Class: Disease-modifying Antirheumatic Drugs
VA Class: MS190
Chemical Name: 1-235-Tumor necrosis factor receptor (human) fusion protein with 236-467-immunoglobulin G1 (human γ1-chain Fc fragment), dimer
Molecular Formula: C2224H3472N618O701S36 (monomer)
CAS Number: 185243-69-0
- Serious Infections
Increased risk of serious infections involving various organ systems and sites that may require hospitalization or result in death; tuberculosis (frequently disseminated or extrapulmonary), invasive fungal infections (may be disseminated), bacterial (e.g., legionellosis, listeriosis) and viral infections, and other opportunistic infections reported.1 27 129 137 (See Infectious Complications under Cautions.)
Evaluate patients for latent tuberculosis infection prior to and periodically during etanercept therapy; if indicated, initiate appropriate antimycobacterial regimen prior to initiating etanercept therapy.1 137
Closely monitor patients for infection, including active tuberculosis in those with a negative tuberculin skin test, during and after treatment.1 129 137 Discontinue etanercept if serious infection or sepsis occurs.1 129 Consider empiric antifungal therapy if serious systemic illness occurs in a patient at risk for invasive fungal infections.1 129 137
Biologic response modifier and disease-modifying antirheumatic drug (DMARD); a recombinant DNA-derived human immunoglobulin G1 (IgG1) monoclonal antibody specific for human tumor necrosis factor (TNF; TNF-α).1 2 3 4 5 6 8 9 32 33
Uses for Etanercept
Rheumatoid Arthritis in Adults
Used to manage the signs and symptoms of rheumatoid arthritis, to induce a major clinical response, to improve physical function, and to inhibit progression of structural damage associated with the disease in adults with moderate to severe active rheumatoid arthritis.1 2 3 4 5 6 7 8 15 17 32 33 34 70 111 112 117
Can be initiated in combination with methotrexate or alone.1
Used to manage the signs and symptoms of active arthritis, to improve physical function, and to inhibit progression of structural damage associated with the disease in patients with psoriatic arthritis.1 72 76 118
Has been investigated for the management of Wegener’s granulomatosis†34 59 (designated an orphan drug by FDA for this use).57 Use with standard immunosuppressive agents has been associated with an increased incidence of solid malignant tumors without added clinical benefit.103 110 122 Use to induce or maintain remission currently is not justified.103 110 122 Use in patients with Wegener’s granulomatosis† receiving immunosuppressive therapy is not recommended.1 (See Malignancies and Lymphoproliferative Disorders under Cautions and see Specific Drugs and Laboratory Tests under Interactions.)
Inflammatory Bowel Disease
Etanercept Dosage and Administration
Glucocorticoids, NSAIAs, and analgesics may be continued in pediatric patients with juvenile idiopathic arthritis.1
Administer sub-Q injections into the thighs, abdomen, or upper arm.132 133 134 Rotate injection sites.132 133 134 Do not inject into areas where skin is tender, bruised, red, or hard or into scars, stretch marks, or psoriatic lesions.132 133 134
Development of local reactions at the injection site does not preclude continued therapy.64
For greater patient comfort, may allow etanercept prefilled syringe to reach room temperature (about 15–30 minutes) prior to administration.1 Leave prefilled auto-injector at room temperature for ≥30 minutes prior to administration.1 Do not remove the needle cover from the prefilled syringe or prefilled auto-injector until immediately before administration.1 132 133 Solution may contain small, white, proteinaceous particulates; do not administer if discolored or cloudy, or if foreign particulate matter is present.1
Intended for use under the guidance and supervision of a clinician, but may be self-administered if the clinician determines that the patient and/or their caregiver is competent to prepare and safely administer the drug.1 55 The initial self-administered dose should be made under the supervision of a healthcare professional.1
Reconstitution (25-mg Multiple-dose Vial)
For greater patient comfort, may allow dose tray containing etanercept lyophilized powder and diluent to reach room temperature (about 15–30 minutes) prior to administration.1
Reconstitute lyophilized powder by adding 1 mL of bacteriostatic water for injection (containing 0.9% benzyl alcohol) provided by the manufacturer to a 25-mg vial to provide a solution containing 25 mg/mL.1
During reconstitution, very slowly add the diluent to the vial and gently swirl the contents to minimize foaming during dissolution; some foaming will occur.1
May use vial adapter supplied by manufacturer to facilitate reconstitution and withdrawal of dose if only one dose will be withdrawn from the vial.1 If multiple doses will be withdrawn from the vial, use a syringe with a 25-gauge needle for reconstitution and withdrawal of dose from vial.1 134 Use a 27-gauge needle to administer the dose.1
Avoid shaking and excessive or vigorous agitation of the vial to avoid excessive foaming.1
The final volume in the vial will be about 1 mL.134
Dissolution usually takes less than 10 minutes.1
Do not filter solutions during preparation or administration.1
Children 2–17 years of age: 0.8 mg/kg (maximum 50 mg) per week.1
50 mg weekly.1
50 mg weekly.1
50 mg weekly.1
Maintenance dosage: 50 mg once weekly.1
Maximum 50 mg weekly.1
Maximum 50 mg weekly.1
Maximum 50 mg weekly.1
Maximum 50 mg weekly.1
Limited data indicate that dosage adjustment is not necessary in patients with renal failure.123
Cautions for Etanercept
Increased risk of serious infections involving various organ systems and sites that may require hospitalization or result in death.1 137 Opportunistic infections caused by bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic organisms (e.g., aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, tuberculosis) reported, particularly in patients receiving concomitant therapy with immunosuppressive agents (e.g., methotrexate, corticosteroids).1 27 129 137 Infections frequently are disseminated.1 (See Boxed Warning.)
Patients >65 years of age, with comorbid conditions, and/or receiving concomitant therapy with immunosuppressive agents (e.g., corticosteroids, methotrexate) may be at increased risk of infection.1 137
Do not initiate etanercept in patients with active infections, including clinically important localized infections.1 16 36 48 Consider potential risks and benefits of the drug prior to initiating therapy in patients with a history of chronic, recurring, or opportunistic infections; patients with underlying conditions that may predispose them to infections; and patients who have been exposed to tuberculosis or who have resided or traveled in regions where tuberculosis or mycoses such as histoplasmosis, coccidioidomycosis, and blastomycosis are endemic.1 137
Closely monitor patients during and after etanercept therapy for signs or symptoms of infection (e.g., fever, malaise, weight loss, sweats, cough, dyspnea, pulmonary infiltrates, serious systemic illness including shock).1 129 137
If new infection occurs during therapy, perform thorough diagnostic evaluation (appropriate for immunocompromised patient), initiate appropriate anti-infective therapy, and closely monitor patient.1 129 Discontinue etanercept if serious infection or sepsis develops.1 16 36 48 129
Evaluate all patients for active or latent tuberculosis and for risk factors for tuberculosis prior to and periodically during therapy.1 137 When indicated, initiate appropriate antimycobacterial regimen for treatment of latent tuberculosis infection prior to etanercept therapy.1 Also consider antimycobacterial therapy prior to etanercept therapy for individuals with a history of latent or active tuberculosis in whom an adequate course of antimycobacterial treatment cannot be confirmed and for individuals with a negative tuberculin skin test who have risk factors for tuberculosis.1 Consultation with a tuberculosis specialist is recommended when deciding whether to initiate antimycobacterial therapy.1
Reactivation of latent tuberculosis reported in patients receiving etanercept, although data suggest that risk is lower with etanercept than with TNF-blocking monoclonal antibodies.1
Monitor all patients, including those with negative tuberculin skin tests, for active tuberculosis.1 Strongly consider tuberculosis in patients who develop new infections while receiving etanercept, especially if they previously have traveled to countries where tuberculosis is highly prevalent or have been in close contact with an individual with active tuberculosis.1
Failure to recognize invasive fungal infections has led to delays in appropriate treatment.129 Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.1 129 137 Whenever feasible, consult specialist in fungal infections when making decisions regarding initiation and duration of antifungal therapy.1 129
When deciding whether to reinitiate TNF blocking agent therapy following resolution of an invasive fungal infection, reevaluate risks and benefits, particularly in patients who reside in regions where mycoses are endemic.129 Whenever feasible, consult specialist in fungal infections.129
Malignancies and Lymphoproliferative Disorders
Lymphoma and other malignancies (some fatal) reported during postmarketing surveillance in children and adolescents receiving TNF blocking agents, particularly in those receiving other immunosuppressive agents (e.g., azathioprine, methotrexate) concomitantly.1 128 Malignancies included lymphomas (about 50% of the cases) (e.g., Hodgkin’s disease, non-Hodgkin’s lymphoma) and various other malignancies (e.g., leukemia, melanoma, solid organ cancers), including rare malignancies usually associated with immunosuppression and malignancies not usually observed in children and adolescents (e.g., leiomyosarcoma, hepatic malignancies, renal cell carcinoma).1 128 Median time to occurrence was 30 months (range: 1–84 months) after the initial TNF blocking agent dose.1 FDA has concluded that there is an increased risk of malignancy with TNF blocking agents in children and adolescents; however, the strength of the association is not fully characterized.128
Hepatosplenic T-cell lymphoma (a rare, aggressive, usually fatal T-cell lymphoma) reported mainly in adolescents and young adults with Crohn’s disease or ulcerative colitis receiving TNF blocking agents and/or thiopurine analogs (mercaptopurine or azathioprine).138 Most of the patients received a combination of immunosuppressive agents, including TNF blocking agents and thiopurine analogs.138
In controlled studies, lymphoma was reported more frequently in patients receiving etanercept or other TNF blocking agents than in control patients.1 99 Patients with Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or plaque psoriasis, especially those with highly active disease, may be at increased risk of lymphoma;1 138 may be difficult to measure added risk of TNF-blocking agents, azathioprine, and/or mercaptopurine.138
Acute and chronic leukemias (some fatal) reported during postmarketing surveillance of TNF blocking agents in adults and pediatric patients, particularly in those receiving other immunosuppressive agents concomitantly.1 128 Leukemia (most commonly acute myeloid leukemia, chronic lymphocytic leukemia, and chronic myeloid leukemia) generally occurred during first 2 years of therapy.128 FDA has concluded that there is a possible association between TNF blocking agents and development of leukemia; interpretation of findings is complicated because patients with rheumatoid arthritis may be at increased risk for leukemia independent of any treatment with TNF blocking agents.1 128
Melanoma and nonmelanoma skin cancer reported in patients receiving TNF blocking agents, including etanercept.1 Merkel cell carcinoma reported infrequently in patients who received etanercept.1 Consider periodic dermatologic examinations in all patients at increased risk.1
For malignancies other than lymphoma and nonmelanoma skin cancer, no differences in exposure-adjusted occurrence rates observed between etanercept-treated patients and control patients.1
Solid noncutaneous malignant tumors reported in patients with Wegener’s granulomatosis receiving etanercept and cyclophosphamide; malignancies not reported in control patients receiving standard immunosuppressive therapy (corticosteroids plus cyclophosphamide or methotrexate) for Wegener’s granulomatosis.1 122 (See Specific Drugs and Laboratory Tests under Interactions.)
In controlled studies of other TNF blocking agents in adults at increased risk of malignancies (e.g., patients with COPD and a history of heavy smoking), a greater proportion of malignancies occurred in patients receiving the TNF blocking agent compared with control patients.142
Some immune-related diseases (e.g., Crohn’s disease) have been shown to increase risk of cancer independent of treatment with TNF blocking agents, while for others (e.g., juvenile idiopathic arthritis) it is unknown whether there is an increased risk of cancer.128
Carefully consider risks and benefits of TNF blocking agents, especially in adolescents and young adults and especially in the treatment of Crohn’s disease or ulcerative colitis;138 etanercept is not effective in the management of inflammatory bowel disease.1
Other Warnings and Precautions
Nervous System Effects
New onset or exacerbation of CNS demyelinating disorders (some presenting with mental status changes and some associated with permanent disability) and peripheral nervous system demyelinating disorders reported rarely with etanercept or other TNF blocking agents.1 TNF blockers associated with increased disease activity in patients with multiple sclerosis.71 73 74
Multiple sclerosis,1 88 transverse myelitis,1 optic neuritis,1 Guillain-Barré syndrome,1 peripheral demyelinating neuropathies,1 and new onset or exacerbation of seizure disorders1 reported in patients receiving etanercept.1
Worsening CHF (with and without identifiable precipitating factors) and, rarely, new-onset CHF (including in patients without known cardiovascular disease) reported, sometimes in patients <50 years of age.1 Use with caution and monitor carefully in patients with heart failure.1
One study evaluating etanercept for treatment of CHF suggested higher mortality rate in etanercept-treated patients versus placebo recipients.1
Possible pancytopenia including aplastic anemia, sometimes with fatal outcome.1 Use with caution in patients with a history of substantial hematologic abnormalities.1 Consider discontinuance in patients with confirmed hematologic abnormalities.1
Reactivation of HBV infection reported in patients previously infected with the virus.1 Death reported in a few individuals.1 Use of multiple immunosuppressive agents may contribute to HBV reactivation.1
Screen at-risk patients prior to initiation of therapy.1 Evaluate and monitor patients with prior HBV infection before, during, and for up to several months after therapy.1 Safety and efficacy of concomitant antiviral therapy for prevention of HBV reactivation not established.1
Discontinue etanercept and initiate appropriate treatment (e.g., antiviral therapy) if HBV reactivation occurs.1 Not known whether etanercept can be readministered once control of a reactivated HBV infection is achieved; caution advised in this situation.1
Patients may receive inactivated vaccines.1 Avoid live vaccines (e.g., measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, poliovirus vaccine live oral, typhoid vaccine live oral, varicella virus vaccine live, yellow fever vaccine).1 (See Interactions.)
Immunologic Reactions and Antibody Formation
Possible formation of autoimmune antibodies.1 15 32 33 Lupus-like syndrome or autoimmune hepatitis reported rarely;1 87 may resolve upon discontinuance of the drug.1 If manifestations suggestive of lupus-like syndrome or autoimmune hepatitis develop, discontinue etanercept and carefully evaluate patient.1 36 48 56
New-onset psoriasis, including pustular and palmoplantar psoriasis, and exacerbation of existing psoriasis reported with TNF blocking agents, including etanercept.1 128 Most patients experienced improvement following discontinuance of the TNF blocking agent.128
Consider possibility of and monitor for manifestations (e.g., new rash) of new or worsening psoriasis, particularly pustular and palmoplantar psoriasis.128
Patients with Alcoholic Hepatitis
Use in patients with moderate to severe alcoholic hepatitis associated with higher mortality rate following 6 months of use; use with caution in such patients.1
Patients with Diabetes Mellitus
Limited data suggest etanercept crosses the placenta in small amounts; in 3 neonates, cord blood concentrations at the time of delivery were 3–32% of maternal serum concentrations.1 Clinical implications of in utero exposure are unknown.1 (See Pediatric Use under Cautions.)
Pregnancy registry at 800-772-6436 (for patients and clinicians).1
Limited data indicate etanercept is distributed into human milk in low concentrations and is minimally absorbed by breast-fed infants.1 Caution when used in nursing women.1 Consider benefits of breast-feeding, importance of etanercept to the woman, and potential adverse effects on the breast-fed child from the drug or underlying maternal condition.1
Women who choose to continue etanercept therapy while nursing are encouraged to enroll in the manufacturer's lactation surveillance program at 800-772-6436 (for patients and clinicians).1
Used for treatment of polyarticular course juvenile idiopathic arthritis in children ≥2 years of age.1 Not studied in children <2 years of age with juvenile idiopathic arthritis.1 Safety and efficacy not established in children with plaque psoriasis.1
Consider risks and benefits of administering live vaccines to infants who were exposed to etanercept in utero; safety of live vaccines in these infants is unknown.1 (See Pregnancy under Cautions.)
Varicella infection associated with aseptic meningitis reported.1 If a varicella-susceptible child has a clinically important exposure to varicella while receiving etanercept, discontinue the drug temporarily and consider use of varicella-zoster immune globulin.1
Frequencies and types of adverse effects reported in pediatric patients similar to those in adults.1 Adverse effects reported in children 2–4 years of age similar to those reported in older children.1
Inflammatory bowel disease reported rarely in patients with juvenile idiopathic arthritis receiving etanercept; the drug is not effective in the management of inflammatory bowel disease.1
No substantial differences in safety or efficacy relative to younger adults;1 34 61 however, insufficient experience in geriatric patients with psoriasis to determine whether they respond differently than younger adults.1
Possible increased incidence of infections in geriatric patients; use with caution.1
Common Adverse Effects
Injection site reactions, infections (including respiratory tract and other infections).1
Interactions for Etanercept
Administered concomitantly with methotrexate, glucocorticoids, salicylates, NSAIAs, and/or analgesics in clinical studies.1
Biologic Antirheumatic Agents
Use caution when switching from one biologic DMARD to another, since overlapping biologic activity may further increase the risk of infection.142
Patients may receive inactivated vaccines.1
Specific Drugs and Laboratory Tests
Drug or Test
Use caution when switching from one biologic DMARD to another, since overlapping biologic activity may further increase risk of infection142
Concomitant use not recommended1
Use caution when switching from one biologic DMARD to another, since overlapping biologic activity may further increase risk of infection142
Concomitant use not recommended1
Pharmacokinetic interaction unlikely1
Concomitant use not associated with additive toxicity7
Pneumococcal polysaccharide vaccine
B-cell immune response adequate in etanercept-treated psoriatic arthritis patients, although titers moderately lower and twofold increases less common than in controls1
Clinical importance of observed differences not known1
Increased risk of serious infection reported in patients who received rituximab and subsequently received a TNF blocking agent142
Use caution when switching from one biologic DMARD to another, since overlapping biologic activity may further increase risk of infection142
Decrease in neutrophil counts reported1
Clinical importance unknown1
Test for troponin
False-positive troponin determinations using murine monoclonal antibody-based assay (i.e., AxSym Troponin, Abbott)65
Concomitant use not studied; possibility of increased immunosuppression and increased risk of infection139
Avoid concomitant use139
Limited data suggest etanercept crosses the placenta in small amounts.1
Limited data indicate etanercept distributes into human milk in low concentrations.1
Powder for Injection
May store individual dose trays containing etanercept powder for injection and diluent at 20–25°C for a maximum single period of 14 days, with protection from light, heat, and humidity.1 Following storage at room temperature, do not return to refrigerator; discard if not used within 14 days.1
Prefilled Syringe and Prefilled Auto-injector
May store individual prefilled syringes or auto-injectors at 20–25°C for a maximum single period of 14 days, with protection from light and heat.1 Following storage at room temperature, do not return to refrigerator; discard if not used within 14 days.1
High binding affinity for TNF and lymphotoxin-α (TNF-β);1 2 3 4 5 6 8 9 13 33 35 37 each molecule can bind to 2 TNF molecules.33 Prevents the binding of TNF to cell surface TNF receptors, thereby blocking the biologic activity of TNF.1 2 3 4 5 6 7 8 9 33 37
Produced by recombinant DNA technology in a mammalian cell expression system.1
Advice to Patients
A copy of the manufacturer’s patient information (medication guide) for etanercept should be provided to all patients with each prescription of the drug.1 128 Importance of advising patients about potential benefits and risks of etanercept.1 128 137 138 Importance of patients reading the medication guide prior to initiation of therapy and each time the prescription is refilled.128 136 137 138
If the patient or caregiver is to administer etanercept, provide careful instructions regarding proper dosage and administration of etanercept, including proper aseptic technique, and proper disposal of needles and syringes.1
Increased susceptibility to infection.1 136 137 Importance of seeking immediate medical attention if signs and symptoms suggestive of infection (e.g., fever, chills, flu-like symptoms, cough, burning or pain on urination) develop.1 136
Risk of lymphoma, including hepatosplenic T-cell lymphoma, leukemia, or other malignancies with TNF blocking agents.1 128 138 Importance of informing patients and caregivers about the increased risk of cancer development in children, adolescents, and young adults, taking into account the clinical utility of TNF blocking agents, the relative risks and benefits of these and other immunosuppressive drugs, and the risks associated with untreated disease.1 128 138 Importance of promptly informing clinicians if signs and symptoms of malignancies (e.g., unexplained weight loss; fatigue; abdominal pain; persistent fever; night sweats; easy bruising or bleeding; swollen lymph nodes in the neck, underarm, or groin; easy bruising or bleeding; hepatomegaly or splenomegaly) occur.128 138
Importance of informing clinician of any new or worsening medical conditions (e.g., neurologic conditions [e.g., demyelinating disorders], heart failure, autoimmune disorders [e.g., lupus-like syndrome, autoimmune hepatitis], psoriasis, cytopenias).1 128 136
Importance of alerting clinician if allergy to latex exists.1
Importance of promptly contacting a clinician if manifestations of an allergic reaction (e.g., rash, facial swelling, difficulty breathing) occur.136
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses or any history of cancer, tuberculosis, HBV infection, or other chronic or recurring infections.1 129 137
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
For injection, for subcutaneous use
Enbrel (with prefilled syringe containing 1 mL bacteriostatic water for injection [with benzyl alcohol 0.9%] diluent, plunger, and vial adapter)
Injection, for subcutaneous use
25 mg/0.5 mL
Enbrel (available as disposable prefilled syringes)
Enbrel (available as disposable prefilled syringes and prefilled auto-injectors [SureClick])
AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions December 11, 2015. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Amgen. Enbrel (etanercept) prescribing information. Thousand Oaks, CA; 2015 Mar.
2. Murray KM, Dahl SL. Recombinant human tumor necrosis factor receptor (p75) Fc fusion protein (TNFR:Fc) in rheumatoid arthritis. Ann Pharmacother. 1997; 31:1335-8. [IDIS 395067] [PubMed 9391689]
3. Moreland LW, Baumgartner SW, Schiff MH et al. Treatment of rheumatoid arthritis with a recombinant human tumor necrosis factor receptor (p75)-Fc fusion protein. N Engl J Med. 1997; 337:141-7. [IDIS 388682] [PubMed 9219699]
4. Szekanecz Z, Koch AE, Kunkel SL et al. Cytokines in rheumatoid arthritis: potential targets for pharmacological intervention. Drugs Aging. 1998; 12:377-90. [PubMed 9606615]
5. Breedveld F. New tumor necrosis factor-alpha biologic therapies for rheumatoid arthritis. Eur Cytokine Netw. 1998; 9:233-8. [PubMed 9831171]
6. Moreland LW, Margolies G, Heck LW Jr et al. Recombinant soluble tumor necrosis factor receptor (p80) fusion protein: toxicity and dose finding trial in refractory rheumatoid arthritis. J Rheumatol. 1996; 23:1849-55. [IDIS 376410] [PubMed 8923355]
7. Weinblatt ME, Kremer JM, Bankhurst AD et al. A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med. 1999; 340:253-9. [IDIS 417654] [PubMed 9920948]
8. O’Dell JR. Anticytokine therapy—a new era in the treatment of rheumatoid arthritis? N Engl J Med. 1999; 340:310-2. Editorial.
9. Mohler KM, Torrance DS, Smith CA et al. Soluble tumor necrosis factor (TNF) receptors are effective therapeutic agents in lethal endotoxemia and function simultaneously as both TNF carriers and TNF antagonists. J Immunol. 1993; 151:1548-61. [PubMed 8393046]
10. Roux-Lombard P, Punzi L, Hasler F et al. Soluble tumor necrosis factor receptors in human inflammatory synovial fluids. Arthritis Rheum. 1993; 36:485-9. [PubMed 8384452]
11. Cope AP, Aderka D, Doherty M et al. Increased levels of soluble tumor necrosis factor receptors in the sera and synovial fluid of patients with rheumatic diseases. Arthritis Rheum. 1992; 35:1160-9. [PubMed 1329774]
12. Beutler B, van Huffel C. Unraveling function in the TNF ligand and receptor families. Science. 1994; 264:667-8. [PubMed 8171316]
13. Nam MH, Reda D, Boujoukos AJ et al. Recombinant human dimeric tumor necrosis factor (TNF) receptor (TNFR:Fc): safety and pharmacokinetics in human volunteers. Clin Res. 1993; 41:249A.
14. Jacobs CA, Beckmann MP, Mohler K et al. Pharmacokinetic parameters and biodistribution of soluble cytokine receptors. Int Rev Exp Pathol. 1993; 34B:123-35.
15. Moreland LW, Schiff MH, Baumgartner SW et al. Etanercept therapy in rheumatoid arthritis: a randomized, controlled trial. Ann Intern Med. 1999; 130:478-86. [IDIS 421342] [PubMed 10075615]
16. Furst DE, Keystone E, Maini RN et al. Recapitulation of the round-table discussion—assessing the role of anti-tumor necrosis factor therapy in the treatment of rheumatoid arthritis. Rheumatology (Oxford). 1999; 38(Suppl 2):50-3. [PubMed 10646494]
17. Moreland LW, Baumgartner SW, Tindall EA et al. Longterm safety and efficacy of TNF receptor (P75) Fc fusion protein (TNFR:FC; Enbrel) in DMARD refractory rheumatoid arthritis (RA). Arthritis Rheum. 1998; 41(Suppl):S364.
18. Felson DT, Anderson JJ, Boers M et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995; 38:727-35. [PubMed 7779114]
19. Felson DT, Anderson JJ, Boers M et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. Arthritis Rheum. 1993; 36:729-40. [PubMed 8507213]
20. Felson DT, Anderson JJ, Lange MLM et al. Should improvement in rheumatoid arthritis clinical trials be defined as fifty percent or seventy percent improvement in core set measures, rather than twenty percent. Arthritis Rheum. 1998; 41:1564-70. [IDIS 411264] [PubMed 9751088]
21. Giannini EH, Ruperto N, Ravelli A et al. Preliminary definition of improvement in juvenile arthritis. Arthritis Rheum. 1997; 40:1202. [PubMed 9214419]
22. Fisher CJ, Agosti JM, Opal SM et al et al. Treatment of septic shock with the tumor necrosis factor receptor: Fc fusion protein. N Engl J Med. 1996; 334:1697-702. [IDIS 367256] [PubMed 8637514]
23. Kremer JM. Combination therapy with biologic agents in rheumatoid arthritis: perils and promise. Arthritis Rheum. 1998; 41:1548-51. [IDIS 411262] [PubMed 9751086]
24. Hochberg MC, Chang RW, Dwosh I et al. The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis. Arthritis Rheum. 1992; 35:498-502. [PubMed 1575785]
25. Arnett FC, Edworthy SM, Bloch DA et al. The American Rheumatology Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988; 31:315-24. [PubMed 3358796]
26. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis: 2002 update. Arthritis Rheum. 2002; 46:328-46. [IDIS 476480] [PubMed 11840435]
27. Immunex Corporation. Dear healthcare professional letter regarding important drug warning on Enbrel. Seattle, WA; 1999 May 10. From FDA web site.
28. De Benedetti F, Ravelli A, Martini A. Cytokines in juvenile rheumatoid arthritis. Curr Opinion Rheumatol. 1997; 9:428-33.
29. Lovell DJ, Giannini EH, Reiff A et al. Etanercept in children with polyarticular juvenile rheumatoid arthritis. N Engl J Med. 2000; 342:763-9. [IDIS 442440] [PubMed 10717011]
30. Grom AA, Murray KJ, Luyrink L et al. Patterns of expression of tumor necrosis factor alpha, tumor necrosis factor beta, and their receptors in synovia of patients with juvenile rheumatoid arthritis and juvenile spondylarthropathy. Arthritis Rheum. 1996; 39:1703-10. [PubMed 8843861]
31. Lebsack ME, Hanna RK, Lange MA et al. Absolute bioavailability of TNF receptor fusion protein following subcutaneous injection in healthy volunteers. Pharmacotherapy. 1997; 17:1118-9.
32. Immunex Corp. Enbrel (etanercept) AHFS product information form. Seattle, WA; 1998 Nov.
33. Jarvis B, Faulds D. Etanercept: a review of its use in rheumatoid arthritis. Drugs. 1999; 57:945-66. [PubMed 10400407]
34. Immunex, Seattle, WA: Personal communication.
35. Franklin CM. Clinical experience with soluble TNF p75 receptor in rheumatoid arthritis. Semin Arthritis Rheum. 1999; 29:172-82. [PubMed 10622681]
36. Furst DE, Breedveld FC, Kalden JR et al. Building towards a consensus for the use of tumour necrosis factor blocking agents. Ann Rheum Dis. 1999; 58:725-6. [PubMed 10577955]
37. Garrison L, McDonnell ND. Etanercept: therapeutic use in patients with rheumatoid arthritis. Ann Rheum Dis. 1999; 58(Suppl I):165-9.
38. Robak T, Gladalska A, Stepien H. The tumour necrosis factor family of receptors/ligands in the serum of patients with rheumatoid arthritis. Eur Cytokine Netw. 1998; 9:145-54. [PubMed 9681390]
39. Anon. Drugs for rheumatoid arthritis. Med Lett Drugs Ther. 2000; 42:57-64. [PubMed 10887424]
40. Korth-Bradley JM, Rubin AS, Hanna RK et al. The pharmacokinetics of etanercept in healthy volunteers. Ann Pharmacother. 2000; 34:161-4. [IDIS 439866] [PubMed 10676822]
41. Pincus T, O’Dell JR, Kremer JM. Combination therapy with multiple disease-modifying antirheumatic drugs in rheumatoid arthritis: a preventive strategy. Ann Intern Med. 1999; 131:768-74. [IDIS 436171] [PubMed 10577301]
42. Tugwell P, Pincus T, Yocum D et al. Combination therapy with cyclosporine and methotrexate in severe rheumatoid arthritis. N Engl J Med. 1995; 333:137-41. [IDIS 349609] [PubMed 7791814]
43. O’Dell JR, Haire CE, Erikson N et al. Treatment of rheumatoid arthritis with methotrexate alone, sulfasalazine and hydroxychloroquine, or a combination of all three medications. N Engl J Med. 1996; 334:1287-91. [IDIS 364429] [PubMed 8609945]
44. Boers M, Verhoeven AC, Markusse HM et al. Randomised comparison of combined step-down prednisolone, methotrexate and sulphasalazine with sulphasalazine alone in early rheumatoid arthritis. Lancet. 1997; 350:309-18. [IDIS 389250] [PubMed 9251634]
45. Maini RN, Breedveld FC, Kalden JR et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor α monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum. 1998; 41:1552-63. [IDIS 411263] [PubMed 9751087]
46. Weinblatt ME, Kremer JM, Coblyn JS et al. Pharmacokinetics, safety, and efficacy of combination treatment with methotrexate and leflunomide in patients with active rheumatoid arthritis. Arthritis Rheum. 1999; 42:1322-8. [IDIS 433335] [PubMed 10403258]
47. The North American Rheumatoid Arthritis Study Group. Selection of DMARD therapy in early rheumatoid arthritis. Arthritis Rheum. 1998; 41(Suppl 9):S269.
48. Access to disease modifying treatments for rheumatoid arthritis patients. Ann Rheum Dis. 1999; 58(Suppl 1):1129-30.
49. Gallagher KT, Bernstein B. Juvenile rheumatoid arthritis. Curr Opin Rheumatol. 1999; 11:372-6. [PubMed 10503657]
50. Brion PH, Mittal-Henkle A, Kalunian KC et al. Autoimmune skin rashes associated with etanercept for rheumatoid arthritis. Ann Intern Med. 1999; 131:634. [IDIS 434945] [PubMed 10523238]
51. Moreland LW, Bucy RP, Weinblatt ME. Effects of TNF receptor (P75) fusion protein (TNFR:Fc; Enbrel) on immune function. Arthritis Rheum. 1998; 41(Suppl):S59.
52. Baumgartner SW, Moreland LW, Schiff MH et al. Response of elderly patients to TNF receptor P75 FC fusion protein TNFR:FC; Enbrel). Arthritis Rheum. 1998; 41(Suppl):S59.
53. Janssen NM, Genta MS. The effects of immunosuppressive and anti-inflammatory medications on fertility, pregnancy, and lactation. Arch Intern Med. 2000; 160:610-9. [IDIS 444392] [PubMed 10724046]
54. Pisetsky DS. Tumor necrosis factor blockers in rheumatoid arthritis. N Engl J Med. 2000; 342:810-1. [IDIS 442442] [PubMed 10717018]
55. Finck BK, Jones FL. Dear healthcare provider letter regarding self-administration of Enbrel. Seattle, WA and Philadelphia, PA: Immunex and Wyeth Laboratories; 2000 May 12. From FDA web site.
56. Reviewer comments (personal observations).
57. Food and Drug Administration. Orphan designation pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act. (P.L. 97-414). Rockville, MD; From FDA website.
58. Sharp JT. Scoring radiographic abnormalities in rheumatoid arthritis. Radiol Clin North Am. 1996; 34:233-41. [PubMed 8633113]
59. Stone JH, Uhlfelder ML, Hellmann DB et al. Etanercept combined with conventional treatment in Wegener’s granulomatosis: a six-month open-label trial to evaluate safety. Arth Rheum. 2001; 44:1149-54.
60. Murphy FT, Enzenauer RJ, Battafarano DF et al. Etanercept-associated injection-site reactions. Arch Dermatol. 2000; 136:556-7. [IDIS 445774] [PubMed 10768663]
61. Fleischmann R, Moreland L, Baumgartner S et al. Response to Enbrel (etanercept) in rheumatoid arthritis (RA) patients over 65 years: a retrospective analysis of clinical trial results. Poster presented at 63rd annual meeting of the American College of Rheumatology. Boston, MA. 1999 Nov 16. Abstract No. 1657.
62. Maini R, St Clair EW, Breedveld F et al. Infliximab (chimeric anti-tumor necrosis factor α monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomized phase III trial. Lancet. 1999; 364:1932-9.
63. Kavanaugh A, St Clair EW, McCune WJ et al. Chimeric anti-tumor necrosis factor-α monoclonal antibody treatment of patients with rheumatoid arthritis receiving methotrexate therapy. J Rheumatol. 2000; 27:841-50. [IDIS 445435] [PubMed 10782805]
64. Murphy FT, Enzenauer RJ. Etanercept-associated injection-site reactions. Arch Dermatol. 2000; 136:556-7. [IDIS 445774] [PubMed 10768663]
65. Russell E, Zeihen M, Wergin S et al. Patients receiving etanercept may develop antibodies that interfere with monoclonal antibody laboratory assays. Arthritis Rheum. 2000; 43:944. [IDIS 446205] [PubMed 10765944]
66. Working Party of the British Society for Rheumatology. Guidelines for prescribing TNF-α-blockers in adults with RA. London; British Society for Rheumatology: 2000 Apr 14.
67. Abbott. Axsym (troponin-I) system prescribing information. Abbott Park, IL: 1999 May.
68. Skytta E, Pohjankoski H, Savolainen A. Etanercept and urticaria in patients with juvenile idiopathic arthritis. Clin Exp Rheumatol. 2000; 18:533-4. [PubMed 10949736]
69. Enbrel Enrollment Program: important information. From product website. 2002 Oct 1.
70. Bathon JM, Martin RW, Fleishmann RM et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med. 2000; 343:1586-93. [IDIS 456068] [PubMed 11096165]
71. Klippel JH. Biologic therapy for rheumatoid arthritis. N Engl J Med. 2000; 343:1640-1. [IDIS 456071] [PubMed 11096174]
72. Mease PJ, Goffe BS, Metz J et al. Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomized trial. Lancet. 2000; 356:385-90. [IDIS 451432] [PubMed 10972371]
73. The Lenercept Multiple Sclerosis Study Group and the University of British Columbia MS/MRI Analysis Group. TNF neutralization: results of a randomized, placebo-controlled multicenter study. Neurology. 1999; 53:457-465. [IDIS 431529] [PubMed 10449104]
74. van Oosten BW, Barkhof F, Truyen L et al. Increased MRI activity and immune activation in two multiple sclerosis patients treated with monoclonal anti-tumor necrosis factor antibody cA2. Neurology. 1996; 1531-4.
75. Galaria NA, Werth VP, Schumacher HR. Leukocytoclastic vasculitis due to etanercept. J Rheumatol. 2000; 27:2041-4. [IDIS 451046] [PubMed 10955351]
76. Yazici Y, Erkan D, Lockshin MD. A preliminary study of etanercept in the treatment of severe, resistant psoriatic arthritis. Clin Exp Rheumatol. 2000; 18:732-4. [PubMed 11138337]
77. Schmeling H, Mathony K, John V et al. A combination of etanercept and methotrexate for the treatment of refractory juvenile idiopathic arthritis: a pilot study. Ann Rheum Dis. 2001; 60:410-2. [IDIS 461367] [PubMed 11247875]
78. Kietz DA, Pepmueller PH, Moore TL. Clinical response to etanercept in polyarticular course juvenile rheumatoid arthritis. J Rheumatol. 2001; 28:360-2. [IDIS 460423] [PubMed 11246677]
79. Sandborn WJ, Hanauer SB, Katz S et al. Etanercept for active Crohn’s disease: a randomized, double-blind, placebo-controlled trial. Gastroenterology. 2001; 121:1088-94. [IDIS 471715] [PubMed 11677200]
80. Klareskog L, Moreland LM, Cohen SB et al. Global safety and efficacy of up to five years of etanercept (Enbrel) therapy in rheumatoid arthritis. Poster presented at the American College of Rheumatology 65th National Science Meeting. San Francisco, CA: 2001 Nov 12. Abstract 150.
81. Kremer JM, Weinblatt ME, Fleischmann RM et al. Etanercept (Enbrel) in addition to methotrexate (MTX) in rheumatoid arthritis (RA): long-term observations. Poster presented at the American College of Rheumatology 65th National Science Meeting. San Francisco, CA: 2001 Nov 12. Abstract 152.
82. Ilowite NT. Current treatment of juvenile rheumatoid arthritis. Pediatrics. 2002; 109:109-15. [IDIS 477889] [PubMed 11773549]
83. Johnson CJ, Reilly KM, Murray KM. Etanercept in juvenile rheumatoid arthritis. Ann Pharmacother. 2001; 35:464-71. [IDIS 461576] [PubMed 11302411]
84. Kietz DA, Pepmueller PH, Moore TL. Therapeutic use of etanercept in polyarticular course juvenile idiopathic arthritis over a two year period. Ann Rheum Dis. 2002; 61:171-3. [IDIS 475713] [PubMed 11796406]
85. Baghai M, Osmon DR, Wolk DM et al. Fatal sepsis in a patient with rheumatoid arthritis treated with etanercept. Mayo Clin Proc. 2001; 76:653-6. [IDIS 464295] [PubMed 11393506]
86. Smith D, Letendre S. Viral pneumonia as a serious complication of etanercept therapy. Ann Intern Med. 2002; 136:174. [IDIS 474993] [PubMed 11790076]
87. Shakoor N, Michalska M, Harris CA et al. Drug-induced systemic lupus erythematosus associated with etanercept therapy. Lancet. 2002; 359:579-80. [IDIS 479476] [PubMed 11867114]
88. Sicotte NL, Voskuhl RR. Onset of multiple sclerosis associated with anti-TNF therapy. Neurology. 2001; 57:1885-8. [IDIS 472761] [PubMed 11723281]
89. Ritchlin C, Haas-Smith SA, Hicks D et al. Patterns of cytokine production in psoriatic synovium. J Rheumatol. 1998; 25:1544-52. [PubMed 9712099]
90. Pisetsky DS, St. Clair EW. Progress in the treatment of rheumatoid arthritis. JAMA. 2001; 286:2787-90. [IDIS 473355] [PubMed 11735734]
91. Hickling P, Jacoby RK, Kirwan JR and the Arthritis and Rheumatism Council low dose glucocorticoid study group. Joint destruction after glucocorticoids are withdrawn in early rheumatoid arthritis. Br J Rheumatol. 1998; 37:930-6. [PubMed 9783756]
92. Kirwan JR for the Arthritis and Rheumatism Council low-dose glucocorticoid study group. The effect of glucocorticoids on joint destruction in rheumatoid arthritis. N Engl J Med. 1995; 333:142-7. [IDIS 349610] [PubMed 7791815]
93. McCain ME, Quinet RJ, Davis WE. Etanercept and infliximab associated with cutaneous vasculitis. Rheumatology. 2002; 41:116-7. [PubMed 11792895]
94. Furst DE, Breedveld FC, Burmester GR et al. Updated consensus statement on tumour necrosis factor blocking agents for the treatment of rheumatoid arthritis (May 2000). Ann Rheum Dis. 2000; 59(suppl 1):11-12.
95. Emery P, Reginster J-Y, Appelboom T et al. WHO collaborating centre consensus meeting on anti-cytokine therapy in rheumatoid arthritis. Rheumatology. 2001; 40:699-702. [PubMed 11426031]
96. Anon. Anakinra (Kineret) for rheumatoid arthritis. Med Lett Drugs Ther. 2002; 44:18-19. [PubMed 11856953]
97. Lovell DJ, Giannini EH, Reiff A et al. Long-term efficacy and safety of etanercept in children with polyarticular-course juvenile rheumatoid arthritis; interim results from an ongoing multicenter, open-label, extended-treatment trial. Arthritis Rheum. 2003; 48:218-26. [IDIS 492005] [PubMed 12528122]
98. Lee J-H, Slifman NR, Gershon SK et al. Life-threatening histoplasmosis complicating immunotherapy with tumor necrosis factor α antagonists infliximab and etanercept. Arthritis Rheum. 2002; 46:2565-70. [IDIS 488162] [PubMed 12384912]
99. Brown SL, Greene MH, Gershon SK et al. Tumor necrosis factor antagonist therapy and lymphoma development: twenty-six cases reported to the Food and Drug Administration. Arthritis Rheum. 2002; 46:3151-8. [PubMed 12483718]
100. Smith KJ, Skelton HG. Rapid onset of cutaneous squamous cell carcinoma in patients with rheumatoid arthritis after starting tumor necrosis factor alpha receptor IgG1-Fc fusion complex therapy. J Am Acad Dermatol. 2001; 45:953-6. [IDIS 473157] [PubMed 11712048]
101. Peno-Green L, Lluberas G, Kingsley T et al. Lung injury linked to etanercept therapy. Chest. 2002; 122:1858-60. [IDIS 490069] [PubMed 12426295]
102. Kaipiainen-Seppañnen O, Leino M. Recurrent uveitis in a patient with juvenile spondylarthropathy associated with tumor necrosis factor α inhibitors. Ann Rheum Dis. 2003; 62:88-9. [IDIS 491764] [PubMed 12480683]
103. Furst DE, Breedveld FC, Kalden JR et al. Updated consensus statement on biological agents, specifically tumour necrosis factor α (TNFα) blocking agents and interleukin-1 receptor antagonist (IL-1ra), for the treatment of rheumatic diseases, 2005. Ann Rheum Dis. 2005; 64:iv2-14. [IDIS 544680] [PubMed 16239380]
104. Centocor Inc. Ramicade (infliximab) for IV injection prescribing information. Malvern, PA; 2003 Apr 1.
105. Travers SB. Etanercept for Crohn’s disease. N Engl J Med. 2004; 350: Letter.
106. Kupper TS. Etanercept for Crohn’s disease. N Engl J Med. 2004; 840: Reply.
107. Van den Brande JM, Braat H, van den Brink GR et al. Infliximab but not etanercept induces apoptosis in lamina propria T-lymphocytes from patients with Crohn’s disease. Gastroenetrology. 2003; 124:1774-85.
108. Leonardi CL, Powers JL, Matheson RT et al. Etanercept as monotherapy in patients with psoriasis. N Engl J Med. 2003; 349:2014-22. [IDIS 507153] [PubMed 14627786]
109. Papp KA, Tyring S, Lahfa M et al. A global phase III randomized controlled trial of etanercept in psoriasis; safety, efficacy, and effect of dose reduction. Br J Dermatol. 2005; 152:1304-12. [PubMed 15948997]
110. Mukhtyar C, Luqmani R. Current state of tumour necrosis factor (alpha) blockade in Wegener’s granulomatosis. Ann Rheum Dis. 2005; 64 (suppl 4);iv31-6. [IDIS 544683] [PubMed 16239383]
111. Anon. Drugs for rheumatoid arthritis. Treat Guide Med Lett. 2005; 3:83-90.
112. Genovese MC, Bathon JM, Fleischmann RM et al. Long-term safety, efficacy, and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritis. J Rheumatol. 2005; 32:1232-42. [IDIS 537965] [PubMed 15996057]
113. Weinblatt ME. Keystone EC, Furst DE et al. Adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate. The ARMADA trial. Arthritis Rheum. 2003; 48:35-45. [IDIS 492001] [PubMed 12528101]
114. Keystone EC, Kavanaugh AF, Sharp JT et al. Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum. 2004; 50:1400-11. [IDIS 516423] [PubMed 15146409]
115. Weinblatt ME, Keystone EC, Furst DE et al. Long-term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis: ARMADA 4-year extended study. Ann Rheum Dis. 2005 Dec 1 (Epub ahead of print)
116. Navarro-Sarabia F, Ariza-Ariza R, Hernandez-Crus B, Villanueva I. Adalimumab for treating rheumatoid arthritis. Cochrane Database Syst Rev. 2005; 3: CD005113.
117. Klareskog L, van der Heijde D, de Jager JP et al. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: a double-blind randomised controlled trial. Lancet. 2004; 363:675-81. [IDIS 513141] [PubMed 15001324]
118. Mease PJ, Kivitz AJ, Burch FX et al. Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on disease progression. Arthritis Rhuem. 2004; 50:2264-72.
119. Krueger GG, Langley RG, Finlay AY et al. Patient-reported outcomes of psoriasis improvement with etanercept therapy: results of a randomized phase III trial. Br J Dermatol. 2005; 153:1192-9. [IDIS 545564] [PubMed 16307657]
120. Klareskog L, van der Heijde D, Wajdula S et al. Sustained efficacy and safety of etanercept and methotrexate, combined and alone, in RA patients: year 3 TEMPO trial results. Ann Rheum Dis. 2005; 64 (suppl III): 59. [PubMed 15130901]
121. Davis JC, van der Heijde DM, Braun J et al. Sustained durability and tolerability of etanercept in ankylosing spondylitis for 96 weeks. Ann Rheum Dis. 2005; 64:1557-62. [IDIS 544512] [PubMed 15843448]
122. The Wegener’s Granulomatosis Etanercept Trial (WGET) research group. Etanercept plus standard therapy for Wegener’s granulomatosis. N Engl J Med. 2005; 352:351-61. [PubMed 15673801]
123. Don BR, Spin G, Nestorov I et al. The pharmacokinetics of etanercept in patients with end-stage renal disease on haemodialysis. J Pharm Pharmacol. 2005; 57:1407-13. [IDIS 545799] [PubMed 16259772]
124. Food and Drug Administration. Natural rubber-containing medical devices; user labeling. 21 CFR Part 801. Final rule. (Docket No. 96N-0119) Fed Regist. 1997; 62:51021-30.
125. Food and Drug Administration. Amended economic impact analysis of final rule requiring use of labeling on natural rubber containing devices. 21 CFR Part 801. Final rule. (Docket No. 96N-0119) Fed Regist. 1998; 63:50660-704.
126. Food and Drug Administration. Latex-containing devices; user labeling. 21 CFR Part 801. Proposed rule. (Docket No. 96N-0119) Fed Regist. 1996; 61:32617-21.
127. Bristol-Myers Squibb. Orencia (abatacept) prescribing information. Princeton, NJ; 2011 Sep.
128. Food and Drug Administration, Center for Drug Evaluation and Research. Information for healthcare professionals: Tumor necrosis factor (TNF) blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi). FDA alert. Rockville MD; 2009 Aug 4. Available from FDA website (). Accessed 2009 Nov 3.
129. Food and Drug Administration, Center for Drug Evaluation and Research. FDA alert: Information for healthcare professionals Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab). Rockville MD: Food and Drug Administration; 2008 Sep 4. Available from FDA website. Accessed 2008 Oct 20.
130. Enbrel (etanercept) risk evaluation and mitigation strategy (REMS). From FDA website (). Accessed 2010 Jul 26.
132. Amgen. Patient instructions for use of Enbrel (etanercept) single-use prefilled SureClick autoinjector. Thousand Oaks, CA; 2015 Mar.
133. Amgen. Patient instructions for use of Enbrel (etanercept) single-use prefilled syringe. Thousand Oaks, CA; 2013 Sep.
134. Amgen. Patient instructions for use of Enbrel (etanercept) multiple-use vial. Thousand Oaks, CA; 2013 Sep.
135. Amgen/Wyeth Corporation. Enbrel (etanercept) prescribing information. Thousand Oaks, CA; 2008 Jun.
136. Amgen. Enbrel (etanercept) medication guide. Thousand Oaks, CA; 2013 Nov.
137. US Food and Drug Administration. FDA drug safety communication: Drug labels for the tumor necrosis factor-alpha (TNFα) blockers now include warnings about infection with Legionella and Listeria bacteria. Rockville, MD; 2011 Sep 7. From FDA website. Accessed 2011 Oct 2.
138. US Food and Drug Administration. FDA drug safety communication: Safety review update on reports of hepatosplenic T-cell lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine. Rockville, MD; 2011 Apr 14. From FDA website. Accessed 2011 Jul 26.
139. Genentech. Actemra (tocilizumab) injection prescribing information. South San Francisco, CA; 2011 Apr.
140. Biovitrum. Kineret (anakinra) injection prescribing information. Thousand Oaks, CA; 2009 Dec 15.
141. Genentech. Rituxan (rituximab) injection prescribing information. South San Francisco, CA; 2011 Apr.
142. Janssen Biotech Inc. Simponi (golimumab) injection prescribing information. Horsham, PA; 2011 Sep.
143. UCB, Inc. Cimzia (certolizumab pegol) for subcutaneous injection prescribing information. Smyrna, GA; 2011 Sep.
144. Abbott Laboratories. Humira (adalimumab) injection prescribing information. North Chicago, IL; 2011 Sep.
145. Janssen Biotech, Inc. Remicade (infliximab) for IV injection prescribing information. Horsham, PA; 2011 Sep.
146. US Food and Drug Administration. Approved risk evaluation and mitigation strategies (REMS). Available from FDA website. Accessed 2011 Nov 3.
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- Other brands: Enbrel