Long-term BE HEARD Data Show Durable HiSCR Responses With Bimekizumab in HS

At the 2026 American Academy of Dermatology Annual Meeting, UCB presented new post hoc analyses from its phase 3 BE HEARD program evaluating bimekizumab-bkzx in moderate to severe hidradenitis suppurativa (HS), offering a closer look at long-term disease control and potential predictors of response.¹

Durable Control and Flare Reduction

Hidradenitis suppurativa remains a chronic, relapsing inflammatory disease characterized by painful nodules, abscesses, and draining tunnels, with flares contributing substantially to patient burden.² According to Steven Daveluy, MD, FAAD, more than 80% of patients experience at least monthly exacerbations, underscoring the need for sustained disease control strategies.

In the BE HEARD open-label extension (BE HEARD EXT), investigators assessed outcomes through 3 years (week 148) among patients initially randomized to bimekizumab who completed the parent trials and entered the extension (n=367).³ Across this cohort, 86.1% of patients remained free of acute exacerbations at scheduled visits over the 3-year period. Flares were defined as a ≥25% increase in abscess and inflammatory nodule count relative to baseline, with an absolute increase of at least two lesions.

While flare reduction was not a primary endpoint in the pivotal trials—and did not separate from placebo at week 16 in BE HEARD II—the long-term extension data suggest that sustained IL-17A and IL-17F inhibition may translate into more stable disease control over time.

Disease Duration and Severity: A “Window of Opportunity”?

A second post hoc analysis explored whether baseline disease characteristics influenced long-term outcomes. Patients with shorter disease duration (<2.38 years) and moderate disease severity (Hurley Stage II) demonstrated higher response rates at three years compared with those with longer disease duration (≥10.74 years) and more severe disease (Hurley Stage III).

Specifically, HiSCR90 and HiSCR100 responses were achieved by 74.1% and 62.1% of patients in the early/moderate group, respectively, compared with 51.5% and 33.3% in the late/severe group. These findings align with the concept of a therapeutic “window of opportunity” in HS, where earlier intervention may lead to more robust and durable responses.

Although these analyses are exploratory, they reinforce a growing body of evidence suggesting that prolonged inflammatory burden and structural damage—hallmarks of advanced HS—may limit the ceiling of achievable response, even with targeted biologic therapy.

Consistency Across Patient Subgroups

A third analysis evaluated treatment response across clinically relevant subgroups, including age, sex, body mass index (BMI), disease duration, and baseline severity. Bimekizumab was associated with maintained improvements in HiSCR responses across all subgroups through 3 years.

Notably, efficacy appeared consistent regardless of BMI category, an important consideration given the high prevalence of obesity in HS populations and its known association with disease severity and treatment response variability. Similarly, responses were observed across both younger and older patients, as well as across sexes.

These subgroup findings suggest that while earlier treatment and lower baseline severity may optimize outcomes, meaningful clinical benefit remains achievable across a broad spectrum of patients.

Context Within the BE HEARD Program

The BE HEARD I and II trials were multicenter, randomized, placebo-controlled phase 3 studies enrolling more than 1,000 patients with moderate to severe HS. The primary endpoint in both trials was HiSCR50 at week 16. Patients completing 48 weeks of treatment were eligible to enter the open-label extension, where dosing could be adjusted based on response.

The approved dosing regimen for HS—320 mg every 2 weeks through week 16, followed by every 4 weeks—was reflected in the extension, with some protocol-driven adjustments over time.

Interpreting Post Hoc Findings

As with all post hoc analyses, these findings should be interpreted cautiously. The analyses were not prespecified, and the extension population represents a subset of patients who completed earlier trial phases, potentially introducing selection bias. Observed case methodology further limits generalizability, as outcomes reflect only those remaining in the study at each time point.

Nevertheless, the durability of response and low flare rates over 3 years contribute to an evolving understanding of long-term HS management with biologic therapy.

Looking Ahead

The data presented at AAD 2026 add to a growing evidence base supporting sustained IL-17 pathway inhibition in HS. For clinicians, the findings highlight 2 key considerations: the importance of long-term disease control beyond initial response, and the potential benefits of earlier intervention in altering disease trajectory.

As therapeutic options expand, integrating these insights into clinical decision-making may help optimize outcomes for patients with this often debilitating condition.

References

1. UCB announces new BIMZELX[®] (bimekizumab-bkzx) data at AAD showing durable symptom control throughout three years in hidradenitis suppurativa. News release. UCB. Published March 27, 2026. Accessed March 27, 2026. https://www.ucb.com/newsroom/press-releases/article/ucb-announces-new-bimzelxr-bimekizumab-bkzx-data-at-aad-showing-durable-symptom-control-throughout-three-years-in-hidradenitis-suppurativa
2. Garg A, Hsiao J, Porter ML, Shi V. Current treatments and future directions for hidradenitis suppurativa: a narrative review of completed and ongoing phase 3 clinical trials of biologic therapies. Dermatol Ther (Heidelb). 2025;15(9):2361-2377. doi:10.1007/s13555-025-01487-y
3. Sayed CJ, Kirby B, Garg A, et al. Bimekizumab demonstrated a favorable safety profile and high levels of efficacy with up to 2 years of treatment in patients with moderate to severe hidradenitis suppurativa: Pooled results from two phase 3 randomized, controlled trials and their open-label extension. J Am Acad Dermatol. 2026;94(3):867-878. doi:10.1016/j.jaad.2025.11.031