Linda Stein Gold, MD, is a dermatologist at Henry Ford Health. 

Linda Stein Gold, MD

US Food and Drug Administration (FDA) approval

 of icotrokinra (Icotyde) for moderate to severe plaque psoriasis was announced for adults and adolescents aged 12 and older with a weight of at least 40 kg who are candidates for systemic therapy or phototherapy.

 interviewed Linda Stein Gold, MD, about icotrokinra’s recent FDA approval, the gaps this treatment fills for patients with 

, and the significance of the drug’s approval as first oral targeted peptide to selectively block the interleukin (IL)-23 receptor.

The introduction of this new mechanistic class to the psoriasis armamentarium was highlighted in this interview. The following Q&A with 

 transcribes the interview in its entirety:

As one of the investigators on the ICONIC program, what did you observe that you think practicing dermatologists should know when thinking about where this drug fits relative to agents they're already comfortable prescribing?

 I think we've had a big unmet need for our moderate to severe plaque psoriasis patients. We have great biologic agents, we have good topical agents, but the oral space really needed something that had very good efficacy, very good safety, and very good tolerability. So I think that this drug fills that need, and where we see efficacy that's similar to biologic agents, yet we still have the good safety and tolerability. I think that this fits in nicely for any patient that needs systemic therapy.

What does the efficacy and safety picture tell a dermatologist who is deciding whether to reach for icotrokinra after topical failure, or to reserve it for patients who have already tried a systemic agent?

When we look at the efficacy data, we see that this drug kicks in pretty rapidly. It was studied in in several phase three clinical trials against placebo, but it was also studied against deucravacitinib, prior to this drug, and this had the best efficacy for any of the oral drugs in that treatment space. What we see is the drug starts to kick in fairly rapidly.

We see a nice, deep slope, and there's good separation from the placebo, but also from deucravacitinib as early as Week Four. That continues over the 16 weeks, and we see up to about 70% of patients getting to clear or almost clear by Week Sixteen, and that continues through even the long term studies.

The approval includes adolescents aged 12 and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy. For pediatric dermatologists who manage patients right at that threshold, how do the trial data and experience inform the potential of this agent in pediatric populations?

The pediatric population who have moderate to severe psoriasis is a really important patient population. A lot of them would prefer an oral agent, and we need drugs that have been shown to be both safe and efficacious in the adolescent population. What we found was really good news. This drug actually performed even even better in the adolescence that it did in the adults, and it was equally well tolerated and a very good safety profile.

 What did you observe in the trial around adherence and caregiver involvement among adolescent participants that practicing pediatric providers should factor into their own counseling?

In the clinical trials, we asked the patients to take the medication once a day, generally in the morning after they wake up. For most people, it really fit in well with their activities of daily living. Some people take other pills, so they're used to taking a pill. For our adolescents, the idea that they didn't have to have a shot was good news for a lot of them. I think it's pretty easy, especially because it's a once daily dosing.

Based on what you saw in the trial population, what would you want a primary care clinician to take away about recognizing when a patient has outgrown what topicals can offer?

We tend to have treatment inertia. When it comes to our psoriasis patients, [let’s say] we put them on a topical medication. Maybe they're not doing so well, so maybe we think about another topical medication. We don't always progress to a systemic medication, probably, as quickly as we need to. So, for those patients who aren't getting a really good treatment efficacy with topical medication, it's a good idea to start thinking about a systemic medication. Icotrokinra is an oral peptide. It's targeting the IL-23 receptor.

This is a key receptor in the key pathway in the pathogenesis of psoriasis, and we understand this pathway really well. We've seen with this medication, it's easy to take. You just take it once a day, usually on the in the morning, on an empty stomach. We saw efficacy start to kick in within the first several weeks, and continued improvements over the primary endpoint, which was Week Sixteen, and continued efficacy, even in the long term. I think that this fulfills an unmet need. A lot of our patients would prefer an oral option, so now we have one that really has that triad of efficacy, safety, and tolerability.

 How would you encourage a primary care provider to re-open that conversation with a patient who previously said no to injectables and what from the trial gives you confidence that the oral route could change that dynamic?

We have to remember that psoriasis is a systemic disease and that there's systemic inflammation, especially for those patients who have moderate to severe plaque psoriasis. I tell my patients that I really want to treat them as a whole. I want to get the disease under control, but I really think that they need a systemic medication. This drug allows us to offer an oral agent that targets at the key inflammatory pathway that we understand is at the root of the pathogenesis of psoriasis. It's been shown to kick in pretty rapidly, really, within the first several weeks.

It's been shown to be superior not only to the placebo, but also against oral deucravacitinib, which was the highest efficacy drug that we had prior to the approval of icotrokinra. I'm I have good confidence, especially because it was studied in adolescence down to age twelve. So, I love the fact that we have a new option for our adolescents as well as our adults who are systemic candidates.

Where do you hope that any additional research goes for icotrokinra and its use among such patients?

I hope that we see continued research in psoriatic arthritis. I'd also love to see FDA approval for our younger patients. We know that the pediatric population psoriasis doesn't start at age twelve, and we can see it even younger. To have an oral option for our younger patients would be wonderful.

Campbell P. Icotrokinra, an Oral Il-23 Inhibitor, Receives FDA Approval for Psoriasis. HCPLive. March 18, 2026. Accessed March 20, 2026. 

https://www.hcplive.com/view/icotrokinra-receives-fda-approval-for-psoriasis

Johnson and Johnson. FDA approves ICOTYDE (icotrokinra), the first and only targeted oral peptide IL-23 receptor antagonist, for the treatment of moderate-to-severe plaque psoriasis. Press release. Published March 18, 2026. Accessed March 20, 2026. 

https://www.jnj.com/media-center/press-releases

Articles

Icotrokinra (Icotyde) received FDA approval for moderate-to-severe plaque psoriasis in adults and adolescents ≥12 years weighing ≥40 kg who are candidates for systemic therapy or phototherapy. Positioned as the first oral targeted peptide selectively antagonizing the IL-23 receptor, it addresses an unmet need in the oral systemic space by pairing biologic-like efficacy with favorable safety and tolerability. Phase 3 data demonstrated rapid onset with separation from placebo and deucravacitinib by Week 4 and ~70% achieving clear/almost clear by Week 16, with durability long term.

In this Q&A, Linda Stein Gold, MD, shares her views on the clinical significance of icotrokinra's FDA approval and the data leading to this approval.

Q&A: Research Leading to FDA Approval of Icotrokinra for Psoriasis, With Linda Stein Gold, MD

Takeaways on Icotrokinra and FDA approval and Psoriasis for Clinicians, With Linda Stein Gold, MD

Takeaways on Icotrokinra and Psoriasis for Clinicians, With Linda Stein Gold, MD

In the second part of her interview, Linda Stein Gold, MD, of Henry Ford Health System, touched on the gap between what topicals can realistically offer and when systemic therapy should enter the picture, how icotrokinra's oral profile can change the conversation among hesitant patients, and where she hopes the research goes following the 

 editorial team what primary care clinicians should take away about recognizing when a psoriasis patient has outgrown topical therapy, Stein Gold opened with a candid observation about a pattern she sees across the field: treatment inertia.

“We tend to have treatment inertia,” Stein Gold said. “When it comes to our psoriasis patients, we put them on a topical medication. Maybe they're not doing so well, so maybe we think about another topical medication, and we don't always progress to a systemic medication, probably as quickly as we need to first.”

Her message to primary care providers suggests when topical therapy is not delivering meaningful improvement, it may be time to consider a systemic option rather than cycling through more of the same. This framing set up Stein Gold’s response to the second question, which inquired as to how a clinician might reopen the systemic therapy conversation with a patient who has previously declined injectables.

Stein Gold's answer centered on what icotrokinra can provide as an oral agent. She pointed to the nature of psoriasis as a systemic disease driven by systemic inflammation, particularly in those living with moderate to severe plaque involvement, and that treating the whole patient means addressing that underlying pathway rather than managing surface symptoms alone.

Icotrokinra targets the interleukin (IL)-23 receptor, which she described as a key receptor in a pathway now well understood and recognized as central to the pathogenesis of psoriasis. For individuals who have resisted treatment escalation because of a fear of injections, Stein Gold pointed to icotrokinra's once-daily oral dosing on an empty stomach in the morning as removing the primary barrier.

Efficacy begins within the initial few weeks of use and builds through the primary 16-week endpoint and beyond. The trial data, Stein Gold noted, gives her genuine confidence in recommending the drug to systemic candidates across age cohorts. On the question of what she hopes comes next for icotrokinra research, Stein Gold was specific and forward-looking.

She expressed hope for continued investigation into psoriatic arthritis (PsA), described as the natural next step in research on icotrokinra given how central the IL-23 pathway is to both skin and joint disease. She also made a point of flagging the pediatric age gap. While the current FDA approval extends down to age 12, she noted psoriasis does not begin at 12 and describes an oral option for an even younger population as a meaningful advance.

Disclosures: Stein Gold has reported serving as an investigator, advisor, or speaker for AbbVie, Amgen, Arctis, Bristol Myers Squibb, Dermavant, Eli Lilly, Johnson & Johnson, Novartis, Pfizer, and UCB. AWA has served as a research investigator, scientific advisor, or speaker to AbbVie, Amgen, Arcutis, BMS, Boehringer Ingelheim, Dermavant Sciences, Eli Lilly, Galderma, Incyte, Johnson & Johnson, Leo Pharma, Novartis, Parexel, Pfizer, Regeneron, Sanofi, Takeda, and UCB. RB is an advisory board member, consultant, speaker, investigator for, or received honoraria or grants from AbbVie, Alumis, Amgen, AnaptysBio, Arcutis, BMS/Celgene, Eli Lilly, Johnson & Johnson, LEO Pharma, Organon, Nimbus, Takeda, UCB, VentyxBio, Vyne, Xencor, and Zurabio, and is also an employee and shareholder of Innovaderm Research.

Videos

After the oral IL-23 inhibitor icotrokinra's (Icotyde) FDA approval, this interview covers what primary care clinicians should conclude.


Key Points on Icotrokinra Following FDA Approval for Psoriasis, With Linda Stein Gold, MD

 editorial team about icotrokinra (Icotyde) and its recent approval by the US Food and Drug Administration (FDA) for moderate to severe plaque psoriasis in adult and adolescent patients aged 12 and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy.

Stein Gold addressed the gap this medication fills. Icotrokinra is the first oral targeted peptide to selectively block the interleukin (IL)-23 receptor, introducing a new mechanistic class to the psoriasis armamentarium. In her responses, Stein Gold framed the approval as addressing a longstanding unmet need in the oral treatment space.

“I think we've had a big unmet need for our moderate to severe plaque psoriasis patients,” Stein Gold explained. “We have great biologic agents, we have good topical agents, but the oral space really needed something that had very good efficacy, very good safety, and very good tolerability. So I think that this drug fills that need.”

While biologics and topical agents have served those living with moderate to severe psoriasis reasonably well, Stein Gold noted the oral category had been missing an option. In her view, the treatment delivers on all efficacy, safety, and tolerability, producing efficacy she described as comparable to a biologic agent while preserving the convenience and tolerability expected of an oral medication. That profile, she said, positions it well for any patient who needs systemic therapy.

She was also asked about the efficacy and safety picture for dermatologists weighing icotrokinra against agents they already know. In her response, Stein Gold pointed to the breadth and design of the ICONIC phase 3 program as the basis for confidence. The drug was studied not only against a placebo but also head-to-head against deucravacitinib, which she identified as having previously demonstrated the best efficacy record among oral medications in this space.

“What we see is the drug starts to kick in fairly rapidly,” Stein Gold said. “We see a nice steep slope, and there's good separation from the placebo, but also from deucravacitinib, as early as week four.”

This separation was described as continuing across the full 16-week primary endpoint period. Approximately 70% of those assessed attained clear or almost clear skin by the 16-week mark, with this level of response holding through long-term follow-up.

Stein Gold also described the adolescent data as good news, noting, for pediatric dermatologists managing patients right at the approved threshold of 12 years and 40 kg, icotrokinra actually performed better in adolescents than it did in adults. This was noted, while the drug maintained the same strong tolerability and safety profile seen across the broader trial population.

The once-daily oral dosing was also highlighted by Stein Gold as a practical advantage for this age cohort. She noted many adolescent patients had been and would be relieved not to require an injection.

Linda Stein Gold, MD, shares her perspective on the clinical significance of icotrokinra's FDA approval and what dermatologists need to know.

Identifying and Managing Patients with Moderate Psoriasis

In this episode, "Identifying and Managing Patients with Moderate Psoriasis," the expert dermatologists explore the challenges of classifying psoriasis severity and the practical framework for identifying which patients are candidates for systemic therapy.

Dr. Stein Gold opens by highlighting the confusion surrounding severity classification, noting that BSA and Investigator's Global Assessment can yield very different conclusions for the same patient. By BSA, moderate psoriasis is defined as 3 to 10% body surface area involvement, yet clinical trials typically require at least 10% BSA for inclusion. She points out that the International Psoriasis Council guidelines recognize that many moderate patients fall below that threshold.

Dr. Crowley elaborates on this gap, citing clinical trial data showing that patients with mild to moderate disease still report quality of life scores comparable to those seen in phase three trials involving patients with much higher BSA. Dr. Stein Gold further reinforces this point by referencing a study using risankizumab, demonstrating that even when BSA is reduced significantly in moderate patients, the DLQI score barely moves, underscoring that visible disease in any amount continues to affect patients meaningfully.

Dr. Song adds that high impact areas carry a quality of life burden disproportionate to their BSA, and supports aligning with the NPF and IPC recommendations to reframe mild versus moderate and severe around treatment approach rather than BSA thresholds, with mild corresponding to topical-managed patients and moderate to severe corresponding to systemic candidates.

Dr. Crowley offers a practical clinical lens, suggesting the key question is simply whether a patient can adequately control their disease with topicals. If not, they are a systemic therapy candidate regardless of BSA. Dr. Song builds on this by referencing newly published IPC guidelines defining topical failure as two consecutive four-week treatment courses without reaching the treatment goal, providing clinicians and payers a clearer, more actionable standard for escalating care.

The next episode in this series, "Redefining Treatment Success in Psoriasis," features the panelists advancing their conversation on psoriasis and focusing on the evolution of treatment goals toward complete skin clearance, the role of NPF treat-to-target guidelines in combating treatment inertia, and practical strategies for determining when to optimize, modify, or switch therapy based on individual patient response and disease location.

Psoriasis severity goes beyond BSA: IGA, DLQI and high-impact areas redefine “moderate,” guiding when to move from topicals to systemic therapy.