Dual IL-17A/F blocker significantly reduces spinal radiographic progression in radiographic axSpA

New data from the 2-year open-label extension (OLE) study of BE MOBILE 2 showed that bimekizumab effectively minimised spinal radiographic progression in patients with radiographic axial spondyloarthritis (axSpA). At 2 years, 85% of the participants treated with the dual IL-17A and IL-17F blocker exhibited no radiographic progression, supporting its potential as a long-term treatment option.

“What we always wanted to know is how bimekizumab modifies disease progression but also radiographic progression in terms of clinical data,” explained Prof. Xenofon Baraliakos (Ruhr-University Bochum, Germany) [1]. To answer this question, the ongoing OLE (NCT04436640) of the phase 3 BE MOBILE 2 study (NCT03928743) assesses the impact of bimekizumab on spinal radiographic progression over 164 weeks. Prof. Baraliakos presented the interim analysis at week 104. “We need at least 2 years of follow-up to assess radiographic changes,” Prof. Baraliakos explained.

The BE MOBILE 2 study involved 332 participants, 286 of whom entered the OLE, and 267 completed the 104 weeks. The participants received bimekizumab 160 mg subcutaneously every 4 weeks. “Because damage at the beginning is the most important factor for disease progression, we assessed it at baseline,” Prof. Baraliakos said. Baseline modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) was relatively high at 7.3. Radiographs were repeated at week 104, with progression independently assessed by 2 central readers using the mSASSS (range 0–72).

At 2 years, the results showed only minimal spinal radiographic progression in participants treated with bimekizumab. The mean mSASSS change from baseline was 0.3. No radiographic progression was shown by 85.3% of the participants (mSASSS change ≤0.5), and 92.1% showed less than 2 points increase in mSASSS. Moreover, non-progressors at week 104 included 83.1% of the participants with pre-existing structural damage.

No significant predictive factors for spinal radiographic progression were identified, including baseline mSASSS, age, sex, BMI, ethnicity, smoking status, baseline Ankylosing Spondylitis Disease Activity Score (ASDAS), baseline high-sensitivity C-reactive protein level, prior TNF inhibitor use, and ASDAS and Assessment in SpondyloArthritis international Society 40% (ASAS40) response at week 104.

Only a fraction of participants had new syndesmophytes at 2 years of bimekizumab treatment, including almost one-fifth who had existing syndesmophytes at baseline. This shows that participants with syndesmophytes at baseline are particularly prone to progress. Safety data indicated that bimekizumab was well-tolerated, with no unexpected adverse events reported.

Prof. Baraliakos concluded that the high proportion of participants maintaining a ‘non-progression’ status over 2 years in this study supports the use and further investigation of bimekizumab as a viable long-term treatment option for axSpA.

1. Baraliakos X. et al. Minimal spinal radiographic progression in patients with radiographic axial spondyloarthritis over 2 years of bimekizumab treatment: Results from a phase 3 open-label extension study. LBA0003, EULAR 2024 Congress, 12–15 June, Vienna, Austria.

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Posted on 29 July 2024