ACTEMRA Delivered Rapid and Increased Clinical Responses in TNF-IR Patients12,13
ACR20 responses over time in TNF-IR patients12,13*
*The same patients may not have responded at each time point.
†Intent-to-treat (ITT) population
§ACR20 at Week 24 was the primary endpoint of the study.
ACR=American College of Rheumatology; BL=baseline; TNF-IR=inadequate response to TNF antagonists
Gastrointestinal Perforations
Events of gastrointestinal perforation have been reported in clinical trials, primarily as complications of diverticulitis. ACTEMRA should be used with caution in patients who may be at increased risk for gastrointestinal (GI) perforation. Patients presenting with new-onset abdominal symptoms should be evaluated promptly for early identification of GI perforation.
ACTEMRA responses in an open-label long-term extension study
Long-term response in TNF-IR patients14
- Care should be exercised when interpreting open-label results due to the inability to minimize bias
- At 24 weeks, patients could continue on ACTEMRA 8 mg/kg + MTX in a long-term extension
- This analysis included all patients who received at least one dose of ACTEMRA (4 mg/kg or 8 mg/kg) + MTX
- Baseline is considered as the time when patients received their first ACTEMRA dose. Thus patients could have received their first ACTEMRA dose in the controlled study (either 4 mg/kg or 8 mg/kg), as rescue therapy (8 mg/kg only) or when they entered the long-term extension study (8 mg/kg only)
Laboratory Monitoring
Neutrophils, platelets, lipids and hepatic transaminases should be monitored as changes in these parameters were associated with treatment with ACTEMRA. Dosage modifications may be required. Please see full prescribing information for more information.
DAS28 <2.6 response rates at Week 24 in TNF-IR patients12,15
*Observed population.
DAS28=Disease Activity Score based on a 28-joint count.
ACTEMRA improves signs and symptoms of RA in TNF-IR patients
Percent change in ACR core components at Week 24 in TNF-IR patients16
*0=best, 100=worst.
†0=best, 3=worst.
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.
The resource above is provided in Adobe® Reader® format (PDF). To view or print, you must have Adobe Reader (version 3.0 or higher) installed on your computer. Download the free Adobe Reader here.
