Clinical trial data offers immense insight into a drug’s safety, efficacy, and tolerability. But it can also share how combining two treatments can impact patient outcomes or whether a new therapy is more effective than the current standard-of-care. In a recent press release, biopharmaceutical company Aurinia Pharmaceuticals Inc. (“Aurinia”) shared that The Lancet published data from the Phase 3 AURORA 1 clinical trial evaluating LUPKYNIS (voclosporin) for patients with lupus nephritis (LN). During the trial, researchers determined that LUPKYNIS, used in conjunction with either low-dose corticosteroids or mycophenolate mofetil, resulted in better patient outcomes than either of the therapies used alone. Read the full study findings here.
In January 2021, the FDA approved LUPKYNIS in conjunction with another immunosuppressant for patients with LN. The AURORA 1 clinical trial also highlighted the benefits of LUPKYNIS, an orally administered immunosuppressive drug. LUPKYNIS works by inhibiting cytokine and T-cell activation, preventing an overactive immune response from permanently damaging the kidneys.
Within the AURORA 1 trial, researchers sought to understand the safety, efficacy, and tolerability of twice-daily LUPKYNIS when used with either corticosteroids or mycophenolate mofetil. Altogether, 357 patients enrolled. All patients were diagnosed with both systemic lupus erythematosus (often referred to simply as lupus) and lupus nephritis. The primary trial endpoint was complete renal response with stabilized kidney function, without the need for rescue medication. Additionally, the endpoint would be met if patients did not require over 10mg prednisone daily for 3+ consecutive, or 7+ total, days near the end of the trial. Excitingly, this endpoint was achieved. 41% of patients who received LUPKYNIS had a complete response, versus 23% who only received a placebo.
Ultimately, LUPKYNIS was relatively safe and well-tolerated. However, some adverse reactions did occur. These included:
- Bacterial, fungal, and viral infections
- Appetite loss
- High blood pressure
- Anemia (low red blood cell count)
- Mouth ulcers
- Alopecia (sudden and patchy hair loss)
- Urinary tract infections (UTIs)
- Abdominal pain
- Renal impairment
Lupus Nephritis (LN)
Altogether, an estimated 300,000 U.S. citizens live with systemic lupus erythematosus (“lupus”). Of these, nearly 50% of adults and 80% of children develop lupus nephritis (LN), a lupus-related complication. In LN, the immune system and lupus autoantibodies begin to attack certain areas of the kidneys. Unable to effectively filter out waste, the kidney becomes inflamed, resulting in a host of additional health issues. Lupus and LN are more common in females than males. Additionally, LN affects Black and Asian individuals at a significantly higher rate than Caucasians. Without treatment and management, LN can result in permanent kidney damage. Symptoms include:
- High blood pressure
- Swelling from excess fluid, particularly in the feet, ankles, and legs
- Dark and/or foamy urine
- Proteinuria (excess protein in the urine)
- Increased frequency of urination, particularly at night
- Joint and muscle pain
- Unintended weight gain
- Butterfly-shaped red rash on the face
- Kidney failure