Trial results for a Phase 3 study evaluating bimekizumab for moderate to severe hidradenitis suppurativa (HS) were posted on ClinicalTrials.gov on 2021-11-09. The study showed that bimekizumab achieved a Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) in 53.8% and 52.0% of participants across two dosing regimens, compared to 32.2% for placebo.
Background
The study investigated bimekizumab for participants with moderate to severe hidradenitis suppurativa (HS).
Trial design
The Phase 3 study (NCT04242498) enrolled 509 participants with moderate to severe hidradenitis suppurativa. The trial aimed to evaluate the efficacy and safety of bimekizumab across two dosing regimens compared to placebo. A key outcome measured was the percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16.
Key results
The trial reported the following key results at Week 16:
- For Hidradenitis Suppurativa Clinical Response 50 (HiSCR50):
- BKZ Dosing Regimen 1 achieved HiSCR50 in 53.8% of participants.
- BKZ Dosing Regimen 2 achieved HiSCR50 in 52.0% of participants.
- Placebo achieved HiSCR50 in 32.2% of participants.
- For Hidradenitis Suppurativa Clinical Response 75 (HiSCR75):
- BKZ Dosing Regimen 1 achieved HiSCR75 in 33.7% of participants.
- BKZ Dosing Regimen 2 achieved HiSCR75 in 35.7% of participants.
- Placebo achieved HiSCR75 in 15.6% of participants.
- For Percentage of Participants With Flare:
- BKZ Dosing Regimen 1 reported 23.6% of participants with flare.
- BKZ Dosing Regimen 2 reported 28.8% of participants with flare.
- Placebo reported 28.0% of participants with flare.
- For Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score:
- BKZ Dosing Regimen 1 showed a mean change of -4.7 (Standard Error: 0.5).
- BKZ Dosing Regimen 2 showed a mean change of -4.6 (Standard Error: 0.3).
- Placebo showed a mean change of -3.2 (Standard Error: 0.6).
Key analyses using Logistic Regression showed:
- For HiSCR50, BKZ Dosing Regimen 1 vs. Placebo: Odds Ratio (OR) of 2.422 (97.5% CI: 1.221, 4.804), with a p-value of 0.004.
- For HiSCR50, BKZ Dosing Regimen 2 vs. Placebo: Odds Ratio (OR) of 2.287 (97.5% CI: 1.22, 4.291), with a p-value of 0.003.
- For HiSCR75, BKZ Dosing Regimen 1 vs. Placebo: Odds Ratio (OR) of 2.722 (97.5% CI: 1.182, 6.267), with a p-value of 0.007.
- For HiSCR75, BKZ Dosing Regimen 2 vs. Placebo: Odds Ratio (OR) of 3.007 (97.5% CI: 1.374, 6.581), with a p-value of 0.002.
- For Percentage of Participants With Flare, BKZ Dosing Regimen 1 vs. Placebo: Odds Ratio (OR) of 0.798 (97.5% CI: 0.378, 1.683), with a p-value of 0.497.
- For Percentage of Participants With Flare, BKZ Dosing Regimen 2 vs. Placebo: Odds Ratio (OR) of 1.05 (97.5% CI: 0.541, 2.041), with a p-value of 0.868.
What this means
The results from this Phase 3 study suggest that bimekizumab significantly improves clinical response rates in patients with moderate to severe hidradenitis suppurativa compared to placebo. Both dosing regimens of bimekizumab demonstrated superior HiSCR50 and HiSCR75 rates, indicating a meaningful reduction in disease activity. The observed improvements in Dermatology Life Quality Index (DLQI) scores also suggest a positive impact on patients' quality of life. The lower percentage of participants with flare in BKZ Dosing Regimen 1 compared to placebo, although not statistically significant, further supports the potential benefit of bimekizumab in managing HS symptoms. These findings indicate a potential new therapeutic option for patients suffering from this chronic inflammatory skin condition.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04242498, titled 'A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa', were posted on 2021-11-09 on clinicaltrials.gov.