UCB presented four-year long-term data of Bimzelx in patients with moderate to severe plaque psoriasis
In a recent groundbreaking revelation at the initiation of Year 4, it has been unveiled that Bimzelx (bimekizumab) exhibits prolonged efficacy in treating moderate-to-severe plaque psoriasis. The late-breaking platform presentation showcased that BIMZELX consistently achieved and upheld notably high rates of clinical and health-related quality-of-life responses over the course of four years, with an impressive 90.9 percent of patients achieving complete skin clearance by Year 4.
Over a span of four years, data was collated from various studies including BE VIVID, BE READY, BE SURE, and their respective open-label extension (OLE Week 144) BE BRIGHT. Analyzed individuals were randomly assigned to receive BIMZELX 320 mg every four weeks (Q4W) until Week 16, following which they continued with either BIMZELX Q4W or Q8W until OLE entry. The assessment of clinical and health-related quality-of-life responses, including PASI90 and PASI100, body surface area (BSA) ≤1 percent, and Dermatology Life Quality Index (DLQI) 0/1, persisted until Year 4 (OLE Week 144). For all participants who received continuous BIMZELX from baseline and entered the OLE (n=771):
At Week 16, 90.9 percent achieved PASI90, maintaining at 86.1 percent through Year 4.
At Week 16, 65.8 percent achieved PASI100, maintaining at 64.7 percent through Year 4.
At Week 16, 78.5 percent achieved BSA ≤1 percent, maintaining at 79.8 percent through Year 4.
At Week 16, 71.5 percent achieved DLQI 0/1, maintaining at 78.7 percent through Year 4.
In a responder analysis to Year 4, participants who completed the BE VIVID, BE SURE, and BE READY Phase 3 studies were eligible to enter the BE BRIGHT OLE. Those analyzed were initially randomized to receive BIMZELX 320 mg Q4W until Week 16, then continued with BIMZELX Q4W or Q8W until OLE entry, and further adjusted based on PASI response or prior dose. The maintenance of PASI90 and PASI100 was evaluated among Week 16 responders up to Year 4 (OLE Week 144), resulting in:
87.7 percent of those who achieved PASI90 at Week 16 (n=693) maintaining their response to Year 4.
73.3 percent of those who achieved PASI100 at Week 16 (n=503) maintaining their response to Year 4.
Janssen aims to strengthen its psoriasis portfolio with oral JNJ-2113
Fresh data reveal that JNJ-2113, an oral peptide under investigation, upheld skin clearance in individuals with moderate-to-severe plaque psoriasis for a duration of one year. The extended study FRONTIER 2 of JNJ-2113 showcased sustained effectiveness from Week 16 to Week 52, alongside safety outcomes consistent with earlier reported data (FRONTIER 1 Study). This revelation was shared during a late-breaking oral presentation at the American Academy of Dermatology 2024 Annual Meeting.
Janssen disclosed the inaugural data from FRONTIER 2, the long-term extension of Phase 2b FRONTIER 1 clinical trial exploring JNJ-2113. This peptide is designed to obstruct the IL-23 receptor. IL-23 assumes a pivotal role in activating pathogenic T-cells in moderate-to-severe plaque psoriasis (PsO) and underlies the inflammatory response in PsO and various other IL-23-mediated conditions in dermatology, rheumatology, and gastroenterology.
In FRONTIER 2, JNJ-2113 maintained substantial rates of skin clearance over 52 weeks in adults grappling with moderate-to-severe plaque PsO. Across the five JNJ-2113 treatment cohorts, gauged by the Psoriasis Area and Severity Index (PASI), response rates endured from Week 16 to Week 52. The cohort receiving 100 mg twice daily displayed the highest PASI 75 response, registering 78.6% at 16 weeks and 76.2% at 52 weeks. Similar to the primary endpoint, responses were sustained through Week 52 across all five JNJ-2113 treatment groups for key secondary endpoints such as PASI 90, PASI 100, Investigator’s Global Assessment (IGA) 0/1, and IGA 0.
Safety profiles during the extended study (Week 16 through Week 52) remained consistent with prior findings from FRONTIER 1. Across JNJ-2113 treatment arms, 58.6% of participants encountered adverse events (AEs), with no observable evidence of a dose-dependent escalation in AEs, notably gastrointestinal issues.
Continuation of dosing regimens from FRONTIER 1 was observed in patients who initially received JNJ-2113 during the first 16 weeks, while those initially in the placebo group received JNJ-2113 100 mg once daily in FRONTIER 2. Data from the Phase 2b FRONTIER 1 study assessing JNJ-2113 in adults with moderate-to-severe PsO were recently disseminated in The New England Journal of Medicine.
The pivotal Phase 3 ICONIC clinical development program is presently ongoing to assess the safety and efficacy of JNJ-2113 in adults with moderate-to-severe plaque PsO, including the ICONIC-LEAD and ICONIC-TOTAL studies. This program operates under the license and collaboration agreement between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc. Additional Phase 3 studies within the development program have commenced, including ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, aiming to compare the safety and efficacy of JNJ-2113 with both placebo and deucravacitinib.
The outcomes from the FRONTIER 1 and FRONTIER 2 clinical trials underline the potential of JNJ-2113 across various IL-23-mediated diseases.
Consequently, J&J has initiated the Phase 2b ANTHEM-UC study to evaluate the safety and effectiveness of JNJ-2113 compared with placebo in participants with moderately to severely active ulcerative colitis.
Lebrikizumab study for atopic dermatitis shows skin improvement in people with skin of color
Lilly has revealed findings from a groundbreaking study of lebrikizumab tailored specifically for individuals with skin of color and moderate-to-severe atopic dermatitis (eczema). The study, a Phase 3 trial, highlights the effectiveness of lebrikizumab in enhancing skin clearance and alleviating itch.
Initial data from the study, covering the first 16 weeks, involved 50 patients with moderate-to-severe atopic dermatitis and darker skin tones, as per the Fitzpatrick scale. All participants received an initial subcutaneous dose of lebrikizumab 500 mg, followed by 250 mg subcutaneously every two weeks up to Week 16. The results at 16 weeks aligned with those observed in the ADhere and ADvocate 1 & 2 studies.
Key findings from the study include:
68% of participants experienced significant improvement of at least 75% in disease extent and severity (EASI-75).
46% of participants witnessed at least 90% improvement in disease extent and severity (EASI-90).
39% of participants achieved clear or almost clear skin (IGA 0,1) with a reduction of at least two points from baseline.
56% of participants experienced clinically meaningful relief from itch (PNRS ≥4-point improvement).
No new safety concerns emerged during the study, and there were no reports of serious adverse events. The study also involved a physician assessment of changes in post-inflammatory pigmentation using the newly developed PDCA-Derm scale.