AE | LUPKYNIS 23.7 mg BID (n=267) |
MMF + Low-dose Steroids (n=266) |
---|---|---|
Glomerular filtration rate decreased | 26% | 9% |
Hypertension | 19% | 9% |
Diarrhea | 19% | 13% |
Headache | 15% | 8% |
Anemia | 12% | 6% |
Cough | 11% | 2% |
Urinary tract infection | 10% | 6% |
Abdominal pain upper | 7% | 2% |
Dyspepsia | 6% | 3% |
Alopecia | 6% | 3% |
Renal impairment | 6% | 3% |
Abdominal pain | 5% | 2% |
Mouth ulceration | 4% | 1% |
Fatigue | 4% | 1% |
Tremor | 3% | 1% |
Acute kidney injury | 3% | 1% |
Decreased appetite | 3% | 1% |
aGFR decreased was the most frequently reported kidney AE. Other kidney AEs were kidney impairment, acute kidney injury, blood creatinine increased, azotemia, kidney failure, oliguria, and proteinuria.1
bClinically significant AEs included serious infections, nephrotoxicity, hypertension, neurotoxicity, lymphoma and other malignancies, hyperkalemia, pure red cell aplasia, and QTc prolongation.1
AE=adverse event; BID=twice daily; MMF=mycophenolate mofetil.
References: 1. LUPKYNIS. Package insert. Aurinia Pharma U.S., Inc; 2021. 2. Aurinia Pharma U.S., Inc. Data on file.
LUPKYNIS (n=116) |
MMF + Low-dose Steroids (n=100) |
|
---|---|---|
Any AE | 86.2% | 80.0% |
Treatment-related AE | 24.1% | 21.0% |
Serious AE | 18.1% | 23.0% |
Treatment-related serious AE | 0.9% | 2.0% |
AEs leading to discontinuation | 9.5% | 17.0% |
Deaths (n) | 0 | 4 |
Disease-related AE | 43.1% | 34.0% |
Disease-related serious AE | 6.0% | 11.0% |
In AURORA 2, LUPKYNIS demonstrated safety comparable to that seen in AURORA 1 with no unexpected safety signals observed.2
cAE was defined as any untoward medical occurrence that occurred on or after entrance into AURORA 2 and up to 30 days after study treatment end.2
dThree deaths occurred during the study, and one death occurred during follow-up.2
AE=adverse event; BID=twice daily; MMF=mycophenolate mofetil.
References: 1. LUPKYNIS. Package insert. Aurinia Pharma U.S., Inc; 2021. 2. Aurinia Pharma U.S., Inc. Data on file.