The Results of a Clinical Trial With Jakafi in Steroid-Refractory Acute GVHD


Understanding how Jakafi was evaluated in a clinical trial

Hear about the results of the REACH1 clinical trial for Jakafi® (ruxolitinib) in patients with acute graft-versus-host disease (GVHD) who did not respond well to treatment with steroids.

Video Transcript

Onscreen text and narrator: For Patients With Steroid-Refractory Acute Graft-Versus-Host Disease: The Results of a Clinical Trial With Jakafi® (ruxolitinib)

Onscreen text and narrator: Jakafi® (ruxolitinib) is the first and only prescription medicine approved by the FDA 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 is discussed later in this video.

Onscreen text and narrator: This video is intended for informational use only and is not medical advice. Your Healthcare Professional is the best source for treatment-related questions and medical advice.

Emily: Hi. I’m Emily Knight, an oncology clinical nurse educator for Incyte. For more than 14 years prior to joining Incyte, I worked with patients who had cancer, as well as patients who had stem cell transplants, including those who experienced acute graft-versus-host disease or GVHD.

Emily: Before a medicine can be approved for Healthcare Professionals to prescribe, researchers perform studies called clinical trials. These studies help us to understand how medicines work in people with specific conditions and what side effects they may cause.

Emily: Jakafi, also known as ruxolitinib, was studied in a clinical trial called REACH1.

Emily: As you may know, acute GVHD is a serious complication that can affect people who’ve had a stem cell or bone marrow transplant using cells from another person.

Emily: The most common symptoms of acute GVHD are…skin rashes, which can affect all parts of the body; gastrointestinal problems, like nausea or diarrhea; and liver issues that can be identified with blood tests.

Onscreen text: Approximately half of patients do not respond well enough to steroids.

Emily: These problems can become severe if acute GVHD progresses. Typically, patients with acute GVHD are treated with steroids. But about half of these patients just don’t respond well enough to them and may need another treatment.

Emily: Jakafi is a medicine that works differently than steroids.

Emily: Jakafi was studied in a clinical trial called the REACH1 trial, which enrolled 71 patients with acute GVHD who were not responding well to steroids with or without other medicines that suppress the immune system. All patients were treated with Jakafi. Forty-nine patients who had steroid-refractory acute GVHD, meaning that they had not responded to steroid treatment alone, were evaluated to see how well treatment worked. These 49 patients had moderate to severe acute GVHD, based on their signs and symptoms.

Emily: Doctors grade the severity of acute GVHD from 0, meaning no signs or symptoms, to 4, meaning severe.

Emily: In the REACH 1 study, the 49 patients had Grades 2, 3, or 4 acute GVHD. That’s considered moderate to severe acute GVHD.

Emily: During the trial, each patient continued taking their steroids and other medicines that suppress the immune system and were also given Jakafi.

Onscreen text: 57% (28 of 49 patients) had a response with Jakafi at 1 month

Emily: Researchers looked at how well Jakafi worked after one month of treatment. About 57%, or 28 of the 49 patients, who hadn’t responded to steroids alone did respond to the Jakafi treatment added to their regimen.

Emily: Of note is that these responders to Jakafi treatment included all patients who had Grade 2, or moderate, acute GVHD symptoms.

Emily: It also included 40% of the patients with Grade 3 and 44% of patients with Grade 4 acute GVHD.

Emily: Of the patients who responded at 1 month, 68% (19 of 28 patients) showed a response within 7 days.

Emily: More than half, or 15 of these 28 patients who responded to Jakafi, had a complete response—meaning all of their signs and symptoms went away.

Emily: The remaining patients experienced improvement in some of their signs and symptoms, without worsening or new symptoms in another organ.

Onscreen text: For 47% (14 of 30 patients), steroid dose reduced by half or more

Emily: Another point to note: While it was not the main focus of the study, doctors also looked to see what happened to patients’ steroid doses when the patients were also treated with Jakafi. Among patients who were still taking both a steroid and Jakafi at one month, about 47%, or 14 out of 30, were able to have their steroid dose reduced by half or more.

Emily: Not everyone responds the same way to Jakafi and your results may vary. Talk to your Transplant Team if you have questions or to discuss whether Jakafi may be right for you.

Emily: Like all clinical trials, this one also looked for any side effects the patients experienced while taking Jakafi. The most common side effects included low blood counts, infection, and fluid retention.

Emily: Now let's review the Important Safety Information for Jakafi.

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: for certain types of MF and PV – low platelet or red blood cell counts, bruising, dizziness, headache, and diarrhea; 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.

Emily: Visit jakafi.com to learn more about the possible risks and benefits of Jakafi for the treatment of acute GVHD for patients who have already taken corticosteroids and they did not work well enough.

Onscreen text: Please visit Jakafi.com to learn more.

This video is sponsored by Incyte Corporation.
Jakafi and the Jakafi logo are registered trademarks of Incyte.
© 2020, Incyte Corporation. MAT-JAK-00502  03/20

Expand Collapse

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, headache, and diarrhea; 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.