Physician Opinion
Physician insights into biologic monotherapy
  • "...monotherapy represents a real paradigm shift..."
    James E Loveless, MD, FACR
    Medical Director of Adult Rheumatology and Research
    St. Luke's Rheumatology and Research Center in Boise, Idaho
  • "...that methotrexate combination with the biologic might be good for some patients, but...might not be required for every individual patient."
    Alvin F Wells, MD, PhD
    Rheumatologist
    Franklin, Wisconsin
  • "As much as we, in rheumatology, love methotrexate, there are patients who simply can't tolerate it, even in modest doses."
    Glenn Ehresmann, MD
    Associate Professor, Keck School of Medicine
    University of Southern California
  • "The problem is patients don't always want exactly the same thing we want."
    Anthony I Sebba, MD, FACR
    Assistant Clinical Professor, Dept. of Rheumatology
    University of South Florida
  • "...we should consider this covert noncompliance when choosing our biologic therapies."
    Ara Dikranian, MD
    Rheumatologist
    San Diego, California
Next: About ACTEMRA »
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James E Loveless, MD, FACR

Medical Director of Adult Rheumatology and Research,
St. Luke's Rheumatology and Research Center, Boise, Idaho

Alvin F Wells, MD, PhD

Rheumatologist, Franklin, Wisconsin

Glenn Ehresmann, MD

Associate Professor, Keck School of Medicine,
University of Southern California

Anthony I Sebba, MD, FACR

Assistant Clinical Professor, Dept. of Rheumatology,
University of South Florida

Ara Dikranian, MD

Rheumatologist, San Diego, California

Important Safety Information

Serious Infections

Serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral and other opportunistic infections, have occurred in patients receiving ACTEMRA. The most common serious infections included pneumonia, urinary tract infection, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis and bacterial arthritis. Among opportunistic infections, tuberculosis (TB), cryptococcus, aspergillosis, candidiasis and pneumocystosis were reported with ACTEMRA.

ACTEMRA should not be administered during an active infection, including localized infections. Prior to initiating ACTEMRA, a test for latent TB should be performed. If the test is positive, treatment for TB should be started prior to starting ACTEMRA. Antituberculosis therapy should also be considered prior to initiation of ACTEMRA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but having risk factors for TB infection. All patients should be monitored for active TB during treatment, even if the initial latent TB test is negative.

The benefits and risks of treatment should be considered prior to initiating ACTEMRA in patients:
  • with chronic or recurrent infection
  • who have been exposed to TB
  • who have a history of serious or opportunistic infections
  • who have resided or traveled in areas of endemic TB or mycoses
  • with underlying conditions that may predispose them to infection

Please see full Prescribing Information including Boxed Warning for additional important safety information.

Important Safety Information

Laboratory Parameters

Neutrophils Treatment with ACTEMRA was associated with a higher incidence of neutropenia. Infections have been uncommonly reported in association with treatment-related neutropenia in long-term extension studies and postmarketing clinical experience. It is not recommended to initiate ACTEMRA treatment in patients with an absolute neutrophil count (ANC) <2000/mm3. In patients who develop an ANC <500/mm3, treatment is not recommended. Neutrophils should be monitored every 4 to 8 weeks. Dosage modifications based on ANC may be required.

Platelets Treatment with ACTEMRA was associated with a reduction in platelet counts. It is not recommended to initiate ACTEMRA treatment in patients with a platelet count <100,000/mm3. In patients who develop a platelet count <50,000/mm3, treatment is not recommended. Platelets should be monitored every 4 to 8 weeks. Dosage modifications based on platelet counts may be required. Please see full Prescribing Information for more information.

Please see full Prescribing Information including Boxed Warning for additional important safety information.

Important Safety Information

Laboratory Parameters

Hepatic Transaminases Treatment with ACTEMRA was associated with a higher incidence of transaminase elevations. Increased frequency and magnitude of these elevations was observed when potentially hepatotoxic drugs (eg, methotrexate) were used in combination with ACTEMRA. It is not recommended to initiate ACTEMRA treatment in patients with elevated transaminases ALT or AST >1.5x ULN. In patients who develop elevated ALT or AST >5x ULN, treatment is not recommended. ALT and AST levels should be monitored every 4 to 8 weeks. When clinically indicated, other liver function tests such as bilirubin should be considered. Dosage modifications based on transaminases may be required.

Lipids Treatment with ACTEMRA was associated with increases in lipid parameters such as total cholesterol, triglycerides, LDL cholesterol and/or HDL cholesterol. Assessment of 10 lipid parameters should be performed approximately 4 to 8 weeks following initiation of ACTEMRA therapy, then at approximately 6-month intervals. Patients should be managed according to clinical guidelines for the management of hyperlipidemia.

Please see full Prescribing Information including Boxed Warning for additional important safety information.

Important Safety Information

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis and death, have occurred with infusion of ACTEMRA. ACTEMRA should only be administered by a healthcare professional with appropriate medical support to immediately manage anaphylaxis. If anaphylaxis or other clinically significant hypersensitivity reaction occurs, administration of ACTEMRA should be stopped immediately and ACTEMRA should be permanently discontinued. Do not administer ACTEMRA to patients with known hypersensitivity to ACTEMRA.

Clinically significant hypersensitivity reactions, including anaphylaxis associated with ACTEMRA and requiring treatment discontinuation, were reported in 0.1% (3 out of 2644) in the 24-week controlled trials and in 0.2% (8 out of 4009) in the all-exposure population. In the postmarketing setting, these events have occurred as early as the first infusion of ACTEMRA.

Please see full Prescribing Information including Boxed Warning for additional important safety information.

Important Safety Information

Immunosuppression

The impact of treatment with ACTEMRA on the development of malignancies is not known, but malignancies were observed in clinical studies with ACTEMRA. ACTEMRA is an immunosuppressant, and treatment with immunosuppressants may result in an increased risk of malignancies.

Please see full Prescribing Information including Boxed Warning for additional important safety information.