The safety of ixekizumab in psoriasis drug therapy

ABSTRACT

Introduction: Ixekizumab, a humanized IgG4 monoclonal antibody that selectively binds and neutralizes interleukin IL-17A, has been approved by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of moderate to severe plaque psoriasis (2016), active psoriatic arthritis (FDA 2017, EMA 2018), and active ankylosing spondylitis (FDA 2019).

Areas covered: This review evaluates the safety profile of ixekizumab for the treatment of moderate-to-severe psoriasis. A literature search was performed for articles published through November 2019.

Expert opinion: These studies show that ixekizumab demonstrates a favorable safety profile. Antidrug antibodies can be detected in up to 17% of patients but they do not significantly affect clinical response or safety of the treatment. Injection site reactions, erythema or pain, develop in up to 10% of the patients during the first 12 weeks of treatment, an incidence similar to that of etanercept. Infections overall do not cause a safety problem; mucocutaneous Candida infections, occur at a rate of in 1.9/100 patient-years, but are easily managed and usually do not determine treatment discontinuation. The occasional de novo appearance or exacerbation of preexistent inflammatory bowel disease remains a cause of concern, and requires close monitoring of patients at risk.

KEYWORDS:

• Interleukin-17A
• psoriasis
• safety
• ixekizumab

Box 1. Drug summary.

Declaration of interest

L Puig has received consultancy/speaker’s honoraria from and/or participated in clinical trials sponsored by Abbvie, Almirall, Amgen, Baxalta, Biogen, Boehringer Ingelheim, Celgene, Gebro, Janssen, Leo-Pharma, Lilly, Merck-Serono, MSD, Mylan, Novartis, Pfizer, Regeneron, Roche, Sandoz, Samsung-Bioepis, Sanofi, and UCB. 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 reviewer on this manuscript has disclosed that they are a consultant for the makers of IXE A reviewer on this manuscript has disclosed that did the phase 3 trials for IXE in US as well as Genital Ps and Pedi trials in the US using IXE. A reviewer on this manuscript has disclosed that they are a consultant for Abbvie and Celgene. A reviewer on this manuscript has disclosed that they have done the clinical trials for all the biologics in the US for the treatment of Ps or AD. All other peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.