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UCB have released Bimzelx (bimekizumab) 5 year data.
Five-year efficacy and safety:
A US/Canadian subgroup of 153 patients completing BE VIVID/BE SURE/BE READY and the BE BRIGHT open-label extension could enter a second 48-week extension (OLE2), where all patients received Q8W. Bimekizumab-bkzx demonstrated high rates of clinical and health-related quality of life responses, which were highly durable to Year 5. It was generally well tolerated in this patient subgroup, with no unexpected safety findings, over five years:
Of the 153 patients analyzed, 75.2% and 67.7% patients achieved PASI100 at one year and five years, respectively. Similarly, 92.8% and 84.9% achieved PASI90 at one year and five years, respectively
Over five years, in the subgroup of 153 patients, the four most common treatment emergent adverse events (TEAEs) were: nasopharyngitis (9.7/100PY), oral candidiasis (7.6/100PY), coronavirus infection (6.1/100PY) and upper respiratory tract infection (5.8/100PY).
Weight stratification:
Bimekizumab-bkzx demonstrated long-term efficacy across four years regardless of patients’ weight subgroup at baseline (either <90 kg or ≥90 kg):
Of the 420 patients analyzed who were <90 kg, 88.5%/67.4% achieved PASI90/PASI100 at four years
Of the 351 patients analyzed who were ≥90 kg, 83.0%/61.6% achieved PASI90/PASI100 at four years
Skin clearance rates in patients with cardiometabolic comorbidities:
High and durable levels of complete or near-complete skin clearance were achieved after four years of bimekizumab-bkzx treatment in 771 patients with PSO, regardless of baseline hypertension, elevated BMI, or hyperglycemia:
Of the 375 patients with baseline hypertension, 82.8%/59.3%, respectively, achieved PASI90/PASI100 at four years
Of the 344 patients with baseline elevated BMI, 82.5%/60.7%, respectively, achieved PASI90/PASI100 at four years
Of the 62 patients with baseline hyperglycemia, 80.4%/56.9%, respectively, achieved PASI90/PASI100 at four years
Patients at risk of progressing to psoriatic arthritis (PsA):
The rates of complete skin clearance (PASI100) were high after three years in bimekizumab-bkzx-treated patients with PSO and risk factors for progression to PsA, or who screened PsA-positive, consistent with the overall bimekizumab-bkzx-treated group. Outcomes were similar when the analysis was restricted to patients with only psoriasis at baseline.
*All patients received bimekizumab-bkzx every four weeks (Q4W) to Week 16, then received either Q4W or Q8W depending upon response to treatment. Receiving Q4W to Week 16, then Q8W thereafter is the approved dosing regimen (Q4W/Q8W). Results included patients receiving both Q4W/Q8W and Q4W/Q4W.
Source: ucb.com
Bimzelx (bimekizumab)
- Sustained complete skin clearance over five years: In a subset of 153 patients from the second extension of BE BRIGHT, 67.7% of patients with moderate-to-severe plaque psoriasis (PSO) treated with BIMZELX® (bimekizumab-bkzx) achieved PASI100 at five years
- Durable and broad efficacy across patient subgroups at four years: Consistently high rates of complete or near-complete skin clearance seen at four years regardless of baseline weight or baseline cardiometabolic comorbidities such as hypertension, hyperglycemia or elevated BMI
- High response rates in patients at risk of psoriatic arthritis at three years: Data showed 68.7–71.6% of PSO patients at risk of developing psoriatic arthritis (PsA) achieved complete skin clearance, generally consistent with the overall treated group. Similar results were seen in all patients with PSO, including those with PsA at baseline
- Dual inhibition: BIMZELX® is the first and only approved medicine designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F)
Five-year efficacy and safety:
A US/Canadian subgroup of 153 patients completing BE VIVID/BE SURE/BE READY and the BE BRIGHT open-label extension could enter a second 48-week extension (OLE2), where all patients received Q8W. Bimekizumab-bkzx demonstrated high rates of clinical and health-related quality of life responses, which were highly durable to Year 5. It was generally well tolerated in this patient subgroup, with no unexpected safety findings, over five years:
Of the 153 patients analyzed, 75.2% and 67.7% patients achieved PASI100 at one year and five years, respectively. Similarly, 92.8% and 84.9% achieved PASI90 at one year and five years, respectively
Over five years, in the subgroup of 153 patients, the four most common treatment emergent adverse events (TEAEs) were: nasopharyngitis (9.7/100PY), oral candidiasis (7.6/100PY), coronavirus infection (6.1/100PY) and upper respiratory tract infection (5.8/100PY).
Weight stratification:
Bimekizumab-bkzx demonstrated long-term efficacy across four years regardless of patients’ weight subgroup at baseline (either <90 kg or ≥90 kg):
Of the 420 patients analyzed who were <90 kg, 88.5%/67.4% achieved PASI90/PASI100 at four years
Of the 351 patients analyzed who were ≥90 kg, 83.0%/61.6% achieved PASI90/PASI100 at four years
Skin clearance rates in patients with cardiometabolic comorbidities:
High and durable levels of complete or near-complete skin clearance were achieved after four years of bimekizumab-bkzx treatment in 771 patients with PSO, regardless of baseline hypertension, elevated BMI, or hyperglycemia:
Of the 375 patients with baseline hypertension, 82.8%/59.3%, respectively, achieved PASI90/PASI100 at four years
Of the 344 patients with baseline elevated BMI, 82.5%/60.7%, respectively, achieved PASI90/PASI100 at four years
Of the 62 patients with baseline hyperglycemia, 80.4%/56.9%, respectively, achieved PASI90/PASI100 at four years
Patients at risk of progressing to psoriatic arthritis (PsA):
The rates of complete skin clearance (PASI100) were high after three years in bimekizumab-bkzx-treated patients with PSO and risk factors for progression to PsA, or who screened PsA-positive, consistent with the overall bimekizumab-bkzx-treated group. Outcomes were similar when the analysis was restricted to patients with only psoriasis at baseline.
*All patients received bimekizumab-bkzx every four weeks (Q4W) to Week 16, then received either Q4W or Q8W depending upon response to treatment. Receiving Q4W to Week 16, then Q8W thereafter is the approved dosing regimen (Q4W/Q8W). Results included patients receiving both Q4W/Q8W and Q4W/Q4W.
Source: ucb.com
Bimzelx (bimekizumab)
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