Neal Bhatia, MD

 of a Biologics License Application (BLA) for imsidolimab in generalized pustular psoriasis (GPP) was announced, the 

 editorial team spoke in an interview with a dermatology leader regarding this move’s significance for patients with GPP.

Vanda Pharmaceuticals' investigational interleukin (IL)-36 receptor inhibitor could potentially add to the limited armamentarium of agents implemented within the GPP patient population. The medication is currently under formal review by the agency as a potential addition to the emerging class of IL-36–targeted drugs in the dermatology space.

Neal Bhatia, MD, a dermatologist at Therapeutics Clinical Research whose location served as an investigator site for the development of spesolimab (Spevigo; Boehringer Ingelheim), the first IL-36 receptor inhibitor approved for GPP, spoke in this Q&A interview about this new announcement regarding imsidolimab:

I wanted to ask you a little bit about the FDA’s acceptance of the BLA for imsidolimab and the significance of this move. What might this mean for patients with generalized pustular psoriasis, and how significant would you say it is for clinicians to see another therapy targeting the IL-36 pathway?

 I think it's actually very novel and well-timed. We were an investigator site for the Boehringer Ingelheim drug, which is now spesolimab. That was the first IL-36 to make it to dermatology for us, which was great to have another molecule, which is even better, and adds to the significance. Leo Pharma now brings spesolimab map to the market for us and they've done a good job with that. That being said, Vanda makes good drugs, from what I understand. I think this is another one where the GEMINI trials. 53% of the patients got to clear or almost clear by Week 4.

For many of these patients who suffer in a prison of misdiagnosis or just not having options, it is really some game-changing stuff for them. More importantly, we're understanding how rapidly the disease can be mitigated with the onset of the intravenous dosage. We saw that with the Effisayil 2 trials and the Effisayil 1 trial as well, and it brought them both to relevance. The Effisayil 2 trials, specifically with the SubQ to keep things away…I think what imsidolimab is showing us is that it's got a very similar destiny, if you will. Clinically, thinking about durability, the 2-year maintenance period without flares is a significant improvement from what we know from a patient's quality of life standpoint.

My biggest take home point is that I hear a lot about a lot of dermatologists say, ‘Well, my patients got better with a 17 inhibitor or a 23 inhibitor.’ From a psoriasis pathway, there is always a little bit of overlap. What interleukin-17, what IL-23 does, and what some crossovers like IL-22 are involved with is that they're all intermixed into it. There's going to be a little impact from what targeting those cytokines can do. But GPP is well established in an interleukin-36 milieu, where that cytokine is the main driver. You see a lot of neutrophils and a lot of reactive oxygen species, a lot of tissue damage. All of that is unique to the IL-36 pathway, and by inhibiting that, just like we saw with spesolimab, we'll see that with imsidolimab. We can make real headway in keeping the disease away. Not just making it go away.

You mentioned to the 53% of patients attained clear or almost clear skin by Week 4. How meaningful would you say that level of rapid response is for clinicians managing acute GPP flares?

You can look at it from the dermatologist's side as well as the patient's side. Obviously, from the patient side, if they have had no relief of the pain of the visceral symptoms, the fevers, the misery that they go through with the pustules, this will be a godsend for them. I would say that first and foremost, a lot of these patients just live in fear of their next flare. Even when their flare is put out, the first thing they do is worry about when the next one is. Again, that is the nature of the disorder. I think even more so, to see some quick onset of relief, it should take away the thought process of turning to a 17 inhibitor or 23 inhibitor, when that isn't the pathway of choice, and it's not really what we see under the hood for GPP. With the label of psoriasis under generalized pustular psoriasis, there's going to be a mindset that says, ‘Sure, these psoriasis drugs should work.’ But I think we've seen enough data, as well as seen enough mechanism of action discussion, that we know that the inhibition of the 36 pathway is really the key to success for these patients.

 From a clinical perspective, how important is the reported durability of response over the roughly 2-year maintenance period with flares in the active treatment arm?

If we can put out the flares and give patients some relief of their potential onset, that's a very significant win for how this drug could impact the market. Understanding 2 years [of maintenance] for patients who have had this disease, you can imagine what that does to quality of life. We talk about quality, like for eczema, psoriasis, and other disorders like hidradenitis, and these are all very significant. But from what we've seen of GPP, we haven't had an option that has really been a benefit. We've seen cyclosporine and some of these other Th1 drugs go after that process, which is incomplete. They're slow-acting, and they come with their own baggage. So, to see where we can get some real relief from what the GEMINI trials showed us, as well as what we can see in the 2-year data, I think we have a lot of opportunities to put out fires that didn't get put out before.

 If it is approved by the FDA, where do you think imsidolimab could fit within the current treatment landscape for GPP?

If you look at, you know, spesolimab against the current market-approved treatments, it would probably be side-by-side with that. I would hope that the dermatologists are understanding that that pathway is not the pathway that affects GPP, even though there may be some anecdotal evidence. A lot of dermatologists will say, ‘Oh, sure, my patients do better on 17, 23,’ as I said, and for me, that makes sense, because you have easy access to it. You have easy access to a sample of it to get them started. But if that is the way to get the ball rolling and then get them on an IL-36-modifying treatment, I think that would be a paradigm that would actually make a lot of sense.

Given the rarity and the severity of GPP, how might a therapy with a favorable safety profile and low incidence of anti-drug antibodies influence treatment decision-making in clinical practice?

 I think the first key is just making the diagnosis. Get that diagnosis confirmed. I would give the patient their own path report so that they carry it around in case they run into trouble, or they get into an emergency room or urgent care where they can't get treated. They can show whoever has seen them that this is their diagnosis. I think the other key to the equation, too, is to get them to a place where infusion can be as easy as possible, or at least have access to the drug within a day or 2, to try to get them out of the flare.

Really thinking about the big picture for the dermatologist is being an advocate for these patients, saying, ‘Look, this is a rare disease. This is not just a variant of psoriasis that I can try to knock down with other therapies that I have samples of.’ I think even more so, just to support the research as well as the approval of some of these newer therapies and say, ‘Well, we're going to welcome those into dermatology and not give these away to rheumatologists and oncologists.’ Because that's where we lose our edge on our specialty. That would just be a shame.

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

Smith T. FDA Accepts BLA for Imsidolimab as Generalized Pustular Psoriasis Treatment. HCPLive. February 25, 2026. Accessed April 28, 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 April 28, 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

Articles

FDA acceptance of a BLA places imsidolimab, an investigational IL‑36 receptor inhibitor, under review as a second targeted option for generalized pustular psoriasis alongside spesolimab. GEMINI results showed 53% achieving clear/almost clear skin by week 4, supporting rapid control of painful systemic flares. Reported durability with roughly two years of maintenance without flares could meaningfully improve quality of life versus slower, toxic immunosuppressants. Emphasis remains on correct diagnosis, timely infusion access, and prioritizing IL‑36 over IL‑17/23 off‑pathway use in routine practice.

In this Q&A interview, Bhatia discusses the FDA's recent acceptance of BLA for imsidolimab for generalized pustular psoriasis (GPP).

Q&A: Discussing Imsidolimab for Generalized Pustular Psoriasis, With 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.

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. 

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 whose 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

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.