Neal Bhatia, MD

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

, the potential for 2 flare-free years could represent a fundamental shift in what GPP treatment can offer.

 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.

"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.

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

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

Videos

This segment of Bhatia's interview highlights imsidolimab's reported durability of response for those with generalized pustular psoriasis (GPP).

What Is the Significance of New Data on Imsidolimab for GPP? With Neal Bhatia, MD

US Food and Drug Administration (FDA)'s acceptance

 of a Biologics License Application (BLA) for imsidolimab, Vanda Pharmaceuticals' investigational interleukin (IL)-36 receptor inhibitor for 

, could represent a meaningful step forward for a patient population with historically limited treatment options. The therapy is now under formal review as a potential addition to the emerging class of IL-36–targeted agents in dermatology.

Neal Bhatia, MD, a dermatologist at Therapeutics Clinical Research who’s location served as an investigator site for the development of spesolimab (Spevigo; Boehringer Ingelheim), the first IL-36 receptor inhibitor approved for GPP, referred to the development as "novel and well timed." Having another molecule targeting the same pathway, Bhatia highlighted, only adds clinical relevance.

"…[For] many of these patients who suffer in a prison of misdiagnosis or just not having options, this is really some game-changing stuff for them," Bhatia said.

Central to his enthusiasm are the GEMINI-1 and GEMINI-2 trial results, in which a single intravenous dose of imsidolimab led 53% of treated patients to achieve a Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) score of 0 or 1, suggesting clear or almost clear skin — by week 4, compared with 13% on placebo. Bhatia emphasized that rapid onset is particularly consequential in GPP, where flares can escalate to life-threatening complications including cardiovascular failure and sepsis.

The durability data may be equally compelling. Patients who continued into a roughly 2-year maintenance phase on monthly dosing experienced no disease flares in the active treatment arm, a finding Bhatia described as a significant quality-of-life advance for patients who, even in remission, live in fear of their next episode.

Bhatia also addressed a persistent clinical misconception: the tendency among some dermatologists to reach for IL-17 or IL-23 inhibitors in GPP given their established efficacy in plaque psoriasis. While cytokine pathway overlap exists, he was direct in distinguishing GPP's pathophysiology.

"…GPP is well established in an interleukin-36 milieu, where that cytokine is the main driver," Bhatia expressed. He pointed to the prominent role of neutrophils, reactive oxygen species, and tissue damage unique to IL-36 dysregulation. Targeting that pathway specifically, as both spesolimab and potentially imsidolimab do, is what Bhatia characterized as the key to not just resolving flares, but keeping the disease away.

Smith T. FDA Accepts BLA for Imsidolimab as Generalized Pustular Psoriasis Treatment. HCPLive. February 25, 2026. Accessed March 10, 2026. 

https://www.hcplive.com/view/fda-accepts-bla-imsidolimab-generalized-pustular-psoriasis-treatment

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. Accessed March 10, 2026. 

This interview highlights the significance of the potential FDA approval of imsidolimab for patients with generalized pustular psoriasis (GPP).

On February 18, Eli Lilly and Company released 

 suggesting adults with moderate-to-severe plaque psoriasis and obesity or overweight treated with ixekizumab (Taltz) combined with tirzepatide (Zepbound) saw significantly greater improvements in skin clearance and weight reduction versus ixekizumab alone.

These data, drawn from the open-label TOGETHER-PsO trial, were discussed by TOGETHER-PsO investigator and director of Clinical Dermatology at Therapeutics Clinical Research, Neal Bhatia, MD.

 interview, regarding these data on ixekizumab and tirzepatide as a potential combination therapy for adults addressing psoriasis and weight loss, is summarized in the following Q&A:

We wanted to ask you about the release by Eli Lilly that came out regarding ixekizumab and tirzepatide. How significant are these findings showing improved skin clearance and weight loss with the combination therapy, as opposed to only the monotherapy, particularly for patients with psoriasis and elevated BMI?

Well, it's fortunate that one manufacturer makes both drugs. It makes eventual access to both down the road, as well as you know the utility in the trial for tirzepatide and ixekizumab together. I mean, mechanistically, it makes a lot of sense when you see what GLP-1 agonists do under the hood with the immune mechanisms. There's a lot of impact on NF-κB as a neurotransmitter; both interleukin-1 and interleukin-17 pathways are actually inhibited, or at least modulated by their impact. Tumor necrosis factor, which obviously we know again with psoriasis, has a lot of roles, as well as being suppressed just by tirzepatide alone.

Then you add just the active ingredient of…an IL-17 inhibitor. So I think from the standpoint of the combination of the two mechanisms, you really have a lot of potential synergy, as well as activity against the immune cascades that work. When you think about a patient who has a high BMI, for example, they might be experiencing issues in terms of insulin resistance, in terms of the psychosocial changes, obviously, that go along with being heavier. Then, of course, the lack of ability to exercise some of the other components of intragious friction and all those other components.

There is a lot of evidence supporting that if you can find weight loss methods for these patients, they will do extremely well. I think that expands not just from psoriasis, but you'll see that with hidradenitis suppurativa as well. But in this study, they actually show that around 40% of the subjects who were treated with both drugs with both active agents experienced PASI-100, as opposed to ixekizumab alone. I think from that data alone, you see the benefit of the additive effect. Obviously, it's a shot a week for those patients who are on the tirzepatide arm. But you know, many won't care, to be honest with you, as long as they see what they're getting in terms of quality of life and improved health.

There's a lot of talk out there right now about GLP-1 agonists in dermatology. What is your opinion about the potential for future research regarding tirzepatide alone?

Well, that would be interesting to see what tirzepatide alone could do, maybe in a pilot study or a proof of concept study. I don't think it would be something that would reach a phase 3, pivotal type of trial where you're looking for a label. But to just see the individual effects, you could probably make the case that an additive arm of tirzepatide alone to the combination of the two and ixekizumab alone. It'd be an interesting comparison of those three side by side, not just the combination of the two.

Intuitively, I would think you still need an anti-psoriasis mechanism, but there could definitely be some improvement. A lot of psoriasis patients, they'll say they cut out drinking alcohol, they improve their diet, they start exercising, and their psoriasis improves. Is that a function of insulin resistance improving? Is that a function of the anti-inflammatory improvements from their quality of life changes? There's a lot of evidence to bring that up as well. So to say that a GLP-1 agonist might provide that same benefit, I could see how that would happen. But you know, if dietary and exercise modification does that as well, then I think we have the scientific benefit for the scientific knowledge from there alone.

Beyond psoriasis, do you see a potential role for GLP-1 or dual incretin therapies for other diseases like HS?

Hidradenitis suppurativa is probably the next obvious step, and again, there are some diseases that are BMI-dependent. There are some that kind of go along with those methods [for determining if] you improve their disease by improving their weight or by improving their BMI. I think the sky's the limit in the opportunities with the inflammatory cascade…

There's been increasing discussion about adipose tissue as an active inflammatory organ. How does that concept sort of reshape the way dermatologists could be thinking about treating patients with obesity and chronic inflammatory disease?

Adipose tissue has immune effects, just like the impact of insulin growth factor, maybe some other neurotransmitters that are impacting other cascades. It kind of goes in reverse. If you reduce the amount of adipose tissue, would you see a reduction in insulin growth factor? You know, we're seeing adipose tissue can be a strong source of inflammatory mediators. I think the sky's the limit of what we can discover by, again, changing someone's body mass index, for example, or adding these therapies to treatments that might not be successful…So there are a lot of different ways to look at the potential for improvements there.

From a practical standpoint, what would you say is the value of integrating metabolic management into dermatologic care, rather than referring weight management entirely to primary care or endocrinologists?

I think dermatologists, we should have no problem writing Metformin for a lot of patients who might be a little heavier and who have insulin resistance that's affecting their skin disease. We should have no problem writing GLP-1s. I mean, patients are getting it themselves. We dermatologists, would be completely missing the bus if we're not, you know, endorsing these drugs when they're appropriate for the right patient. But I also think just talking to patients simply about the dietary benefits of exercise, of weight loss, of cutting out alcohol and cigarettes, and watching their diet, is helpful. I mean, we talk about it with rosacea, we talk about it with other integrative-type processes.

I don't think there should be any reason why we shouldn't be taking some of this on ourselves. I mean, getting the help of a dietitian should also be something to turn to, but not everybody has that access or the time…I think we just need to have that extra couple of minutes conversation with the patients while we have them in the audience, and the same with their spouses and the parents of their kids. When we think about young kids with eczema, if they're a little bit heavy, you know, putting them in a good weight loss program would definitely help.

The quotes in this summary were edited for the purposes of clarity.

Lilly's Taltz (ixekizumab) and Zepbound (tirzepatide) used together delivered superior efficacy in first-of-its-kind Phase 3b trial for adults with psoriasis and obesity or overweight. Eli Lilly. February 18, 2026. Accessed March 6, 2026. 

https://investor.lilly.com/news-releases/news-release-details/lillys-taltz-ixekizumab-and-zepbound-tirzepatide-used-together-0

Smith T. Ixekizumab, Tirzepatide Effective Together for Psoriasis and Obesity or Overweight. HCPLive. February 18, 2026. Accessed March 6, 2026. 

https://www.hcplive.com/view/ixekizumab-tirzepatide-effective-together-psoriasis-obesity-overweight

Articles

Phase 3b TOGETHER-PsO data suggest combining ixekizumab with tirzepatide in adults with moderate-to-severe plaque psoriasis plus overweight/obesity yields superior skin clearance and weight loss versus ixekizumab alone, with ~40% achieving PASI-100 on combination therapy. Proposed biological rationale includes GLP-1/GIP–mediated immunometabolic effects modulating NF-κB and inflammatory cytokine pathways (including IL-1, IL-17, and TNF). Findings reinforce adipose tissue as an active inflammatory organ and support integrating metabolic management into dermatologic practice.

This Q&A with Neal Bhatia, MD, features a discussion conducted regarding GLP-1 use in patients with psoriasis and obesity or overweight.

Q&A on Treating Psoriasis, Obesity with Tirzepatide and Ixekizumab, With Neal Bhatia, MD

Discussing GLP-1 or Dual Incretin Therapies in IL-17 Mediated Disease, With Neal Bhatia, MD

 seen in patients with moderate-to-severe psoriasis and obesity or overweight treated with combined ixekizumab (Taltz) and tirzepatide (Zepbound), released by Eli Lilly and Company, the 

 team spoke in an interview with trial investigator and director of Clinical Dermatology at Therapeutics Clinical Research, Neal Bhatia, MD.

 about these new phase 3b TOGETHER-PsO trial data and their significance for patients with psoriasis and elevated body mass index (BMI).

 He had touched on the potential of GLP-1 agonists on immune pathways. Beyond psoriasis, Bhatia was later asked whether he sees a potential role for GLP-1 or dual incretin therapies in other interleukin (IL)-17–mediated conditions such as hidradenitis suppurativa (HS).

“There are some diseases that are BMI dependent, and there are some that kind of go along with those methods [where you see if you can] improve their disease by improving their weight or by improving their BMI,” Bhatia said. “I think again, the sky's the limit in the opportunities with the inflammatory cascade.”

Bhatia highlighted the benefits observed in the IL-17 pathway. However, he noted it is not yet clear for conditions such as lichen simplex chronicus (LSC) or prurigo nodularis. The efficacy and the strength of such inhibition would have to be more elucidated, but he described research into topical steroids versus topical steroids with the GLP-1 agonists as a potentially useful comparison.

The increasing level of discussion seen in dermatology regarding adipose tissue as an active inflammatory organ was also highlighted. Bhatia was asked in this interview how such a concept could reshape the way in which dermatologists think about treating patients with obesity and chronic inflammatory skin disease.

“We're seeing that adipose tissue can be a strong source of inflammatory mediators,” Bhatia explained. “I think the sky's the limit of what we can discover by, again, changing someone's body mass index, for example, or adding these therapies to treatments that might not be successful.”

The quotes in this video summary were edited for clarity.

Bhatia has 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.

Lilly's Taltz (ixekizumab) and Zepbound (tirzepatide) used together delivered superior efficacy in first-of-its-kind Phase 3b trial for adults with psoriasis and obesity or overweight. Eli Lilly. February 18, 2026. Accessed March 2, 2026. 

Bhatia N. Discussing Promising New Findings on GLP-1 Use in Psoriasis Management, With Neal Bhatia, MD. HCPLive. February 26, 2026. Accessed March 2, 2026. 

https://www.hcplive.com/view/discussing-promising-new-findings-glp-1-use-psoriasis-management-neal-bhatia-md

Neal Bhatia, MD, speaks on new data on ixekizumab and tirzepatide for weight loss and psoriasis, as well as the implications of these data regarding GLP-1 use.