PASI 100 CONSISTENTLY DEMONSTRATED ACROSS HEAD-TO-HEAD CLINICAL TRIALS2-4
Results like this make dermatologists like us stand up and take notice.
Watch how BIMZELX is reaching higher in psoriasis treatment by targeting COMPLETE CLEARANCE (PASI 100) in head-to-head clinical trials against COSENTYX® (secukinumab), HUMIRA® (adalimumab), and STELARA® (ustekinumab). Then explore the data demonstrating why patients can expect RAPID results and MAINTAIN longer-term clearance with BIMZELX.
Treatment Response Time
Learn how you can give many of your patients the opportunity to achieve skin clearance that can last.
Head-to-Head
Hear how BIMZELX performed in clinical trials against three of the most prescribed biologics.
THE BIMZELX DIFFERENCE IS IN THE MOA*
BIMZELX is the first and only approved biologic to inhibit
*The clinical relevance of the mechanism of action is unknown.
Across different patient populations with different levels of inflammatory skin disease, the amazing thing was the consistency we saw with BIMZELX‑highlighting that IL-17A and IL-17F are really at the heart of this skin disorder.
-Dr. Stevan Shaw
Targeting IL-17A and IL-17F
Discover the significance of IL-17F in psoriasis pathogenesis.
BIMZELX: The Discovery
Learn the story behind BIMZELX from Dr. Stevan Shaw, VP, Head of Immunology Research for UCB.
A CONSISTENT SAFETY PROFILE WITH 4 YEARS OF DATA6
The chronic nature of psoriasis requires persistent management, making long-term safety assessment of treatment a cornerstone for clinical decision-making. BIMZELX demonstrated a consistent safety profile over 4 years with low incidences of adverse events across the pooled analysis of short-term and long-term safety data.6
Robust Safety Data Across 5 Phase 3/3b Clinical Trials6
SHORT TERM (PHASE 3)* Weeks 0-16 % (n) |
LONGER TERM (PHASE 3/3B)† Year 4 EAIR/100 PY (95% CI) |
||
---|---|---|---|
BIMZELX 320 MG (n=989) | PLACEBO (n=169) | BIMZELX ALL DOSES (n=2,186) | |
Candida infections |
9.1% (90) |
0% |
10.4 (9.5, 11.3) |
Oral candidiasis |
7.6% (75) |
0% |
8.9 (8.1, 9.7) |
Injection site reactions |
2.7% (27) |
1.2% (2) |
1.7 (1.4, 2.0) |
ALT or AST elevations |
|
|
|
>3x ULN
|
1.3% (13) |
1.2% (2) |
1.9 (1.6, 2.3) |
>5x ULN‡ |
0.3% (3) |
0% |
0.5 (0.4, 0.7) |
Malignancies (inc. NMSC) |
0.4% (4) |
0.6% (1) |
0.9 (0.6, 1.1) |
Serious infections |
0.3% (3) |
0% |
1.3 (1.0, 1.6) |
Adjudicated MACE |
0.1% (1) |
0% |
0.6 (0.4, 0.8) |
Adjudicated inflammatory bowel disease§ |
0.1% (1) |
0% |
0.2 (0.1, 0.3) |
Adjudicated suicidal ideation and behavior |
0% |
0% |
0.1 (0.1, 0.2) |
Serious hypersensitivity reactionsll |
0% |
0% |
0.1 (0.0, 0.2) |
* Pooled short-term data from Weeks 0-16 of 3 Phase 3 trials (BE SURE, BE VIVID, and BE READY).6 † Longer-term data from 5 Phase 3/3b trials (Phase 3: BE SURE, BE VIVID, BE READY and their OLE BE BRIGHT; Phase 3b: BE RADIANT). BE RADIANT ran for 3 years; therefore, the total pooled exposure only includes BE RADIANT data to Year 3 (cut-off May 6, 2022) in addition to BE BRIGHT data to Year 4 (cut-off Nov. 14, 2022).6 ‡ Patients with elevations >5x ULN were a subset of patients with elevations >3x ULN. § Includes any TEAE adjudicated as definite or probable IBD.6 Long-term data included in the BIMZELX Prescribing Information includes seven cases of new onset IBD (including ulcerative colitis, Crohn’s disease, and IBD-undetermined) in subjects exposed to BIMZELX (0.12 per 100 PY).1 II No anaphylactic reactions associated with BIMZELX were reported.6 ALT=alanine aminotransferase. AST=aspartate aminotransferase. CI=confidence interval. EAIR=exposure-adjusted incidence rate. IBD=inflammatory bowel disease. MACE=major adverse cardiovascular events. NMSC=non-melanoma skin cancer. PY=patient-year. ULN=upper limit of normal. |
Investigator ExperienceS
Hear as two investigators share their clinical experiences with BIMZELX in the Phase 3 clinical trials.
Investigator Experience–Jamie Weisman, MD
Clinical trial investigator Jamie Weisman, MD, of Atlanta Medical Dermatology Specialists, Inc., discusses her experience with BIMZELX.
Investigator Experience–Jeffrey Weinberg, MD
Clinical trial investigator Jeffrey Weinberg, MD, of Infinity Dermatology NYC and Mt. Sinai, discusses his experience with BIMZELX.
References
1. BIMZELX [prescribing information]. Smyrna, GA: UCB, Inc. 2. Reich K, et al. N Engl J Med. 2021;385(2):142-152. 3. Reich K, et al. Lancet. 2021;397(10273):487-498. 4. Warren RB, et al. N Engl J Med. 2021;385(2):130-141. 5. Gordon KB, et al. Lancet. 2021;397(10273):475-486. 6. Data on file. UCB, Inc., Smyrna, GA.
08/2024 US-BK-2400881
EXPLORE RAPID, COMPLETE, AND MAINTAINED CLEARANCE FROM THE VERY FIRST DOSE1-5*
*From the very first dose as measured at Week 4;
results were not immediate.
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