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Your patients may have higher risk disease than you realize


MF, similar to other malignancies, is a serious disease that may require active management at diagnosis.1


aFive-year overall survival rates were estimated using SEER data obtained from population-based cancer registries of the US population and SEER*Stat Software version 8.3.2. The analysis included patients with initial/primary site diagnosis between years 2007-2011. Overall survival is defined as the time from diagnosis until death from any cause.


In MF, the presence of any of the following risk factors* indicates that a patient is already intermediate risk3,4:

  • Hemoglobin level <10 g/dL
  • Leukocyte count >25 × 109/L
  • Age >65 years
  • Red cell transfusion dependency
  • Circulating blast cells ≥1%
  • Platelet count <100 × 109/L
  • Constitutional symptoms
  • Unfavorable karyotype

*As included in the Dynamic International Prognostic Scoring System Plus tool.

In a study of patients with primary MF, approximately 90% (375/428) of evaluable patients were considered to be intermediate or high risk within 1 year of diagnosis4

Image of graphic that reads – 90% In a study of patients with primary MF, approximately 90% (375/428) of evaluable patients were considered to be intermediate or high risk within 1 year of diagnosis

In a study of patients with primary MF, approximately 90% (375/428) of evaluable patients were considered to be intermediate or high risk within 1 year of diagnosis4

Consider one of your patients with myelofibrosis

Which risk factors does your patient have?

As the clinical understanding of myelofibrosis has evolved, a variety of prognostic systems have been developed.3

All of the systems utilize a group of risk factors to assign risk level (low, intermediate, or high) which may be useful in counseling patients with MF and deciding on therapeutic approach.3-5

One of these systems, DIPSS Plus, is based on 8 risk factors, including karyotype, transfusion dependency, and platelet count less than 100 × 109/L.4

Select as many risk factors as apply for your patient. When done, click "Submit." To consider another patient, click "Reset."

 
 

As included in the Dynamic International Prognostic Scoring System Plus tool.


SUBMIT RESET Scroll down to see results.

FOR EDUCATIONAL PURPOSES ONLY. This does not take the place of a physician’s clinical judgment. Results provide a suggested approach to risk assessment and are not a substitute for a series of clinical decisions over time for each individual patient.

Dynamic International Prognostic Scoring System Plus4

Risk Factors
Risk Stratification
Median Life Expectancy
0
Low Risk
15.4 years
1
Intermediate-1
6.5 years
2-3
Intermediate-2
2.9 years
4 or more
High Risk
1.3 years

Adapted from Gangat, J Clin Oncol. 2011; 29:392-397.4

Actively manage your patients by intervening at diagnosis.

…of patients with primary MF may be appropriate for treatment with Jakafi

Image of graphic that reads – 90% …of patients with primary MF may be appropriate for treatment with Jakafi

…of patients with primary MF may be appropriate for treatment with Jakafi

Based on a study of patients with primary MF, approximately 90% (375/428) of evaluable patients were considered to be intermediate or high risk within 1 year of diagnosis.4



New or increasing splenomegaly is considered to be a marker of disease progression in myelofibrosis.6

IWG-MRT and ELN response criteria state that a palpable spleen extending ≥5 cm below the left costal margin constitutes progressive disease

  • Splenomegaly can cause/exacerbate cytopenias due to splenic sequestration7
  • Splenomegaly may cause pain, early satiety, abdominal discomfort, and other symptoms7,8
  • In a pooled overall survival analysis of 528 patients from the COMFORT||¶ trials, larger baseline spleen volume was associated with incremental increases in the risk of death over 3 years, irrespective of treatment9#

In a study of 1,054 patients with primary myelofibrosis, approximately 90% of patients for whom data were available had palpable splenomegaly at diagnosis3**

Image of graphic that reads – 90% … In a study of 1,054 patients with primary myelofibrosis, approximately 90% of patients for whom data were available had a palpable splenomegaly at diagnosis

In a study of 1,054 patients with primary myelofibrosis, approximately 90% of patients for whom data were available had palpable splenomegaly at diagnosis3**

§Progressive disease assignment for splenomegaly requires confirmation by CT or MRI showing a ≥25% increase in spleen volume from baseline. Baseline values for both physical examination and imaging studies refer to pretreatment baseline and not to posttreatment measurements.6

||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 myelofibrosis. The primary end point was the proportion of subjects achieving a ≥35% reduction in spleen volume from baseline to week 24 as measured by CT or MRI.10,11

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 myelofibrosis. The primary end point was the proportion of patients achieving a ≥35% reduction in spleen volume from baseline at week 48 as measured by CT or MRI.10,12

#14% increase in risk of death for each additional 5 dL of spleen volume at baseline (hazard ratio, 1.14; 95% confidence interval, 1.07-1.21).9

**Data were available for 768 patients, 681 of whom had palpable spleen.3

References

  1. Barbui T, Barosi G, Birgegard G, et al. Philadelphia-negative classical myeloproliferative neoplasms: critical concepts and management recommendations from European LeukemiaNet. J Clin Oncol. 2011;29(6):761-770.
  2. Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database: Incidence - SEER 18 Regs Research Data + Hurricane Katrina Impacted Louisiana Cases, November 2015 Submission (1973-2013 varying) - Linked To County Attributes - Total U.S., 1969-2014 Counties. Accessed January 4, 2017.
  3. Cervantes F, Dupriez B, Pereira A, et al. New prognostic scoring system for primary myelofibrosis based on a study of the International Working Group for Myelofibrosis Research and Treatment. Blood. 2009;113(13):2895-2901.
  4. Gangat N, Caramazza D, Vaidya R, et al. DIPSS plus: a refined Dynamic International Prognostic Scoring System for primary myelofibrosis that incorporates prognostic information from karyotype, platelet count, and transfusion status. J Clin Oncol. 2011;29(4):392-397.
  5. Passamonti F, Cervantes F, Vannucchi AM, et al. A dynamic prognostic model to predict survival in primary myelofibrosis: a study by the IWG-MRT (International Working Group for Myeloproliferative Neoplasms Research and Treatment). Blood. 2010;115(9):1703-1708.
  6. Tefferi A, Cervantes F, Mesa R, et al. Revised response criteria for myelofibrosis: International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) consensus report. Blood. 2013;122(8):1395-1398.
  7. Mesa RA. How I treat symptomatic splenomegaly in patients with myelofibrosis. Blood. 2009;113(22):5394-5400.
  8. Scherber RM, Geyer HL, Mesa RA. Quality of life in MPN comes of age as a therapeutic target. Curr Hematol Malig Rep. 2014;9(4):324-330.
  9. Vannucchi AM, Kantarjian HM, Kiladjian JJ, et al; on behalf of the COMFORT Investigators. A pooled analysis of overall survival in COMFORT-I and COMFORT-II, 2 randomized phase III trials of ruxolitinib for the treatment of myelofibrosis. Haematologica. 2015;100(9):1139-1145.
  10. Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation.
  11. 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.
  12. 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.

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 (GVHD) 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 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
  • In myelofibrosis and polycythemia vera, the three most common nonhematologic adverse reactions (incidence >10%) were bruising, dizziness and headache. In acute graft-versus-host disease, the most common nonhematologic adverse reactions (incidence >50%) were infections and edema
  • Dose modifications may be required when administering Jakafi with strong CYP3A4 inhibitors or fluconazole 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 two weeks after the final dose

Please see Full Prescribing Information for Jakafi.