Jakafi^® (ruxolitinib) safety and tolerability data: JUMP expanded-access study^1,2

JUMP study design¹

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 costal 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*^†
The primary endpoint was assessment of Jakafi safety and tolerability by the frequency, duration, and severity of AEs. Additional endpoints included the proportion of patients with ≥50% reduction in palpable spleen length

JUMP hematologic AEs^1,2

^aDIPSS scores were determined using patient characteristics at baseline. Results are based on a 07/05/17 cutoff date.¹

JUMP hematologic AEs^1,2

^aDIPSS scores were determined using patient characteristics at baseline. Results are based on a 07/05/17 cutoff date.¹

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 protocol¹
- 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 AEs leading to discontinuation were thrombocytopenia (3%, 58/1784) and anemia (2%, 35/1784)²

Reduction in spleen length by disease severity

JUMP efficacy data

At week 96, 67% (423/636) of efficacy-evaluable patients achieved a ≥50% reduction from baseline in palpable spleen length¹

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

Reduction in Palpable Spleen Length Over Time^a

^aPatients 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.¹

Intermediate-1–risk MF²

Best Percentage Change From Baseline in Palpable Spleen Length Through End of Study

Graph Spleen Length Percentage Change From Baseline

One question I am often asked is … would I initiate Jakafi for my intermediate-1–risk patients or those appropriate patients who are earlier in the course of the disease? And my answer is yes.

HEAR HOW DR FAZAL TREATS HIS INTERMEDIATE-1–RISK PATIENTS

EARLIER VS LATER
INTERVENTION EXPLORE OS DATA

*DIPSS scores were determined using patient characteristics at baseline. Results are based on a 07/05/17 cutoff date.¹

^†Patients 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.¹

AE=adverse event; DIPSS=Dynamic International Prognostic Scoring System; MF=myelofibrosis; OS=overall survival.

References: 1. Al-Ali HK, Griesshammer 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. 2. Data on file. Incyte Corporation. Wilmington, DE.

Indications and Usage

Jakafi^® (ruxolitinib) 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 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
Herpes zoster infection has been reported in patients receiving Jakafi. Advise patients about early signs and symptoms of herpes zoster and to seek early treatment. Herpes simplex virus reactivation and/or dissemination has been reported in patients receiving Jakafi. Monitor patients for the development of herpes simplex infections. If a patient develops evidence of dissemination of herpes simplex, consider interrupting treatment with Jakafi; patients should be promptly treated and monitored according to clinical guidelines
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.