Bimzelx (bimekizumab) Demonstrates Long-Term Skin Clearance in Moderate-to-Severe Plaque Psoriasis
UCB has shared extended findings from Phase 3 trials and their open-label extensions, evaluating Bimzelx in adults with moderate-to-severe PSO. The data highlights sustained clinical benefits across various patient groups.
Consistent Skin Clearance Over Five Years
A subset of 153 patients from the second extension of the BE BRIGHT study showed that 67.7% of individuals with moderate-to-severe plaque psoriasis (PSO) treated with Bimzelx (bimekizumab) achieved complete skin clearance (PASI100) at the five-year mark.
Among individuals who had only PSO at baseline but were at risk for developing PsA, between 68.7% and 71.6% achieved PASI100 at three years, aligning closely with the 72% achieved by the general treatment group. In a subset of 153 patients from the U.S. and Canada who completed five years of an open-label extension, 67.7% achieved PASI100, while 84.9% reached PASI90. The treatment was generally well tolerated, with no new safety concerns emerging over this period.
Lasting and Wide-Ranging Efficacy at Four Years
Regardless of initial weight or pre-existing cardiometabolic conditions such as high blood pressure, elevated blood sugar levels, or increased BMI, patients maintained high levels of complete or nearly complete skin clearance after four years of treatment.
A total of 771 PSO patients with conditions such as high blood pressure, elevated BMI, or hyperglycemia showed significant and sustained skin clearance at four years:
Among 375 patients with hypertension, 82.8% achieved PASI90 and 59.3% reached PASI100.
Among 344 patients with elevated BMI, 82.5% achieved PASI90 and 60.7% reached PASI100.
Among 62 patients with hyperglycemia, 80.4% achieved PASI90 and 56.9% reached PASI100.
Strong Response Rates in Patients at Risk for Psoriatic Arthritis
Between 68.7% and 71.6% of PSO patients who were at risk of developing psoriatic arthritis (PsA) achieved full skin clearance at three years. These results were in line with those seen in the broader treatment group, including individuals diagnosed with PsA at the start of treatment.
Dual Mechanism of Action
Bimzelx is the first and only approved treatment that specifically targets and inhibits both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), contributing to its effectiveness in treating plaque psoriasis.
Bristol Myers Squibb Unveils Promising Phase 3 POETYK PsA-2 Trial Results for Sotyktu in Psoriatic Arthritis Treatment
Bristol Myers Squibb (BMS) has released compelling late-breaking data from its Phase 3 POETYK PsA-2 trial (IM011-055), demonstrating the efficacy of Sotyktu (deucravacitinib) in treating adults with active psoriatic arthritis (PsA). The trial’s findings highlight that patients receiving Sotyktu showed significantly better response rates in comparison to those on a placebo.
Key Findings from the POETYK PsA-2 Trial
The study successfully met its primary endpoint, with 54.2% of Sotyktu-treated patients achieving an ACR20 response—a measure indicating at least a 20% improvement in PsA symptoms—compared to 39.4% in the placebo group.
Beyond the primary endpoint, secondary assessments also revealed promising results.
Patients receiving Sotyktu experienced notable improvements in disease activity at Week 16, including a significantly higher rate of achieving a Psoriasis Area and Severity Index (PASI) 75 response compared to placebo. Additionally, Sotyktu-treated individuals reported greater improvements in physical function, as reflected by a greater reduction in the Health Assessment Questionnaire-Disability Index (HAQ-DI) score (-0.32 versus -0.21).
POETYK PsA Clinical Trial Program Overview
BMS’s Phase 3 PsA program encompasses two large-scale, multicenter, placebo-controlled trials—POETYK PsA-1 (IM011-054; NCT04908202) and POETYK PsA-2 (IM011-055; NCT04908189).
POETYK PsA-1 involved around 670 biologic disease-modifying antirheumatic drug (bDMARD)-naïve patients, while POETYK PsA-2 included approximately 730 patients, some of whom had prior exposure to TNFα inhibitors.
Each trial follows a 52-week treatment plan, starting with a placebo-controlled phase through Week 16, followed by continued active treatment. The primary measure for both studies was the percentage of participants achieving an ACR20 response by Week 16, along with secondary endpoints assessing broader PsA disease activity.
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Lilly’s Baricitinib Shows Promising Hair Regrowth Results in Adolescents with Severe Alopecia Areata
Eli Lilly and Incyte have announced positive results from the Phase 3 BRAVE-AA-PEDS study, demonstrating that baricitinib leads to significant hair regrowth in adolescents with severe alopecia areata (AA).
The findings, presented at the American Academy of Dermatology (AAD) meeting, revealed that 42.4% of patients receiving 4 mg of baricitinib achieved at least 80% scalp hair coverage by Week 36.
Key Findings from the BRAVE-AA-PEDS Study
The study involved 257 adolescents (ages 12 to under 18) who were randomized to receive either a 4 mg or 2 mg daily dose of baricitinib, or a placebo. Participants initially had an average of 89% scalp hair loss, with a majority experiencing minimal to no eyebrow or eyelash hair.
At Week 36, the results showed:
60.0% of those on baricitinib 4 mg and 36.9% on baricitinib 2 mg experienced at least a 50% improvement in scalp hair coverage, compared to 5.7% in the placebo group.
42.4% of patients on baricitinib 4 mg and 27.4% on baricitinib 2 mg achieved 80% or greater scalp hair coverage, compared to just 4.5% on placebo.
36.5% of baricitinib 4 mg users and 21.4% of baricitinib 2 mg users attained 90% or more scalp hair coverage (SALT ≤10), versus 2.3% of placebo users.
50.0% of those on baricitinib 4 mg and 24.1% on baricitinib 2 mg saw significant eyebrow regrowth, compared to none in the placebo group.
42.9% of baricitinib 4 mg recipients and 25.5% of those on baricitinib 2 mg showed substantial eyelash regrowth, compared to 14.0% on placebo (p=0.002 for 4 mg, p=0.097 for 2 mg).
Comparison to Adult Treatment Outcomes
Interestingly, adolescent patients in this study achieved similar results at 36 weeks to what adults in previous BRAVE-AA1 and BRAVE-AA2 trials accomplished at 52 weeks. Among adults, 40.9% on baricitinib 4 mg and 21.2% on 2 mg achieved 80% or more scalp hair coverage at Week 52, suggesting that younger patients may experience faster hair regrowth.
Dupixent (dupilumab) Shows Promising Results in Bullous Pemphigoid Treatment
New late-breaking data from a pivotal trial reveal that Dupixent (dupilumab) significantly improves disease remission rates in adults with bullous pemphigoid (BP), according to findings presented by Regeneron and Sanofi. The study showed that five times more patients on Dupixent achieved sustained disease remission at 36 weeks compared to those on placebo. Additionally, Dupixent demonstrated marked reductions in disease severity and itch.
Key Findings from the ADEPT Trial
The ADEPT trial, which included 106 adults with moderate-to-severe BP, assessed the efficacy of Dupixent in comparison to a placebo. Participants were randomly assigned to receive either Dupixent 300 mg every two weeks after an initial loading dose or a placebo, in addition to standard oral corticosteroid (OCS) treatment. Patients followed a protocol-driven tapering regimen to gradually reduce their OCS intake.
Results at 36 weeks demonstrated the following outcomes for Dupixent-treated patients versus placebo:
20% achieved sustained disease remission, compared to 4% in the placebo group.
40% showed at least a 90% reduction in disease severity, compared to 10% in the placebo group.
40% reported significant itch relief, versus 11% on placebo.
1678 mg reduction in cumulative OCS exposure and a 54% lower need for rescue medication
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