Bimekizumab shows long-term benefits across axSpA spectrum

Treatment with bimekizumab showed sustained efficacy for up to 3 years in patients with nonradiographic (nr) and radiographic (r) axial spondyloarthritis (axSpA), based on a pooled analysis of the two phase III studies (BE MOBILE 1 and 2) and combined open-label extension (OLE) study presented at EULAR 2025.

“Long-term data, showing that patients living with axSpA can maintain high levels of clinical response, are invaluable for informed treatment decisions. It’s particularly compelling to see sustained responses with bimekizumab treatment at 3 years with stringent outcome measures like ASAS40* and low disease activity (LDA),” said Prof Xenofon Baraliakos from Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany, in a press release.

This pooled data included 586 patients with nr-axSpA (n=254) or r-axSpA (n=332) from the BE MOBILE 1 and 2 studies, respectively, who received subcutaneous bimekizumab 160 mg Q4W from week 16. A total of 494 participants entered the OLE study at week 52, and 425 patients (n=175 [nr-axSpA] and n=250 [r-axSpA]) completed week 164 by September 2024.

Of patients who achieved ASAS40 at week 104, 60.4 percent with nr-axSpA and 60.1 percent with r-axSpA maintained this response at week 164, with 32.4 percent and 36.5 percent, respectively, achieving ASAS partial remission. [EULAR 2025, abstract POS0788]

Achievement of ASDAS** LDA (<2.1) was also sustained in both nr-axSpA (59.9 percent) and r-axSpA (61.8 percent) cohorts through week 164.

ASDAS inactive disease <1.3 was achieved by 28.6 percent and 31 percent of nr- and r-axSpA patients, respectively, at week 164.

From baseline to week 164, bimekizumab treatment resulted in sustained control of MRI inflammation, as evidenced by reductions in MRI SPARCC*** sacroiliac joint (SIJ) score by -7.5 in patients with nr-axSpA and MRI Berlin spine score by -2.8 in patients with r-axSpA.

Additionally, 59.3 percent and 77.8 percent of the participants achieved MRI SPARCC SIJ remission (score <2) and Berlin spine remission (score ≤2), respectively.

“These endpoints are key indicators of durable inflammation control in axSpA, and achieving this level of sustained disease management is likely to have a profound impact on patients’ daily lives,” said Baraliakos.

In terms of safety, 90.4 percent of the patients experienced ≥1 treatment-emergent adverse event (TEAE), with COVID-19 (34 percent), nasopharyngitis (24.2 percent), and upper respiratory tract infection (15.3 percent) being the most frequently reported TEAEs.

There were no deaths or adjudicated MACE reported.

“No new safety signals were observed. Bimekizumab was well tolerated with a favourable safety profile,” the researchers noted.

“Overall, patients treated with bimekizumab demonstrated sustained clinical response and control of inflammation through 3 years across nr- and r-axSpA patients,” said the researchers.