Acne

Psoriasis

Join leading dermatology experts as they review the Risk Evaluation and Mitigation Strategy (REMS) program for plaque psoriasis! Click <a target="_blank" rel="noopener noreferrer" href="https://google.com">here</a>

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The REMS Process for Psoriasis

Ortho Siliq REMS 2023

An Introduction to the REMS Program for Psoriasis and Beginning the Patient Conversation

The following are opinions of Dr. Mark Lebwall and not intended to replace the informed consent process between a doctor and patient, nor is it intended to serve as medical and or legal advice. This video is not intended to replace all of the REM's requirements. More information will be discussed later in this video. Hello, I'm Dr. Mark Lebwall, dean for clinical therapeutics at the Icon School of Medicine at Mount Sinai in New York and chairman emeritus of the Department of Dermatology. I have been practicing dermatology for over four decades, and I was the principal investigator in the clinical trials for siliq bordeliumab. Today I'd like to talk to you about Siliq and the Siliq risk Evaluation and Mitigation strategy, or REMS program. Siliq is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. I choose Siliq when an adult patient has failed on a biologic, so it is usually my second choice. That means we're dealing with a more difficult to treat patient. Individual results may vary, but in my experience we have had good results and passy 100 is not out of the question. To put patients on Salik, they have to enroll in the REMS program and doctors must be certified in the program. Salik has a boxed warning and the full prescribing information because there were four suicides among more than 4400 patients with psoriasis treated with SiliQ in the clinical trials. Although there is no causal relationship to Siliq established, it is still a worthwhile and simple conversation to have with your patients. Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SiliQ in the clinical trials. The REMS program helps ensure that patients are informed about the risks of suicidal ideation and behavior so that they keep this in mind to help detect and get medical attention to manage any such issues that arise. We'll also cover more details about the siliq boxed warning and other important safety information in this video. You know, we're talking about a condition where patients are normally depressed, but we did see those four cases in the trials, and to be careful, the FDA instituted the ReVs program. And that's fine. It's necessary and it's simple to do. So here's how I handle it with my patients. The conversation is actually fairly easy, especially because it's not the first drug they're using and it takes me less than a minute. And I say to them, this is what we saw in the clinical trials about how effective it was. The trials had over 4400 patients in them. And we talk about what they can expect in terms of efficacy and safety. And I say, but also in those trials, there were four patients who committed suicide. And I tell them what's happened there and what the experience has been since the drug was approved. And I say, so we have this Rems program we have to do at that point. I will take them through the patient enrollment form, which you see here. And as it says in the form, I explain to them, I have to go through this with you, and I've already discussed with you that suicides and suicidal thoughts can occur if you feel worsening feelings or withdrawal, depression, anxiety, helplessness, or other mood changes. I want you to contact either me or the National Suicide Prevention Hotline. And if you're thinking of hurting or killing yourself, you have to call me or the National Suicide Prevention Hotline. If you are imminently at the point of harming yourself, you must immediately call 911. Here's the card you should keep in your wallet. The card covers what we just talked about and has the phone numbers you need. You should understand that someone from the Siliq Rems program may contact me or may contact you. And at that point, I ask them if they agree to using Salik, which the vast majority do, and if so, to sign the form. And then I just cut off the bottom of the sheet at the dotted line and give it to them. My staff actually fills out all of their data and all of my data beforehand. So all patients have to do is agree and sign. So the whole thing that I do with patients takes as much time as it just took me to go through it with you. And that's how I make sure I follow the REMS program requirements with my patients who need Salik. The form can be done electronically now, too. Providers have to register@salikrems.com. But once you've done that, you can log in and enroll patients quite easily that way. And I say you. But it can be done by, say, your bio coordinator. As I said at the beginning, patients I consider for SiLiQ have psoriasis that hasn't responded to other treatments, so they're more difficult to treat. When I review the efficacy and safety of Siliq with patients and then go over the REMS program information with them, very few of them hesitate to go on it. And most of those who hesitate do end up going on it anyway. They need what the drug can offer. For patients who fail to respond to other drugs, Siliq may be the answer they're looking for. The REMS program helps ensure patients are informed about the risks and helps doctors document that conversation. We owe it to our patients to enroll them so they can get SILIQ when they need it. Before closing, please take a moment to listen to some additional information about the Siliq REMS program and important safety information for Salik. The Siliq REMS program physicians must register for the Siliq REmS program@salikrems.com. Discontinuation or transfer of care must be reported to the Siliq REMS program. This video is not intended to replace all of the REMS requirements. Complete details about the SiLiq REMs are available@salikrems.com. Indication Siliq injection is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. Important safety information warning suicidal ideation and behavior suicidal ideation and behavior, including completed suicides, have occurred in patients treated with Siliq. Prior to prescribing siliq, weigh the potential risks and benefits in patients with a history of depression and or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes. See warnings and precautions in the full prescribing information. Because of the observed suicidal behavior in subjects treated with SilIq, SiLIQ is available only through a restricted program under a risk evaluation and mitigation strategy rems, called the SilIq REMS program. See warnings and precautions in the full prescribing information. Crohn's disease Siliq is contraindicated in patients with Crohn's disease. In clinical trials, which excluded Crohn's patients, one siliq patient was withdrawn after developing Crohn's disease. Discontinue Siliq if a patient develops Crohn's disease. Siliq risk evaluation and mitigation Strategy REMS program SilIQ is available only through a restricted program called the SiLIq rems. Because of observed suicidal ideation and behavior in patients treated with SiLIq. Before prescribing SiLIq, prescribers must be certified with the program. Have each patient sign a patient prescriber agreement form and provide the patient a wallet card describing symptoms requiring immediate medical evaluation. Pharmacies must be certified and only dispensed to patients authorized to receive SiLIQ. More information is available@saliquerems.com or by calling the Salik REMS program call center at 855-11-6135 infections SiLIQ may increase the risk of infections. Serious infections and fungal infections were observed at a higher rate in patients treated with SiLIQ than placebotreated patients in clinical trials, including one case of cryptococcal meningitis that led to discontinuation of therapy. Consider risks and benefits prior to prescribing SiLIQ in patients with a chronic infection or history of recurrent infection. Instruct patients to seek treatment if signs or symptoms of a chronic or acute infection occur. Risk for latent tuberculosis TB reactivation evaluate patients for TB prior to initiating treatment with SiliQ and do not treat patients with active TB. Initiate treatment for latent TB prior to starting Siliq and consider anti TB therapy prior to initiation in patients with history of latent TB if adequate treatment cannot be confirmed, monitor closely for symptoms of active tb during and after treatment. Immunizations avoid use of live vaccines in patients treated with Siliq. Adverse reactions the most commonly reported adverse reactions in clinical trials were arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinia infections. To report suspected adverse reactions, contact Bauch Health at 1803 214576 or the FDA at 1800 FDA 1088 or visit FDA gov medwatch. Please see full prescribing information, including boxed warning about suicidal ideation and behavior@salik.com.

Join Mark Lebwohl, MD, as he provides an introduction and overview of the REMS program for patients undergoing treatment for moderate-to-severe plaque psoriasis. Dr. Lebwohl discusses the background and rationale of the REMS program, the program requirements, and how he counsels his patients on utilizing the program to help ensure their well-being.

Navigating Patient Conversations

The following are opinions of Dr. Tina Bhutani and are not intended to replace the informed consent process between a doctor and patient, nor is it intended to serve as medical and or legal advice. This video is not intended to replace all of the REMS requirements. More information will be discussed later in this video. Hello, I'm Tina Bhutani, the co director of the UCSF Psoriasis and Skin Treatment center and the UCSF Dermatology Clinical Research unit director. I work at a tertiary referral center at a university, so patients come to me after they have tried and failed biologics. I rarely see patients who are biologic naive for the adult patient who has tough to treat psoriasis and has already tried one, two, now even sometimes three biologics. By the time they come into my office, I think about Siliq I am a certified Siliq prescriber. I'm here today to talk to you about an important conversation you should have about suicidal ideation and behavior with patients you're considering prescribing Siliq for, and to take the mystery out of that worthwhile and simple conversation. Siliq is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond to or have lost response to other systemic therapies. Patients who come to me with tough to treat psoriasis have usually failed other biologics and don't really think there's much hope of finding a treatment that may work for them and that can really take a toll on them. We know that unfortunately, patients with psoriasis are more likely to be diagnosed with mental health disorders such as depression and anxiety, so we should be talking to them about this. I bring this up because to put patients on Siliq, you have to follow the Siliq risk evaluation and mitigation strategy, or REMS program. The reason for this is during the clinical trials for Siliq, there were some patients who had suicidal thoughts and unfortunately, a few who also died by suicide. While we don't think this is unique to Siliq, it's important to inform your patients about it. And remember, patients with a history of depression can still use siliq as long as their depression is controlled. However, there is a boxed warning for suicidal ideation behavior. Today I will cover how I discuss important safety information about Siliq, including the boxed warning and the REMS program with my patients who are first starting Siliq. My REMS conversation is fairly easy and it typically takes about three minutes I start off with what to expect in terms of efficacy and safety, and then tell them you're going to notice there's a warning about suicidal ideation and behavior. We know that patients with psoriasis are more likely to be diagnosed with depression. In line with that during the clinical trials. Sadly, four patients out of 4400 committed suicide because of this warning. We're going to talk about it today and go through some paperwork and have you sign off on the REMS program. I'll pull out the paper form from the drawer and walk through the form step by step. The forms are quick and easy. I will talk about suicidal ideation and behavior and the fact that it's a comorbidity of psoriasis. I explained to them, I want you to be very aware of your mood, and should you notice any new or worsening depression or any depressed thoughts whatsoever, or if you have any thoughts of hurting yourself, I want you to get in touch with me as quickly as possible. If you can't get in touch with me, we're going to give you this card that has the phone number for the National Suicide Prevention hotline. I want you to keep this card in your wallet at all times, and I want you to call this number and seek immediate attention should you have any issues while you're taking this drug. I also want you to ask people around you to let you know if they notice you're becoming depressed, because sometimes you're not aware of your mood changes, but others around you might be. At the end of the discussion, the patient signs the form, and my office staff will fax it. And that's really it. That's how I make sure I'm following the sale REMS program requirement. The paper forms for us are quick and easy. While I typically stick to the paper process, the electronic component is available and does a good job. Electronic forms would save my office the time of faxing in the form. Even though it doesn't take that long, some REMS programs can seem very burdensome and time consuming. The Siliq REMS program is not like this. It's super quick and easy to not only register yourself as a rems provider, but also to get your patients signed up for the first time, you prescribe siliq. When patients come to me, they're tired and have seen a ton of doctors. They don't really think anything will help them, but they still want to talk about it. I've had so many of these patients put on Siliq, and they're responding, which is a great thing. We know that areas like the scalp, the palms, and the soles are tougher to treat. I've had great experiences using siliq with many patients in the past. There's a case of two brothers with terrible, tough to treat psoriasis. They had tried and failed cyclosporin, methotrexate, and all the biologics. We put them on Siliq and they responded. Even today, they're still clear. Generally, by the three month point, we see a lot of clinical improvement for these patients. Solique has helped so many of my patients, and having these brief rems conversations saves a lot of time in the long run. You're documenting exactly the conversation that you're having, and it has the patient's signature right there on it. A REMS program ensures that the patient and the doctor have a full conversation versus when we're prescribing many other biologics, it is important to talk about it in our practice. We should be encouraging these types of conversations because for our patients, having psoriasis can be tough as it is now. Before we close, I want to be sure you get a chance to hear some additional information about the Siliq REMS program and important safety information for SiLIQ. The Siliq REMS program physicians must register for the Siliq REmS program@salerems.com. Discontinuation or transfer of care must be reported to the Siliq REMS program. This video is not intended to replace all of the REMS requirements. Complete details about the SiLIQ rems are available@salikrems.com. Indication SilIQ injection is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. Important safety information warning suicidal ideation and behavior suicidal ideation and behavior, including completed suicides, have occurred in patients treated with Siliq. Prior to prescribing SilIq, weigh the potential risks and benefits in patients with a history of depression and or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes. See warnings and precautions in the full prescribing information. Because of the observed suicidal behavior in subjects treated with SiLIQ, SiLIQ is available only through a restricted program under a risk evaluation and mitigation strategy rems, called the Siliq REMS program. See warnings and precautions in the full prescribing information. Crohn's disease Siliq is contraindicated in patients with Crohn's disease. In clinical trials, which excluded Crohn's patients, one Siliq patient was withdrawn after developing Crohn's disease. Discontinue Siliq if a patient develops Crohn's disease. Siliq risk evaluation and mitigation strategy REMS program Siliq is available only through a restricted program called the sale rems because of observed suicidal ideation and behavior in patients treated with Siliq. Before prescribing Siliq, prescribers must be certified with the program. Have each patient sign a patient prescriber agreement form and provide the patient a wallet card describing symptoms requiring immediate medical evaluation. Pharmacies must be certified and only dispensed to patients authorized to receive SiLIQ. More information is available@saliquerems.com or by calling the Salik REMS program call center at 855-11-6135 infections SiLIQ may increase the risk of infections serious infections and fungal infections were observed at a higher rate in patients treated with SiLIQ than placebotreated patients in clinical trials, including one case of cryptococcal meningitis that led to discontinuation of therapy. Consider risks and benefits prior to prescribing SiLIQ in patients with a chronic infection or history of recurrent infection. Instruct patients to seek treatment if signs or symptoms of a chronic or acute infection occur. Risk for latent tuberculosis TB reactivation evaluate patients for TB prior to initiating treatment with SiliQ and do not treat patients with active TB. Initiate treatment for latent TB prior to starting SilIQ and consider anti TB therapy prior to initiation in patients with history of latent TB if adequate treatment cannot be confirmed. Monitor closely for symptoms of active TB during and after treatment immunizations avoid use of live vaccines in patients treated with Siliq. Adverse reactions the most commonly reported adverse reactions in clinical trials were arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinia infections. To report suspected adverse reactions, contact Bauch Health at 1803 214576 or the FDA at 1800 FDA 1088 or visit FDA Gov medwatch. Please see full prescribing information, including boxed warning about suicidal ideation and behavior@salique.com.

Watch as Tina Bhutani, MD, explains how she discusses an important topic with her patients being treated for moderate-to-severe plaque psoriasis who participate in the REMS program. Dr. Bhutani describes how she structures the patient conversation about the program, the importance of discussing the mental health comorbidities of psoriasis, and how she advises patients on what to do if they notice changes in mood or symptoms of depression. She also describes the simple process of navigating and submitting the REMS program forms.

Important and Easy Conversations

The following are opinions of Dr. Scott Drew and are not intended to replace the informed consent process between a doctor and patient, nor is it intended to serve as medical and or legal advice. This video is not intended to replace all of the REMS requirements. More information will be discussed later in this video. Hi there. I'm Dr. Scott Drew, a medical and surgical dermatologist at Dermatology Associates of mid Ohio. I've been practicing dermatology for over 30 years, and I've been using SiLIQ extensively since it was approved in 2017. I'd like to share with you my approach to discussing Siliq with my patients, and in particular the Siliq Risk Evaluation and mitigation strategy, or REMS program. This video will cover the Siliq boxed warning and other important safety information. Siliq is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. Let me start by saying I choose siliq because it has a unique mechanism of action. It acts as a cell membrane and binds to the IL 17 receptor, so it blocks the whole IL 17 family, not just the IL 17 a homodimers, but also the IL 17 af heterodymers. It's an important drug for many of my adult patients with psoriasis. We have a unique practice in that we're often a referral center for psoriasis. Some patients who come to us have had Pasi 20 or 30 or 40 on other systemic treatments or light therapy, including other biologics. This is when we think about Celik. But to use SilIQ, patients have to enroll in the REMS program. As dermatologists, we are familiar with this sort of program, especially for patients with serious skin diseases and the kind of treatments that we use. We do it for those products. We need to do it for Salik, too. And the reason for the Salik REMS program is that, sadly, there were four suicides in the phase three trials for Salik out of over 4400 patients. For this reason, Salik has a box warning in the full prescribing information. So we need to disclose that suicidal ideation and behavior, including completed suicides, have occurred in patients treated with Siliq in the clinical trials. The REMS program helps ensure that we, patients and doctors, both keep this in mind and detect and deal with any concerns that arise. And I explain that to patients. And to put it in perspective, we have not seen any suicides since the drug has been approved. Nevertheless, it is important that we talk to our patients about the risk of suicidal behavior. I think the management of psoriasis or any other disease really depends upon the trust our patients put in us to make them feel that they are part of the human continuum, even though they have psoriasis and that we have tools to help them. And when you earn that trust from a patient, they look to you not just for choices, but they also look to you for guidance. So I say something like this. I know that psoriasis is quite bothersome to you, and you've had many other therapies. I would like to talk to you about a drug called siliq, and I explain what they can expect in terms of efficacy and safety. Then I say, now I have to tell you that there were a few people who were in the trials who had some depression before they enrolled. And during the trial, sadly, four people committed suicide. The investigators didn't find a causal connection to the drug. But as a result of that, I need to go over this form with you, and I show them the form. It's pretty straightforward. And there's a hotline number on this wallet card. I ask them to carry it and call the number and seek immediate attention should they have any thoughts of self harm. While on Salik, I cover all the information that's here and fill it in. Name, address, all of that. We specifically ask if the patient has history of depression or suicide, suicidal thoughts or behavior. And I say, this is all about you having more information, helping you get the medicine you need, increasing your safety during treatment. And then we sign the form and send it in. It can be done electronically, too@salerems.com. I will say that when Siliq first came out, I was skeptical. I was a big biologic writer, and I thought I would never, ever write that drug because of this issue. And I believe that may still be a very common misconception among some dermatologists. And my advice is to register@salikrems.com and give Siliq a try for your appropriate patients. My first patients were those who didn't get better on all of the best stuff we had at the time. And all I will say is, it's worth it. Your patients are worth it. And now, before we close, I want to be sure you get a chance to hear some additional information about the SILIq REMS program and important safety information for SiLIq. The Siliq REMS program physicians must register for the SiLiq REMS program@salehrems.com. Discontinuation or transfer of care must be reported to the Siliq REMS program. This video is not intended to replace all of the REMS requirements. Complete details about the SILIQ rems are available@salikrems.com. Indication Siliq injection is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. Important safety information warning suicidal ideation and behavior suicidal ideation and behavior, including completed suicides, have occurred in patients treated with Siliq. Prior to prescribing SiLIq, weigh the potential risks and benefits in patients with a history of depression and or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior. New onset or worsening depression, anxiety, or other mood changes. See warnings and precautions in the full prescribing information. Because of the observed suicidal behavior in subjects treated with SilIq, SiLIQ is available only through a restricted program under a risk evaluation and mitigation strategy rems, called the Siliq REMS program. See warnings and precautions in the full prescribing information. Crohn's disease Siliq is contraindicated in patients with Crohn's disease. In clinical trials, which excluded Crohn's patients, one SiliQ patient was withdrawn after developing Crohn's disease. Discontinue Soleik if a patient develops Crohn's disease. Siliq risk evaluation and mitigation strategy REMS program SilIQ is available only through a restricted program called the SiLIQ rems because of observed suicidal ideation and behavior in patients treated with Siliq. Before prescribing SiLIQ, prescribers must be certified with the program. Have each patient sign a patient prescriber agreement form and provide the patient a wallet card describing symptoms requiring immediate medical evaluation. Pharmacies must be certified and only dispense to patients authorized to receive SILIQ. More information is available@saliquerems.com or by calling the SILIQ REMS program call center at 855-511-6135 infections SiLIQ may increase the risk of infections. Serious infections and fungal infections were observed at a higher rate in patients treated with SiLIQ than placebotreated patients in clinical trials including one case of cryptococcal meningitis that led to discontinuation of therapy. Consider risks and benefits prior to prescribing SILIQ in patients with a chronic infection or history of recurrent infection. Instruct patients to seek treatment if signs or symptoms of a chronic or acute infection occur. Risk for latent tuberculosis TB reactivation evaluate patients for TB prior to initiating treatment with SiLIQ and do not treat patients with active TB. Initiate treatment for latent TB prior to starting SilIQ and consider anti TB therapy prior to initiation in patients with history of latent TB. If adequate treatment cannot be confirmed, monitor closely for symptoms of active TB during and after treatment immunizations avoid use of live vaccines in patients treated with Siliq. Adverse reactions the most commonly reported adverse reactions in clinical trials were arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinia infections. To report suspected adverse reactions, contact Bauch Health at 1803 214576 or the FDA at 1800 FDA 1088 or visit FDA slash Medwatch. Please see full prescribing information, including boxed warning about suicidal ideation and behavior@siliq.com. Premiumpeed.com.

Join Scott Drew, MD, as he shares his approach to discussing the REMS program with his patients. Dr Drew details how he offers guidance to his patients undergoing treatment for moderate-to-severe-plaque psoriasis, the importance of discussing the patient’s mental health history, and how he explains and contextualizes important information for patients participating in the REMS program.

An Obligation to Our Patients

The following are opinions of Melody Young, MSN AGNPC, and are not intended to replace the informed consent process between the provider and patient, nor is it intended to serve as medical and or legal advice. This video is not intended to replace all of the REMS requirements. More information will be discussed later in this video. Hello. I am Melody Young and I am a nurse practitioner at Mindful Dermatology and modern research associates located in Texas. I have more than 30 years of experience in dermatology and even served as one of the investigators for the Siliq clinical trials. I am a certified Siliq prescriber. I'm here today to talk to you about an important conversation you should have about suicidal ideation and behavior with patients you're considering prescribing SiLIq for, and to take the mystery out of that worthwhile and simple conversation. Siliq is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. I position Salik as second line therapy for psoriasis and we use it in our most difficult cases. In my experience, Siliq is very much predictably effective. Many of my patients were able to attain 100% clearance or have very little evidence of disease while taking Siliq. Before any patient can start Siliq, though, they need to enroll in the SiLIQ risk evaluation and mitigation strategy or REMS program. So it is important to review the boxed warning for suicidal ideation and behavior in the full prescribing information with them. The RIMS program is not something that's foreign to dermatology and this program is in place for public safety and to protect providers. There is a precedent with other products where we have to discuss rims. So you already have your rhythm. My RimS conversation lasts less than a minute. I start off by telling my patients, hey, I've got a drug with a different mechanism of action and that we use in our most difficult cases. I think it's a good option for you. Here's how you inject it and we talk about setting expectations about what they are likely to see and when benefits are going to start to show. I will then discuss the safety piece of it. I tell my patients there are potential side effects with Siliq and we talk about what to expect in terms of safety. I will then say, the one thing that I will be watching for on this drug is I'm going to ask you, how are you doing physically and emotionally every time. I then go over the information on the rims enrollment form and the concern about suicidal ideation and discuss it with them, I will often say it's a possible event, but not a probable event based on statistics. That's why I'm going to ask you that question. I will then tell them. The form says that I have warned you that there are reports in the trials of patients experiencing depression. Depression can show up as sleepiness, loss of interest in activities, change in appetite, wanting to drink more, wanting to take more over the counter pain meds, a change in relationships, and not wanting to go to work. It can be all that, but it can also be a lot of other things. If you don't feel good and several days pass or a couple of weeks pass and you're worried, just call us. If you can't get in touch with me. We're going to give you this card and the phone number for the National Suicide Prevention hotline. I want you to call this number and seek immediate attention if you have any suicidal thoughts or changes in behavior while taking this drug. I will then show the patient this form and tell them. And by us signing this form, we are confirming that we've talked about it and that you know that I'm the person you're going to contact if you have problems. If you're having some kind of side effect with this medication, we'll decide together whether to keep you on it or not. I'm going to hold your hand through it, but I'm going to be strict. It only takes one extra minute to sign the paper and go through the entire conversation. There is even an electronic form which makes it easier to get onto the chart, less paperwork. It's just a simple assessment to register as a Siliq provider. I can see a new psoriasis patient decide on a therapy, do the coaching for the therapy, and have the paperwork signed in under two minutes. Most of my patients want to be on Salik, even with the RIMS program information I have. People panic at the thought of not being able to get Siliq because they have tried one or two other biologics before that didn't work. They've all been through some trauma, physical or emotional, when they had bad psoriatic disease, and they depend on me to help them find alternative therapies that may work for them. They want something that works, and for most of my patients, Salique clinically makes sense. Salique has helped so many of my patients and having these brief rims conversations saves a lot of time in the long run. Now, before we close, I want to be sure you get a chance to hear some additional information about the Siliq RIMS program and important safety information for Salik. The Siliq REMS program physicians must register for the Siliq REmS program@salikrems.com. Discontinuation or transfer of care must be reported to the Siliq REMS program. This video is not intended to replace all of the REMS requirements. Complete details about the SiLiq rems are available@salikrems.com. Indication Siliq injection is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. Important safety information warning suicidal ideation and behavior suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SilIq. Prior to prescribing siliq weigh the potential risks and benefits in patients with a history of depression and or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety or other mood changes. See warnings and precautions in the full prescribing information. Because of the observed suicidal behavior in subjects treated with SilIQ, SiLIQ is available only through a restricted program under a risk evaluation and mitigation strategy rems, called the Siliq REMS program. See warnings and precautions in the full prescribing information. Crohn's disease Siliq is contraindicated in patients with Crohn's disease. In clinical trials, which excluded Crohn's patients, one Siliq patient was withdrawn after developing Crohn's disease. Discontinue Siliq if a patient develops Crohn's disease. Siliq Risk evaluation and mitigation Strategy REMS program Siliq is available only through a restricted program called the Siliq REMs because of observed suicidal ideation and behavior in patients treated with Siliq. Before prescribing SiLIq, prescribers must be certified with the program. Have each patient sign a patient prescriber agreement form and provide the patient a wallet card describing symptoms requiring immediate medical evaluation. Pharmacies must be certified and only dispense to patients authorized to receive salik. More information is available@salehrems.com. Or by calling the SILIQ REMS program call center at 855-511-6135 infections SILIQ may increase the risk of infections. Serious infections and fungal infections were observed at a higher rate in patients treated with SiliQ than placebo treated patients in clinical trials, including one case of cryptococcal meningitis that led to discontinuation of therapy. Consider risks and benefits prior to prescribing SiLIQ in patients with a chronic infection or history of recurrent infection. Instruct patients to seek treatment if signs or symptoms of a chronic or acute infection occur. Risk for latent tuberculosis TB reactivation evaluate patients for tb prior to initiating treatment with Siliq and do not treat patients with active TB. Initiate treatment for latent TB prior to starting Siliq and consider antiTB therapy prior to initiation in patients with history of latent TB. If adequate treatment cannot be confirmed, monitor closely for symptoms of active TB during and after treatment. Immunizations avoid use of live vaccines in patients treated with Siliq. Adverse reactions the most commonly reported adverse reactions in clinical trials were arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinia infections. To report suspected adverse reactions, contact Bauch Health at 1803 214576 or the FDA at 1800 FDA 1088 or visit FDA gov Medwatch. Please see full prescribing information, including boxed warning about suicidal ideation and behavior@salik.com.

In this video, Melodie Young, MSN, A/GNP-C, walks through how she structures a consultation with new patients who have moderate-to-severe plaque psoriasis that is difficult to treat. She shares examples of conversations she has with her patients about serious and important topics related to a REMS program, what to expect in follow-up visits, and what to do if patients begin experiencing adverse effects or changes in mood while being treated for plaque psoriasis.