Filgotinib for moderately to severely active ulcerative colitis

ABSTRACT

Introduction

Filgotinib is an oral Janus kinase type 1 (JAK1) selective inhibitor with demonstrated efficacy and safety in ulcerative colitis (UC). The aim of this review is to summarize the available evidence on pharmacological characteristics, efficacy, and safety of filgotinib in UC.

Areas covered

Pubmed, Scopus, and Embase databases were searched for all relevant studies reporting the efficacy and safety of filgotinib in patients with moderate to severe UC. We particularly focused on the risk of zoster infection and venous thromboembolism compared to other JAK inhibitors.

Expert opinion

Filgotinib has remarkable efficacy, safety, and tolerability profiles in the treatment of moderate-to-severe active UC. It can be used in both biologic-naïve and biologic-experienced patients. The rapid mechanism of action and its oral administration route make it a reliable therapeutic option.

KEYWORDS:

• JAK inhibitor
• selective
• inflammatory bowel diseases
• small molecule
• ulcerative colitis

Article highlights

• Filgotinib, an oral preferential JAK1 inhibitor, is effective in inducing and maintaining the remission in patients with moderate to severe ulcerative colitis

• The selectivity of filgotinib may be associated with an improved safety profile compared with non-selective JAK inhibitors

• Filgotinib is given orally at 200 mg once a day, without significant pharmacological interactions so far, and it is not influenced by meals or by diet content

• Filgotinib is safe and well tolerated with a demonstrated consistent safety profile. The incidence of adverse events and infections is not higher than placebo neither during induction nor during maintenance.

• The key advantages of filgotinib include the oral route of administration, the rapid efficacy, and the lack of immunogenicity, compared to biologic drugs

Authors’ contributions

A Mannucci, A El Saadi, and F D’Amico wrote the article and created the figures. L Peyrin-Biroulet and S Danese critically reviewed the content of the paper and supervised the project. The manuscript was approved by all authors.

Declaration of interests

F D’Amico has served as a speaker for Janssen, Galapagos, Sandoz, and Omega Pharma. L Peyrin-Biroulet declares personal fees from Galapagos, AbbVie, Janssen, Genentech, Ferring, Tillots, Celltrion, Takeda, Pfizer, Index Pharmaceuticals, Sandoz, Celgene, Biogen, Samsung Bioepis, Inotrem, Allergan, MSD, Roche, Arena, Gilead, Amgen, BMS, Vifor, Norgine, Mylan, Lilly, Fresenius Kabi, OSE Immunotherapeutics, Enthera, Theravance, Pandion Therapeutics, Gossamer Bio, Viatris, and Thermo Fisher. Grants from Abbvie, MSD, Takeda, and Fresenius Kabi. Stock options: CTMA. S Danese has served as a speaker, consultant and advisory board member for Schering-Plough, AbbVie, MSD, UCB Pharma, Ferring, Cellerix, Millenium Takeda, Nycomed, Pharmacosmos, Actelion, Alphawasserman, Genentech, Grunenthal, Pfizer, Astra Zeneca, Novo Nordisk, Cosmo Pharmaceuticals, Vifor and Johnson & Johnson, Nikkiso Europe GMBH, and Theravance. 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

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

Scientific accuracy review

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

Additional information

Funding

This paper was not funded.