Myelofibrosis

What Long-Term Data Are Available for Jakafi?


Understanding long-term data available for Jakafi

Hematologist-oncologist Gary Grad, MD, reviews the results of two clinical studies that explored spleen size and analyzed overall survival in people with intermediate or high-risk myelofibrosis (MF). ...more

Video Transcript

Onscreen copy and narrator: What Long-Term Data, Including Overall Survival, Are Available for Jakafi® (ruxolitinib) in the Treatment of Certain Types of Myelofibrosis?

Onscreen copy and narrator: This video is intended for informational use only, and is not designed to replace the medical advice of your Healthcare Professional.

Onscreen copy: Your Healthcare Professional is the best source for treatment-related questions and medical advice.

Dr Grad: Hi. I’m Dr Gary Grad, a hematologist-oncologist based in the Chicago area. I treat patients with myelofibrosis, or MF, and other conditions in my practice.

Onscreen copy and narrator: : Jakafi is a prescription medicine available as a pill. Jakafi is used to treat people with certain types of myelofibrosis (MF).

Important Safety Information is discussed later in this video.

Onscreen copy and narrator: Jakafi is the first and only prescription medicine approved by the FDA for the treatment of people with intermediate- or high-risk MF.

Dr Grad: In order to better understand how medicines may work and what side effects they may cause, researchers perform clinical trials, sometimes by comparing new treatments with existing treatments and sometimes comparing to a placebo or sugar pill.

Two clinical trials were conducted to evaluate Jakafi in the treatment of patients with intermediate-2 or high-risk myelofibrosis.

In one clinical trial, Jakafi was compared with a placebo or sugar pill, and in the other Jakafi was compared with other best available therapy, which included other treatments used for MF.

Onscreen copy: In people with intermediate- or high-risk MF, Jakafi may significantly reduce spleen size.

Dr Grad: In both trials, Jakafi was better able to reduce spleen size in patients with enlarged spleens.

Onscreen copy: Percentage of people taking Jakafi who experienced a 35% or more reduction in spleen size

Dr Grad: In the first trial, when measured after 6 months of treatment, Jakafi reduced the size of the spleen by 35% or more in 42% of people with MF. By contrast, less than 1% of people taking a placebo or sugar pill reached that goal. In the second trial, Jakafi also reduced the size of the spleen in more patients than best available therapy. You can see the results for both trials in the Full Prescribing Information or by asking your Healthcare Professional.

Dr Grad: In the first trial, 99% of people on Jakafi had a reduction in spleen size even if it was less than the 35% goal achieved by some patients. By contrast, most patients receiving placebo or a sugar pill experienced an increase in spleen size.

Onscreen copy and narrator: Jakafi is used to treat people with intermediate- or high-risk myelofibrosis (MF).

Important Safety Information is discussed later in this video.

Dr Grad: We’re going to focus now on some other data from these trials.

Results from clinical trials can be complex and understanding the data can be challenging.

If you have questions, make sure to talk to your Healthcare Professional about these data to help you understand.

Every person is unique. How your MF progresses and how you may respond to Jakafi depends on your individual circumstances.

Recall I said earlier that these patients were initially observed for a number of months in the two clinical trials we’ve been reviewing. The patients continued to be observed for several years with the goal of seeing how long they lived.

In fact, the clinical trial required that these patients be checked at regular time points of 1, 2 and 3 years.

Researchers used the data collected at 1, 2 and 3 years to generate a special type of graph that Healthcare Professionals use to understand estimates of survival.

This graph is called a Kaplan-Meier curve and it shows the likelihood that patients in the trial would still be alive at certain time points.

This is known as survival probability.

Dr Grad: You can find Kaplan Meier curves for both trials in the full Prescribing Information for Jakafi that is available online. Remember to talk to your healthcare professional to help you understand this information.

Kaplan Meier curves help to show the estimated likelihood of survival for patients who either started the clinical trials being treated with Jakafi or started on placebo or best available therapy. In both clinical trials, all patients receiving placebo or best available therapy were eventually switched to treatment with Jakafi or discontinued from the study.

Along with the Kaplan Meier curves you’ll find a list of percentages.

The researchers in the first clinical trial estimated the probability that patients would still be alive at 1, 2 and 3 years following the start of the trial. At 3 years, survival probability was estimated to be 70% for patients who started the trial taking Jakafi and 61% for those who started the trial taking a placebo.

Similar data are shown here for the second trial. At 3 years, survival probability was estimated to be 79% for patients who started the clinical trial taking Jakafi and 59% for those who started on best available therapy.

In order to really understand these data and what they may mean, you should speak with your Healthcare Professional so that he or she can explain the results to you.

Every person is unique. How you may respond to Jakafi depends on your individual circumstances.

Talk to your Healthcare Professional to learn more about the safety of Jakafi and how patients responded to the medication in clinical trials.

Onscreen text and narrator: Important Safety Information

Jakafi can cause serious side effects, including:

Low blood counts: Jakafi® (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.

Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.

Increases in cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.

The most common side effects of Jakafi include: low platelet count, low red blood cell counts, bruising, dizziness, headache.

These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB) or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, had skin cancer, or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change your dose or stop taking Jakafi without first talking to your healthcare provider. Do not drink grapefruit juice while on Jakafi.

Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.

Please see the Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You may also report side effects to Incyte Medical Information at 1-855-463-3463.

Onscreen copy: Register now for information, support, and resources. Visit Jakafi.com/Register

Onscreen text: This video is sponsored by Incyte Corporation.

Jakafi and the Jakafi logo are registered trademarks of Incyte.
© 2019, Incyte Corporation. MAT-JAK-00390   03/19

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INDICATIONS AND USAGE

INDICATIONS AND USAGE

Jakafi is a prescription medicine used to treat adults with polycythemia vera who have already taken a medicine called hydroxyurea and it did not work well enough or they could not tolerate it.

Jakafi is used to treat adults with certain types of myelofibrosis.

Jakafi is also used to treat adults and children 12 years of age and older with acute graft-versus-host disease (GVHD) who have taken corticosteroids and they did not work well enough.

Important Safety Information

Jakafi can cause serious side effects, including:

Low blood counts: Jakafi® (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.

Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.

Increases in cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.

The most common side effects of Jakafi include: for certain types of MF and PV – low platelet or red blood cell counts, bruising, dizziness, and headache; and for acute GVHD – low platelet, red or white blood cell counts, infections, and fluid retention.

These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB) or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, have high cholesterol or triglycerides, had skin cancer, or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change your dose or stop taking Jakafi without first talking to your healthcare provider.

Women should not take Jakafi while pregnant or planning to become pregnant. Do not breastfeed during treatment with Jakafi and for 2 weeks after the final dose.

Please see the Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You may also report side effects to Incyte Medical Information at 1-855-463-3463.