Unable to view this email?   Ruxolitinib: Two phase III trials demonstrating superior efficacy in spleen volume reduction in patients with myelofibrosis1,2*   *Intermediate or high-risk myelofibrosis. Dear Dr [Name], We are pleased to announce the recent publication of results from the 2 phase III clinical trials for Jakafi® (ruxolitinib) in the New England Journal of Medicine. COMFORT-I COMFORT-I was a phase III, randomized, double-blind, placebo-controlled trial in patients with myelofibrosis who were refractory to or not candidates for available therapy.1†,‡ • Significantly more patients receiving Jakafi achieved a >35% reduction from baseline in spleen volume vs those taking placebo at Week 24 (41.9% vs 0.7%, P < 0.0001)3 • A significantly higher proportion of patients receiving Jakafi had a >50% reduction in Total Symptom Score (TSS) vs those taking placebo at Week 24 (45.9% vs 5.3%, P < 0.0001)3§ — The individual symptoms that contributed to the TSS were abdominal discomfort, pain under left ribs, early satiety, night sweats, pruritus and bone/muscle pain3 • Reduction in spleen volume and improvements in TSS were seen with Jakafi in both JAK2V617F-positive and JAK2V617F-negative patients, relative to placebo1 Most patients receiving Jakafi achieved some reduction in spleen volume.4 COMFORT-I Learn more about Jakafi vs placebo COMFORT-II Learn more about Jakafi vs best available therapy Jakafi.com Visit for more information on Jakafi and myelofibrosis   Each bar represents an individual patient's response.3 Jakafi significantly improved TSS3,4 Each bar represents an individual patient's response. Worsening of TSS is truncated at 150%.3 COMFORT-II COMFORT-II was a phase III, open-label, randomized study of Jakafi vs best available therapy.2|| • Significantly more patients receiving Jakafi achieved a >35% reduction from baseline in spleen volume vs those taking best available therapy at Week 48 (28.5% vs 0.0%, P < 0.0001)3 — Best available therapy was selected by the investigator on a patient-by-patient basis. Medications received by more than 10% of patients were hydroxyurea (47%) and glucocorticoids (16%)3 † The primary endpoint was the proportion of patients achieving a >35% reduction in spleen volume from baseline to Week 24, as measured by magnetic resonance imaging (MRI) or computed tomography (CT). A key secondary endpoint was the proportion of patients achieving a >50% reduction in TSS from baseline to Week 24, as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF v2.0).1 ‡ Symptoms were measured by the MFSAF v2.0 tool, a daily diary capturing the core symptoms of myelofibrosis (abdominal discomfort, early satiety, pain under left ribs, pruritus, night sweats and bone/muscle pain). Symptom scores ranged from 0 to 10 with 0 representing symptoms "absent" and 10 representing "worst imaginable" symptoms. These scores were added to create the daily total score, which has a maximum of 60.1,3 § At baseline, the mean TSS was 18.0 in the group receiving Jakafi and 16.5 in the placebo group.3 || The primary endpoint was the proportion of patients with a >35% reduction in spleen volume from baseline to Week 48, as measured by MRI or CT.2     Indications and Usage Jakafi is indicated for treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post–polycythemia vera myelofibrosis and post–essential thrombocythemia myelofibrosis. Important Safety Information • Treatment with Jakafi can cause hematologic adverse reactions, including thrombocytopenia, anemia and neutropenia, which are each dose-related effects, with the most frequent being thrombocytopenia and anemia. A complete blood count must be performed before initiating therapy with Jakafi. Complete blood counts should be monitored as clinically indicated and dosing adjusted as required • The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache • Patients with platelet counts <200 x 109/L at the start of therapy are more likely to develop thrombocytopenia during treatment. Thrombocytopenia was generally reversible and was usually managed by reducing the dose or temporarily withholding Jakafi. If clinically indicated, platelet transfusions may be administered • Patients developing anemia may require blood transfusions. Dose modifications of Jakafi for patients developing anemia may also be considered • Neutropenia (ANC <0.5 x 109/L) was generally reversible and was managed by temporarily withholding Jakafi • Patients should be assessed for the risk of developing serious bacterial, mycobacterial, fungal and viral infections. Active serious infections should have resolved before starting Jakafi. Physicians should carefully observe patients receiving Jakafi for signs and symptoms of infection (including herpes zoster) and initiate appropriate treatment promptly • A dose modification is recommended when administering Jakafi with strong CYP3A4 inhibitors or in patients with renal or hepatic impairment [see Dosage and Administration]. Patients should be closely monitored and the dose titrated based on safety and efficacy • There are no adequate and well-controlled studies of Jakafi in pregnant women. 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 breast-feed. Discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother Please see Full Prescribing Information. References: 1. Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012;366:799-807. 2. Harrison C, Kiladjian JJ, Al-Ali HK, et al. JAK inhibition with ruxolitinib vs best available therapy for myelofibrosis. N Engl J Med. 2012;366:787-798. 3. Jakafi Prescribing Information. Incyte Corporation. November 2011. 4. Data on file. Incyte Corporation.     Jakafi is a trademark of Incyte Corporation. © 2012, Incyte Corporation. All rights reserved. RUX-1016F 04/12   Incyte Corporation P.O. Box 4689 Trenton, NJ 08650 For more information, please contact us at 1-855-4-Jakafi (855-452-5234).