Continuous Pain Reductions Observed in HS Patients Treated with Bimekizumab

Lauren Orenstein, MD, MSc

Credit: Emory School of Medicine

Individuals with hidradentitis suppurativa (HS) who were treated with bimekizumab had continuous skin pain reductions for up to 48 weeks, according to new findings, as indicated by clinically significant improvements observed over different skin pain outcomes.¹

These findings were presented at the 2024 American Academy of Dermatology (2024) Annual Meeting in San Diego, California. The research was led by Lauren Orenstein, MD, MSc, an assistant professor at Emory University’s department of dermatology.

Bimekizumab is a humanized IgG1 monoclonal antibody which is known to inhibit interleukin (IL)-17F and IL-17A. Following the US Food and Drug Administration’s (FDA) approval of bimekizumab for psoriasis, it became the first dual inhibitor of IL-17A and IL-17F for this specific patient population.²

Now, Orenstein and colleagues highlighted their new research from the BE HEARD I and II phase 3 trials on HS. During the phase 3 studies, individuals with moderate to severe HS were given bimekizumab (BKZ) at an 320mg initial/maintenance dose every 2 weeks (Q2W), BKZQ2W/Q4W, BKZQ4W/Q4W, or they were placed in the placebo arm followed later by BKZQ2W.¹

The investigators included the HS Symptom Questionnaire (HSSQ) in their assessment of the study participants with HS, evaluating their individual symptom items through the implementation of a scale of 0–10 and a specific focus on participants’ skin pain.

The team's criteria for response in skin pain was defined beforehand as a 30% diminishment and at least a single point decrease from the point of baseline, with the score at baseline having been equal to or more than 3. The research team also noted when HSSQ skin pain=0.

The investigators carried out their evaluation on observed cases (OC) and modified non-responder imputation (mNRI), and they calculated the change from baseline up to the 48-week mark. They looked at participants’ Change in Severity of Skin Pain (PGI-C-SP) as well as their Patient Global Impression of Severity of Skin Pain (PGI-S-SP) up to the same 48-week mark, utilizing the OC methodology.

The research team randomized 1,014 subjects across the different treatment arms, with 288 in the BKZQ2W/Q2W cohort, 292 in BKZQ2W/Q4W, 288 in BKZQ4W/Q4W, and 146 in placebo(PBO)/BKZQ2W. The team established that the mean baseline HSSQ skin pain score was shown to be 5.8 among all of the study arms.

The investigators highlighted that participants’ ratings of PGI S-SP as being ‘severe’ were observed among 28.5–33.3%. They also found that a ‘mild’ rating on the same scale was reported among 15.1–16.7% of the subjects.

At the 48-week mark, the team determined that 64.6% - 75.7% of the participants had been shown to achieve a HSSQ skin pain response, as per the team’s OC and mNRI criteria (51.7–61.0%). In a similar vein, the investigators noted that HSSQ skin pain scores of 0 were reported among 12.7–19.8% of subjects (mNRI: 11.3–15.5%).

Overall, across all of the groups analyzed, the research team found that there had been a consistent diminishing (36.9–43.7%) of subjects’ HSSQ skin pain scores from the point of baseline to 48 weeks. In their assessment of patient-reported outcomes, the team found that around 55.9–63.7% of these individuals were shown to have rated their skin pain as being ‘much better’ according to PGI-C-SP.

Additionally, the investigators reported that there was a decline in the percentage of individuals with a rating PGI-S-SP of ‘severe’ from 3.9–7.8%. They added that 45.6–47.4% had written their own rating as ‘mild.’

In sum, the investigators did find that bimekizumab ended up showing clinically significant skin pain improvements over the 48 treatment course.

References

1. ^{Garg A, et al. J Am Acad Dermatol 2020;82:366–76; 2. Adams R et al. Front Immunol 2020;11:1894; 3. BE HEARD I: www.clinicaltrials.gov/study/NCT04242446; 4. BE HEARD II: www.clinicaltrials.gov/study/NCT04242498.}
2. ^{Kunzmann K. FDA Approves Bimekizumab for Adults with Plaque Psoriasis. HCPLive. October 18, 2023. https://www.hcplive.com/view/fda-approves-bimekizumab-adults-plaque-psoriasis. Date accessed: March 8, 2024.}