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CONTINUING EDUCATION PROGRAM P10031 • RELEASE DATE: JUNE 30, 2010 • EXPIRATION DATE: JUNE 30, 2011 ESTIMATED TIME TO COMPLETE: 1.0 HOUR
Perspectives on Idiopathic Thrombocytopenia Purpura: ASH 2009 By Gary C. Yee, PharmD, FCCP, BCOP Professor of Pharmacy Practice and Associate Dean, College of Pharmacy, University of Nebraska Medical Center, Omaha
TARGET AUDIENCE
This activity was developed for pharmacists and other healthcare professionals. LEARNING OBJECTIVES
Upon completion of this activity, participants will be able to: • Provide payers with a practical understanding of the key clinical, business, and regulatory factors, guidelines, and research advances involving idiopathic thrombocytopenia purpura (ITP) treatment that providers are using as the basis for their treatment decisions • Offer payers a multistakeholder commentary on this information, to identify the impact on different stakeholders of these changes to treatment • Illuminate the different perspectives and incentives of the various stakeholders involved in ITP treatment decisions— patients, providers, payers, purchasers, distributors, regulatory agencies, and manufacturers • Align incentives with providers and transform payer drug management policies into patient-centered, value-based models
I
diopathic thrombocytopenia purpura (ITP) is an autoimmune disorder mediated by platelet antibodies that accelerate platelet destruction and inhibit their production.1 Most cases of ITP are acquired (ie, primary), but ITP can also occur with other disorders (ie, secondary). Although the presenting signs and symptoms of ITP vary widely, the primary clinical manifestation is bleeding. Bleeding risk generally correlates with the severity of thrombocytopenia. Until recently, the primary goal of treatment was to interfere with the antibody-mediated platelet destruction. The primary treatment options were intravenous (IV) immune globulin and corticosteroids. Other treatment options were immunosuppressive agents (eg, cyclosporine, azathioprine, cyclophosphamide, and mycophenolate mofetil), rituximab, danazol, dapsone, and vinca alkaloids. Most patients with newly diagnosed (ie, acute) primary ITP respond without treatment or to first-line therapy with corticosteroids or IV immune globulin.
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Patients who fail first-line therapy are treated with splenectomy or other second-line therapies. Patients with ITP lasting for more than 12 months are considered to have chronic ITP. In 2008, two novel thrombopoietin receptor agonists (sometimes referred to as thrombopoietin mimetics) were US Food and Drug Administration (FDA)approved for the treatment of chronic ITP: romiplostim and eltrombopag. Both agents activate the receptor for thrombopoietin, which is the primary regulator of thrombopoiesis in humans. By stimulating platelet production, these agents provide clinicians with new treatment options for ITP. The availability of thrombopoietin receptor agonists has stimulated interest in the biology and treatment of ITP. An international working group recently published a report to standardize terminology, definitions, and outcome criteria in ITP,2 and another international group recently published an evidence-based guideline for the diagnosis and treatment of ITP.3 At the last annual meeting of the American Society of Hematology (ASH), more than 60 studies were presented on ITP. This report highlights the results of some of the major studies on ITP to provide decision makers with information on the clinical and economic implications of those studies. PHARMACISTS DESIGNATION
Medical Learning Institute, Inc., is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Completion of this activity provides for 1.0 contact hour (0.1 CEU) of continuing education credit. The universal activity number for this activity is 468-9999-10-025-H01-P. INSTRUCTIONS FOR CREDIT
1. Read the article in its entirety 2. Go to www.TheOncologyPharmacist.com 3. Select “Continuing Education” 4. Click on this article’s title from the list shown 5. Select “Click here to complete the posttest and obtain a CE certificate online” 6. Complete and submit the CE posttest and CE Activity Evaluation and Request for Credit Form online 7. Print your Certificate of Credit This activity is provided free of charge to participants. Upon completion of the evaluation and
Role of rituximab as first-line treatment of ITP Although not FDA-approved for ITP, rituximab is sometimes used as second-line therapy in ITP patients, based on uncontrolled trials.4 Few studies have evaluated rituximab in previously untreated patients. In a recently published multicenter, open-label, randomized, controlled trial (ML18542), dexamethasone alone was compared with dexamethasone plus rituximab in 101 adults with newly diagnosed or persistent/chronic ITP.5 All patients received 40 mg of dexamethasone orally for 4 consecutive days (days 1-4); patients in the rituximab group received 375 mg/m2 of rituximab on days 7, 14, 21, and 28. Patients who received dexamethasone plus rituximab were more likely to achieve a sustained response, defined as a platelet count ≥50 ¥ 109/L at 6 months compared with those treated with dexamethasone alone (63% vs 36%; P = .004). A similar pattern was noted for higher platelet counts at 6 months (≥100 ¥ 109/L or 150 ¥ 109/L). Patients in the dexamethasone group who failed therapy were treated with salvage dexamethasone plus rituximab. Patients who received dexamethasone plus rituximab had a higher incidence of grades 3/4 adverse events (10% vs scoring 70% or better on the posttest, you will immediately receive your certificate online. If you do not achieve a score of 70% or better on the posttest, you will be asked to take it again. Please retain a copy of the certificate for your records. FACULTY DISCLOSURES
Before the activity, all faculty will disclose the existence of any financial interest and/or relationship(s) they might have with the manufacturer(s) of any commercial product(s) to be discussed during their presentation(s): honoraria, expenses, grants, consulting roles, speaker’s bureau membership, stock ownership, or other special relationships. Presenters will inform participants of any off-label discussions. The associates of Medical Learning Institute, Inc., and Center of Excellence Media, LLC, have no financial relationships to disclose. Gary C. Yee, PharmD, FCCP, BCOP, is on the Advisory Board of Amgen and Eisai.
2%; P = .082), but the incidence of serious adverse events was similar.5 At the ASH meeting, Zaja and colleagues reported on the long-term (>6 months) safety and efficacy of patients enrolled in the ML18542 trial.6 Patients were evaluated every 4 months during the planned 30-month observation period. Eighty patients were available for evaluation (median follow-up: 20 months); 54 of these 80 patients achieved a sustained response at 6 months and were evaluated for response duration. The rates of relapse, defined as platelets <50 ¥ 109/L, in the dexamethasone alone, dexamethasone plus rituximab, and salvage dexamethasone plus rituximab groups were 23%, 26%, and 14%, respectively. The only delayed adverse event was a case of herpes zoster reactivation in a patient who initially received dexamethasone alone, but later received salvage dexamethasone plus rituximab therapy.6 Although these results are interesting, higher response rates have been reported with 4 cycles of dexamethasone (40 mg/day for 4 days) given every 14 days.7 Some experts are concerned about the additional cost and potential toxicity of rituximab. Romiplostim in chronic ITP One of the most interesting abstracts was a randomized, open-label, phase 3b DISCLAIMER
The information provided in this CE activity is for continuing education purposes only and is not meant to substitute for the independent medical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition. SPONSOR
This activity is jointly sponsored by Medical Learning Institute, Inc., a nonprofit medical accreditation company, and Center of Excellence Media, LLC. COMMERCIAL SUPPORT ACKNOWLEDGMENT
This activity is supported by an educational grant from Amgen. FACULTY
Gary C. Yee, PharmD, FCCP, BCOP Professor, Department of Pharmacy Practice College of Pharmacy Universtiy of Nebraska Medical Center 986045 Nebraska Medical Center Omaha, NE 68198-6045
www.theOncologyPharmacist.com