medwireNews: Bimekizumab shows sustained benefit in the treatment of patients with ankylosing spondylitis, 48-week data show.
The findings, presented at 2019 ACR/ARP Annual Meeting in Atlanta, Georgia, USA, support and expand on the initial 12-week BE-AGILE results previously reported by medwireNews that showed a rapid dose-dependent response to the drug.
At 12 weeks patients initially randomly assigned to receive bimekizumab 160 mg or 320 mg continued on the same dose up to 48 weeks, while those on placebo or lower doses of the drug were reassigned to either of the higher doses in a dose-blind regimen.
Efficacy continued to improve beyond 12 weeks and was sustained at 48 weeks, by which time up to a third of the 265 patients were in clinical remission, said presenter Désirée van der Heijde, from Leiden University Medical Center in the Netherlands.
ASAS40 response rates further improved up to week 24 and were maintained at 48 weeks, increasing from around 45% at the 12-week mark to 59% with the 160 mg dose and 62% with the 320 mg dose at 48 weeks.
Improvements observed at week 12 for other efficacy endpoints were also sustained for the 48 weeks of study, at which point ASAS20 response rates ranged from 51.9% to 80.0%, ASAS5/6 from 41.9% to 80.0%, and ASAS partial remission from 12.9% to 34.4%.
The reduction in BASDAI and BASFI from baseline to week 48 ranged from a respective 3.1–3.9 and 2.3–2.9, while ASDAS scores improved by between 1.6 and 2.9 points from baseline. The sustained benefits were also seen for ASDAS-major improvement, ASDAS-ID, and ASDAS-LDA.
The drug was generally well tolerated, with no unexpected safety findings. Treatment-emergent adverse events were reported by 77.6% of patients, most commonly nasopharyngitis and bronchitis, but they were mild to moderate in severity.
There were 18 cases of mild to moderate oral candidiasis, which the researchers found resolved with treatment and did not lead to drug discontinuation. This was the same for the four cases of inflammatory bowel disorder.
“These data show that neutralizing both IL-17F and IL-17A may be a useful treatment for patients with active ankylosing spondylitis,” van der Heijde concluded.
“The treatment will be further evaluated in a phase III clinical trial program also including patients with nonradiographic axial spondyloarthritis.”
By Lucy Piper
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