Results from the PHASE3 study investigating Bimekizumab (Bimzelx) in participants with active Psoriatic Arthritis were posted on 2021-12-08. The trial demonstrated that Bimekizumab 160mg achieved an American College of Rheumatology 50 (ACR50) response in 43.4% of participants, compared to 6.8% for placebo.

Background

This study investigated Bimekizumab for the treatment of subjects with active Psoriatic Arthritis (PsA) who were inadequate responders to tumor necrosis factor alpha (TNFα) inhibitors.

Trial design

The PHASE3 study, identified as NCT03896581, enrolled 400 participants with active Psoriatic Arthritis. The study aimed to evaluate the clinical efficacy, safety, and tolerability of Bimekizumab administered subcutaneously compared with placebo in participants who were tumor necrosis factor alpha-inadequate responders (TNFα-IR).

Key results

Key efficacy outcomes at Week 16 included:

  • Percentage of Participants With American College of Rheumatology 50 (ACR50) Response: Bimekizumab 160mg achieved a response in 43.4% of participants, compared to 6.8% for Placebo. A logistic regression analysis showed an Odds Ratio (OR) of 11.139 (95.0% CI: 5.402, 22.969) with a p-value of 0.001.
  • Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score: Participants receiving Bimekizumab 160mg showed a mean change of -0.3751 (Standard Error: 0.0286), while the Placebo group showed a mean change of -0.0701 (Standard Error: 0.0432). The ANCOVA analysis indicated a Least Square (LS) mean difference of -0.326 (95.0% CI: -0.42, -0.233) with a p-value of 0.001.
  • Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 (in participants with psoriasis): 68.8% of participants in the Bimekizumab 160mg group achieved PASI90, versus 6.8% in the Placebo group. A logistic regression analysis showed an Odds Ratio (OR) of 30.237 (95.0% CI: 12.365, 73.94) with a p-value of 0.001.
  • Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) Score: The Bimekizumab 160mg group had a mean change of 7.258 (Standard Error: 0.531), compared to 1.413 (Standard Error: 0.714) for Placebo. The ANCOVA analysis showed an LS mean difference of 6.037 (95.0% CI: 4.386, 7.688) with a p-value of 0.001.
  • Minimal Disease Activity (MDA) at Week 16: 44.2% of participants treated with Bimekizumab 160mg achieved MDA, compared to 6.0% in the Placebo group. A logistic regression analysis showed an Odds Ratio (OR) of 13.089 (95.0% CI: 6.119, 27.999) with a p-value of 0.001.

What this means

The results from the PHASE3 study NCT03896581 indicate that Bimekizumab 160mg significantly improved key measures of disease activity and quality of life in participants with active Psoriatic Arthritis who were inadequate responders to TNFα inhibitors. The substantial improvements observed across multiple endpoints, including ACR50, HAQ-DI, PASI90, SF-36 PCS, and MDA, suggest a strong clinical benefit for Bimekizumab in this patient population.

Source

This information was sourced from ClinicalTrials.gov, documenting the primary completion results of trial NCT03896581, which were posted on 2021-12-08. The study details are available on clinicaltrials.gov.