Breakthrough Clinical Results
UCB announced three-year data from Phase 3 trials and open-label extensions showing sustained efficacy of BIMZELX® (bimekizumab) in treating adults with active psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). BIMZELX®, a dual inhibitor of IL-17A and IL-17F, demonstrated lasting control of inflammation and significant improvements in various clinical endpoints, including ACR50 and ASAS40 responses, in both PsA and axSpA patients. The drug was generally well-tolerated with no new safety signals observed. These long-term results highlight BIMZELX®'s potential to improve long-term outcomes and prevent structural damage in these chronic inflammatory diseases.
Key Highlights
- Sustained symptom relief in PsA patients for up to three years, with a significant percentage achieving elimination of swollen joints and minimal disease activity.
- Lasting improvements in physical function across axSpA patients, maintaining high levels of clinical response with stringent outcome measures like ASAS40.
- Consistent sustainability of efficacy across stringent clinical endpoints in PsA, nr-axSpA, and AS, showing potential to improve long-term outcomes and prevent structural damage.
- BIMZELX® is the first and only approved medicine designed to selectively inhibit both IL-17A and IL-17F.
Economic Burden
Psoriatic Arthritis (PsA) Economic Burden: USA and Europe
PsA imposes a substantial economic burden on both patients and healthcare systems in the USA and Europe. Quantifying this burden is complex, varying based on factors like disease severity, healthcare access, and the perspective of the analysis (societal, payer, patient). Here's a summary of findings from various studies, focusing on more recent data where available:
USA:
- A 2020 study found annual all-cause healthcare costs per patient were $29,742 for PsA, significantly higher than psoriasis ($11,062) and controls ($7,470). Costs increased over the 5-year follow-up. This study highlights the substantial economic burden and unmet medical need in PsA.
- A 2014 study comparing moderate-to-severe psoriasis patients with and without PsA found those with PsA had significantly higher comorbidity and healthcare utilization and costs. The adjusted annual cost difference per patient was $23,160, with pharmacy costs accounting for $17,696 and medical costs for $5,077.
- A 2017 study found that moderate to severe psoriasis and/or PsA patients persistent on biologic treatment had higher pharmacy costs ($10,684 vs. $7,849 for non-persistent patients) but lower medical costs ($3,395 vs. $5,041), resulting in similar total costs between the groups ($22,678 vs. $21,477). Persistence on biologics, while expensive pharmaceutically, may lead to lower medical costs overall.
- A 2018 study estimated the total annual healthcare costs for PsA in the US to be as high as $1.9 billion (in 2009 USD). Indirect costs (e.g., lost productivity) accounted for 52% to 72% of total costs, increasing with worsening physical function and disease activity.
Europe (specifically UK):
- A 2019 study in the UK found the mean annual healthcare cost per PsA patient (excluding medication) was £1586 (ranging from £174 to £8854). A 1-point increase in the Health Assessment Questionnaire-Disability Index (HAQ-DI) score was associated with a £547.49 increase in total costs, primarily driven by secondary care consultations.
- A 2014 systematic review focusing on indirect costs of PsA found the average annual cost per patient ranged from US$1693.83 to $12,318.45 using the friction cost approach and US$1750.68 to $50,270.52 using the human capital approach (all in 2013 USD). A meta-analysis estimated the cost of work disability at US$10,754.04 per patient per year.
General Observations:
- Indirect costs, such as lost productivity due to work disability, represent a significant portion of the overall economic burden of PsA in both regions.
- Disease severity and functional status are strongly correlated with higher costs.
- Biologic therapies, while initially expensive, may lead to long-term cost offsets by reducing the need for other healthcare services.
- There's a need for more standardized and comprehensive cost-of-illness studies in PsA to better inform resource allocation and treatment strategies.
Bimekizumab (BIMZELX®) is being clinically developed for several indications besides psoriatic arthritis, including:
- Psoriasis: Bimekizumab has shown promising results in treating moderate-to-severe plaque psoriasis. A phase 2b study investigated different dosing regimens (320 mg every 2 weeks, 320 mg every 4 weeks, 160 mg every 4 weeks, 16 mg every 4 weeks, and placebo) and found significant improvements in skin clearance with bimekizumab compared to placebo. Another study explored dosing intervals during maintenance therapy, finding that both 8-week and 4-week intervals could maintain clear skin. A systematic review comparing ixekizumab and secukinumab (both IL-17A inhibitors) found bimekizumab offered better PASI response than many other treatments.
- Ankylosing Spondylitis: Phase 3 trials (BE MOBILE 1 and 2) have evaluated bimekizumab's efficacy in both non-radiographic and radiographic axial spondyloarthritis (axSpA), which encompasses ankylosing spondylitis. These trials demonstrated significant improvements in multiple outcome measures, including ASAS40 response, BASDAI, and quality of life scores, with bimekizumab compared to placebo. A cost-effectiveness analysis suggested bimekizumab was a cost-effective option for axSpA in Scotland, compared to secukinumab and ixekizumab.
- Hidradenitis Suppurativa: Two phase 3 trials (BE HEARD I and II) assessed bimekizumab in patients with moderate-to-severe hidradenitis suppurativa. The trials showed that bimekizumab, administered every 2 weeks or every 4 weeks, led to significant improvements in HiSCR50 response compared to placebo. The drug was well-tolerated and maintained its efficacy over 48 weeks.
The intervention models for these trials generally involve:
- Randomized, double-blind, placebo-controlled design: This is the standard for phase 3 trials, ensuring rigorous evaluation of efficacy and safety by comparing the drug to placebo. Blinding prevents bias from both patients and researchers.
- Various dosing regimens: Different doses and dosing intervals are often tested to determine the optimal regimen for each indication. Loading doses may also be used to achieve faster initial responses.
- Active comparators: In some cases, the drug may be compared to an existing standard treatment to assess its relative efficacy.
- Long-term extension studies: These studies follow patients for extended periods to evaluate the long-term safety and efficacy of the drug.
It's important to note that clinical trials are ongoing, and the specific intervention models may vary depending on the trial design and objectives.