RHEUMATOID ARTHRITIS (RA)
The most common serious adverse reactions were serious infections. The most common serious infections included pneumonia, urinary tract infection, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis and bacterial arthritis. In the ACTEMRA-IV monotherapy clinical study, the rate of serious infections was 3.6 per 100 patient-years in the ACTEMRA group and 1.5 per 100 patient-years in the methotrexate group. The rate of serious infections in the 4 mg/kg and 8 mg/kg ACTEMRA plus DMARD groups was 4.4 and 5.3 events per 100 patient-years, respectively, compared to 3.9 events per 100 patient-years in the placebo plus DMARD group.
In the 5 Phase III clinical trials, the most common adverse reactions (≥5% of patients treated with ACTEMRA-IV) through 6 months were:
|
ACTEMRA-IV
8 mg/kg
Monotherapy (%) |
Methotrexate (%) |
ACTEMRA-IV
4 mg/kg
+ DMARDs (%) |
ACTEMRA-IV
8 mg/kg
+ DMARDs (%) |
Placebo
+ DMARDs (%) |
---|
URTI |
7 |
5 |
6 |
8 |
6 |
Nasopharyngitis |
7 |
6 |
4 |
6 |
4 |
Headache |
7 |
2 |
6 |
5 |
3 |
Hypertension |
6 |
2 |
4 |
4 |
3 |
Increased ALT |
6 |
4 |
3 |
3 |
1 |
The safety observed for ACTEMRA administered subcutaneously was consistent with the known safety profile of intravenous ACTEMRA, with the exception of injection-site reactions, which were more common with ACTEMRA-SC compared with placebo-SC injections (IV-arm).
In the 6-month control period, in SC-I, the frequency of injection-site reactions was 10.1% (64/631) and 2.4% (15/631) for the weekly ACTEMRA-SC and placebo-SC (IV-arm) group, respectively. In SC-II, the frequency of injection-site reactions was 7.1% (31/437) and 4.1% (9/218) for the every other week ACTEMRA-SC and placebo-SC groups, respectively. These injection-site reactions were mild to moderate in severity. The majority resolved without any treatment and none necessitated drug discontinuation.