Bimzelx psoriatic arthritis phase 3 results

[Caroline]

Difficult to read.

Following on from this thread Bimzelx for psoriasis two year data UCB have released phase 3 results ofr treating psoriatic arthritis.

Quote:

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UCB today announced positive top-line results from the Phase 3 BE COMPLETE study, which evaluated the efficacy and safety of BIMZELX® (bimekizumab) in the treatment of adults with active psoriatic arthritis, who were inadequate responders or intolerant to anti-tumor necrosis  factor-alpha (anti-TNF-α) therapy.

Well, this is looking good !! Another solution for people who have failed anti-TNF treatments.

BE COMPLETE met its primary endpoint, demonstrating that significantly more patients treated with bimekizumab achieved 50 percent or greater improvement in signs and symptoms of disease from baseline, compared with placebo, as measured by the American College of Rheumatology (ACR) 50 response at week 16.

I read in above that the average improvement is 50%, perhaps even more.
ACR50 means at least 50% improvement for people global achievement, pain and function… it is measured with a questionnaire.

The study also met all ranked secondary endpoints. Bimekizumab showed significant improvements over placebo at week 16 in physical function, as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI); skin clearance, as measured by at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI90); physical health status, as measured by the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) score; and low disease activity, as measured by the Minimal Disease Activity (MDA) index.

Above even looks better.

“The BE COMPLETE results mark the latest positive data in a series of four Phase 3 readouts for bimekizumab in the treatment of psoriatic arthritis and axial spondyloarthritis. We believe that these consistent and robust results have the potential to elevate the standard of care for patients, “Both psoriatic arthritis studies in the program used ACR50 as the primary outcome measure. The positive findings in both studies highlight the clinical potential of bimekizumab in psoriatic arthritis for both biologic naïve and anti-TNF therapy experienced patients.”

great that it works for Psoriatic Arthritis too.

In BE COMPLETE, the safety profile of bimekizumab was consistent with safety data seen in previous studies with no new observed safety signals. 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.

What!!!!! ????  The safety is not established ? It is not approved for Psoriatic Arthritis ? What have I been reading   
Was it all a lie?

The top-line results from the BE COMPLETE study build on the positive top-line interim analysis results from the Phase 3 BE OPTIMAL study in adults with active psoriatic arthritis, who were biologic disease-modifying anti-rheumatic drug (bDMARD) naïve, reported in November 2021. Based on these results, UCB plans to submit regulatory applications for bimekizumab in psoriatic arthritis in the United States and the European Union in Q3 2022.

But they will send it in…. But it is strange as the BE COMPLETE study seems to state that the safety is not established.

Sometimes I think: “These researchers should be forced to follow a studies of at least three years, so that they become more able to write their abstracts in a much more easy to read and consistent way.

Source: ucb.com

Bimzelx (bimekizumab)