Real-World Safety Experience and Clinical Takeaways from the BE BOLD Trial

Continuing the Managed Healthcare Executive Between the Lines series, Philip Mease, MD, of Swedish Medical Center, Providence St. Joseph Health, and the University of Washington, asks Saakshi Khattri, MD, of the Icahn School of Medicine at Mount Sinai, to reflect on her real-world experience with bimekizumab's safety profile and the broader clinical takeaways from the BE BOLD trial.

Dr. Khattri confirms that her practice mirrors the trial data, with no notable signal for serious infections, MACE events, or malignancy. When counseling patients starting bimekizumab, she flags the risk of oral, mucocutaneous yeast infections specifically, taking care to clarify that this is not genital candidiasis, a distinction she says helps avoid unnecessary alarm. Drawing on her internal medicine background, she notes that oral thrush is mild to moderate and straightforward to manage with nystatin swish-and-spit or oral fluconazole, adding that she hasn't had to discontinue bimekizumab in any patient for this reason, and that incidence tends to decline with continued treatment. Turning to the 16-week data as a whole, Dr. Khattri highlights that bimekizumab's IL-17A/F inhibition met the trial's primary ACR50 endpoint against risankizumab's IL-23 inhibition, demonstrating superiority in patients with active PSA. She frames this in the context of the many systemic therapy options available, noting that treatment choice still depends on a patient's specific disease domains and prior therapy, but that having head-to-head data now gives clinicians a clearer basis for comparison. Asked how this changes her own practice, she says it's a nuanced call, but that bimekizumab is now a therapy she offers as first-line treatment for patients with active PSA. Dr. Mease agrees that head-to-head data like this is valuable precisely because it allows for more direct, evidence-based conversations with patients.

Final thoughts and closing perspectives from Dr. Mease and Dr. Khattri will be shared in the next segment.