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- First presentations from the BE OPTIMAL and BE COMPLETE studies evaluating bimekizumab in the treatment of adults with active psoriatic arthritis who were biologic-naïve and TNF-inadequate responders, respectively
- A higher proportion of patients treated with bimekizumab vs. placebo achieved improvements in joint symptoms at week 16 as measured by ACR50, with a consistent clinical response across biologic-naïve (43.9 percent vs. 10.0 percent; p<0.001) and TNF-inadequate responder populations (43.4 percent vs. 6.8 percent; p<0.001)
- At week 16, a greater proportion of bimekizumab-treated patients achieved high levels of skin clearance, PASI90, vs. placebo, with a consistent clinical response across populations (61.3 percent vs. 2.9 percent for biologic naïve and 68.8 percent vs. 6.8 percent for TNF-inadequate responders; p<0.001 for each)
- At week 16, over 40 percent of bimekizumab-treated patients vs. placebo achieved minimal disease activity in both studies (p<0.001)
BRUSSELS and ATLANTA, May 23, 2022 /PRNewswire/ — UCB, a global pharmaceutical company, today announced detailed results from two Phase 3 studies which evaluated the efficacy and safety of bimekizumab versus placebo in the treatment of adults with active psoriatic arthritis who were biologic disease-modifying anti-rheumatic drug naïve (BE OPTIMAL) and in adults who had an inadequate response or intolerance to tumor necrosis factor (TNF) inhibitors (BE COMPLETE).1,2 The safety and efficacy of bimekizumab in psoriatic arthritis have not been established, and it is not approved for use in psoriatic arthritis by any regulatory authority worldwide.
Both studies met their primary endpoint of ACR50 at week 16 and all ranked secondary endpoints compared with placebo with statistical significance.1,2 At week 16, patients treated with bimekizumab achieved clinically relevant improvements over placebo in both joint and skin symptoms with efficacy outcomes consistent across both biologic-naïve and TNF-inadequate responder populations.1,2 In addition, at week 16, over 40 percent of patients in both studies achieved a minimal disease activity response compared with placebo.1,2 The adverse event profile of bimekizumab was consistent with those seen in previous studies.1,2 The results will be presented at the European Congress of Rheumatology, EULAR 2022, in Copenhagen, Denmark, June 1-4.1,2
“Our Phase 3 clinical studies with bimekizumab used ACR50 at week 16 as the primary endpoint reflecting our goal to raise the treatment bar for people with psoriatic arthritis. Results show that bimekizumab addressed the debilitating joint symptoms of active psoriatic arthritis, while also providing high levels of skin clearance compared to placebo,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of US, UCB. “Importantly, the consistent findings seen across populations suggest that bimekizumab can provide a similar clinical response in patients that have an inadequate response or intolerance to TNF inhibitors, and in patients that are new to biologics.”
“Today’s findings from the BE OPTIMAL and BE COMPLETE studies provide clear evidence supporting the potential of bimekizumab, a dual IL-17A and IL-17F inhibitor, in the treatment of active psoriatic arthritis. This painful, chronic condition can greatly impact patients’ lives . Achieving minimal disease activity is an important goal of treatment, that can ultimately lead to improved quality of life for people with psoriatic arthritis,” said Joseph F. MerolaMD, MMSc, Associate Professor, Harvard Medical School and Brigham and Women’s Hospital.
Data from BE COMPLETE (16-week analysis) and BE OPTIMAL (24-week interim analysis)
Joint Symptoms: In both studies, patients treated with bimekizumab (160 mg every four weeks [Q4W]) achieved statistically significant improvements in the primary endpoint of at least 50 percent or greater improvement from baseline in the American College of Rheumatology response criteria (ACR50) at week 16, compared with placebo.1,2
- In BE OPTIMAL, at week 16, 43.9 percent (n=189/431) of biologic naïve patients treated with bimekizumab achieved ACR50 versus 10.0 percent (n=28/281) of patients on placebo; p<0.001.1
- In BE COMPLETE, at week 16, 43.4 percent (n=116/267) of TNF-inadequate responder patients treated with bimekizumab achieved ACR50 versus 6.8 percent (n=9/133) of patients on placebo; p<0.001.2
Skin Symptoms: In both studies, patients treated with bimekizumab achieved statistically significant improvements in levels of skin clearance, as measured by the secondary endpoint of at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI90) at week 16, compared with placebo.1.2
- In BE OPTIMAL, at week 16, 61.3 percent (n=133/217) of biologic naïve patients treated with bimekizumab achieved PASI90 versus 2.9 percent (n=4/140) on placebo; p<0.001.1
- In BE COMPLETE, at week 16, 68.8 percent (n=121/176) of TNF-inadequate responder patients treated with bimekizumab achieved PASI90 versus 6.8 percent (n=6/88) on placebo; p<0.001.2
Minimal Disease Activity: In both studies, a significantly higher proportion of patients treated with bimekizumab achieved the ranked secondary endpoint of Minimal Disease Activity (MDA) response, compared with placebo at week 16.1,2
- In BE OPTIMAL, at week 16, 45.0 percent (n=194/431) of biologic-naïve patients treated with bimekizumab achieved MDA versus 13.2 (n=37/281) percent on placebo; p<0.001.1
- In BE COMPLETE, at week 16, 44.2 percent (n=118/267) of TNF-inadequate responder patients treated with bimekizumab achieved MDA versus 6.0 percent (n=8/133) on placebo; p<0.001.2
“In the BE OPTIMAL and BE COMPLETE studies, bimekizumab demonstrated clinically relevant improvements in musculoskeletal …
Full story available on Benzinga.com
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