, Leo-Pharma, Eli-Lilly, Novartis, Admirall, Sanofi, Janssen-Cilag. Parodi A has participated in clinical trials and has served as an advisory board member for Abbvie, Pfizer, Celgene, Novartis, Galderma, Lilly, LEO pharma, Almirall. Rongioletti F has been an advisor and speaker for Abbvie, Novartis, Ely-Lilly, Janssen, Sanofi, Almirall. Calzavara-Pinton P has served as an advisory board member or lectured for: Galderma, Almirall, LEO Pharma, Sanofi, Meda, and AbbVie. Girolomoni G has been principal investigator in clinical trials sponsored by and/or has received personal fees from AbbVie, Abiogen, Almirall, Amgen, Bayer, Biogen, Bristol-Meyers Squibb, Celgene, Eli-Lilly, Genzyme, Leo Pharma, Menlo therapeutics, Merck, MSD, Novartis, Pfizer, Pierre Fabre, Regeneron, Samsung, Sandoz, Sanofi, and Sun Pharma. 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

One reviewer has worked as speaker and a member of advisory boards for AbbVie, Jansen Cilag, Eli Lilly, Leo Pharma, CSL, and Almirall. Another reviewer is a former consultant of Almirall (until August 2019). Another reviewer has been PI/SI, speaker and/or advisor at Celgene, Janssen, Lilly, Novartis, Leo Pharma, Pfizer, MSD, Abbvie, Biogen Amgen, Sandoz, Biogen. Peer reviewers on this manuscript have no other relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.