Clinical use of biologics for Crohn’s disease in adults: lessons learned from real-world studies

ABSTRACT

Introduction

The therapeutic armamentarium for managing Crohn’s disease (CD) has expanded significantly in recent decades. Several biologics with three different mechanisms of action [anti-tumor necrosis factor (TNF)-α, anti-integrin α4β7, and anti-IL 12/23] are currently available to manage CD.

Area covered

This narrative review aims to summarize the most significant efficacy and safety data on the use of infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ) and ustekinumab (UST) for the treatment of CD obtained from studies conducted in the real world (RW), compared to the results of randomized clinical trials (RCTs).

Expert opinion

RW studies reported that biologic agents included in this analysis have higher remission rates and lower adverse event rates than findings from RCTs for treating patients with CD. All biological agents have proven effective and safe in RW studies, even when using biosimilars or switching to subcutaneous administration of the molecules for which they are available. Finally, anti-TNF-α agents, particularly IFX, have a higher rate of adverse events (AEs) than VDZ and UST. Therefore, patients at higher risk of AEs may benefit from other biologics than anti-TNF-α. However, further long-term RW studies are needed to confirm these findings.

KEYWORDS:

• Crohn’s disease
• anti-TNF-α
• ustekinumab
• vedolizumab
• efficacy
• safety

Article highlights

• Current data from studies conducted in the real world (RW) for treating patients with CD report essential results for the clinicians, sometimes differing from those from randomized clinical trials (RCTs).

• In RW, anti-tumor necrosis factor (TNF)-α (infliximab, IFX; adalimumab, ADA) antibodies, vedolizumab (VDZ) and ustekinumab (UST) biologic agents have higher remission rates and lower adverse event rates than that recorded by RCTs.

• All these biological agents have proven effective and safe in RW studies, even when using biosimilars or switching to subcutaneous administration of the molecules for which they are available.

• Regarding safety profile, the risk of infections, malignancies, immunogenicity, and metabolic disorders may vary with different treatment options. It should be weighted alongside the efficacy of each therapy during shared decision-making with patients.

Declaration of interest

A Tursi served as speaker and/or consultant for AbbVie, Galapagos, Janssen, Nalkein and Omega Pharma. G Mocci served as speaker and/or consultant for AbbVie, Amgen, Aurora Biopharma, Biogen, Celltrion, Chiesi, Ferring, Galapagos, Janssen, MSD, Omega Pharma, Pfizer, Sandoz, Takeda, Vifor Pharma and Zambon. A Papa received speaker fees from Janssen. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

A peer reviewer on this manuscript has received an honorarium from Expert Opinion on Biological Therapy for their review work. The reviewers have no other relevant financial relationships to disclose.

Additional information

Funding

This paper was not funded.