Infliximab versus interferon-alpha in the treatment of Behçet's Syndrome: Clinical data from the BIO-BEH&Ccedil;ET'S randomised controlled trial

Robert J Moots; Farida Fortune; Richard Jackson; Tony Thornburn; Ann Morgan; Daniel F Carr; Philip I Murray; Graham R Wallace; Deva Situnayake

doi:10.1093/rheumatology/keae585

Infliximab versus interferon-alpha in the treatment of Behçet's Syndrome: Clinical data from the BIO-BEHÇET'S randomised controlled trial

Rheumatology (Oxford). 2024 Oct 21:keae585. doi: 10.1093/rheumatology/keae585. Online ahead of print.

Authors

Robert J Moots^{1

2}, Farida Fortune³, Richard Jackson⁴, Tony Thornburn⁵, Ann Morgan⁶, Daniel F Carr⁷, Philip I Murray⁸, Graham R Wallace⁸, Deva Situnayake⁹

Affiliations

¹ Department of Academic Rheumatology, Liverpool University Hospitals NHS Foundation Trust, Aintree University Hospital, Liverpool, UK.
² Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, UK.
³ Queen Mary University of London, UK; Barts Health NHS Trust, The London Hospital, UK, Blizard Building, London, UK.
⁴ Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.
⁵ Behçet's UK, UK, London.
⁶ Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK; NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
⁷ Institute of Systems, Molecular and Integrated Biology, University of Liverpool, Liverpool, UK.
⁸ Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK.
⁹ Department of Rheumatology, Sandwell and West Birmingham Hospitals, Birmingham, UK.

PMID: 39432564
DOI: 10.1093/rheumatology/keae585

Abstract

Objectives: Whilst biologic therapy is used for Behçet's Syndrome of all subtypes refractory to first-line immunomodulation, there has been an absence of high-quality evidence-and no predictive biomarkers to optimally inform choice. BIO-BEHÇET'S was a randomised, controlled, head-to-head clinical trial comparing the two most frequently used biologics in active refractory Behçet's.

Methods: Bayesian-designed, pragmatic, standard of care, two-arm, parallel head-to-head trial at four UK centres. Patients with active disease randomised to infliximab or interferon-α2a, and received follow-up with symptom-directed examination at Weeks 12 and 24. Primary outcome was Behçet's Disease Activity Index (BDAI) at 12 weeks. Secondary outcomes included BDAI at 24 weeks and significant improvement in individual organ systems, including ocular symptoms, oral and genital ulcers, arthritis pain, quality of life, disease activity, and steroid use. Biomarkers were also investigated but are reported elsewhere.

Results: 79 patients were recruited. Both treatments were equally effective, with a mean difference of 0.13 in BDAI (80% CI: -0.19, 0.46). No significant differences were observed for secondary outcomes, though there were clinically significant within-group reductions for each over time. A modest steroid-sparing effect was observed, with complete cessation of steroids in 20% and 44% of those randomised to infliximab and interferon-α2a, respectively. There was a trend for minor benefit in favour of infliximab in terms of tolerability and persistence.

Conclusion: In this first reported, high-quality, head-to-head trial of two biologics in Behçet's, both infliximab and interferon-α2a showed comparable short-term clinical efficacy and safety in refractory active disease of all subtypes.

Trial registration: EudraCT: 2014-005390-36; ISRCTN: ISRCTN49793874.

Keywords: Behçet’s; biologic therapy; infliximab; interferon; randomised controlled clinical trial.