Bimekizumab linked to improved outcomes, QoL in ankylosing spondylitis
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Treatment with bimekizumab over 48 weeks resulted in rapid, sustained improvements in patient-reported outcomes, sleep and quality of life among those with ankylosing spondylitis, according to data presented at the EULAR 2020 E-Congress.
“Bimekizumab is a monoclonal antibody that neutralizes both interleukin-17A and IL-17F, which are established treatment targets in ankylosing spondylitis,” Désirée van der Heijde, MD, PhD, of the Leiden University Medical Center, in the Netherlands, told attendees on the webcast. “The safety and efficacy of bimekizumab over 48 weeks has been demonstrated in patients with active ankylosing spondylitis in BE-AGILE, a phase 2b, randomized, double-blind, placebo-controlled, dose-ranging study.”
In her presentation, van der Heijde reported on patient-reported outcomes after 48 weeks of treatment with bimekizumab (UCB), compared with placebo, in the in BE-AGILE study. Investigators randomly assigned 303 adult patients with active ankylosing spondylitis and an inadequate response to, or intolerance of, NSAIDs, to one of five treatment regimens: 16 mg, 64 mg, 160 mg or 320 mg of bimekizumab every 4 weeks, or placebo. After week 12, researchers rerandomized participants in the placebo, 16 mg and 64 mg groups to begin receiving either 160 mg or 320 mg of the drug.
Patient-reported outcomes data were reported from the 181 patients who were initially randomized to the placebo, 160 mg, or 320 mg groups, van der Heijde said. These outcomes included spinal pain, fatigue (BASDAI Q1), morning stiffness (BASDAI Q5 and 6), Bath AS Functional Index (BASFI), the Medical Outcomes Study Sleep Problems Index II and the AS Quality of Life questionnaire. Among the participants included in the patient-reported outcomes portion of the study, 179 completed 12 weeks of treatment, while 161 remained through week 48.
According to van der Heijde, improvements in pain, fatigue, morning stiffness BASFI, sleep and quality of life were greater at week 12 among patients treated with bimekizumab, compared with those who received a placebo. These responses were further improved or maintained through week 48, with no meaningful differences between participants in the 160 mg and 320 mg bimekizumab groups.
Serious treatment-emergent adverse events occurred in 4.3% of the total study population of 303 participants. These included two major cardiac events that were deemed unrelated to the study drug, and oral candidiasis, which occurred in 5.3% of patients.
“Over 48 weeks of bimekizumab treatment, patients with active ankylosing spondylitis demonstrated rapid and sustained improvements in patient-reported pain, fatigue, sleep, functioning and quality of life,” van der Heijde said. “At week 12, improvements were greater in bimekizumab-treated patients compared with placebo-treated patients. Responses were further improved or maintained to week 48, with no meaningful differences between patients treated with bimekizumab 160 mg or 320 mg.”
“At week 48, improvements were similar for patients initially randomized to bimekizumab and for patients who were switched to bimekizumab at week 12,” she added. “In addition, bimekizumab was generally well tolerated with no unexpected safety findings.”
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van der Heijde D. Efficacy and safety of bimekizumab in ankylosing spondylitis: 48-week patient-reported outcomes from a phase 2b, randomized, double-blind, placebo-controlled, dose-ranging study. Presented at EULAR 2020 Congress; June 3-6, 2020; Virtual.
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