The primary completion of a Phase 3 study evaluating bimekizumab (Bimzelx) for moderate to severe hidradenitis suppurativa was posted on 2022-04-07. The trial demonstrated that bimekizumab achieved higher Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) rates, with 45.3% and 47.8% for two dosing regimens, compared to 28.7% for placebo at Week 16.
Background
The study investigated bimekizumab for participants with moderate to severe hidradenitis suppurativa (HS). Hidradenitis suppurativa is a chronic inflammatory skin condition characterized by painful nodules, abscesses, and scarring, significantly impacting patients' quality of life.
Trial design
The Phase 3 study (NCT04242446) enrolled 505 participants with moderate to severe hidradenitis suppurativa. The trial's purpose was to evaluate the efficacy and safety of bimekizumab. Participants were assigned to either a placebo group or one of two bimekizumab dosing regimens. Efficacy was primarily assessed by the percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16.
Key results
At Week 16, the study reported the following efficacy outcomes:
- For Hidradenitis Suppurativa Clinical Response 50 (HiSCR50):
- Placebo: 28.7%.
- BKZ Dosing Regimen 1: 45.3%.
- BKZ Dosing Regimen 2: 47.8%.
- For Hidradenitis Suppurativa Clinical Response 75 (HiSCR75):
- Placebo: 18.4%.
- BKZ Dosing Regimen 1: 24.7%.
- BKZ Dosing Regimen 2: 33.4%.
Regarding quality of life and pain, absolute change from baseline at Week 16:
- Dermatology Life Quality Index (DLQI) Total Score:
- Placebo: -2.7 (SE: 0.9)
- BKZ Dosing Regimen 1: -5.5 (SE: 0.6)
- BKZ Dosing Regimen 2: -5.0 (SE: 0.4)
- Worst Skin Pain Score:
- Placebo: -0.99 (SE: 0.38)
- BKZ Dosing Regimen 1: -1.56 (SE: 0.26)
- BKZ Dosing Regimen 2: -2.00 (SE: 0.17)
Key statistical analyses included:
- Logistic regression: OR 2.0 (97.5% CI: 0.979 to 4.089), p-value 0.03.
- Logistic regression: OR 2.234 (97.5% CI: 1.159 to 4.307), p-value 0.006.
- Logistic regression: OR 1.416 (97.5% CI: 0.615 to 3.26), p-value 0.35.
- Logistic regression: OR 2.175 (97.5% CI: 1.021 to 4.635), p-value 0.021.
- ANCOVA: LS mean difference -2.574 (97.5% CI: -4.472 to -0.675), p-value 0.002.
- ANCOVA: LS mean difference -2.682 (97.5% CI: -4.394 to -0.97), p-value 0.001.
What this means
The Phase 3 trial results indicate that bimekizumab demonstrated superior efficacy compared to placebo in treating moderate to severe hidradenitis suppurativa. Both bimekizumab dosing regimens achieved a greater percentage of participants reaching HiSCR50 and HiSCR75 at Week 16. The HiSCR50 rates were notably higher for bimekizumab (45.3% and 47.8%) compared to placebo (28.7%). Additionally, participants treated with bimekizumab showed greater improvements in Dermatology Life Quality Index (DLQI) and reductions in worst skin pain scores. These findings, supported by multiple statistically significant outcomes, suggest bimekizumab could be a valuable therapeutic option for patients with this debilitating condition.
Source
The information for this drug update was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04242446, titled "A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa", were posted on 2022-04-07 on clinicaltrials.gov.