For steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years of age and older1

Identify Steroid-Refractory Acute GVHD (aGVHD) Early and Intervene With Jakafi

For steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years of age and older1

Identify Steroid-Refractory Acute GVHD (aGVHD) Early and Intervene With Jakafi

Jakafi Is the First and Only FDA-Approved Treatment for Patients With Steroid-Refractory aGVHD1

Majority of Evaluable Patients in REACH1 Responded

After 28 days of treatment with Jakafi, responses were achieved for the majority of patients in REACH1.1

More than half of the patients who responded by day 28 (54%; 15 of 28 patients) achieved a complete response.1

Image of a chart showing Day 28 Responses Were Achieved in the Majority of Patients Treated with Jakafi

CI, confidence interval; CR, complete response; ORR, overall response rate; PR, partial response; VGPR, very good partial response.

*Prior to the initiation of new anti-aGVHD therapy.2

Time from date of first Jakafi dosing to date when aGVHD response (CR, VGPR, or PR) was first reported, prior to initiation of new anti-aGVHD therapy.2

A ±2-day window was permitted for assessment of response; thus, the "Day 7" visit included patients assessed up to Day 9.2

Responses With Jakafi by Day 28 Across All Grades Studied

In a subgroup analysis of overall response rate at day 28, all 13 patients with Grade II acute GVHD (aGVHD) at baseline responded to treatment with Jakafi, and over 40% of patients in both the Grade III or IV aGVHD groups responded.1

Image of a graph showing Baseline Grade of aGVHD

ORR, overall response rate.

Responses With Jakafi by Day 28 Affecting All Organs

In a subgroup analysis of overall response rate at day 28, responses with Jakafi were seen across all affected organs.2

Image of a chart showing subgroup analysis of overall response rate at day 28 Image of a chart showing subgroup analysis of overall response rate at day 28

CI, confidence interval; GI, gastrointestinal; ORR, overall response rate.

Exploratory Analysis: Reduction in Steroid Dose With Jakafi

Almost half of patients in REACH1 who remained on Jakafi and steroids at day 28 were able to reduce their steroid dose by at least 50%.2

Image of a chart showing Exploratory Analysis: Reduction in On-Study Steroid Dose Image of a chart showing Exploratory Analysis: Reduction in On-Study Steroid Dose

  • The effect of Jakafi on steroid reduction is difficult to determine without a control group. Interpret these data with caution

aFor days 14, 28, 56, 100, and 180, average corticosteroid dose (mg/day) = total corticosteroid dose (mg) for the week ending on the specified study day/7.2 Corticosteroid dose (mg) = methylprednisolone dose (mg) × 1.25 + prednisone dose (mg).2
bNumber of patients taking corticosteroids among patients whose last day of Jakafi treatment was on or after the specified study day.2
cPercentage of patients still receiving Jakafi and corticosteroids who had a ≥50% decrease in corticosteroid dose relative to initial dose.2

Median Duration of Response

The median duration of response in REACH1 for patients who responded by day 28 was calculated using 2 measures, each with a different definition of disease progression:

METHOD 1) Calculated from Day 28 until need for new therapy for acute GVHD, death, or worsening in any organ by one stage compared to prior response assessment (disease progression)

For this measure, the median duration of response was 16 days (95% CI: 9, 83)

METHOD 2) Calculated from Day 28 until need for new therapy for acute GVHD, death, or increase in steroid dose from baseline (disease progression)

For this measure, the median duration of response was 173 days (95% CI: 66, NE)

Image of a chart showing Median Duration of Response Image of a chart showing Median Duration of Response

CI, confidence interval; DOR, duration of response; NE, not evaluable.

aProgression was defined as worsening by 1 stage in any organ without improvement in other organs in comparison to prior response assessment.

bIncrease from baseline dose.

Get REACH1 safety results.

References

  1. Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation.
  2. Data on file. Incyte Corporation. Wilmington, DE.

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 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 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 2 weeks after the final dose

Please see Full Prescribing Information for Jakafi.