Risankizumab to treat moderately to severely active Crohn’s disease in adults: an evaluation of trials and data

ABSTRACT

Introduction

Risankizumab is a humanized monoclonal antibody that selectively inhibits interleukin (IL)-23. It is approved for the treatment of moderate-to-severe plaque psoriasis, psoriatic arthritis, and more recently moderate-to-severe Crohn’s disease (CD).

Areas Covered

After examining the current landscape of CD management including therapies which are currently approved and those in late stages of development, we will review the interleukin pathway and discuss the specific mechanism of targeted IL-23 inhibition, summarize available clinical trial data on efficacy and safety of Risankizumab, consider future positioning of Risankizumab in the therapeutic armamentarium, and ultimately discuss future needs for the field.

Expert Opinion

Risankizumab represents the first and only targeted IL-23 inhibitor approved for the treatment of CD, providing a promising addition to the therapeutic armamentarium for CD, with a favorable safety profile and demonstrated efficacy in both biologic-naïve and exposed populations. It is possible that the targeted nature of Risankizumab may enhance efficacy and safety over combined IL-12/23 inhibition, with trials underway attempting to shed light on that hypothesis.

KEYWORDS:

• Risankizumab
• Crohn’s disease
• interleukin (IL)-23
• inflammatory bowel disease (IBD)
• interleukin
• biologic

Article highlights

• Risankizumab is a humanized IgG1 monoclonal antibody selecting targeting the p19 subunit of interleukin-23

• Pivotal phase 2 and 3 clinical trials have demonstrated that Risankizumab is effective at inducing and maintaining clinical and endoscopic remission in both biologic naïve and biologic-exposed patients with moderate-to-severe CD

• Based on short term safety data from phase 2 and 3 clinical trials in CD, as well as long term data in the psoriasis population, the safety profile of Risankizumab appears overall favorable with no significant increased risk of infection, and no concerning signals for malignancy or major adverse cardiac events

• More studies are needed to understand optimal positioning of Risankizumab in the current CD management paradigm, as well as how it compares to ustekinumab, an IL-12/23 inhibitor

Declaration of interests

EV L has consulted for AbbVie, Alvotech, Amgen, Arena, Avalo Therapeutics, Boehringer Ingelheim, Bristol-Myers Squib, Celltrion Healthcare, Eli Lilly, Fresenius Kabi, Genentech, Gilead, GlaxoSmithKline, Gossamer Bio, Iota Biosciences, Iterative Scopes, Janssen, KSL Diagnostics, Morphic, Ono, Protagonist, Scipher, Sun, Surrozen, Takeda, and UCB. EV L has also had research support from AbbVie, Bristol-Myers Squib, Celgene/Receptos, Genentech, Gilead, Gossamer Bio, Janssen, Pfizer, Takeda, Theravance, and UCB. Shareholder of Exact Sciences. 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

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Scientific accuracy review

AbbVie provided a scientific accuracy review at the request of the journal editor.

Additional information

Funding

This paper was not funded.