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Bimekizumab improved BASDAI response in ankylosing spondylitis
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Bimekizumab was associated with improved pain and functionality outcomes compared with placebo in a cohort of patients with ankylosing spondylitis, according to findings presented at the EULAR Annual Congress.
“Bimekizumab, which selectively neutralizes both inflammatory cytokines IL-17A and IL-17F, has been shown to more potently suppress inflammation than targeting IL-17A alone in preclinical research,” Emmanuel Caeymaex, head of immunology and executive vice president of the Immunology Patient Value Unit at UCB, said in a press release.
Désirée van der Heijde, MD, of Leiden University Medical Center in the Netherlands, and colleagues, presented findings for 297 patients with a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 4 or higher, and spinal pain of 4 or higher on a 0 to 10 rating scale. The analysis included 61 patients treated with 16 mg of bimekizumab (UCB); 61 patients treated with 64 mg of bimekizumab; 60 patients treated with 160 mg of bimekizumab; 61 patients treated with 320 mg of bimekizumab; and 60 patients who received placebo every 4 weeks for 12 weeks.
The primary outcome was measured as at least a 50% improvement in several domains of the BASDAI score, such as pain, fatigue, morning stiffness, and function. Other outcomes that underwent review included Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Quality of Life (ASQoL) and Patient’s Global Assessment of Disease Activity (PGADA) at week 12. Safety endpoints also underwent analysis.
Results showed that BASDAI50 responses in the target domains ranged from 23.7% to 47.5% across the four dosing regimens of bimekizumab, compared with 11.9% for placebo.
Looking closer at individual BASDAI components, bimekizumab bested placebo in fatigue (–1.6 to –2.5 for bimekizumab vs. –0.8 for placebo); neck, back, or hip pain (–2 to –3.3 vs. –1.2); discomfort due to tenderness to touch or pressure (–1.6 to –3 vs. –1.1); presence of morning stiffness (–2.5 to –3.5 vs. –1.2); and duration of morning stiffness (–1.7 to –3.3 vs. –1.4).
Similarly, BASFI scores improved by –1.4 to –2.2 for bimekizumab, compared with –0.6 for placebo. In addition, both ASQoL (–2.3 to –4.6 vs –1.3) and PGADA (–1.9 to –3.3 vs –1) scores improved in patients assigned bimekizumab compared with those assigned placeboes.
Safety data showed that treatment-emergent adverse events occurred in 36.6% of patients treated with bimekizumab and 38.3% of those who received placebo. Most of these events were mild or moderate.
Nasopharyngitis and headache were the most commonly reported events among patients treated with bimekizumab.
“The new week 12 data from the phase 2b AS study suggest that bimekizumab may deliver results that improve disease activity and outcomes that are most important from the patient perspective, like pain, fatigue, stiffness, mobility and function,” Caeymaex said. – by Rob Volansky
Reference:
van der Heijde D, et al. OP0231. Presented at: EULAR Annual Congress; June 12-15, 2019; Madrid.
Disclosure: van der Heijde reports consulting for AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, and Union Chimique Belge. Caeymaex is an employee of UCB.