Adalimumab slashes Behçet’s uveitis relapse rate significantly more than cyclosporine
Click Here to Manage Email Alerts
Key takeaways:
- Adalimumab plus corticosteroids significantly outperformed cyclosporine plus corticosteroids to delay Behçet’s disease uveitis relapse.
- Cyclosporine had no substantial difference with interferon alfa-2a.
Adalimumab combined with corticosteroids led to a significantly lower rate of relapse in Behçet’s disease uveitis vs. cyclosporine alongside corticosteroids, according to data published in The Lancet Rheumatology.
“Although several immunomodulatory drugs, including cyclosporine, interferon alfa-2a and adalimumab are used in combination with corticosteroids for Behçet’s disease uveitis in clinical practice, there is no scientific consensus on which agent is preferred,” Zhenyu Zhong, MD, of the First Affiliated Hospital of Chongqing Medical University, in China, and colleagues wrote. “Biologics might be superior to conventional immunosuppressants (eg, cyclosporine); however, comparative effectiveness data have been mixed.”
To assess the safety and efficacy of cyclosporin, interferon alfa-2a and adalimumab (Humira, AbbVie), all in combination with corticosteroids, Zhong and colleagues conducted a randomized, open-label, assessor-masked, head-to-head trial at a large, specialized uveitis center in China from May 12, 2020, to February 22, 2022. The study included 270 adults (mean age, 38.1 years) with severe Behçet’s disease uveitis who were using corticosteroids and were naïve to anti-TNF therapy.
The patients were randomly assigned to receive either cyclosporine, interferon alfa-2a or adalimumab, with 90 patients in each group. The primary outcome was the annualized rate of uveitis relapse, with a non-inferiority margin of one between the interferon alfa-2a and adalimumab groups. Safety was assessed in all patients who received at least one dose of the trial drug.
“The annualized relapse rate was determined by estimating the least-squares mean with the corresponding 95% CI for each group, and the least-squares mean difference between groups was tested to assess the absolute estimate of treatment effect,” Zhong and colleagues wrote.
According to the researchers, patients using cyclosporine demonstrated a significantly higher annualized relapse rate vs. those receiving adalimumab (least-squares mean difference = 0.9; 95% CI, 0.27-1.53). Meanwhile, the least-squares mean difference between interferon alfa-2a and adalimumab did not meet non-inferiority criteria (0.5; 95% CI, –0.04 to 1.4). There was also no substantial difference in the annualized relapse rate between interferon alfa-2a and cyclosporine (least squares mean difference = –0.4; 95% CI, –1.05 to 0.25).
Serious adverse events were reported by 12% of patients on cyclosporine, 9% of patients on interferon alfa-2a and 8% of patients using adalimumab.
“In this randomized trial involving adults with severe Behçet’s disease uveitis on corticosteroid therapy, the combination regimen of adalimumab plus corticosteroids was superior to that of cyclosporine plus corticosteroids, resulting in a significantly lower uveitis relapse rate,” Zhong and colleagues wrote. “Further studies are warranted to conduct head-to-head comparisons of azathioprine with anti-TNF drugs and to detect differences in visual acuity with adequate power.
“Our findings also underscore the need for randomized trials designed to evaluate the benefits of combining immunosuppressants (eg, cyclosporine or azathioprine) with anti-TNF therapies for improving outcomes and sparing corticosteroids in severe Behçet’s disease,” they added.
Collapse
Click Here to Manage Email Alerts