Navigating Patient Conversations
Associate Professor, Department of Dermatology
University of California
San Francisco, CA
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 Solik 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 Solik, 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 explain 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 SILIQ 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 solik 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. SILIQ 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@SILIQrems.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@SILIQrems.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 dispensed to patients authorized to receive SILIQ. More information is available@SILIQrems.com or by calling the SILIQ 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@SILIQ.com.
Watch as Tina Bhutani, MD, explains how she discusses an important topic with her adult patients being treated for moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.
Dr. Bhutani describes how she structures her SILIQ® (brodalumab) injection Risk Evaluation and Mitigation Strategy (REMS) conversations with patients. She emphasizes the importance of discussing the mental health comorbidities of psoriasis and advises patients on what to do if they notice changes in mood or symptoms of depression, suicidal ideation or behavior.
See the Full Prescribing Information, including BOXED WARNING about suicidal ideation and behavior, here.