Do you think there is a role for belimumab in treating lupus nephritis and if so, in which patients would you considering adding it on?
Will you consider adding belimumab to MMF in treatment naïve lupus nephritis patients?
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The results from BLISS-LN showed modest efficacy as an add-on therapy to standard of care. The improvement was significant only in the non-black patients receiving mycophenolate mofetil (MMF) as standard of care. The primary endpoint was changed in the midst of the trial but still, the complete renal response was 1.5 times more likely in patients receiving belimumab.
Based on these results, I would consider adding belimumab to:
- Non-black patients on background MMF, who have either failed cyclophosphamide (CYC) OR flared after an initial response to MMF or CYC.
- Patients with LN with ongoing requirements for moderate to high doses of steroids.
The questions to be answered by subsequent belimumab trials include:
- Is belimumab and steroid combination without background MMF efficacious in LN?
- Role of belimumab in patients with disease recalcitrant to both MMF and CYC?
2020 will probably go down as the year where new medications for the treatment of lupus nephritis will get approved by the FDA. Not only belimumab but also voclosporin appear to be safe and result in the improvement of outcomes in lupus nephritis.
For the time being it is reasonable to use belimumab:
(a) In the treatment of patients with a relapse of their nephritis (biopsy with high activity score and peripheral hypocomplementemia +/- dsDNA positivity);
(b) In patients with poor prognostic markers, especially if they are undergoing treatment with cyclophosphamide/azathioprine as other medications such as calcineurin inhibitors are untested in this latter treatment group;
(c) In patients who may benefit significantly from the potential steroid sparring effect of belimumab.
Moving forward, the questions that should be answered are:
(a) Should belimumab be automatically be added to the standard of care for all patients even at the first episode of nephritis or reserved for resistant cases? Real-world data may help with this.
(b) How does the belimumab+mycophenolate combination compare to calcineurin inhibitors+mycophenolate in terms of both efficacy and safety?