Transcript
Announcer:
Welcome to ReachMD. This medical industry feature, titled “Medically Complex Patients with Moderate-to-Severe Plaque Psoriasis: Applying a ‘Do No Harm’ Mindset to Long-Term Treatment Selection,” is sponsored by Sun Pharma. This program is intended for US healthcare professionals. The speakers have been compensated by Sun Pharma to conduct this presentation. Here’s your host, Dr. Charles Turck.
Dr. Turck:
Hello everyone, and thanks for joining us. In today’s conversation, we’ll begin by introducing ILUMYA, which is an IL-23 inhibitor indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.¹
ILUMYA also has long-term clinical data extending up to 8 years.² These data are particularly relevant when considering treatment selection for medically complex patients with moderate-to-severe plaque psoriasis, including those with comorbidities such as hypertension, obesity, high cholesterol, diabetes, or cardiovascular disease, those managing polypharmacy, or those with a history of malignancy.
In these patients with moderate-to-severe plaque psoriasis, treatment decisions are led especially by the clinical guiding principle of “do no harm,” where predictability, stability, and confidence in a therapy’s long-term profile may take priority over short-term efficacy alone. That often means looking beyond rapidity of clearance and asking whether a therapy can be maintained safely and consistently over many years. Throughout this discussion, we’ll explore how clinicians apply this mindset in real-world practice, using patient vignettes to examine how medical complexity shapes treatment decisions and long-term management, and how the long-term safety and durability data for ILUMYA can support sustained clinical confidence.
Joining me in this discussion are Dr. Sam Awan and Dr. Tina Bhutani, both of whom work with patients with moderate-to-severe plaque psoriasis.
Dr. Sam Awan is a dermatologist at U.S. Dermatology in McKinney, Texas, and Clinical Instructor at the University of Connecticut Department of Dermatology. Dr. Awan, thanks for being here today.
Dr. Awan:
Hey, thanks for having me. Really excited to be here.
Dr. Turck:
Thank you, Dr. Awan. And Dr. Tina Bhutani is the CEO at Synergy Dermatology and also an Associate Clinical Professor in the UCSF Department of Dermatology. Dr. Bhutani, it’s great to have you with us, as well.
Dr. Bhutani:
Thank you! So glad to be connecting here today!
Dr. Turck:
Well, thank you, Dr. Bhutani. Now, before we begin, let's take a moment to review some Important Safety Information.
Announcer:
INDICATION AND IMPORTANT SAFETY INFORMATION
ILUMYA® (tildrakizumab-asmn) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
CONTRAINDICATIONS
ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.
Please listen to the additional Important Safety Information at the end of this podcast and see the Full Prescribing Information at ILUMYApro.com
Dr. Turck:
Dr. Awan, to start us off, would you briefly share your background in dermatology, including how long you’ve been in practice and your experience treating patients with psoriasis?
Dr. Awan:
Sure thing. So, I trained at the University of Connecticut, where we had a very busy psoriasis specialty clinic, and that’s really where I began treating complex psoriasis patients. I’ve been in practice for 8 years now in the Dallas suburbs, and the majority of my practice is inflammatory skin disease – atopic derm, HS, and quite a bit of both psoriasis and psoriatic arthritis.
Dr. Turck:
And Dr. Bhutani, what about you?
Dr. Bhutani:
Sure. I had the pleasure of co-directing the Psoriasis and Skin Treatment Center at UCSF for over 8 years. I also directed the Dermatology Clinical Trials Unit where we did a number of studies focused on psoriatic disease. Now in my clinical practice I continue to focus on complex medical dermatology which includes seeing a number of patients with psoriasis who may need systemic treatment to get their disease under better control.
Dr. Turck:
Thank you both for sharing your backgrounds. As I’ve mentioned, today, we’re focusing on medically complex patients with psoriasis. How do you define a medically complex patient in your practices?
Dr. Awan:
There really isn’t a single, formal definition of a medically complex patient, right? The term itself is heterogenous, making it difficult to define clear thresholds for how many comorbidities a patient must have or how severe those conditions must be to meet a strict definition.³
Overall, I think it comes down to comorbidities, medical history, and the severity level of those comorbidities. In psoriasis specifically, we know that approximately half of patients will have at least one comorbidity.⁴ Patients with psoriasis are more likely to have major adverse cardiac events compared to the general population,⁵ and psoriasis patients who are 65 or older carry a high risk of hypertension and dyslipidemia as well.⁶
In recent years, we’re learning more about how common metabolic fatty liver disease is in these patients.⁷ There’s two ways to think about all this medical complexity. First, how do we find the right approach to appropriately screen or manage these comorbidities, or get patients to an appropriate specialist to help treat these comorbidities. The second is thinking about how these comorbidities change our treatment options for the psoriasis itself. All of these factors can influence how cautious and deliberate we are when making long-term treatment decisions for medically complex patients.
Dr. Bhutani:
I agree with that perspective, which naturally brings us to the “do no harm” mindset—something we’re all familiar with in clinical practice. In principle, this mindset reminds us to weigh the potential morbidity of our interventions against their intended benefits,⁸ especially when treatment decisions extend over long periods of time.
In medically complex patients, this mindset becomes even more important. Our risk tolerance shifts, and treatment selection is often guided by a greater emphasis on safety—alongside efficacy, durability, and tolerability. For many of us, that translates into looking for therapies with well-characterized long-term data and no major safety signals over time.
Dr. Turck:
Thank you for illustrating the medically complex patient. And how does ILUMYA fit into your approach when you’re considering treatment options for their moderate-to-severe plaque psoriasis?
Dr. Bhutani:
As we touched upon earlier, safety becomes paramount when treating medically complex patients. What gives me confidence with ILUMYA is not just the Phase 3 trial data, but the depth and duration of the long-term extension experience. In the pivotal reSURFACE trials, ILUMYA demonstrated safety rates that were comparable to placebo. The most commonly reported adverse events that were more frequent than the placebo treatment were upper respiratory tract infections in about 14% of patients, injection site reactions in roughly 3%, and diarrhea in about 2%.¹ Importantly, patients in the long-term extension studies were followed for up to an additional 368 weeks and no new safety signals were identified during that time.² Also, the overall frequency of adverse events did not increase with longer exposure,² which is something we pay close attention to when evaluating cumulative immune modulation.
In these long-term studies, events such as severe infections, malignancies, and major adverse cardiovascular events were observed.² However, these are events we would expect to see in a chronic moderate-to-severe plaque psoriasis population followed for many years, particularly in patients with underlying risk factors. What is reassuring is that the rates were low and consistent across both reSURFACE trials, and did not show any pattern of increasing incidence over time.²
Dr. Awan:
It’s also important to distinguish overall observed events from treatment-related events. Serious adverse events that were considered related to treatment were uncommon, and discontinuations due to treatment-related adverse events were low in both studies—2.2% in reSURFACE 1, and 1% overall in reSURFACE 2.² That separation matters when we’re thinking about causality and long-term management.
Overall, the Prescribing Information for ILUMYA reflects a well-established safety profile that is comparable to placebo,¹ and findings from long-term extension studies remain consistent with those seen in earlier clinical trials over extended treatment periods.²
Finally, another reassuring aspect is immunogenicity. Fewer than 10% of patients developed anti-drug antibodies during long-term treatment, and there was no consistent relationship between antibody formation and safety outcomes.² That adds to the sense of durability and predictability over time, which is particularly meaningful when managing medically complex patients who benefit from treatment continuity.
Dr. Bhutani:
Absolutely. We can also consider the subgroup analyses from the reSURFACE trials that specifically evaluated patients with moderate-to-severe plaque psoriasis and metabolic syndrome, which includes conditions such as hypertension, obesity, dyslipidemia, and dysglycemia.⁹ This subgroup is highly representative of the medically complex moderate-to-severe plaque psoriasis patients we commonly see in clinical practice.
From a safety perspective, these analyses showed a comparable 5-year safety profile in patients with and without metabolic syndrome, across categories such as serious infections, cardiovascular disorders, and respiratory disorders. Importantly, the efficacy findings were also consistent, with sustained improvements in moderate-to-severe plaque psoriasis area and severity index scores regardless of metabolic syndrome status.⁹
For clinicians, that consistency across higher-risk subgroups is particularly meaningful. These are the patients we’re most cautious with, and seeing stability maintained in this population reinforces our confidence that we’re not adding incremental long-term risk.
Dr. Turck:
As we think about treating medically complex patients with moderate-to-severe plaque psoriasis, how does the safety profile for ILUMYA factor into long-term treatment decisions? Would you share a patient scenario that illustrates how ILUMYA has been used in this type of patient?
Dr. Awan:
I had a 78-year old male patient who had a history of venous thromboembolism (VTE), laryngeal carcinoma treated with surgery and radiation, anemia, and a history of recurrent pneumonia. He also had significant nail psoriasis. When he came to me, he’d already seen several dermatologists who had treated with just topicals, and were hesitant to start the patient on a systemic because of his medical history. The patient was miserable, his hands and nails particularly affected his day-to-day functioning. Given his history of malignancy, VTE, and the recurrent infection, we really wanted to prioritize safety but balanced it with efficacy and durability. ILUMYA, like other IL-23 inhibitors, may increase the risk of infection, but I considered the potential benefit to outweigh that risk in this case.
We started the patient on ILUMYA, and he had an excellent response. His skin responded with a few doses, and by six months, his nails were about 90% better. His improvement in day to day use of his hands and function was the biggest change in his daily life. And then most importantly, he’s been on ILUMYA for over 5 years now with excellent control and no treatment-related adverse events. So, this is a great example of a patient who I would argue was undertreated because of his medical comorbidities, who absolutely qualified for systemic therapy, and who has had a durable improvement. His life has been completely changed by his experience on ILUMYA.
Dr. Turck:
That is a fantastic example—thank you for sharing. What about you, Dr. Bhutani?
Dr. Bhutani:
Sure. Another relevant case is a 47-year old female patient with severe plaque psoriasis that affected her back, nails, scalp, and her entire lower body since her early 20s, with a BSA of 26%. Over time, she had tried various topical therapies and long-term systemic treatments, but they were largely unsuccessful. Her severe plaque psoriasis made her very self-conscious about her skin, and she believed it would never be possible for her to have clear skin.¹⁰
Her medical history was further complicated because she was an active smoker who also had hypertension, obesity, and ADHD.¹⁰ In this context, we would be looking for a safe moderate-to-severe plaque psoriasis treatment that would not exacerbate any of her ongoing medical concerns while also addressing her ongoing and severe plaque psoriasis.
The patient was started on ILUMYA and saw noticeable results. At week 8, she had a BSA of 22% and by week 12, her BSA reduced to 16%. By week 16, her BSA was 14% and she had a PASI score of 8. She was very enthusiastic about her results with ILUMYA and felt very hopeful about continuing her treatment.¹⁰
Dr. Turck:
As we near the end of today’s podcast, I want to thank you both for sharing these examples and insights. The discussion around ILUMYA and its use in medically complex patients gives us a thoughtful framework to carry forward as we consider long-term treatment decisions for medically complex patients in practice.
Dr. Awan:
Thanks for having me, it was a pleasure.
Dr. Bhutani:
Thank you so much for having me! It was a pleasure to be here!
Dr. Turck:
Indeed, it was a pleasure! And we’ve covered several important topics today, particularly around emphasizing a “do no harm” mindset to long-term treatment selection for medically complex patients with moderate-to-severe plaque psoriasis. We also discussed how medical complexity, including comorbidities, polypharmacy, and a history of malignancy, shapes clinician confidence and risk tolerance when making treatment decisions. Through real-world examples, we explored how predictability and stability, rather than short-term efficacy alone, often guide therapy selection in these patients. We then examined how the long-term safety and durability of ILUMYA, including data in patients with moderate-to-severe plaque psoriasis and metabolic syndrome, can support sustained clinical confidence.
Ultimately, managing moderate-to-severe plaque psoriasis, especially in medically complex patients, requires treatment approaches that are designed to be stable, predictable, and appropriate for long-term use. A well-characterized safety profile and sustained response over years, not just months, can meaningfully influence treatment confidence.
We hope this conversation provides useful perspectives you can bring into your own clinical discussions. Thank you for joining us.
For ReachMD, I’m Dr. Charles Turck. Let’s take a moment to review some Important Safety Information.
Announcer:
WARNINGS AND PRECAUTIONS
Hypersensitivity
Cases of angioedema and urticaria occurred in ILUMYA-treated subjects in clinical trials. If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy.
Infections
ILUMYA may increase the risk of infection. Treatment with ILUMYA should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated.
Consider the risks and benefits of treatment prior to prescribing ILUMYA in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving ILUMYA to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and consider discontinuation of ILUMYA until the infection resolves.
Pretreatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ILUMYA should be monitored closely for signs and symptoms of active TB during and after treatment.
Immunizations
Prior to initiating therapy with ILUMYA, consider completion of all age-appropriate immunizations according to current immunization guidelines. Patients treated with ILUMYA should not receive live vaccines.
Adverse Reactions
The most common (≥1%) adverse reactions associated with ILUMYA treatment that were more frequent than in the placebo group are upper respiratory infections, injection-site reactions, and diarrhea.
Announcer:
For more information on ILUMYA® including the Important Safety Information, visit ILUMYApro.com. That’s I-L-U-M-Y-A-p-r-o dot com. This medical industry feature was sponsored by Sun Pharma. To access this and other episodes in our series, visit DermConsult on ReachMD.com, where you can Be Part of the Knowledge. ILUMYA trademarks are owned or licensed to Sun Pharma group companies. All other trademarks are the property of their respective owners.
- ILUMYA. Prescribing Information. Sun Pharmaceutical Industries, Inc.; 2025.
- Reich K, Piaserico S, Warren RB, et al. Safety, immunogenicity, and efficacy of tildrakizumab in patients with chronic plaque psoriasis: Final results from the reSURFACE 1 and reSURFACE 2 long-term extension studies. In: 2025.
- Grant RW, Ashburner JM, Hong CS, Chang Y, Barry MJ, Atlas SJ. Defining patient complexity from the primary care physician’s perspective: a cohort study. Ann Intern Med. 2011;155(12):797-804. doi:10.7326/0003-4819-155-12-201112200-00001
- Kimball AB, Guérin A, Tsaneva M, et al. Economic burden of comorbidities in patients with psoriasis is substantial. J Eur Acad Dermatol Venereol JEADV. 2011;25(2):157-163. doi:10.1111/j.1468-3083.2010.03730.x
- Mehta NN, Yu Y, Pinnelas R, et al. Attributable Risk Estimate of Severe Psoriasis on Major Cardiovascular Events. Am J Med. 2011;124(8):775.e1-775.e6. doi:10.1016/j.amjmed.2011.03.028
- Takeshita J, Gelfand JM, Li P, et al. Psoriasis in the US Medicare Population: Prevalence, Treatment, and Factors Associated with Biologic Use. J Invest Dermatol. 2015;135(12):2955-2963. doi:10.1038/jid.2015.296
- Hu J, Shao Y, Gui C, Xiao Y, Li L, Li Z. Prevalence and risk of nonalcoholic fatty liver disease among adult psoriatic patients: A systematic review, meta-analysis, and trial sequential analysis. Medicine (Baltimore). 2024;103(18):e38007. doi:10.1097/MD.0000000000038007
- Brewer Eberly J, Frush BW. First, Do No Harm (to the One You Train). Linacre Q. 2025;92(2):137-149. doi:10.1177/00243639241311315
- Sun Pharmaceutical Industries, Inc., data on file.
- Cullingham K, Grewal P, Guénin S, Sauder M, Lynde C. Real World Canadian Case Series: Use of Tildrakizumab for Moderate-to-Severe Psoriasis. Published online 2025:2-11.
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