Novel and emerging drugs for the treatment of Crohn’s disease: a review of phase II and III trials

ABSTRACT

Introduction

Crohn’s disease (CD) is a chronic inflammatory bowel disease characterized by unpredictable flare-ups and periods of remission. While several therapeutic options, such as anti-tumor necrosis factor (TNF), anti-integrin, and interleukin (IL) 12/23 inhibitors, as well as IL-23 and Janus kinase (JAK) inhibitors, have been approved for CD treatment, a substantial number of patients fail to respond adequately or experience a loss of response over time. In recent years, the scientific community has been actively investigating novel agents to address these challenges and improve the management of CD.

Areas covered

This comprehensive narrative review provides an overview of recent developments in CD treatment, summarizing phase 2 and phase 3 clinical trial data. We delve into the clinical efficacy and safety profiles of emerging therapies, encompassing JAK inhibitors, IL-23 inhibitors, anti-adhesion molecules, S1P1 receptor modulators, and combined targeted treatments.

Expert opinion

The armamentarium of CD therapeutic agents is constantly expanding. We analyze pivotal findings from phase 2 and phase 3 CD treatment trials. We also underscore the existing gaps in therapy and the paramount role of ongoing research and innovation in CD management.

KEYWORDS:

• Crohn’s disease
• inflammatory bowel disease
• biologic
• small molecules
• therapy
• clinical trial

Declaration of interest

P Wetwittayakhlang has been a speaker for Takeda, Pfizer, Janssen, Ferring, A. Menerini, and MSD, and an advisory board member for Pfizer, Takeda, and Sanzdoz.

T Bessissow has been a speaker or advisory board member for Takeda, Janssen, AbbVie, Merck, Pfizer, Pendopharm, Ferring, Shire, Sandoz, BMS, and Roche.

P.L Lakatos has been a speaker and/or advisory board member: AbbVie, Amgen, BioJamp, Bristol Myers Squibb, Fresenius Kabi, Genetech, Gilead, Janssen, Merck, Mylan, Organon, Pendopharm, Pfizer, Roche, Sandoz, Takeda, Tillots and Viatris and has received unrestricted research grant: AbbVie, Gilead, Takeda and Pfizer.

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.

Author contributions

P Wetwittayakhlang performed the literature review, wrote the draft, and create table and figures of the manuscript. T Bessissow revised the manuscript. P. L Lakatos performed the literature review, wrote, and supervised the manuscript. All authors reviewed and approved the last version of this manuscript.

Reviewer disclosures

A reviewer on this manuscript has been recruited by Research Square. Reviewers with declared or apparent competing interests are not utilized for these reviews. This reviewer was paid a small honorarium for completing the review within a specified timeframe. Honoraria for reviews such as this are paid regardless of the reviewer recommendation. Another reviewer on this manuscript has declared serving on the advisory board meeting for Janssen in 2023.

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

Additional information

Funding

This paper was not funded.