Are you comfortable using belimumab in patients with a history of significant depression?
YES! (look at the numbers below)... edited as I accidentally initially said no.
There was numerically increased suicidality and depression in the phase 3 clinical trials of IV belimumab (BLISS-52 and BLISS-76). Unfortunately, there were two completed suicides. Two things occurred due to this:
- Subseq...
Initial RCTs for belimumab in non-renal SLE surprisingly showed an association with this drug and increased risk of depression, leading to a black box warning on FDA prescribing instructions. Subsequent studies and meta-analyses have further evaluated this risk, which show a modest increased risk of...
If the patient has depression on treatment with control or a history of depression, I discuss the potential risk of belimumab possibly making it worse. I discuss with them that they need to let me know and their PCP or mental health professional if they note a change in their mood and/or developing ...