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Jakafi is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults.1

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Jakafi® (ruxolitinib) Efficacy and Safety Data in Patients With Intermediate-1–Risk MF Brochure

See data about the efficacy and safety of Jakafi across the COMFORT-I and COMFORT-II studies, as well as the JUMP study.

Image of texts that says COMFORT-I Primary Endpoint*Image of texts that says COMFORT-I Primary Endpoint*

  • 4.4 yearsmedian duration of spleen response among primary responders (n = 65)3†

Image of texts that says COMFORT-II Primary Endpoint*Image of texts that says COMFORT-II Primary Endpoint*

  • 4.4 years median duration of spleen response among primary responders (n = 65)

COMFORT-I hematologic adverse reactions1,2

COMFORT-I Hematologic Adverse Reactions

  • The most frequently observed reactions were anemia and thrombocytopenia1,2
  • Perform a pre-treatment complete blood count (CBC), and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated1

COMFORT-I nonhematologic adverse reactions1,4

COMFORT-I nonhematologic adverse reactions1,3

COMFORT-I Nonhematologic Adverse Reactions

ALT, alanine transaminase; AST, aspartate transaminase.

JUMP Expanded-Access Study

JUMP study design5

  • JUMP (JAK Inhibitor RUxolitinib in Myelofibrosis Patients) was a single-arm, open-label, phase 3b expanded-access study that enrolled adult patients with primary or secondary MF classified as intermediate-1–, intermediate-2–, or high-risk MF. Patients with intermediate-1–risk MF were required to have a palpable spleen (≥5 cm from the coastal margin)
    • The study enrolled 2233 patients. At study entry, 835 patients had intermediate-1–risk MF, 755 patients had intermediate-2–risk MF, and 194 patients had high-risk MF#II
  • The primary endpoint was assessment of Jakafi safety and tolerability by the frequency, duration, and severity of adverse events. Additional endpoints included the proportion of patients with ≥50% reduction in palpable spleen length

JUMP Safety Data

JUMP hematologic adverse events4,5

JUMP hematologic adverse events3,5

Image that shows Hematologic Adverse Events in the JUMP TrialImage that shows Hematologic Adverse Events in the JUMP Trial

JUMP nonhematologic adverse events4,5

JUMP nonhematologic adverse events3,5

Image that shows Nonhematologic Adverse Events in the JUMP TrialImage that shows Nonhematologic Adverse Events in the JUMP Trial

In the overall JUMP population, the safety profile was generally consistent with previous reports for Jakafi

  • 58% of all enrolled patients (n = 1283) completed treatment per protocol5
    • Completing treatment was defined as undergoing treatment for up to 24 months after the last patient’s first visit or transitioning to a commercial drug
  • The most common adverse events leading to discontinuation were thrombocytopenia (3%, 58/1784) and anemia (2%, 35/1784)4

In the overall JUMP population, the safety profile was generally consistent with previous reports for Jakafi

  • 58% of all enrolled patients (n = 1283) completed treatment per protocol5
    • Completing treatment was defined as undergoing treatment for up to 24 months after the last patient’s first visit or transitioning to a commercial drug
  • The most common adverse events leading to discontinuation were thrombocytopenia (3%, 58/1784) and anemia (2%, 35/1784)3

JUMP Efficacy Data: Reduction in Spleen Length by Disease Severity

  • At week 96, 67% (423/636) of efficacy evaluable patients achieved a ≥50% reduction from baseline in palpable spleen length5

Intermediate-1–risk MF and intermediate-2–risk MF to high-risk MF4,5

Intermediate-1–risk MF and intermediate-2–risk MF to high-risk MF3,5

Intermediate-1–risk MF and intermediate-2–risk MF to high-risk MFIntermediate-1–risk MF and intermediate-2–risk MF to high-risk MF

Intermediate-1–risk MF4

Intermediate-1–risk MF3

Image showing percentage change in spleen volume in individual patients from baseline to week 24Image showing percentage change in spleen volume in individual patients from baseline to week 24

of patients experienced a reduction in palpable spleen length through the end of the study4

Study Brochure

Study Brochure

Image of Dr Gary Grad

Jakafi® (ruxolitinib) Efficacy and Safety in Patients with Intermediate-1–Risk MF

Read more about the efficacy and safety of Jakafi across multiple clinical trials. Included are data from the COMFORT-I and COMFORT-II studies, as well as the JUMP trial, which included intermediate-1–risk patients.

*COMFORT-I (COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment-I) was a randomized, double-blind, placebo-controlled phase 3 study with 309 patients with intermediate-2–risk or high-risk MF. The primary endpoint was the proportion of patients achieving a ≥35% reduction in spleen volume from baseline at week 24 as measured by computed tomography (CT) or magnetic resonance imaging (MRI).1,2

COMFORT-II (COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment-II) was a randomized, open-label, phase 3 study with 219 patients with intermediate-2–risk or high-risk MF. The primary endpoint was the proportion of patients achieving a ≥35% reduction in spleen volume from baseline at week 48 as measured by CT or MRI.1,3

Best available therapy in COMFORT-II included hydroxyurea (46.6%) and glucocorticoids (16.4%), as well as no medication, anagrelide, epoetin alfa, thalidomide, lenalidomide, mercaptopurine, thioguanine, danazol, peginterferon alfa-2a, interferon-α, melphalan, acetylsalicylic acid, cytarabine, and colchicine.4

§Duration of spleen response was defined as the interval between the first spleen volume measurement that was a ≥35% reduction from baseline and the date of the first measurement that was no longer a ≥35% reduction from baseline that was also a >25% increase from nadir.4

These lab values represent "new or worsening."

#Dynamic International Prognostic Scoring System (DIPSS) scores determined using patient characteristics at baseline. Results are based on a 07/05/17 cutoff date.

IIPatients who were not classified into a risk group (n = 389) and patients with low-risk MF (n = 60) are not included in the data shown.5

*COMFORT-I (COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment-I) was a randomized, double-blind, placebo-controlled phase 3 study with 309 patients with intermediate-2–risk or high-risk MF. The primary endpoint was the proportion of patients achieving a ≥35% reduction in spleen volume from baseline at week 24 as measured by computed tomography (CT) or magnetic resonance imaging (MRI).1,2

Duration of spleen response was defined as the interval between the first spleen volume measurement that was a ≥35% reduction from baseline and the date of the first measurement that was no longer a ≥35% reduction from baseline that was also a >25% increase from nadir.3

COMFORT-II (COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment-II) was a randomized, open-label, phase 3 study with 219 patients with intermediate-2–risk or high-risk MF. The primary endpoint was the proportion of patients achieving a ≥35% reduction in spleen volume from baseline at week 48 as measured by CT or MRI.1,4

§Best available therapy in COMFORT-II included hydroxyurea (46.6%) and glucocorticoids (16.4%), as well as no medication, anagrelide, epoetin alfa, thalidomide, lenalidomide, mercaptopurine, thioguanine, danazol, peginterferon alfa-2a, interferon-α, melphalan, acetylsalicylic acid, cytarabine, and colchicine.3

These lab values represent “new or worsening.”

#Dynamic International Prognostic Scoring System (DIPSS) scores determined using patient characteristics at baseline. Results are based on a 07/05/17 cutoff date.

IIPatients who were not classified into a risk group (n = 389) and patients with low-risk MF (n = 60) are not included in the data shown.5

References

  1. Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation.
  2. Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012;366(9):799-807.
  3. Harrison C, Kiladjian J-J, Al-Ali HK, et al. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med. 2012;366(9):787-798.
  4. Data on file. Incyte Corporation. Wilmington, DE.
  5. Al-Ali HK, Greisshammer M, Foltz L, et al. Primary analysis of JUMP, a phase 3b, expanded-access study evaluating the safety and efficacy of ruxolitinib in patients with myelofibrosis, including those with low platelet counts. Br J Haematol. 2020;189(5):888-903.

References

  1. Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation.
  2. Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012;366(9):799-807.
  3. Data on file. Incyte Corporation. Wilmington, DE.
  4. Harrison C, Kiladjian J-J, Al-Ali HK, et al. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med. 2012;366(9):787-798.
  5. Al-Ali HK, Greisshammer M, Foltz L, et al. Primary analysis of JUMP, a phase 3b, expanded-access study evaluating the safety and efficacy of ruxolitinib in patients with myelofibrosis, including those with low platelet counts. Br J Haematol. 2020;189(5):888-903.

Indications and Usage

Jakafi is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.

Jakafi is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults.

Jakafi is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older.

Jakafi is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Important Safety Information

  • Treatment with Jakafi® (ruxolitinib) can cause thrombocytopenia, anemia and neutropenia, which are each dose-related effects. Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated
  • Manage thrombocytopenia by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary
  • Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi
  • Severe neutropenia (ANC <0.5 × 109/L) was generally reversible by withholding Jakafi until recovery
  • Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay starting Jakafi until active serious infections have resolved. Observe patients receiving Jakafi for signs and symptoms of infection and manage promptly. Use active surveillance and prophylactic antibiotics according to clinical guidelines
  • Tuberculosis (TB) infection has been reported. Observe patients taking Jakafi for signs and symptoms of active TB and manage promptly. Prior to initiating Jakafi, evaluate patients for TB risk factors and test those at higher risk for latent infection. Consult a physician with expertise in the treatment of TB before starting Jakafi in patients with evidence of active or latent TB. Continuation of Jakafi during treatment of active TB should be based on the overall risk-benefit determination
  • Progressive multifocal leukoencephalopathy (PML) has occurred with Jakafi treatment. If PML is suspected, stop Jakafi and evaluate
  • Advise patients about early signs and symptoms of herpes zoster and to seek early treatment
  • Increases in hepatitis B viral load with or without associated elevations in alanine aminotransferase and aspartate aminotransferase have been reported in patients with chronic hepatitis B virus (HBV) infections. Monitor and treat patients with chronic HBV infection according to clinical guidelines
  • When discontinuing Jakafi, myeloproliferative neoplasm-related symptoms may return within one week. After discontinuation, some patients with myelofibrosis have experienced fever, respiratory distress, hypotension, DIC, or multi-organ failure. If any of these occur after discontinuation or while tapering Jakafi, evaluate and treat any intercurrent illness and consider restarting or increasing the dose of Jakafi. Instruct patients not to interrupt or discontinue Jakafi without consulting their physician. When discontinuing or interrupting Jakafi for reasons other than thrombocytopenia or neutropenia, consider gradual tapering rather than abrupt discontinuation
  • Non-melanoma skin cancers (NMSC) including basal cell, squamous cell, and Merkel cell carcinoma have occurred. Perform periodic skin examinations
  • Treatment with Jakafi has been associated with increases in total cholesterol, low-density lipoprotein cholesterol, and triglycerides. Assess lipid parameters 8-12 weeks after initiating Jakafi. Monitor and treat according to clinical guidelines for the management of hyperlipidemia
  • Another JAK-inhibitor has increased the risk of major adverse cardiovascular events (MACE), including cardiovascular death, myocardial infarction, and stroke (compared to those treated with tumor TNF blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Jakafi 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
  • Another JAK-inhibitor has increased the risk of thrombosis, including deep venous thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated. In patients with myelofibrosis (MF) and polycythemia vera (PV) treated with Jakafi in clinical trials, the rates of thromboembolic events were similar in Jakafi and control treated patients. Patients with symptoms of thrombosis should be promptly evaluated and treated appropriately
  • Another JAK-inhibitor has increased the risk of lymphoma and other malignancies excluding NMSC (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated. 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 Jakafi, particularly in patients with a known secondary malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers
  • In myelofibrosis and polycythemia vera, the most common nonhematologic adverse reactions (incidence ≥15%) were bruising, dizziness, headache, and diarrhea. In acute graft-versus-host disease, the most common nonhematologic adverse reactions (incidence >50%) were infections (pathogen not specified) and edema. In chronic graft-versus-host disease, the most common nonhematologic adverse reactions (incidence ≥20%) were infections (pathogen not specified) and viral infections
  • Avoid concomitant use with fluconazole doses greater than 200 mg. Dose modifications may be required when administering Jakafi with fluconazole doses of 200 mg or less, or with strong CYP3A4 inhibitors, or in patients with renal or hepatic impairment. Patients should be closely monitored and the dose titrated based on safety and efficacy
  • Use of Jakafi during pregnancy is not recommended and should only be used if the potential benefit justifies the potential risk to the fetus. Women taking Jakafi should not breastfeed during treatment and for 2 weeks after the final dose

Please see accompanying Full Prescribing Information for Jakafi.