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Clinical trial design and results for OJJAARA

The safety and efficacy of OJJAARA were studied in two clinical trials.

Not actual patient.

Two different groups of people who have myelofibrosis with anemia (Hb <10 g/dL) took part in two 24-week clinical trials testing OJJAARA against two other treatments:

Study 1 included 195 people with MF symptoms and anemia who had taken a JAK inhibitor before

  • 130 people were given OJJAARA

  • 65 people were given danazol

The primary goal of STUDY 1 was to compare the percentage of people treated with OJJAARA or danazol who reduced their overall myelofibrosis symptom score* by 50% or more from the start of the study to Week 24. Secondary goals were comparing the percentage of people who reduced their spleen size by 35% or more and to see if the percentage of people who were transfusion independent† was similar in both treatment groups between Weeks 12 and 24.

Reduced MF symptom score by 50% or more

  • 25% of people taking OJJAARA

  • 9% of people taking danazol

Reduced spleen size by 35% or more

  • 22% of people taking OJJAARA

  • 3% of people taking danazol

Transfusion independence between weeks 12 and 24

  • 30% of people taking OJJAARA

  • 20% of people taking danazol

After 24 weeks of treatment, this study showed that, of the people taking OJJAARA: 1 in 4 had a reduced symptom score, over 1 in 5 had a reduced spleen size, and close to 1 in 3 experienced transfusion independence. Individual patient results may vary.

*The symptom score was measured using a form that tracked myelofibrosis symptoms like fatigue, night sweats, bone pain, and others during treatment.

†Transfusion independence meant no RBC transfusions were needed and all Hb levels were ≥8 g/dL during the time period between Weeks 12 and 24.

Study 2 included 432 people with MF with an enlarged spleen who had never taken a JAK inhibitor before

From this study, a smaller group of 181 patients who had anemia (Hb <10 g/dL) at the start of the study were evaluated.

  • 86 people were given OJJAARA

  • 95 people were given ruxolitinib

A goal of this study was to see if OJJAARA was similar to ruxolitinib in reducing spleen size in people who have myelofibrosis with anemia. This means that a similar percentage of people in both groups would see a reduction in spleen size of 35% or more at Week 24 compared to the start of the study.

 

In STUDY 2, how well OJJAARA worked in patients who had myelofibrosis with anemia was based on spleen size reduction. After 24 weeks of treatment, this study showed that, of the people taking OJJAARA, almost 1 in 3 had a reduced spleen size and 1 in 4 had a reduced symptom score. Individual patient results may vary.

Hb=hemoglobin; JAK=Janus kinase; MF=myelofibrosis; RBC=red blood cell.

Similar spleen size reduction of 35% or more

  • 31% of people with anemia taking OJJAARA

  • 33% of people with anemia taking ruxolitinib

A lower percentage of patients had their total symptom score reduced by 50% or more when treated with OJJAARA (25%) compared with ruxolitinib (36%) at Week 24.

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APPROVED USE & SAFETY INFO

APPROVED USE

IMPORTANT SAFETY INFORMATION

APPROVED USE

OJJAARA is a prescription medicine used to treat adults with certain types of myelofibrosis (MF) who have anemia. It is not known if OJJAARA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

OJJAARA may cause serious side effects, including:

  • Risk of Infections. People who take OJJAARA may develop serious infections that can lead to death, such as bacterial and viral infections, including COVID-19. If you have an active infection, your healthcare provider should not start treatment with OJJAARA until your infection is gone. If you have had hepatitis B for a long time (chronic), OJJAARA may cause your hepatitis B to become active again, and your healthcare provider will check your blood for active hepatitis B before starting treatment. Your healthcare provider will monitor you and treat you for any infections that you get during treatment with OJJAARA. Tell your healthcare provider right away if you develop any of the following symptoms of infection:
    • fever
    • chills
    • cough
    • breathing problems
    • diarrhea
    • vomiting
    • pain or burning feeling when passing urine

  • Low platelet and white blood cell counts. OJJAARA may cause new or worsening low platelet and white blood cell counts. Low platelet counts may increase your risk for bleeding and low white blood cell counts may increase your risk for infection. Your healthcare provider will do blood tests to check your blood counts before you start taking OJJAARA and during treatment. Tell your healthcare provider right away if you have any signs of bleeding during treatment with OJJAARA, including:
    • unusual bleeding
    • black or tarry stools
    • bruising

  • Liver problems. OJJAARA may cause new or worsening increased liver enzymes and bilirubin in your blood. Your healthcare provider will check your liver enzymes before starting treatment, every month for the first 6 months of treatment, and then as needed during treatment with OJJAARA. Your healthcare provider may stop treatment with OJJAARA if your liver enzymes increase. Tell your healthcare provider if you develop any of the following signs or symptoms of liver problems:
    • tiredness
    • loss of appetite
    • pain in your right upper stomach area (abdomen)
    • dark urine
    • yellowing of your skin or the white part of your eyes

  • Major cardiovascular events such as heart attack, stroke, and death. Major cardiac events have happened, especially in people with cardiac risk factors and who are current or past smokers, taking another Janus kinase (JAK) inhibitor to treat rheumatoid arthritis. OJJAARA is in the JAK family of medicines. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking OJJAARA, including:
    • discomfort in your chest that lasts for more than a few minutes, or that goes away and comes back
    • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
    • pain or discomfort in your arms, back, neck, jaw, or stomach
    • shortness of breath with or without chest discomfort
    • breaking out in a cold sweat
    • nausea or vomiting
    • feeling lightheaded
    • weakness in one part or on one side of your body
    • slurred speech

  • Blood clots. Blood clots in the veins of the legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) have happened in some people taking another JAK inhibitor to treat rheumatoid arthritis, and may be life-threatening. Tell your healthcare provider if you have had blood clots in the veins of your legs or lungs in the past. Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with OJJAARA, including:
    • swelling, pain, or tenderness in one or both legs
    • sudden, unexplained chest pain
    • shortness of breath or difficulty breathing

  • New cancers. New cancers, including lymphoma and other cancers, except non-melanoma skin cancer, have happened in some people taking another JAK inhibitor to treat rheumatoid arthritis. The risk of new cancers is further increased in people who smoke or who smoked in the past.

 

The most common side effects of OJJAARA include:

  • low platelet count
  • bleeding
  • bacterial infection
  • tiredness
  • dizziness
  • diarrhea
  • nausea

 

These are not all the possible side effects of OJJAARA. Call your doctor for medical advice about side effects.

 

Before taking OJJAARA, tell your healthcare provider about all your medical conditions, including if you:

  • have an infection
  • have or have had hepatitis B
  • have or have had liver problems
  • have had a heart attack, or have or have had other heart problems, or stroke
  • have or have had a blood clot
  • smoke or were a smoker in the past
  • have or have had any other cancers
  • are pregnant or plan to become pregnant. OJJAARA may harm your unborn baby.
    Females who are able to become pregnant:
    • You should use effective birth control (contraception) during treatment and for 1 week after the last dose of OJJAARA.
    • Tell your healthcare provider right away if you think you are pregnant or become pregnant during treatment with OJJAARA.
  • are breastfeeding or plan to breastfeed. It is not known if OJJAARA passes into your breast milk. You should not breastfeed during treatment and for 1 week after the last dose of OJJAARA. Talk to your healthcare provider about the best way to feed your baby during this time.

 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking OJJAARA with certain other medicines may affect the amount of OJJAARA or the other medicines in your blood and may increase your risk of side effects.

 

Please see full Prescribing Information, including Patient Information for patients.

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 negative side effects to GSK at gsk.public.reportum.com or 1-888-825-5249.
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If you don’t have prescription coverage or need help paying for your medicines, call us at 1-844-4GSK-ONC (1-844-447-5662).