ASH Clinical News July 2017 V2 - Page 26

Literature Scan

Pomalidomide Does Not Significantly Improve RBC Transfusion Needs in Myelofibrosis

Anemia occurs commonly in patients with myeloproliferative neoplasm ( MPN ) -associated myelofibrosis ( MF ), and such patients are often red blood cell ( RBC ) transfusion-dependent . No therapy approved by the U . S . Food and Drug Administration is particularly effective at treating MF-associated anemia .
In a study published in Leukemia , Ayalew Tefferi , MD , from the Division of Hematology in the Department of Internal Medicine at the Mayo Clinic College of Medicine in Rochester , Minnesota , and co-authors examined whether treatment with the immunemodulating drug pomalidomide could increase the proportion of patients achieving RBC transfusion independence , compared with placebo .
Results from previous trials comparing different doses of pomalidomide ( 2.0 or 0.5 mg / day ), with or without prednisone , in this setting suggested that a lower dose of pomalidomide alone was associated with a high platelet response rate , prompting Dr . Tefferi and colleagues to confirm response rates with pomalidomide 0.5 mg in this multicenter , randomized , double-blind , parallel-group , placebo-controlled phase III study . patients were RBC transfusion-dependent ( defined as an average RBC transfusion frequency of ≥2 U / 28 days over ≥84 days immediately prior to randomization , with no interval of > 42 days without ≥1 RBC transfusion ) and had a hemoglobin concentration ≤13.0 g / dL at randomization . Patients were excluded if they had received
RBC transfusions because of bleeding or chemotherapy- or radiation-induced anemia or if they had received thalidomide , lenalidomide , bone marrow suppressants , or any investigational drug within 1 month of randomization .
Patients were randomized 2:1 to receive oral pomalidomide 0.5 mg / day ( n = 152 ) or placebo ( n = 77 ).
The authors found that the rates of transfusion independence were similar

Kogenate ® FS : His life . His treatment .

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■ For use as on-demand treatment in adults and children with hemophilia A
■ Is covered by all major insurance companies
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✓ $ 0 Co-pay Program : Eligible patients can receive up to $ 12,000 in assistance per year
✓ Live Helpline Support : Patients can call for answers to any insurance coverage questions
You and your patients can connect with a Bayer Access Solutions Case Specialist at 1-800-288-8374
8:00 AM – 8:00 PM ( ET ) Monday – Friday

“We conclude no efficacy of pomalidomide in reversing red blood cell transfusion dependence .”

— AYALEW TEFFERI , MD
The trial enrolled 229 adult patients ( median age = 70 years ; range = 40- 90 years ) with MPN-associated MF , including primary MF ( 75 %; n = 172 ), post-polycythemia vera MF ( 11 %; n = 25 ), and post-essential thrombocythemia MF ( 14 %; n = 34 ), between September 2010 and August 2012 . All
* The Kogenate FS Free Trial Program is available to newly diagnosed patients and patients who are currently using other therapy . Patients currently using Kogenate FS are not eligible for the Free Trial Program . Participation in the Kogenate FS Free Trial Program is limited to 1 time only . The medication provided through this program is complimentary and is not an obligation to purchase or use Kogenate FS in the future . Reselling or billing any third party for the free product is prohibited by law .
People with private , commercial health insurance may receive Kogenate FS co-pay or co-insurance assistance based on eligibility requirements . The program is on a first-come , first-served basis . Financial support is available for up to 12 months . Eligible patients can re-enroll for additional 12-month courses . The program is not for patients receiving prescription reimbursement under any federal- , state- , or government-funded insurance programs , or where prohibited by law . All people who meet these criteria are encouraged to apply . Bayer reserves the right to discontinue the program at any time .
The program does not guarantee that patients will be successful in obtaining reimbursement . Support medication provided through Bayer ’ s assistance programs is complimentary and is not contingent on future Kogenate FS purchases . Reselling or billing any third party for free product provided by Bayer ’ s patient assistance programs is prohibited by law . Bayer reserves the right to determine eligibility , monitor participation , determine equitable distribution of product , and modify or discontinue the program at any time .
INDICATIONS
■ Kogenate ® FS is an Antihemophilic Factor ( Recombinant ) indicated for :
■ On-demand treatment and control of bleeding episodes in adults and children with hemophilia A .
■ Perioperative management of bleeding in adults and children with hemophilia A .
■ Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage .
■ Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A .
■ Kogenate FS is not indicated for the treatment of von Willebrand disease .
IMPORTANT SAFETY INFORMATION
■ Kogenate FS Antihemophilic Factor ( Recombinant ) is contraindicated in patients who have life-threatening hypersensitivity reactions , including anaphylaxis to mouse or hamster protein or other constituents of the product .
■ Hypersensitivity reactions , including anaphylaxis have been reported with Kogenate FS . Reported symptoms included facial swelling , flushing , hives , decrease in blood pressure , nausea , rash , restlessness , shortness of breath , tachycardia , tightness of the chest , tingling , urticaria , and vomiting . Discontinue Kogenate FS if symptoms occur and seek immediate emergency treatment .
24 ASH Clinical News
Literature Scan Pomalidomide Does Not Significantly Improve RBC Transfusion Needs in Myelofibrosis Anemia occurs commonly in patients with myeloproliferative neoplasm (MPN)-associated myelofibrosis (MF), and such patients are often red blood cell (RBC) transfusion-dependent. No therapy approved by the U.S. Food and Drug Administration is particu- larly effective at treating MF-associated anemia. In a study published in Leukemia, Ayalew Tefferi, MD, from the Division of Hematology in the Department of Internal Medicine at the Mayo Clinic College of Medicine in Rochester, Minnesota, and co-authors examined whether treatment with the immune- modulating drug pomalidomide could increase the proportion of patients achieving RBC transfu- sion independence, compared with placebo. Results from previous trials comparing different doses of pomalidomide (2.0 or 0.5 mg/day), with or without prednisone, in this setting suggested that a lower dose of pomalidomide alone was associated with a high platelet response rate, prompting Dr. Tefferi and colleagues to confirm response rates with pomalidomide 0.5 mg in this mul- ticenter, randomized, double-blind, parallel-group, placebo-controlled phase III study. patients were RBC transfusion-dependent (defined as an average RBC transfusion frequency of ≥2 U/28 days over ≥84 days immediately prior to randomization, with no interval of >42 days without ≥1 RBC transfusion) and had a hemoglobin con- centration ≤13.0 g/dL at randomization. Patients were excluded if they had received RBC transfusions because of bleeding or chemotherapy- or radiation-induced anemia or if they had received thalidomide, lenalidomide, bone marrow suppressants, or any investigational drug within 1 month of randomization. Patients were randomized 2:1 to receive oral pomalidomide 0.5 mg/day (n=152) or placebo (n=77). The authors found that the rates of transfusion independence were similar Kogenate® FS: His life. His treatment. Kogenate FS, Antihemophilic Factor (Recombinant) 1 : ■ Can be used as routine prophylaxis in adults and children with hemophilia A ■ For use as on-demand treatment in adults and children with hemophilia A ■ Is covered by all major insurance companies Reimbursement Support, Coverage, and Financial Solutions ✓ Free Trial Program*: Talk to your patients about requesting a free trial of Kogenate FS with Vial Adapter ✓ $0 Co-pay Program † : Eligible patients can receive up You and your patients can connect with a Bayer Access Solutions Case Specialist at 1-800-288-8374 to $12,000 in assistance per year ✓ Live Helpline Support: Patients can call for answers 8:00 AM –8:00 PM (ET) Monday–Friday to any insurance coverage questions ‡ “We conclude no efficacy of pomalidomide in reversing red blood cell transfusion dependence.” —AYALEW TEFFERI, MD The trial enrolled 229 adult patients (median age = 70 years; range = 40- 90 years) with MPN-associated MF, including primary MF (75%; n=172), post-polycythemia vera MF (11%; n=25), and post-essential thrombo- cythemia MF (14%; n=34), between September 2010 and August 2012. All *The Kogenate FS Free Trial Program is available to newly diagnosed patients and patients who are currently using other therapy. Patients currently using Kogenate FS are not eligible for the Free Trial Program. Participation in the Kogenate FS Free Trial Program is limited to 1 time only. The medication provided through this program is complimentary and is not an obligation to purchase or use Kogenate FS in the future. Reselling or billing any third party for the free product is prohibited by law. † People with private, commercial health insurance may receive Kogenate FS co-pay or co-insurance assistance based on eligibility requirements. The program is on a first-come, first-served basis. Financial support is available for up to 12 months. Eligible patients can re-enroll for additional 12 F6W'6W2FR&w&2Bf FVG2&V6Vfr&W67&F&V'W'6VVBVFW"fVFW&7FFR"vfW&VBgVFVB7W&6R&w&2"vW&R&&FVB'rVRvVWBFW6R7&FW&&RV6W&vVBFǒ&W"&W6W'fW2FR&vBFF66FVRFR&w&BFR( FR&w&FW2BwV&FVRFBFVG2v&R7V66W76gV'Fr&V'W'6VVB7W'BVF6F&fFVBF&Vv&W.( 2767F6R&w&026ƖVF'B2B6FvVBgWGW&RvVFRe2W&66W2&W6VƖr"&ƖrF&B'Gf"g&VR&GV7B&fFVB'&W.( 2FVB767F6P&w&22&&FVB'r&W"&W6W'fW2FR&vBFFWFW&֖RVƖv&ƗGF"'F6FFWFW&֖RWVF&RF7G&'WFb&GV7BBFg F66FVRFR&w&BFRऔD4D0vVF\*e22FVƖ2f7F"&V6&BF6FVBf#)jFVBG&VFVBB6G&b&VVFrW6FW2GVG2B6G&VvFVƖ)jW&W&FfRvVVBb&VVFrGVG2B6G&VvFVƖ)j&WFR&2F&VGV6RFRg&WVV7b&VVFrW6FW26G&VvFVƖBF&VGV6RFR&6bBFvR6G&VvFWB&RW7FrBFvR)j&WFR&2F&VGV6RFRg&WVV7b&VVFrW6FW2GVG2vFVƖ)jvVFRe22BF6FVBf"FRG&VFVBbfvV'&BF6V6R)j%DB4dUEd$DशvVFRe2FVƖ2f7F"&V6&B26G&F6FVBFVG2vfRƖfRF&VFVpW'6V6FfG&V7F26VFr2FW6R"7FW"&FV"FW"67FGVVG2bFR&GV7B)jW'6V6FfG&V7F26VFr2fR&VV&W'FVBvFvVFRe2&W'FVB7F26VFV@f67vVƖrfW6rfW2FV7&V6R&B&W77W&RW6V&6&W7FW76W726'FW72b'&VFF66&FFvFW72bFR6W7BFvƖrW'F6&Bf֗FrF66FVRvVFRe2b7F267W"B6VVVFFRVW&vV7G&VFVB)je3r#^( У#@46Ɩ6Ww0cr^( ХC3@