Discussing the Significance of Imsidolimab’s Rate of Response in GPP, With Neal Bhatia, MD

For individuals living with generalized pustular psoriasis (GPP), the potential for 2 flare-free years could represent a fundamental shift in what GPP treatment can offer.

This was a central theme in a recent HCPLive interview with Neal Bhatia, MD, who reflected on the maintenance data emerging from the GEMINI trials for imsidolimab, Vanda Pharmaceuticals' investigational interleukin (IL)-36 receptor inhibitor currently under US Food and Drug Administration (FDA) review with a PDUFA target date of December 12, 2026.1,2

"You can imagine what that does to quality of life," Bhatia said of the roughly 2-year maintenance period without flares observed in the active treatment arm. Bhatia contrasted this with the limitations of older systemic options such as cyclosporine, characterizing them as slow-acting and burdened by tolerability concerns. These were considered drugs addressing GPP incompletely. The GEMINI data, in Bhatia’s view, represents a meaningful opportunity to extinguish flares that prior treatment paradigms could not reliably control.

On the question of where imsidolimab could fit within the treatment landscape if approved by FDA officials, Bhatia positioned it alongside spesolimab, the currently approved IL-36 inhibitor for GPP, as a natural companion in that targeted class. He acknowledged the real-world tendency among some clinicians to initiate treatment with IL-17 or IL-23 inhibitors given their accessibility and familiarity, but framed that only as a potential bridge. Getting patients to use an IL-36–modifying therapy, Bhatia expressed, should remain the clinical objective.

The therapy's reported favorable safety profile and low incidence of anti-drug antibody formation also carry practical weight in Bhatia's view, though he highlighted his own view suggesting none of it matters without an accurate diagnosis in hand. He recommended patients carry documentation of their confirmed GPP diagnosis to facilitate appropriate care in emergency or urgent care settings where treating clinicians may be unfamiliar with the condition. Equally important, he stressed, is ensuring these individuals have rapid access to infusion therapy at GPP flare onset.

Bhatia closed with a broader call to action for dermatologists, to advocate for GPP patients, embrace emerging targeted drugs, and resist ceding ground on rare inflammatory skin diseases to other specialties.

“This is a rare disease," Bhatia said. "This is not just a variant of psoriasis that I can try to knock down with other therapies that I have samples of."

The quotes contained in this interview summary were edited for clarity.

Bhatia reported serving as an advisor, consultant, and investigator for AbbVie, Almirall, Arcutis Biotherapeutics, Beiersdorf, Biofrontera, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant Sciences, EPI Health, Ferndale, Galderma, Incyte, ISDIN, Johnson & Johnson, La Roche-Posay, LEO Pharma, Lilly, Ortho Dermatologics, Pfizer, Regeneron Pharmaceuticals, Sanofi, Sun Pharma, and Verrica Pharmaceuticals.

References

1. Vanda Pharmaceuticals Announces FDA Acceptance of Biologics License Application Filing for Imsidolimab for the Treatment of Generalized Pustular Psoriasis. Vanda Pharmaceuticals, Inc. February 25, 2026. https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-fda-acceptance-of-biologics-license-application-filing-for-imsidolimab-for-the-treatment-of-generalized-pustular-psoriasis-302696991.html.

2. Bhatia N. What Is the Significance of New Data on Imsidolimab for GPP? With Neal Bhatia, MD. HCPLive. March 10, 2026. Accessed March 11, 2026. https://www.hcplive.com/view/what-the-significance-new-data-imsidolimab-gpp-neal-bhatia-md.