Efficacy

Lupkynis (Voclosporin) for Systemic Lupus Erythematosus

Lupkynis (voclosporin) is an immunosuppressive medication that has been approved for use in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis, which is a serious complication of Systemic Lupus Erythematosus (SLE). The efficacy of voclosporin was established in the AURORA Phase 3 clinical trial, which demonstrated that patients treated with voclosporin in addition to standard-of-care treatment had a significantly higher rate of renal response at 52 weeks compared to those receiving standard-of-care alone. This suggests that voclosporin can be an effective addition to current treatment regimens for lupus nephritis, potentially improving outcomes for patients with this condition.

The AURORA study showed that the use of voclosporin led to a reduction in proteinuria, which is a marker of kidney damage, and an improvement in renal function markers. The study also indicated that voclosporin was associated with a more rapid response when compared to the control group. The addition of voclosporin to standard therapy has been a significant advancement in the management of lupus nephritis, providing an additional option for patients who may not respond adequately to conventional treatments.

Saphnelo (Anifrolumab) for Systemic Lupus Erythematosus

Saphnelo (anifrolumab) is a monoclonal antibody that has been approved for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy. Anifrolumab targets the type I interferon receptor, thereby blocking the activity of type I interferons, which are believed to play a key role in the pathophysiology of SLE. The efficacy of anifrolumab was demonstrated in the TULIP Phase 3 clinical trials, where it showed a statistically significant reduction in disease activity compared to placebo in patients with SLE.

The TULIP trials found that anifrolumab led to a greater percentage of patients achieving a reduction in steroid dosage and an increase in the number of patients achieving a sustained reduction in overall disease activity. These results indicate that anifrolumab can be an effective treatment for patients with moderate to severe SLE, offering a new mechanism of action that targets the underlying pathophysiology of the disease. This provides a new therapeutic option for patients who may have limited responses to existing treatments or who are looking for alternatives to manage their disease more effectively.