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B O O K - American College of Rheumatology
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NOTES<br />
382<br />
2010 Program Book
NOTES 382 2010 Program Book
Enbrel ® (etanercept) Brief Summary SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION WARNINGS SERIOUS INFECTIONS AND MALIGNANCIES Patients treated with Enbrel are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions and Adverse Reactions]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Enbrel should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: • Active tuberculosis, including reactivation <strong>of</strong> latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Enbrel use and during therapy. Treatment for latent infection should be initiated prior to Enbrel use. • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. • Bacterial, viral, and other infections due to opportunistic pathogens. The risks and benefits <strong>of</strong> treatment with Enbrel should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development <strong>of</strong> signs and symptoms <strong>of</strong> infection during and after treatment with Enbrel, including the possible development <strong>of</strong> tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. MALIGNANCIES Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Enbrel. INDICATIONS AND USAGE Rheumatoid Arthritis Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression <strong>of</strong> structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). Enbrel can be initiated in combination with methotrexate (MTX) or used alone. Polyarticular Juvenile Idiopathic Arthritis Enbrel is indicated for reducing signs and symptoms <strong>of</strong> moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older. Psoriatic Arthritis Enbrel is indicated for reducing signs and symptoms, inhibiting the progression <strong>of</strong> structural damage <strong>of</strong> active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). Enbrel can be used in combination with methotrexate (MTX) in patients who do not respond adequately to MTX alone. Ankylosing Spondylitis Enbrel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS). Plaque Psoriasis Enbrel is indicated for the treatment <strong>of</strong> adult patients (18 years or older) with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. CONTRAINDICATIONS Enbrel should not be administered to patients with sepsis. WARNINGS AND PRECAUTIONS Infections Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving TNF-blocking agents. Among opportunistic infections, tuberculosis, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, listeriosis, and pneumocystosis were the most commonly reported. Patients have frequently presented with disseminated rather than localized disease, and are <strong>of</strong>ten taking concomitant immunosuppressants such as methotrexate or corticosteroids with Enbrel. Treatment with Enbrel should not be initiated in patients with an active infection, including clinically important localized infections. The risks and benefits <strong>of</strong> treatment should be considered prior to initiating therapy in patients: with chronic or recurrent infection; who have been exposed to tuberculosis; who have resided or traveled in areas <strong>of</strong> endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or with underlying conditions that may predispose them to infection, such as advanced or poorly controlled diabetes [see Adverse Reactions]. Patients should be closely monitored for the development <strong>of</strong> signs and symptoms <strong>of</strong> infection during and after treatment with Enbrel. Enbrel should be discontinued if a patient develops a serious infection or sepsis. A patient who develops a new infection during treatment with Enbrel should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and appropriate antimicrobial therapy should be initiated. Tuberculosis Cases <strong>of</strong> reactivation <strong>of</strong> tuberculosis or new tuberculosis infections have been observed in patients receiving Enbrel, including patients who have previously received treatment for latent or active tuberculosis. Data from clinical trials and preclinical studies suggest that the risk <strong>of</strong> reactivation <strong>of</strong> latent tuberculosis infection is lower with Enbrel than with TNF-blocking monoclonal antibodies. Nonetheless, postmarketing cases <strong>of</strong> tuberculosis reactivation have been reported for TNF blockers, including Enbrel. Tuberculosis has developed in patients who tested negative for latent tuberculosis prior to initiation <strong>of</strong> therapy. Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating Enbrel and periodically during therapy. Tests for latent tuberculosis infection may be falsely negative while on therapy with Enbrel. Treatment <strong>of</strong> latent tuberculosis infection prior to therapy with TNF-blocking agents has been shown to reduce the risk <strong>of</strong> tuberculosis reactivation during therapy. Induration <strong>of</strong> 5 mm or greater with tuberculin skin testing should be considered a positive test result when assessing if treatment for latent tuberculosis is needed prior to initiating Enbrel, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG). Anti-tuberculosis therapy should also be considered prior to initiation <strong>of</strong> Enbrel in patients with a past history <strong>of</strong> latent or active tuberculosis in whom an adequate course <strong>of</strong> treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consultation with a physician with expertise in the treatment <strong>of</strong> tuberculosis is recommended to aid in the decision whether initiating antituberculosis therapy is appropriate for an individual patient. Tuberculosis should be strongly considered in patients who develop a new infection during Enbrel treatment, especially in patients who have previously or recently traveled to countries with a high prevalence <strong>of</strong> tuberculosis, or who have had close contact with a person with active tuberculosis. Invasive Fungal Infections Cases <strong>of</strong> serious and sometimes fatal fungal infections, including histoplasmosis, have been reported with TNF blockers, including Enbrel. For patients who reside or travel in regions where mycoses are endemic, invasive fungal infection should be suspected if they develop a serious systemic illness. Appropriate empiric antifungal therapy should be considered while a diagnostic workup is being performed. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. When feasible, the decision to administer empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the diagnosis and treatment <strong>of</strong> invasive fungal infections and should take into account both the risk for severe fungal infection and the risks <strong>of</strong> antifungal therapy. In 38 Enbrel clinical trials and 4 cohort studies in all approved indications representing 27,169 patient-years <strong>of</strong> exposure (17,696 patients) from the United States and Canada, no histoplasmosis infections were reported among patients treated with Enbrel. Neurologic Events Treatment with TNF-blocking agents, including Enbrel, has been associated with rare (< 0.1%) cases <strong>of</strong> new onset or exacerbation <strong>of</strong> central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability. Cases <strong>of</strong> transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barré syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation <strong>of</strong> seizure disorders have been reported in postmarketing experience with Enbrel therapy. Prescribers should exercise caution in considering the use <strong>of</strong> Enbrel in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders [see Adverse Reactions]. Malignancies Lymphomas In the controlled portions <strong>of</strong> clinical trials <strong>of</strong> TNF-blocking agents, more cases <strong>of</strong> lymphoma have been observed among patients receiving a TNF blocker compared to control patients. During the controlled portions <strong>of</strong> Enbrel trials in adult patients with RA, AS, and PsA, 2 lymphomas were observed among 3306 Enbrel-treated patients versus 0 among 1521 control patients (duration <strong>of</strong> controlled treatment ranged from 3 to 36 months). Among 6543 adult rheumatology (RA, PsA, AS) patients treated with Enbrel in controlled and uncontrolled portions <strong>of</strong> clinical trials, representing approximately 12,845 patient-years <strong>of</strong> therapy, the observed rate <strong>of</strong> lymphoma was 0.10 cases per 100 patient-years. This was 3-fold higher than the rate <strong>of</strong> lymphoma expected in the general US population based on the Surveillance, Epidemiology, and End Results (SEER) Database. An increased rate <strong>of</strong> lymphoma up to several-fold has been reported in the RA patient population, and may be further increased in patients with more severe disease activity. Among 4410 adult PsO patients treated with Enbrel in clinical trials up to 36 months, representing approximately 4278 patient-years <strong>of</strong> therapy, the observed rate <strong>of</strong> lymphoma was 0.05 cases per 100 patient-years, which is comparable to the rate in the general population. No cases were observed in Enbrel- or placebo-treated patients during the controlled portions <strong>of</strong> these trials. Leukemia Cases <strong>of</strong> acute and chronic leukemia have been reported in association with postmarketing TNF-blocker use in rheumatoid arthritis and other indications. Even in the absence <strong>of</strong> TNF-blocker therapy, patients with rheumatoid arthritis may be at higher risk (approximately 2-fold) than the general population for the development <strong>of</strong> leukemia. During the controlled portions <strong>of</strong> Enbrel trials, 2 cases <strong>of</strong> leukemia were observed among 5445 (0.06 cases per 100 patient-years) Enbrel-treated patients versus 0 among 2890 (0%) control patients (duration <strong>of</strong> controlled treatment ranged from 3 to 48 months). Among 15,401 patients treated with Enbrel in controlled and open portions <strong>of</strong> clinical trials representing approximately 23,325 patient-years <strong>of</strong> therapy, the observed rate <strong>of</strong> leukemia was 0.03 cases per 100 patient-years. Other Malignancies Information is available from 10,953 adult patients with 17,123 patient-years and 696 pediatric patients with 1282 patient-years <strong>of</strong> experience across 45 Enbrel clinical studies. For malignancies other than lymphoma and non-melanoma skin cancer, there was no difference in exposure-adjusted rates between the Enbrel and control arms in the controlled portions <strong>of</strong> clinical studies for all indications. Analysis <strong>of</strong> the malignancy rate in combined controlled and uncontrolled portions <strong>of</strong> studies has demonstrated that types and rates are similar to what is expected in the general US population based on the SEER database and suggests no increase in rates over time. Whether treatment with Enbrel might influence the development and course <strong>of</strong> malignancies in adults is unknown. Non-melanoma skin cancer (NMSC) Non-melanoma skin cancer has been reported in patients treated with TNF antagonists including etanercept. Among 3306 adult rheumatology (RA, PsA, AS) patients treated with Enbrel in controlled clinical trials representing approximately 2669 patient-years <strong>of</strong> therapy, the observed rate <strong>of</strong> NMSC was 0.41 cases per 100 patient-years vs 0.37 cases per 100 patient-years among 1521 control-treated patients representing 1077 patient-years. Among 1245 adult psoriasis patients treated with Enbrel in controlled clinical trials, representing approximately 283 patient-years <strong>of</strong> therapy, the observed rate <strong>of</strong> NMSC was 3.54 cases per 100 patient-years vs 1.28 cases per 100 patientyears among 720 control-treated patients representing 156 patient-years. Periodic skin examinations should be considered for all patients at increased risk for NMSC. Pediatric Patients Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation <strong>of</strong> therapy at ≤ 18 years <strong>of</strong> age), including Enbrel. Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety <strong>of</strong> different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median <strong>of</strong> 30 months <strong>of</strong> therapy (range 1 to 84 months). Most <strong>of</strong> the patients were receiving concomitant immunosuppressants. These cases were reported postmarketing and are derived from a variety <strong>of</strong> sources, including registries and spontaneous postmarketing reports. In clinical trials <strong>of</strong> 696 patients representing 1282 patient-years <strong>of</strong> therapy, no malignancies, including lymphoma or NMSC, have been reported. Postmarketing Use In global postmarketing adult and pediatric use, lymphoma and other malignancies have been reported. Patients With Heart Failure Two clinical trials evaluating the use <strong>of</strong> Enbrel in the treatment <strong>of</strong> heart failure were terminated early due to lack <strong>of</strong> efficacy. One <strong>of</strong> these studies suggested higher mortality in Enbrel-treated patients compared to placebo [see Adverse Reactions]. There have been postmarketing reports <strong>of</strong> worsening <strong>of</strong> congestive heart failure (CHF), with and without identifiable precipitating factors, in patients taking Enbrel. There have also been rare (< 0.1%) reports <strong>of</strong> new onset CHF, including CHF in patients without known preexisting cardiovascular disease. Some <strong>of</strong> these patients have been under 50 years <strong>of</strong> age. Physicians should exercise caution when using Enbrel in patients who also have heart failure, and monitor patients carefully. Hematologic Events Rare (< 0.1%) reports <strong>of</strong> pancytopenia, including very rare (< 0.01%) reports <strong>of</strong> aplastic anemia, some with a fatal outcome, have been reported in patients treated with Enbrel. The causal relationship to Enbrel therapy remains unclear. Although no high-risk group has been identified, caution should be exercised in patients being treated with Enbrel who have a previous history <strong>of</strong> significant hematologic abnormalities. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive <strong>of</strong> blood dyscrasias or infection (eg, persistent fever, bruising, bleeding, pallor) while on Enbrel. Discontinuation <strong>of</strong> Enbrel therapy should be considered in patients with confirmed significant hematologic abnormalities. Two percent <strong>of</strong> patients treated concurrently with Enbrel and anakinra developed neutropenia (ANC < 1 x 10 9 /L). While neutropenic, one patient developed cellulitis that resolved with antibiotic therapy. Hepatitis B Virus Reactivation Use <strong>of</strong> TNF-blocking agents has been associated with reactivation <strong>of</strong> hepatitis B virus (HBV), including very rare cases (< 0.01%) with Enbrel, in patients who are chronic carriers <strong>of</strong> this virus. In some instances, HBV reactivation occurring in conjunction with TNF-blocker therapy has been fatal. The majority <strong>of</strong> these reports have occurred in patients concomitantly receiving other medications that suppress the immune system, which may also contribute to HBV reactivation. Patients at risk for HBV infection should be evaluated for prior evidence <strong>of</strong> HBV infection before initiating TNF-blocker therapy. Prescribers should exercise caution in prescribing TNF blockers for patients identified as carriers <strong>of</strong> HBV. Adequate data are not available on the safety or efficacy <strong>of</strong> treating patients who are carriers <strong>of</strong> HBV with anti viral therapy in conjunction with TNF-blocker therapy to prevent HBV reactivation. Patients who are carriers <strong>of</strong> HBV and require treatment with Enbrel should be closely monitored for clinical and laboratory signs <strong>of</strong> active HBV infection throughout therapy and for several months following termination <strong>of</strong> therapy. In patients who develop HBV reactivation, consideration should be given to stopping Enbrel and initiating anti viral therapy with appropriate supportive treatment. The safety <strong>of</strong> resuming Enbrel therapy after HBV reactivation is controlled is not known. Therefore, prescribers should weigh the risks and benefits when considering resumption <strong>of</strong> therapy in this situation. Allergic Reactions Allergic reactions associated with administration <strong>of</strong> Enbrel during clinical trials have been reported in < 2% <strong>of</strong> patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration <strong>of</strong> Enbrel should be discontinued immediately and appropriate therapy initiated. Caution: The needle cap on the prefilled syringe and on the SureClick autoinjector contains dry natural rubber (a derivative <strong>of</strong> latex) that may cause allergic reactions in individuals sensitive to latex. Immunizations Live vaccines should not be given concurrently with Enbrel. It is recommended that pediatric patients, if possible, be brought up-to-date with all immunizations in agreement with current immunization guidelines prior to initiating Enbrel therapy [see Drug Interactions]. Autoimmunity Treatment with Enbrel may result in the formation <strong>of</strong> autoantibodies [see Adverse Reactions] and, rarely (< 0.1%), in the development <strong>of</strong> a lupus-like syndrome or autoimmune hepatitis [see Adverse Reactions], which may resolve following withdrawal <strong>of</strong> Enbrel. If a patient develops symptoms and findings suggestive <strong>of</strong> a lupus-like syndrome or autoimmune hepatitis following treatment with Enbrel, treatment should be discontinued and the patient should be carefully evaluated. Immunosuppression TNF mediates inflammation and modulates cellular immune responses. TNFblocking agents, including Enbrel, affect host defenses against infections. The effect <strong>of</strong> TNF inhibition on the development and course <strong>of</strong> malignancies is not fully understood. In a study <strong>of</strong> 49 patients with RA treated with Enbrel, there was no evidence <strong>of</strong> depression <strong>of</strong> delayed-type hypersensitivity, depression <strong>of</strong> immunoglobulin levels, or change in enumeration <strong>of</strong> effector cell populations [see Adverse Reactions]. Use in Wegener’s Granulomatosis Patients The use <strong>of</strong> Enbrel in patients with Wegener’s granulomatosis receiving immunosuppressive agents is not recommended. In a study <strong>of</strong> patients with Wegener’s granulomatosis, the addition <strong>of</strong> Enbrel to standard therapy (including cyclophosphamide) was associated with a higher incidence <strong>of</strong> non cutaneous
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FLOOR PLANS 2010 Program Book 291
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VISIT THE EXHIBIT HALL New and inno
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EXHIBITORS La Lettre Du Rhumatologu
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ACKNOWLEDGEMENTS The ACR, the ARHP
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ACR/ARHP/REF STAFF LISTING Administ
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A Ahmed, Rafi, PhD T cell Memory .
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Cooper, Max D, MD Introduction . .
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Daudon, M 875 Daugas, E 2009 Davatc
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Ehst, B 758 Eicher, JL 688 Eisen, S
- Page 329 and 330:
Gabay, OH 1484 Gaber, T 630, 1418 G
- Page 331 and 332:
Guan, M 965 Guañabens, N 975 Gudbj
- Page 333 and 334: Homme, CL 730 Honda, E 434 Hong, JY
- Page 335 and 336: Kambayashi, T 1354 Kamdar, AA 1160
- Page 337 and 338: Kuller, LH 71 Kumabe, M 1164 Kumaga
- Page 339 and 340: Looney, C 941 Looney, MR 609 Looney
- Page 341 and 342: McCarthy, GM 1109, 1306, 1426 McCau
- Page 343 and 344: Myouzen, K 1577 Mysiw, WJ 2096 Mysl
- Page 345 and 346: Pans, M 1834 Parra, ER 605, 887 Ped
- Page 347 and 348: Radka, S 1174 Radner, H 296, 1745 R
- Page 349 and 350: Sack, KE 1898 Sacli, SF 1312 Saddic
- Page 351 and 352: 1463, 2071, 2140, 2141 Singh, K 212
- Page 353 and 354: Takahata, M 1492 Takasaki, Y 1731 T
- Page 355 and 356: 636 van Dongen, CJJ 90 Van Doornum,
- Page 357 and 358: Witte, T 824, 1578, 1579, 2214 Witt
- Page 359 and 360: A α-galactosylceramide 505 A2A kno
- Page 361 and 362: Behcet’s syndrome 1284, 1288, 129
- Page 363 and 364: cost-utility 759, 1539 couples 1324
- Page 365 and 366: fibroblast like synoviocyte 27 fibr
- Page 367 and 368: impact 1063, 1325 inactive disease
- Page 369 and 370: methylation 826, 1253, 1489 methylt
- Page 371 and 372: 233, 234, 240, 243, 252, 262, 268,
- Page 373 and 374: 1599, 1600, 1603, 1605, 1606, 1609,
- Page 375 and 376: 1226, 1227, 1229, 1230, 1231, 1233,
- Page 377 and 378: Abelson, Abby Goulder, MD Education
- Page 379 and 380: Massarotti, Elena M, MD Systemic Lu
- Page 381 and 382: ACR Annual Meeting fellowS-in-train
- Page 383: NOTES 2010 Program Book 381
- Page 387 and 388: Prescription Enbrel ® (etanercept)
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