ILUMYA SUPPORT® FOR YOUR PATIENTS AND YOUR PRACTICE
SUPPORT AND RESOURCES FOR YOUR PATIENTS AND YOUR PRACTICE
RESOURCES FOR YOUR PATIENTS AND YOUR PRACTICE
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- Watch a healthcare professional properly inject ILUMYA® and watch other clinical highlights videos in the ILUMYA® Video Library below.
ILUMYA SUPPORT® can provide:
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by encouraging them to visit ILUMYA.com.
ILUMYA® (tildrakizumab-asmn) set a new benchmark as the IL-23 inhibitor with the first and longest complete data set from 2 Phase 3 clinical trials for moderate-to-severe plaque psoriasis.
Hear Dr. George Han, MD, System Medical Director for Dermatology at the Mount Sinai Health System and Dr. Stephen Rozzo, PhD., Senior Director of Dermatology Medical Affairs at Sun Pharma discuss what impact this 5-year efficacy and safety data from ILUMYA® could have on the future of IL-23 inhibitors in the treatment of moderate-to severe plaque psoriasis.
Short on time? Learn about the key attributes of ILUMYA® in under 4 minutes. This dynamic video showcases the most important information you need to know about the long-term efficacy, durable safety, and dosing and administration of ILUMYA®.
— New version with 5-year data! —
Watch the video below to see a healthcare professional (Dr. George Han) properly inject ILUMYA®, learn about the dosing benefits of ILUMYA®, and see a dosing comparison of different regimens for the treatment of moderate-to-severe plaque psoriasis.
Watch this video in 3D animation to see how ILUMYA® precisely targets the IL-23 pathway of the inflammatory cycle of psoriasis.
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.
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.
Please see full Prescribing Information.
Tile Page
Logo: ILUMYA® logo, top right
Title: ILUMYA® (tildrakizumab-asmn) after 5 Years: New Benchmarks in the IL-23 Pathway
Summary: Stephen Rozzo, Ph.D. Senior Director of Dermatology Medical Affairs at Sun Pharma and George Han, M.D., System Medical Director for Dermatology at the Mount Sinai Health System, break down the 5-year Phase 3 efficacy and safety data for ILUMYA® (tildrakizumab-asmn) and what the results mean for the future of IL-23 inhibitors in the treatment of moderate-to-severe plaque psoriasis.
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.
Selected 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 see additional Important Safety Information at the end of this video and Full Prescribing Information at ILUMYApro.com.
Speaker Signature Tabs
Location: Names/titles appear in the lower third graphic tab, aligned to the left side of the frame; use clips with the interviewee on the right side of the frame when first introduced with the tab to ensure tab doesn’t encroach on them.
Blurbs:
Stephen Rozzo, PhD., Senior Director of Dermatology Medical Affairs, Sun Pharma
George Han, M.D., System Medical Director for Dermatology, Mount Sinai Health System
Script
Stephen: Nearly 6.4 million people in the United States live with plaque psoriasis – among them, nearly 2 million people have moderate-to-severe plaque psoriasis.i,ii,iii
Of course, in any chronic disease, it is desirable to have a treatment option that can consistently offer both a high level of long-term efficacy as well as a stable, favorable safety profile. That is why it is my pleasure to speak with you today about the recently published 5-year clinical study results of ILUMYA®.
ILUMYA®, also known as tildrakizumab-asmn, is an interleukin 23 antagonist indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It was tested in two phase 3 trials, reSURFACE 1 and 2, and their 4-year extension studies. The results from these studies represent a new benchmark as the first, and longest, complete dataset of any IL-23 inhibitor indicated for this disease. iv
Of course, before starting any treatment, patients should talk to their doctor and review the important safety information to understand the potential risks. ILUMYA® may increase the risk of infection.
The most common adverse reactions associated with ILUMYA® – those that occurred in (≥1%) of patients – were upper respiratory infections, injection site reactions, and diarrhea.
To gain a better perspective on these findings, and what they mean for physicians and their patients, it is my pleasure to have Dr. George Han with us today. Dr. Han is the Medical Director for Dermatology at the Mount Sinai Health System and Chief of Teledermatology at the Icahn School of Medicine.
Stephen: Dr. Han, thank you very much for speaking with me today about the ILUMYA® 5-year results.
Dr. Han: Hi Stephen, thanks for having me!
Steve: The ILUMYA results show that moderate-to-severe plaque psoriasis patients who responded at week 28 generally maintained their clinical improvement as well as low disease activity through 5 years of treatment.
Dr. Han: This data really is crucial. I mean it builds on the three-year data that we had already, which already was quite impressive, but five years begins to paint a picture of the long-term struggle and battle that our patients have with psoriasis. This data really goes to show the long-term durability and disease control that patients can obtain. We’re talking five years of total ILUMYA exposure of more than 5,400 patient years – a lot of good data that just came out.
Stephen: How does long-term efficacy play a role in your decision when considering ILUMYA® for your patients?
Dr. Han: I think it’s really important because when we’re treating our patients with psoriasis, it’s not the short term battle, it’s not near term gains that were looking for, because this is a chronic inflammatory disease that we expect to affect them for the long term, we need a treatment that lines up with that, so when you’re talking about the ILUMYA data now to five years, I think that’s really important that we know that while the patient at week 28 on average get to a medium PASI of 1.8 and an improvement of 90% to know that that’s maintained and further improved actually out to year five, is of critical importance and that really underscores our conversations with our patients.
Steve: That’s really good to hear. Now at the end of the 5-year study, patients treated with ILUMYA 100 mg had median PASI improvement from baseline of 94.3 percent. And also regarding disease activity during treatment, study participants had a median PASI score of 1.1 on the 72 point PASI scale at the end of the study.
Dr. Han: Right and that low residual PASI is really important because it captures the redness, the scaling, the plaque elevation on the patient and that 1.1 is a really small amount especially when you consider that most patients who entered the trial had a PASI of around 20 so that’s a huge improvement and a very low residual disease level.
Steve: Are there other thoughts you would like to share on why these data are of interest to you in your clinical practice?
Dr. Han: when you think about the journey that patients take to get to us, it’s often very frustrating, it takes them a long time to find the right treatment, a lot of times they’ve been put on multiple topicals over the years, they, they’re just frustrated, when you think about that as well as the frustration of being put on an effective medicine only to have it stop working for them afterwards I think that’s really, really disconcerting for patients to go through.
Dr. Han: So, it’s important to find a medicine that keeps them on a good baring to maintain control of their active disease. And I think that ILUMYA represents for me a really ideal match for targeting the pathogenesis of psoriasis. When we think about the IL-23 pathway, and really targeting that central cytokine that seems to have a very clean safety profile. For me it really represents a very good choice.
Stephen: So the 5-year data results also showed a durable safety profile, with no new safety signals regardless of baseline level of disease, age, or background illness related to metabolic syndrome, which can include factors like high serum glucose and high body mass index.4
Dr. Han: Right, and that long term safety is really of critical importance and especially when you put in the context of metabolic syndrome because we’re thinking more and more nowadays about all these comorbidities that our psoriasis patients have, so I think it’s important that we know that we have a reliable medication.
Dr. Han: I was really interested to see that data comparing the two groups and its reassuring to know that their response to treatment is predictable and very strong in both groups, so it doesn’t seem to matter whether they have those comorbidities. They have a very consistent response to ILUMYA.
Stephen: Yes, the rate of serious adverse events over 5,400 patient years of ILUMYA® exposure was 6.3 per 100 patient-years and the incidence rates of various treatment-emergent adverse events were typically similar from year to year during treatment.4 How important is safety when discussing options with patients?
Dr. Han: I think it’s really important when we talk especially about a long-term treatment that we also know and capture the long term safety profile and that low rate of adverse events and no new safety signals popping up, is really important, having this five year data, having the five year safety, it really gives us a lot of reassurance and we’re giving our patients a safe and effective treatment for the long-term.
Stephen: Dr. Han, thank you very much for joining me today and discussing views on the 5-year clinical study results as well as your clinical experiences.
Dr. Han: Thank you, thanks for having me, it was a pleasure.
Closing Slate
Animated ILUMYA® logo and Sun Pharma Logo
HCP ISI
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
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.
Please see the Full Prescribing Information at ILUMYApro.com.
