BE AGILE: Bimekizumab shows promise for ankylosing spondylitis
medwireNews: Bimekizumab may offer a new therapeutic option for patients with ankylosing spondylitis, findings from the BE AGILE study indicate.
The results, presented at the EULAR 2019 congress in Madrid, Spain, showed a greater dose-response improvement in ASAS40 response rates with bimekizumab, a dual interleukin (IL)-17A/IL-17F inhibitor, over placebo after 12 weeks of treatment.
The study involved 303 patients who were randomly assigned to receive bimekizumab, at doses of 16 mg (n=61), 64 mg (n=61), 160 mg (n=60), or 320 mg (n=61), or placebo (n=60) every 4 weeks.
The patients met modified New York criteria for ankylosing spondylitis, had an average BASDAI score of about 6.5, an average total spinal pain score of about 7.0, and were permitted to have prior exposure to one tumor necrosis factor inhibitor.
At week 12, significantly more patients taking bimekizumab than placebo were ASAS40 responders. The response rate improved with increasing dose, and was highest for the patients taking bimekizumab 320 mg, at 45.9%, followed by 46.7% for patients taking 160 mg, 42.6% with the 64 mg dose, and 29.5% with the 16 mg dose. This compared with a low ASAS40 response rate of 13.3% in patients taking placebo.
Similarly, significantly more bimekizumab-treated patients achived a 50% improvement in BASDAI score, with dose-response rates ranging from 23.0% in the 16 mg dose group to 47.5% in the 320 mg group, compared with 11.7% in the placebo group. The mean decreases in BASDAI score from baseline were a respective 1.7 and 2.9 points versus 1.0 points.
Presenter Désirée van der Heijde (Leiden University Medical Center, the Netherlands) pointed out that the dose-response in BASDAI 50 was also seen in the individual components; “the only one that was less clear was fatigue, but this is also a more variable endpoint,” she noted.
And there were “better responses [with bimekizumab] in comparison to placebo in all patient-reported and quality-of-life outcomes,” said van der Heijde, namely for patient global assessment of disease activity, ankylosing spondylitis quality of life, and BASFI, and patients taking the drug reported greater improvements in physical health, while mental health remained in the normal range.
There were no new safety findings and treatment-emergent adverse events were mild-to-moderate intensity and comparable across the treatment groups, at 43.3% in the placebo group versus 29.3─47.5% in the bimekizumab treatment groups. Nasopharyngitis was the most frequent adverse event.. Only six patients taking bimekizumab discontinued treatment due to adverse events
Oral candidiasis was reported by just 1.2% of patients given bimekizumab, and there were no cases of neutropenia, malignancies, hypersensitivity reactions, or suicidal ideation or behavior.
Van der Heijde noted that one patient with several cardiovascular risk factors died from sudden cardiac arrest in the bimekizumab 160 mg group, and this was not considered to be treatment-related.
She concluded: “The date here support bimekizumab’s progression into phase III clinical studies.”
By Lucy Piper
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