No New Safety Signals Over 3 Years in HS With Bimekizumab: Amit Garg, MD

Bimekizumab (Bimzelx) showed no new safety signals and no increase in risk with longer exposure through 3 years in patients with moderate to severe hidradenitis suppurativa (HS), according to pooled data from the BE HEARD program.1 Amit Garg, MD, professor and founding chair of the Department of Dermatology at the Zucker School of Medicine at Hofstra/Northwell and professor at the Feinstein Institutes for Medical Research, discussed the findings with HCPLive.

Garg presented the analysis at the European Academy of Dermatology and Venereology (EADV) Congress 2026 in Vienna, Austria. It pooled 995 patients who received at least 1 bimekizumab dose across the phase 3 BE HEARD I (NCT04242446) and BE HEARD II (NCT04242498) trials and the BE HEARD EXT extension (NCT04901195), totaling 2,118.6 patient-years (PY) of exposure.1-3 Separate BE HEARD EXT data at the meeting tied earlier bimekizumab treatment to higher IHS4-100 rates at 3 years.

"What I found remarkable was that in the bimekizumab long-term extension data, we even see that bimekizumab has the potential to reduce total tunnel count, meaning resolve tunnels. And that is a wild concept because for decades we just always felt that if you were going to resolve a tunnel, it had to be through some sort of procedure," Garg said.

The exposure-adjusted incidence rate (EAIR) of any treatment-emergent adverse event (TEAE) was 243.3 per 100 PY (95% CI, 227.9–259.6), with serious TEAEs at 6.7 per 100 PY and TEAEs leading to discontinuation at 5.3 per 100 PY.1 The most common TEAEs were hidradenitis (19.6 per 100 PY), coronavirus infections (14.1 per 100 PY), and oral candidiasis (9.3 per 100 PY).

Fungal infections occurred at 22.4 per 100 PY, including Candida infections at 13.5 per 100 PY, driven mostly by oral (9.3 per 100 PY) and vulvovaginal (2.1 per 100 PY) candidiasis.1 Garg said oral candidiasis in his practice has been manageable and infrequent. Definite or probable adjudicated inflammatory bowel disease (IBD) occurred at 0.5 per 100 PY, although patients with active symptomatic IBD were excluded and 2 of 8 patients with an IBD history experienced a flare.

Adjudicated suicidal ideation and behavior occurred at 0.6 per 100 PY, with no completed suicides, and malignancies occurred at 0.6 per 100 PY (0.4 per 100 PY excluding nonmelanoma skin cancer).1 Adjudicated major adverse cardiac events occurred at 0.3 per 100 PY. These congress data have not been peer reviewed.

Garg’s relevant disclosures include AbbVie, Almirall, Boehringer Ingelheim, Engitix, Incyte Corporation, Insmed, Novartis, Pfizer, Sonoma Bioherapeutics, Sun Pharma, UCB, UNION Therapeutics, and Zura Bio.

References

1. Garg A, Naik HB, Zouboulis CC, et al. Bimekizumab safety and tolerability in patients with moderate to severe hidradenitis suppurativa: 3-year results from BE HEARD EXT. Abstract 3109. Presented at: EADV Congress 2026; September 30–October 3, 2026; Vienna, Austria.

2. Kimball AB, Jemec GBE, Sayed CJ, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 52-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials. Lancet. 2024;403(10443):2504-2519.

3. A study to test the long-term treatment of bimekizumab in study participants with hidradenitis suppurativa (BE HEARD EXT). ClinicalTrials.gov identifier: NCT04901195. Accessed October 12, 2026. https://clinicaltrials.gov/study/NCT04901195