ACTEMRA Monotherapy Demonstrated Significant ACR Responses
ACR20 responses over time with ACTEMRA monotherapy17
*ITT population.
†ACTEMRA is not indicated for treating MTX-naïve patients with RA.
ACTEMRA is indicated for the treatment of TNF-IR patients with moderately to severely active RA.
ACR20 at Week 24 was the primary endpoint of the study.
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.
ACTEMRA monotherapy delivers significant improvement in DAS28
DAS28 < 2.6 response rates at Week 24 with
ACTEMRA monotherapy17
*Patients in each treatment group had moderately to severely active RA.
They were MTX-free for 6 months or MTX-naïve, and had not failed a TNF antagonist.
†Observed population.
CI=confidence interval.
Patient population
Patients in each treatment group had moderately to severely active RA. They were MTX-free for 6 months or MTX-naïve and had not failed a TNF antagonist.17
ACTEMRA is not indicated for the treatment of MTX-naïve patients with RA.
ACTEMRA is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
ACR responses in monotherapy patients from the AMBITION study
ACR responses at Week 24 with ACTEMRA monotherapy10
*ITT population
§ACR20 at Week 24 was the primary endpoint of the study.
ACR responses in TNF-IR patients from the RADIATE study
ACR responses at Week 24 in TNF-IR patients1
§ACR20 at Week 24 was the primary endpoint of the study.
Indication
ACTEMRA is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
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 manage anaphylaxis.
INDICATION
ACTEMRA is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
IMPORTANT SAFETY INFORMATION
Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt ACTEMRA until the infection is controlled.
ACTEMRA should not be administered to patients with known hypersensitivity to ACTEMRA.
- If anaphylaxis or other clinically significant hypersensitivity reaction occurs, administration of ACTEMRA should be stopped immediately and ACTEMRA should be permanently discontinued.
Other serious or potentially life-threatening adverse reactions that have been reported in clinical trials with ACTEMRA include gastrointestinal perforations and hypersensitivity reactions. Other potential risks of ACTEMRA include demyelinating disorders, malignancies, and changes to certain lab parameters.
Common adverse reactions include upper respiratory infection, nasopharyngitis, headache, hypertension, and increased ALT.
Please see full Prescribing Information including Boxed Warning for additional important safety information.
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