Transcript
Announcer
Welcome to DermConsult on ReachMD.
And this medical industry feature, titled Treating Moderate-to-Severe Plaque Psoriasis in Patients 50+ Including the Medicare Population, is sponsored by Sun Pharma. This program is intended for healthcare professionals.
Here’s your host, Dr Charles Turck.
Dr Turck:
Psoriasis is a chronic, multisystem, inflammatory disorder that follows a relapsing course, with highest prevalence in patients 50 to 59 years old. Disease management considerations are complex for patients aged 50 years and older, as they may face adherence challenges, increased risk of comorbidities, and insurance transitions from commercial to Medicare. Today, we'll explore how we can address these specific treatment needs of this patient population with a treatment called ILUMYA®.
This is ReachMD, and I'm Dr Charles Turck. Joining me to discuss a treatment option for moderate-to-severe plaque psoriasis is Dr Scott Gottlieb, from Schweiger Dermatology Group, in Exton, PA. Thank you for being here today.
Dr Gottlieb:
Thank you for having me.
Dr Turck:
Before we begin, let's take a moment to review some important safety information.
Announcer:
INDICATION
ILUMYA® (tildrakizumab-asmn) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
IMPORTANT SAFETY INFORMATION
ILUMYA may increase the risk of infection. 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.
Please listen to additional Important Safety Information at the end of this podcast and see Full Prescribing Information at ILUMYApro.com.
Dr Turck:
So now, let's talk about your patients with moderate-to-severe plaque psoriasis who are approaching the 50 years and above age group, including those nearing Medicare age. What are important treatment considerations?
Dr Gottlieb:
There are several things I consider when treating this group of patients with ILUMYA®. Many patients approaching this age have likely already tried different treatments. In a multinational, cross-sectional, quantitative web-based survey of approximately 3,800 patients with psoriatic disease and an average age of 45 years, topical, oral, and injectable or IV medications were reported to be burdensome for 75%, 66%, and 84% of patients, respectively.
We know that among patients with current or prior topical treatment, one of the most common reasons for the perceived burden was mess from application cited by over half of patients. For those on current or prior oral medications, more than half discontinue oral treatment, and of these, nearly one-third cite a lack of effectiveness. For biologics, patients also felt burdened, and one of the most common reasons, cited by about a quarter of patients, was fear of adverse events. So, administration method, efficacy, and safety are important considerations and that's why I want to talk about ILUMYA®, which I frequently write for in this age group.
Dr Turck:
I see. So, what else can you tell us about ILUMYA® clinical trial data?
Dr Gottlieb:
In the pivotal reSURFACE trials, patients treated with ILUMYA® had substantial PASI responses. At Week 12, patients were, on average, 83% clearer from baseline, and that was sustained. At Year 1, patients were, on average, 96% clearer, and at Year 5, they were, on average, 94% clearer. I like to find a drug that works for patients from the beginning and continues to work. The ILUMYA® data give me confidence in that.
There was an analysis of these trials that examined efficacy and safety in patients 65 years and older, versus patients younger than 65 years, for up to a 5-year period. The analysis found that there was comparable long-term improvement in PASI scores in those younger than 65 years versus those 65 years and older.
Dr Turck:
And can you tell us a bit about the safety data?
Dr Gottlieb:
Definitely. In regard to safety, the ILUMYA® Prescribing Information does not contain certain warnings that come with other biologic classes, such as cardiac disease, malignancy, suicidal ideation, irritable bowel disease, or demyelinating disease.
Among the IL-23s, it's noteworthy that ILUMYA® has the least number of common adverse reactions occurring more frequently than placebo. This is meaningful information for patients, particularly those who are hesitant about the safety of biologics, which may be up to a quarter of patients based on the survey we mentioned earlier.
The most common adverse reaction seen in the clinical trials with rates similar to placebo, were upper respiratory infections, which occurred in 14% of patients on ILUMYA® versus 12% on placebo, injection-site reactions in 3% of patients on ILUMYA® versus 2% on placebo, and diarrhea was 2% of patients on ILUMYA® versus 1% on placebo.
Dr Turck:
And were the safety data compared between younger and older patients?
Dr Gottlieb:
Yes, the analysis I mentioned earlier also compared safety between patients who were 65 years and older versus those younger than 65 years.
Overall, the safety analysis showed a favorable tolerability profile in both age groups and adverse events were consistent with rates observed in other clinical trials with biologics.
In terms of infection-related adverse events, both age groups shared a similar safety profile, with nasopharyngitis and other respiratory tract infections as the most frequent infections in both age groups.
For cases of confirmed MACE, the older age group had 0.5 events per 100 patient-years of exposure, versus 0.6 events per 100 patient- years in the younger age group. We could think about it this way for each group: for 20 patients treated for 5 years, there would be less than 1 event.
Dr Turck:
Now, we know that patients with psoriasis frequently have special area involvement. Dr Gottlieb, tell us about considerations for treating these special areas.
Dr Gottlieb:
Of course. Special areas are difficult to treat, in part due to challenges of adherence. It's important to consider that those who live alone or have limited support may not be able to successfully apply topical agents due to age-related factors like reduced vision and mobility. Compared to a topical, a biologic may be advantageous. So, I'd like to zero in further on one special area, the scalp, because almost 80% of patients affected by plaque psoriasis eventually developed lesions on the scalp. Data from a Phase 3B, multicenter, randomized trial of ILUMYA® gives me the confidence to treat patients with scalp involvement. It's also relevant that patients included in this study had whole body psoriasis, not just scalp alone.
The data show that at Week 16, the average improvement was 80% based on the Psoriasis Scalp Severity Index, or PSSI. Also at this time point, nearly half of patients treated with ILUMYA® achieved clear or almost clear scalp.
At Week 52, about 63% of patients treated with ILUMYA® achieved clear or almost clear scalp. At this same time, we saw in the other treatment group of patients who switched from placebo to ILUMYA® that 56% achieved clear or almost clear scalp. Through Week 72, no new safety-related events were observed, and most treatment-emergent adverse events were considered mild to moderate and comparable to placebo.
Dr Turck:
There's evidence linking psoriasis and metabolic syndrome, which includes diabetes, hyperlipidemia, hypertension, and obesity. To what extent do you see this, and how do they affect your treatment considerations?
Dr Gottlieb:
Cardiovascular comorbidities are highly prevalent in Medicare-aged patients. A study of Medicare patients with psoriasis estimated nearly 60% had comorbid hyperlipidemia and nearly 70% had comorbid hypertension. In addition, obesity is 114% more common in patients with psoriasis compared to those without.
As the body of evidence linking psoriasis and cardiovascular comorbidities grows, it's important to have data on drugs that show consistent efficacy and safety in patients with and without these comorbidities.
So, once again, ILUMYA® was studied specifically in patients with metabolic syndrome, and in a post hoc analysis of the Phase 3 trials, the improvement in PASI scores and safety outcomes were similar among patients with and without the comorbidities that define metabolic syndrome. Given the high rates of cardiovascular comorbidities in Medicare-aged patients, I appreciate knowing that ILUMYA® has been tested this way.
Dr Turck:
You're listening to DermConsult on ReachMD. I'm Dr Charles Turck, and today I'm speaking with Dr Scott Gottlieb about the right patients for ILUMYA®.
We spoke a bit earlier about clinical trial data, but now, let's shift over to the administration of this drug. What are some important considerations for administering ILUMYA® in patients?
Dr Gottlieb:
There are several things that I consider. It's important to call out that successful long-term management of psoriasis depends on patient compliance. Since ILUMYA® is HCP-administered, it allows me to successfully manage patients who struggle with compliance. Certain patients who come to mind are those with tremors, eyesight problems, and/or osteoarthritis, which present challenges for patients self- administering injectables.
Also, mental anxiety about preparing for self-injection is a perceived burden for almost one-quarter of patients with psoriasis and is a burden that I can help relieve. Another plus for many patients is they like coming into the office every few months to be seen by their doctor.
We are continually challenged by access to state-of-the-art biologics for patients on Medicare. I find that Medicare Part B makes it very easy to access ILUMYA® through the medical benefit. Also, affordability is a concern with many Medicare patients, and a supplemental or secondary plan may reduce coinsurance to $0.
The process is seamless, and I automatically think of ILUMYA® for my Medicare patients.
I also know that in some Medicare markets, the only systemic treatment options are ILUMYA® and methotrexate. In these cases, ILUMYA® provides this opportunity for these patients to be treated with a biologic that they otherwise would not have access to. For patients with commercial insurance who are approaching Medicare age, it makes sense to start them on ILUMYA® since they can continue the drug with Medicare.
And while on commercial insurance, ILUMYA® is also covered through the medical benefit, not just pharmacy. Whether patients have commercial insurance or Medicare, my staff is trained to use ILUMYA SUPPORT®, the patient hub for navigating claims.
Dr Turck:
Dr Gottlieb, we're just about out of time for today. What do you want our listeners to take away from our discussion?
Dr Gottlieb:
I like to write ILUMYA® for my patients approaching 50 years of age and above, who have lived with chronic plaque psoriasis for a while, who have tried different drugs, and are looking for something that works well from the beginning and consistently for the long haul. These patients frequently have scalp involvement and/or comorbidities, like hypertension, hyperlipidemia, and high BMI, and there are great ILUMYA® data for these challenging-to-treat patient types.
I appreciate that ILUMYA® is HCP administered. It's a huge plus for my patients who have age-related compliance challenges. It helps guarantee compliance. When patients are compliant, they achieve consistent long-term results and are happier.
And finally, in terms of insurance access, both Medicare and commercial insurance are options to access ILUMYA® under the medical benefit. ILUMYA SUPPORT® helps make ILUMYA® affordable for patients.
Dr Turck:
Those are great takeaways. I want to thank you very much for joining me in this discussion to better understand the right patients for ILUMYA®. Dr Gottlieb, it was great speaking with you today.
Dr Gottlieb:
Thank you for having me, Dr Turck. It was a pleasure being able to share my experience in treating patients with ILUMYA®.
Dr Turck:
I'm Dr Charles Turck. For more information on ILUMYA®, please visit ilumyapro.com. That's I-L-U-M-Y-A-p-r-o dot com.
Stay tuned for the next episode in this series, where we'll be discussing accessing ILUMYA® through Medicare. Before we close, let's take a moment to review some important safety information.
Announcer:
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.
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.
This program was sponsored by Sun Pharma. If you missed any part of this discussion or would like to find others in this 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.
