Overall Incidence of Adverse Reactions
SUNBEAM AND RADIANCE: POOLED DATA | ||
---|---|---|
Adverse Reactions | Avonex n=885 | ZEPOSIA n=882 |
Upper respiratory infectionb | 23% | 26% |
Hepatic transaminase elevationc | 5% | 10% |
Orthostatic hypotension | 3% | 4% |
Urinary tract infection | 3% | 4% |
Back pain | 3% | 4% |
Hypertensiond | 2% | 4% |
Abdominal pain upper | 1% | 2% |
Adverse reactions are sorted by decreasing incidence in patients treated with ZEPOSIA.
For adverse reactions pertaining to liver function tests, increases were transient and generally resolved without discontinuation.3
Elevations of 3-fold the ULN or greater occurred in 5.5% of patients taking ZEPOSIA and in 3.1% of patients taking Avonex. The majority (79%) continued treatment with ZEPOSIA with values returning to less than 3 times the ULN within approximately 2 to 4 weeks.3
aData are not an adequate basis for comparison of rates between ZEPOSIA and the active control.
bIncludes the following terms: nasopharyngitis, upper respiratory tract infection, pharyngitis, respiratory tract infection, bronchitis, rhinitis, respiratory tract infection viral, viral upper respiratory tract infection, rhinorrhea, tracheitis, and laryngitis.
cIncludes the following terms: alanine aminotransferase increased, gamma-glutamyl transferase increased, aspartate aminotransferase increased, hepatic enzyme increased, liver function test abnormal, and transaminases increased.
dIncludes hypertension, essential hypertension, and orthostatic hypertension.
ULN=upper limit of normal.
Overall Discontinuation Rates3
SUNBEAM | ||
---|---|---|
Adverse Reactions | Avonex n=445 | ZEPOSIA n=448 |
ALT increased | 0% | 0.4% |
Back pain | 0.2% | 0.4% |
Headache | 0% | 0.4% |
RADIANCE | ||
---|---|---|
Adverse Reactions | Avonex n=440 | ZEPOSIA n=434 |
ALT increased | 0.7% | 0.5% |
Urticaria | 0% | 0.5% |
aIncludes all adverse reactions ≥0.4% that led to discontinuation of ZEPOSIA.
ALT=alanine aminotransferase.
MS=multiple sclerosis; S1P=sphingosine-1-phosphate.
ALC=absolute lymphocyte count; BL=baseline; LLN=lower limit of normal.
This information is intended for U.S. Healthcare Professionals.