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

Consider Jakafi at the First Sign of
Steroid-Refractory Acute GVHD (aGVHD)

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

Consider Jakafi at the First Sign of Steroid-Refractory Acute GVHD (aGVHD)

 

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

JAKAFI WAS EVALUATED IN BOTH PHASE 2 AND PHASE 3 CLINICAL STUDIES1-3

FDA approval for Jakafi for the treatments of SR aGVHD was based on the data from the REACH1 study.

Chart showing REACH1 Study Design & REACH2 Study Design Phase 3 StudyChart showing REACH1 Study Design & REACH2 Study Design Phase 3 Study

aGVHD, acute graft-versus-host disease; BID, twice daily; GVHD, graft-versus-host disease; MAGIC, Mount Sinai Acute GVHD International Consortium; ORR, overall response rate; REACH, Ruxolitinib in PatiEnts with RefrACtory Graft-Versus-Host Disease After Allogeneic Stem Cell Transplantation.

aPatients had Grade II to IV aGVHD, as defined according to MAGIC criteria, that occurred after allogeneic hematopoietic stem cell transplant.1
bTwenty-two patients were not included in the efficacy analysis because they received 2 or more prior anti-GVHD therapies (n = 12) or did not receive an adequate dose of corticosteroids (n = 10). All 71 patients were included in the safety analysis.1

GRADING CRITERIA FOR REACH STUDIES

REACH1

At Day 28, Majority of Evaluable Patients in the Phase 2 REACH1 Study Responded

Responses were achieved at Day 28 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 REACH1: ORR at Day 28 (Primary Endpoint)Image of a chart showing REACH1: ORR at Day 28 (Primary Endpoint)

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

aDefined as the proportion of patients who had a CR, VGPR, or PR at Day 28, based on the Center for International Blood and Marrow Transplant Research definitions.1

ORR AT DAY 28 BY BASELINE AGVHD GRADE

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 aGVHDImage of a graph showing Baseline Grade of aGVHD

ORR, overall response rate.

Reference

  1. Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation.

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.3

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

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

REACH1: Median Duration of Response (Key Secondary Endpoint) for Day 28 Responders

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 progression1:

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 Duration of response (DOR) assessmentImage of a chart showing Duration of response (DOR) assessment

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. Jagasia M, Perales MA, Schroeder MA, et al. Ruxolitinib for the treatment of steroid-refractory acute GVHD (REACH1): a multicenter, open-label phase 2 trial. Blood. 2020;135(20):1739-1749.
  3. 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 (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 Full Prescribing Information for Jakafi.

Jakafi and the Jakafi logo are registered trademarks of Incyte. All other trademarks are the property of their respective owners.
© 2014-2021, Incyte Corporation. MAT-JAK-02777  09/21

Jakafi and the Jakafi logo are registered trademarks of Incyte. All other trademarks are the property of their respective owners.
© 2014-2021, Incyte Corporation. MAT-JAK-02777  09/21