Biotech Values

[poorgradstudent]

GLPG:

Since male is much smaller RA population (20-25%), it wouldn't be much different from other dose reduction implemented under different circumstances, for example renal impairment to use 2mg QD for baricitinib and 5mg QD for tofacitinib.

I agree that you can dose differently, and I appreciated your comment on twitter.

My only comment is that if the efficacy tracks as Darwin1/2 have, there is an incentive to be able to dose participants at 200 mg total per day. It's anecdotal in a sense, but in Darwin1 the only doses that reached statistical significance over placebo for ACR20 were the 200 mg once daily and 100 mg twice daily doses.

I don't make too much about ACR20 when you have ACR50/70, but it's still an oft-used primary endpoint in RA trials. I would think GLPG would prefer to dose as many participants as possible at levels above 100 mg/day.