Drug updated on 12/11/2024
Dosage Form | Capsule (oral; 7.9 mg) |
Drug Class | Calcineurin inhibitor immunosuppressants |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN).
Latest News
Summary
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Complete Renal Remission (CRR) in Lupus Nephritis (LN): Voclosporin combined with mycophenolate mofetil (MMF) demonstrated a high efficacy in achieving complete renal remission, showing the highest remission rate among treatments, followed closely by Tacrolimus (TAC). Multitarget therapy had the greatest effect in this outcome with an odds ratio of 2.78 (95% confidence interval (CI): 1.81-4.26).
- Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): The combination of Tacrolimus (TAC), MMF, and glucocorticoids (glucocorticoids (GC) (Surface Under the Cumulative Ranking (SUCRA), 86.63%)) showed the best improvement in SLEDAI scores, with a SUCRA score of 91.00%, indicating strong efficacy in managing systemic lupus activity.
- Significant Differences Among Populations: The studies included predominantly Asian populations, which highlights the need for further research to confirm the generalizability of multitarget therapy and other lupus nephritis treatments in non-Asian patients.
- The combination of voclosporin with MMF was associated with the highest risk of infections and serious infections among the treatment options for lupus nephritis, while Tacrolimus (TAC) with MMF and GC showed a comparatively lower infection risk, indicating a better safety profile for TAC-based therapy.
- The study reported no significant statistical differences in serious adverse events (SAE) across the various treatment options, although specific adverse events like myelosuppression and herpes zoster were more common with combinations like azathioprine (AZA) (SUCRA, 68.59%) plus GC and TAC plus GC respectively.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Lupkynis (voclosporin) Prescribing Information. | 2024 | Aurinia Pharma, Rockville, MD |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Management of systemic lupus erythematosus: a systematic literature review informing the 2023 update of the EULAR recommendations | 2024 | Annals of the Rheumatic Diseases |