Advances in HS treatment with Chris Sayed, MD

Hidradenitis suppurativa (HS) is a chronic, debilitating skin condition that significantly impacts patients' quality of life. Chris Sayed, MD, a professor of dermatology at the University of North Carolina at Chapel Hill and director of its HS clinic, recently discussed advancements in HS treatment, particularly the FDA approval of bimekizumab, with Dermatology Times.

A New Era in HS Treatment

Sayed underscored the transformative potential of the newly approved therapy, stating, “I think the approval of bimekizumab will be a huge shift.”While FDA-approved treatments such as tumor necrosis factor (TNF) inhibitors are available, their long-term efficacy is often limited. Sayed noted, “The majority of patients really don’t respond well to those treatments over time. There’s a need for more therapies to be available, just so we have a broader variety to treat patients with, but also treatments that push the bar forward when it comes to how good those responses actually are.”

Bimekizumab is the first HS treatment approved based on HiSCR75 (≥75% reduction in inflammatory nodules and abscesses), a higher efficacy benchmark than HiSCR50. Sayed explained, “This drug is the first one to be approved where the clinical trials used HiSCR75 instead of HiSCR50. So not just looking at a modest response, but a response that gets to the level of true clinical meaningfulness.”

Trial Data: Sustained Improvements

The BE HEARD I and II phase 3 trials provided the data leading to bimekizumab’s approval. While most HS trials focus on outcomes at week 16, Sayed highlighted the sustained improvements seen in these studies: “What stands out the most to meare looking at week 48 and week 96. I think that’s where we see that continued improvement that happens over time.”

He contrasted bimekizumab’s durability with existing treatments: “Unlike other drugs, like TNF inhibitors, that often can wane over the course of a couple of years, it felt like many of the patients that responded, even partially in the beginning, seemed to continue to improve as more time passed.”

Sayed stressed the critical need for early intervention in HS: “We shouldn’t be waiting for these patients to be the worst of the worst before we start treating. We really want them to be the best they can be, and keep them from progressing to the point that there’s irreversible damage.”He added that patients treated earlier, with fewer draining tunnels, achieved better outcomes, while those with more extensive disease showed dramatic responses but less improvement overall.

Addressing Barriers and Diversity

Access to clinical trials can be challenging for patients, especially those from underserved populations. Sayed praised the supportive measures in the bimekizumab trials: “This trial had some very nice mechanisms in place that provided things like travel support, overnight stays, [and] providing rental cars for patients.” These efforts resulted in a more diverse participant pool, reflecting real-world demographics. “We do know there’s a predilection for patients with lower socioeconomic status, and risk in Black patients is probably about threefold what it is for White patients,”Sayed noted.

Safety Profile and Adverse Events

The safety profile of bimekizumab aligns with other IL-17 inhibitors, with 1 notable exception: “About 10 or 15% of patients tend to get oral thrush,” Sayed reported. However, he emphasized that the condition was mild and manageable with antifungals, stating, “It seems to be something very specific to the oral cavity... pretty much all of those patients were able to treat very effectively.”

This minor adverse event, he noted, should not deter patients: “I think the vast majority of HS patients would very much be willing to trade short-term thrush... compared to how bad HS is.”

Improving Quality of Life

The trials also demonstrated significant improvements in key quality-of-life measures, such as drainage, odor, itch, and pain. Sayed remarked, “I tell patients all the time that the goal of treatment is not that I can count fewer lesions. [It’s] that you feel like you have less pain, less drainage, [and] you can do more of the things that you want to do.”

Expanding the Treatment Landscape

Sayed expressed optimism about the growing number of therapeutic options for HS, stating, “Currently, there are a lot of drugs in clinical development for HS, and that means there are a lot of trials happening.” He also highlighted the need for treatments for younger patients: “We don’t have any drug that’s approved that’s been specifically studied in patients under 18. Adalimumab is approved down to age 12, but there was never an adolescent study done.”

Conclusion

Bimekizumab represents a significant advancement in HS management. As Sayed summarized, “This drug raises the bar, to some extent, in terms of what we can expect.” He is hopeful that its approval will increase public and medical awareness of HS, encouraging earlier referrals and better outcomes. “I’m very excited for what the future holds,”he concluded. “The treatment landscape is just rapidly evolving right now.”

With ongoing research and new therapies on the horizon, bimekizumab is poised to transform the management of HS, offering hope for patients and clinicians alike.