Article Type
Changed
Fri, 08/30/2024 - 10:51

 

TOPLINE:

Patients with axial spondyloarthritis (axSpA) treated with bimekizumab had a lower incidence of uveitis than those receiving placebo in pooled clinical trial data.

METHODOLOGY:

  • Researchers pooled data from two phase 3 trials, one phase 2b trial, and their open-label extensions to evaluate the incidence of uveitis in patients with radiographic and nonradiographic axSpA who were treated with bimekizumab.
  • Patients received either bimekizumab 160 mg (n = 349) or placebo (n = 237) every 4 weeks in the pooled phase 3 data during a 16-week, double-blind treatment period, while 848 patients (mean age, 40.3 years; 71.5% men) received at least one dose of 160 mg bimekizumab in the overall phase 2b/3 pool.
  • Outcomes included the incidence of uveitis events reported as exposure-adjusted incidence rates (EAIRs) and exposure-adjusted event rates reported per 100 patient-years.

TAKEAWAY:

  • The proportion of patients experiencing uveitis was lower in those treated with bimekizumab than in those receiving placebo over 16 weeks (0.6% vs 4.6%; nominal P = .001).
  • In patients with a history of uveitis, incidence was lower with bimekizumab than with placebo (6.2 vs 70.4 per 100 patient-years).
  • Among patients receiving bimekizumab, the EAIR of uveitis was lower among those without a history of uveitis than in those with a history of the condition (0.6 vs 4.6 per 100 patient-years).
  • A higher proportion of patients who experienced uveitis had a history of uveitis, compared with those who did not (56.0% vs 14.1%).

IN PRACTICE:

“These data suggest that [bimekizumab], a dual IL [interleukin]-17A/F inhibitor, may confer protective effects for uveitis in patients with axSpA,” the authors wrote.

SOURCE:

The study, led by Matthew A. Brown, Genomics England, London, England, and Martin Rudwaleit, Klinikum Bielefeld, University of Bielefeld, Germany, was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

The reporting of uveitis in the trials relied on the spontaneous reporting of adverse events, and not all events were evaluated by an ophthalmologist. The duration of the double-blind treatment period was relatively short, and the total number of patients with acute anterior uveitis was limited. Moreover, long-term placebo comparisons extending beyond 16 weeks were lacking.

DISCLOSURES:

The studies included in the pooled data were supported by UCB Pharma. Some authors reported financial ties with UCB and other pharmaceutical companies. Some authors reported being employees and shareholders of UCB Pharma.

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

Publications
Topics
Sections

 

TOPLINE:

Patients with axial spondyloarthritis (axSpA) treated with bimekizumab had a lower incidence of uveitis than those receiving placebo in pooled clinical trial data.

METHODOLOGY:

  • Researchers pooled data from two phase 3 trials, one phase 2b trial, and their open-label extensions to evaluate the incidence of uveitis in patients with radiographic and nonradiographic axSpA who were treated with bimekizumab.
  • Patients received either bimekizumab 160 mg (n = 349) or placebo (n = 237) every 4 weeks in the pooled phase 3 data during a 16-week, double-blind treatment period, while 848 patients (mean age, 40.3 years; 71.5% men) received at least one dose of 160 mg bimekizumab in the overall phase 2b/3 pool.
  • Outcomes included the incidence of uveitis events reported as exposure-adjusted incidence rates (EAIRs) and exposure-adjusted event rates reported per 100 patient-years.

TAKEAWAY:

  • The proportion of patients experiencing uveitis was lower in those treated with bimekizumab than in those receiving placebo over 16 weeks (0.6% vs 4.6%; nominal P = .001).
  • In patients with a history of uveitis, incidence was lower with bimekizumab than with placebo (6.2 vs 70.4 per 100 patient-years).
  • Among patients receiving bimekizumab, the EAIR of uveitis was lower among those without a history of uveitis than in those with a history of the condition (0.6 vs 4.6 per 100 patient-years).
  • A higher proportion of patients who experienced uveitis had a history of uveitis, compared with those who did not (56.0% vs 14.1%).

IN PRACTICE:

“These data suggest that [bimekizumab], a dual IL [interleukin]-17A/F inhibitor, may confer protective effects for uveitis in patients with axSpA,” the authors wrote.

SOURCE:

The study, led by Matthew A. Brown, Genomics England, London, England, and Martin Rudwaleit, Klinikum Bielefeld, University of Bielefeld, Germany, was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

The reporting of uveitis in the trials relied on the spontaneous reporting of adverse events, and not all events were evaluated by an ophthalmologist. The duration of the double-blind treatment period was relatively short, and the total number of patients with acute anterior uveitis was limited. Moreover, long-term placebo comparisons extending beyond 16 weeks were lacking.

DISCLOSURES:

The studies included in the pooled data were supported by UCB Pharma. Some authors reported financial ties with UCB and other pharmaceutical companies. Some authors reported being employees and shareholders of UCB Pharma.

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

 

TOPLINE:

Patients with axial spondyloarthritis (axSpA) treated with bimekizumab had a lower incidence of uveitis than those receiving placebo in pooled clinical trial data.

METHODOLOGY:

  • Researchers pooled data from two phase 3 trials, one phase 2b trial, and their open-label extensions to evaluate the incidence of uveitis in patients with radiographic and nonradiographic axSpA who were treated with bimekizumab.
  • Patients received either bimekizumab 160 mg (n = 349) or placebo (n = 237) every 4 weeks in the pooled phase 3 data during a 16-week, double-blind treatment period, while 848 patients (mean age, 40.3 years; 71.5% men) received at least one dose of 160 mg bimekizumab in the overall phase 2b/3 pool.
  • Outcomes included the incidence of uveitis events reported as exposure-adjusted incidence rates (EAIRs) and exposure-adjusted event rates reported per 100 patient-years.

TAKEAWAY:

  • The proportion of patients experiencing uveitis was lower in those treated with bimekizumab than in those receiving placebo over 16 weeks (0.6% vs 4.6%; nominal P = .001).
  • In patients with a history of uveitis, incidence was lower with bimekizumab than with placebo (6.2 vs 70.4 per 100 patient-years).
  • Among patients receiving bimekizumab, the EAIR of uveitis was lower among those without a history of uveitis than in those with a history of the condition (0.6 vs 4.6 per 100 patient-years).
  • A higher proportion of patients who experienced uveitis had a history of uveitis, compared with those who did not (56.0% vs 14.1%).

IN PRACTICE:

“These data suggest that [bimekizumab], a dual IL [interleukin]-17A/F inhibitor, may confer protective effects for uveitis in patients with axSpA,” the authors wrote.

SOURCE:

The study, led by Matthew A. Brown, Genomics England, London, England, and Martin Rudwaleit, Klinikum Bielefeld, University of Bielefeld, Germany, was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

The reporting of uveitis in the trials relied on the spontaneous reporting of adverse events, and not all events were evaluated by an ophthalmologist. The duration of the double-blind treatment period was relatively short, and the total number of patients with acute anterior uveitis was limited. Moreover, long-term placebo comparisons extending beyond 16 weeks were lacking.

DISCLOSURES:

The studies included in the pooled data were supported by UCB Pharma. Some authors reported financial ties with UCB and other pharmaceutical companies. Some authors reported being employees and shareholders of UCB Pharma.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article