Transparent Talks

Sponsored by Pfizer

Learn more about identifying appropriate patients for CIBINQO in this talk with E. James Song, MD, FAAD.

Narrator: CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. 

Limitations of Use: 
CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants. 

Dr James Song: Hello, my name is Dr James Song, and I am a board-certified dermatologist and the director of clinical research at Frontier Dermatology in Mill Creek, Washington. Today, I'm here on behalf of Pfizer to discuss how I would identify a CIBINQO patient and share with you the types of conversations I'm typically having when I start this patient on treatment.

Now, let me tell you a bit about Tom. Tom isn't a real patient of mine, but he is very similar to the type of patients I see in my practice and who I would consider CIBINQO for. He's a 21-year-old college student, and he was diagnosed with moderate-to-severe atopic dermatitis in high school and has been having worsening symptoms over the past few years.

He was previously treated with topical and systemic corticosteroids and an injectable biologic, but his atopic dermatitis remains inadequately controlled. 

When Tom first came to me, I started off by just simply asking him what impact his atopic dermatitis has had on his life. And while Tom did express that his condition has improved some since starting his injectable biologic, he still has some involvement of his hands and his groin, with particular discomfort in the groin region. He also still reported significant itch, especially at night or when he sweats.

Tom's a college student, and his atopic dermatitis is affecting his performance in school, his part-time job, and makes him feel uncomfortable in social settings. Tom feels that he's already doing everything he can to address his atopic dermatitis and worries that this is all the relief he's going to ever get.

As you can see here, Tom is a moderate-to-severe atopic dermatitis patient who is experiencing uncontrolled symptoms that are refractory to previous treatments, including his current regimen of topical corticosteroids and an injectable biologic. And despite having had some improvement, Tom still isn't at his treatment goal, so we should at least have a discussion about potentially changing his treatment regimen. 

I believe Tom may benefit from a new treatment option and is an example of a patient who I would consider CIBINQO for. But first, let's go over some Important Safety Information about CIBINQO. 

Narrator: Please be aware that CIBINQO Prescribing Information includes the following BOXED WARNING: increased risk of serious bacterial, fungal, viral, and opportunistic infections that may lead to hospitalization or death, including tuberculosis. Avoid use in patients with active serious infection and discontinue treatment if serious or opportunistic infection occurs. Higher rate of all-cause mortality and MACE, defined as cardiovascular death, myocardial infarction, and stroke with another JAK inhibitor vs TNF blockers in rheumatoid arthritis patients. CIBINQO is not approved for use in rheumatoid arthritis: malignancies, MACE, and thrombosis have occurred in patients treated with CIBINQO. Higher rate of lymphomas, lung cancers, MACE, pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs TNF blockers. Patients who are current or past smokers are at increased risk. Discontinue if myocardial infarction, stroke, or symptoms of thrombosis occur. 

Perform recommended testing, evaluations, and immunizations prior to CIBINQO initiation, and monitor patients during treatment.

Please see full Prescribing Information for details. 

Dr James Song: Hello, Tom, thanks for coming in today. So far, we've been treating your moderate-to-severe atopic dermatitis with topical medications as well as oral steroids and injections. I know neither of us has been satisfied with your results because you're still experiencing itching and you're still dealing with bothersome skin lesions.

I also know you said that you are somewhat better than how you were before, but your disease is still negatively impacting you. Based on what you told me, it may be time to consider switching you to another systemic treatment that works differently from the medication that you're currently taking.

I'd like to talk with you about starting a medication called CIBINQO. This is an FDA-approved treatment for moderate-to-severe atopic dermatitis. I know in the past you had hesitations on starting a new treatment, since you do feel comfortable on your current injectable and are afraid that perhaps you may get even worse if you switch to something else. 

Let's talk about CIBINQO. CIBINQO is a once-daily pill that disrupts a process caused by your immune system that can lead to inflammation and itch.

Here's the type of improvement we might expect based on the clinical trial data. CIBINQO was studied in clinical trials in over 1600 patients, 12 years of age and older, who had moderate-to-severe atopic dermatitis. These trials evaluated skin improvement, skin clearance, and itch reduction, which are all important things to consider when treating atopic dermatitis.

In these trials, some patients took CIBINQO alone, others took CIBINQO along with topical corticosteroids, which is often the case in the real world. While these studies included patients who failed topical therapies, CIBINQO is only approved for those who have failed other systemic treatments as well. 

In a study called JADE COMPARE, where patients were allowed to use topical corticosteroids, adults with refractory, moderate-to-severe AD received 1 of 4 treatment options: CIBINQO 100 milligrams, CIBINQO 200 milligrams, dupilumab, or a placebo treatment.

The results of JADE COMPARE show that treatment with CIBINQO in combination with topical corticosteroids was associated with skin clearance at week 12 vs placebo. About 6 out of 10 patients achieved 75% clearer skin with CIBINQO 100 milligrams plus topical corticosteroids in only 12 weeks.

In the same study, over a third of patients achieved clear or almost clear skin (also known as IGA 0/1) with CIBINQO 100 milligrams plus topical corticosteroids in 12 weeks.

I'd like to make sure my patients have a clear understanding of what sort of improvement was demonstrated in clinical trials. Understanding the full clinical data helps me feel confident when I evaluate the risk and benefits of a new medication.

In addition to the Phase 3 study that I just discussed, another piece of data that informs my personal understanding of CIBINQO comes from a post hoc analysis from the JADE EXTEND study. The JADE EXTEND study is an ongoing, long-term extension safety study for eligible patients who have completed a qualifying JADE parent study. 

The primary endpoints in this study included the incidence of safety events and clinical abnormalities. The secondary endpoints included various efficacy outcome measures. 

Some patients who were originally randomized to active treatment or placebo in the JADE COMPARE study did not achieve the prespecified efficacy endpoints in the clinical trial.

A post hoc analysis of JADE EXTEND was conducted, which evaluated these adults who were considered non-responders to dupilumab, possibly like our patient Tom, and then further evaluated those patients after receiving 12 weeks of treatment with CIBINQO.

The post hoc analysis are not controlled for multiplicity and are descriptive in nature, so no conclusions regarding treatment differences should be made. Looking at the patients who did not achieve IGA 0/1 with dupilumab at week 16 in JADE COMPARE, 35% who took CIBINQO 100 milligram, and 47% who took CIBINQO 200 milligrams achieved IGA 0/1 at week 12 in JADE EXTEND. 

Among the patients who did not achieve EASI-75 with dupilumab at 16 weeks in JADE COMPARE (which is defined as those who are unable to achieve 75% clear skin) 68% who took CIBINQO 100 milligrams and 80% who took CIBINQO 200 milligrams achieved EASI-75 at week 12 in JADE EXTEND.

And among the EASI-90 dupilumab non-responders from week 16 of JADE COMPARE (those who are unable to achieve 90% clear skin) 40% who took CIBINQO 100 milligrams and 60% who took CIBINQO 200 milligrams achieved EASI-90 at week 12 in JADE EXTEND. 

These data allows you to understand what a treatment like CIBINQO may be able to offer patients who are taking dupilumab and are considered non-responders.

Like many studies, JADE EXTEND has biases and limitations. Let's take a few minutes to review the associated biases and limitations. 

The adverse reaction rates observed in clinical trials of a drug cannot be compared to rates in clinical trials of a different drug. Also, the rates may not be reflective of rates that are actually observed in clinical practice. Additionally, although data from long-term extension studies may be useful, it should be interpreted with caution if the treatment and dose are known to both the investigator and patient.

There are specific biases and limitations listed here for your reference as well. We will pause for a few moments to ensure you've had enough time to review these. 

Now, let's talk about the safety data. The data shown here, which are from an integrated safety analysis of JADE EXTEND, helps inform my personal understanding of long-latency adverse events associated with CIBINQO.

Based on this data, we can see that serious infections, malignancy, major adverse cardiovascular events, thrombosis, and mortality have been observed in CIBINQO clinical trials. I'll demonstrate in a few moments how I talk about these safety events with patients like Tom. 

CIBINQO is a JAK inhibitor and a medicine that affects your immune system. It can lower the ability of your immune system to fight infections, which is why you may be more prone to developing infections. This class of medication, which is also used in different products for other indications outside of dermatology, has a BOX WARNING about serious risks. These include serious infections, increased risk of death, and heart-related conditions, cancer, and blood clots. These have been seen in CIBINQO clinical trials, so we will discuss what type of screening and monitoring we do before and while on treatment. 

It's also worth noting that the safety of CIBINQO has been studied in multiple clinical trials with over 3500 patients with moderate-to-severe atopic dermatitis. Some of the more common side effects that you may encounter with CIBINQO include nausea, headache, common cold, and others. 

I've already reviewed your medical history and current medications to assess for any risks. So, let's now discuss some of the tests and evaluations I will perform prior to CIBINQO initiation and during treatment with CIBINQO. As we discussed, CIBINQO may increase your risk of serious infections. I'll be screening you for hepatitis and tuberculosis, before we start and during your treatment. I'll also make sure you're up to date on all your vaccines. 

CIBINQO may also impact blood counts and lipid levels, so I'll be ordering labs called a CBC before we start treatment, and in 4 weeks, I'll check both your lipids and your CBC again. And if everything looks within normal limits, I'll be checking your labs again periodically.

I will also want you to let me know immediately if you have any signs or symptoms of an infection, cardiovascular events, or blood clots. We'll also keep an eye on your skin for any cancer, as the risk may be increased with CIBINQO. I want to remind you to limit the time you spend in sunlight, avoid using tanning beds or sunlamps, and wear protective clothing when you're in the sun. Remember to use a sunscreen with an SPF of 30 or higher as well.

Based on the symptoms you are experiencing, I recommend starting you on CIBINQO. We will start you on a 100 milligram dose, which you will take once daily with or without food. I will check in again periodically to make sure you're doing okay. If we feel like your AD is not at treatment goal, we have the flexibility to increase your dose to 200 milligrams.

I wanted to thank you for coming in today, Tom. I know we're both looking for you to feel more relief from your atopic dermatitis, and I'm happy to be able to education you on another treatment option.

I hope my conversation with Tom was helpful for you to see how I would speak to a patient about what they can expect from treatment with CIBINQO.

There are resources designed to help patients "Get to Know CIBINQO." A brochure is available to you, as well as a start guide for clinicians that outlines everything you need to know about dosing and administration.

Pfizer also has a resource called Pfizer Dermatology Patient Access^TM. You can enroll eligible patients for personalized support and savings, including coverage assistance, specialty pharmacy coordination, financial assistance resources, and access to a Patient Support Representative. 

For more information on discussing the safety profile of CIBINQO with your patients, please see the first video in our Transparent Talks series featuring Dr Aaron Farberg. 

Narrator: Important Safety Information and indication. 

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS.

SERIOUS INFECTIONS
Patients treated with CIBINQO may be at increased risk for developing serious infections that may lead to hospitalization or death. The most frequent serious infections reported with CIBINQO were herpes simplex, herpes zoster, and pneumonia.

If a serious or opportunistic infection develops, discontinue CIBINQO and control the infection. 

Reported infections from Janus kinase (JAK) inhibitors used to treat inflammatory conditions:

• Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative latent TB test. 
• Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. 
• Bacterial, viral (including herpes zoster), and other infections due to opportunistic pathogens. 

Avoid use of CIBINQO in patients with an active, serious infection, including localized infections. The risks and benefits of treatment with CIBINQO should be carefully considered prior to initiating therapy in patients with chronic or recurrent infections or those who have resided or traveled in areas of endemic tuberculosis or endemic mycoses. 

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIBINQO, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. 

Consider yearly screening for patients in highly endemic areas for TB. CIBINQO is not recommended for use in patients with active TB. For patients with a new diagnosis of latent TB or prior untreated latent TB, or for patients with a negative test for latent TB but who are at high risk for TB infection, start preventive therapy for latent TB prior to initiation of CIBINQO. 

Viral reactivation, including herpes virus reactivation (eg, herpes zoster, herpes simplex), was reported in clinical studies with CIBINQO. If a patient develops herpes zoster, consider interrupting CIBINQO until the episode resolves. Hepatitis B virus reactivation has been reported in patients receiving JAK inhibitors. Perform viral hepatitis screening in accordance with clinical guidelines before starting therapy and monitor for reactivation during therapy with CIBINQO. CIBINQO is not recommended for use in patients with active hepatitis B or hepatitis C.

MORTALITY
In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another JAK inhibitor to TNF blocker treatment, a higher rate of all-cause mortality (including sudden cardiovascular death) was observed with the JAK inhibitor. CIBINQO is not approved for use in RA patients.

MALIGNANCIES
Malignancies, including non-melanoma skin cancer (NMSC) were reported in patients treated with CIBINQO. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. Perform periodic skin examination for patients who are at increased risk for skin cancer. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC] was observed in patients treated with a JAK inhibitor compared to those treated with TNF blockers. CIBINQO is not approved for use in RA patients. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk.
 
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy when on treatment, and patients who are current or past smokers.

Major adverse cardiovascular events. Major adverse cardiovascular events were reported in patients treated with CIBINQO. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. CIBINQO is not approved for use in RA patients. Patients who are current or past smokers are at additional increased risk. Discontinue CIBINQO in patients that have experienced a myocardial infarction or stroke.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. 

THROMBOSIS
Deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with CIBINQO. Thrombosis, including PE, DVT, and arterial thrombosis, have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of overall thrombosis, DVT, and PE were observed when compared with TNF blockers. CIBINQO is not approved for use in RA patients. 

Avoid CIBINQO in patients that may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue CIBINQO and treat patients appropriately. 

CONTRAINDICATION
CIBINQO is contraindicated in patients taking antiplatelet therapies, except for low-dose aspirin (less than or equal to 81 milligrams daily), during the first 3 months of treatment.

LABORATORY ABNORMALITIES
Hematologic Abnormalities: Treatment with CIBINQO was associated with an increased incidence of thrombocytopenia and lymphopenia. Prior to CIBINQO initiation, perform a complete blood count (CBC). CBC evaluations are recommended at 4 weeks after initiation and 4 weeks after dose increase of CIBINQO. Discontinuation of CIBINQO therapy is required for certain laboratory abnormalities. 

Lipid Elevations: Dose-dependent increase in blood lipid parameters were reported in patients treated with CIBINQO. Lipid parameters should be assessed approximately 4 weeks following initiation of CIBINQO therapy, and thereafter patients should be managed according to clinical guidelines for hyperlipidemia. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined. 

IMMUNIZATIONS
Prior to initiating CIBINQO, complete all age-appropriate vaccinations as recommended by current immunization guidelines, including prophylactic herpes zoster vaccinations. Avoid vaccinations with live vaccines immediately prior to, during, and immediately after CIBINQO therapy. 

RENAL IMPAIRMENT
Avoid use in patients with severe renal impairment or end-stage renal disease, including those on renal replacement therapy.

HEPATIC IMPAIRMENT
Avoid use in patients with severe hepatic impairment. 

ADVERSE REACTIONS
Most common adverse reactions (greater than or equal to 1% with CIBINQO 100 milligrams) are nasopharyngitis, nausea, headache, herpes simplex, increased blood creatine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, impetigo, oropharyngeal pain, hypertension, influenza, gastroenteritis, and dermatitis contact. 

Most common adverse reactions (greater than are equal to 1% with CIBINQO 200 milligrams and greater than CIBINQO 100 milligrams) are nausea, headache, herpes simplex, increased blood creatine kinase, dizziness, urinary tract infection, acne, vomiting, gastroenteritis, upper abdominal pain, abdominal discomfort, herpes zoster, and thrombocytopenia.

Inform patients that retinal detachment has been reported in CIBINQO clinical trials. Advise patients to immediately inform their healthcare provider if they develop any sudden changes in vision.

DRUG INTERACTIONS
Monitor appropriately or dose titrate P-gp substrate where small concentration changes may lead to serious or life-threatening toxicities when coadministered with CIBINQO. See Prescribing Information for clinically relevant drug interactions.

Use in pregnancy. Available data from pregnancies reported in clinical trials with CIBINQO are not sufficient to establish a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Advise patients who can become pregnant that CIBINQO may impair fertility. 
 
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CIBINQO during pregnancy. Pregnant women exposed to CIBINQO and health care providers are encouraged to call 1-877-311-3770 or visit CIBINQOPregnancyRegistry.com.

LACTATION
Advise patients not to breastfeed during treatment with CIBINQO and for one day after the last dose. 

INDICATION
CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when the use of these therapies is inadvisable.

Limitations of Use: CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants. To report suspected adverse reactions, contact Pfizer Incorporated at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.