Filgotinib Cuts Treatment Failures in Uveitis

TOPLINE:

Filgotinib, a Janus kinase 1 inhibitor, was well tolerated and reduced treatment failures in patients with active noninfectious uveitis in a phase 2 randomized trial despite early termination of the study.

METHODOLOGY:

• HUMBOLDT, a phase 2, randomized clinical trial, was conducted at 26 centers across seven countries to assess the efficacy and safety of filgotinib in patients with active noninfectious intermediate uveitis, posterior uveitis, or panuveitis.
• Overall, 74 patients were randomly assigned to receive 200 mg of filgotinib or placebo daily for up to 52 weeks. All participants had active noninfectious uveitis in at least one eye despite receiving maintenance therapy with oral prednisone or oral corticosteroid equivalent for 2 or more weeks.
• Glucocorticoids were tapered and eventually discontinued in all participants by week 15.
• The primary outcome was the proportion of patients who failed treatment with filgotinib or placebo in at least one eye by week 24. The researchers defined treatment failure as the presence of lesions in the retina or choroid, worsening in the clarity of vision, or inability to achieve improved grades of vitreous haze.

TAKEAWAY:

• Treatment failure was significantly less frequent in patients who received filgotinib than in those who received placebo (37.5% vs 67.6%; P = .006), which translated to an absolute risk reduction of 30.1%.
• Patients in the filgotinib group also were less likely to fail treatment on or after week 6 of the study (stratified hazard ratio, 0.31; P = .003).
• A higher number of patients in the filgotinib group reported adverse events (81.1% vs 68.6%), including severe events (13.5% vs 5.7%).
• The trial was terminated early due to business reasons, unrelated to the efficacy or safety of filgotinib, according to the researchers.

IN PRACTICE:

“Overall, results of this trial indicate that filgotinib could be efficacious in individuals with active noninfectious intermediate uveitis, posterior uveitis, or panuveitis and may warrant further investigation,” the authors wrote.

SOURCE:

The study was led by Sunil K. Srivastava, MD, of the Cole Eye Institute at Cleveland Clinic, in Cleveland, and was published online on July 18, 2024, in JAMA Ophthalmology.

LIMITATIONS:

The premature termination of the trial prevented the collection of additional safety or efficacy data on filgotinib. The small sample size was another major limitation of this study. Owing to tapering of the prednisone dose as per the protocol, whether filgotinib could provide significant anti-inflammatory control as a monotherapy during active flares was uncertain.

DISCLOSURES:

This trial was funded by Gilead Sciences, Inc. Four authors declared being employees and shareholders of Gilead Sciences, and other authors reported having several ties with many sources, including Gilead.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.