Lots of scare monger here without understanding the difference between AURORA trial and the rest of trials. one big difference between AURORA and AURA is the number of Hispanic and Black / Mixed race. in AURA those 2 ethnic categories presented 18.5% of the whole study. in AURORA study they should represent around 45% based on the site locations. But when we look at the Placebo values in AURA we see that 0 out of 10 patients achieved CR for the Other category (Black + Central America). Does it mean that the Black and mixed race in AURORA will achieve ZERO CR ? of course not. to find clues on the CR % for Black and Mixed races we can compare MMF numbers of previous trials . 2 examples:
1) the ALMS trial which was a Global trial too and covered various ethnic groups. the CR at 26 week was 8% for MMF group. This trial included around 27% of Blacks and Mixed races, and over 40% Hispanic ( of course some of the Hispanic could be part of the Aztec/Mexican mixed race category). but this 8% gives you an idea of the CR rate
2) the LUNAR trial which was a US trial equally broken down between Black / Hispanic / White. The MMF treatment had a CR at 52 weeks of 31% with no big difference between ethnic categories.
so why do we have this big difference between the 2 trials and which one is the right one ? first the study protocol and his stringent it is when it comes to CR conditions. 1)The LUNAR study had all patients Class III or IV ( ALMS and AURORA have pure class V). 2)the MMF was 3 mg / day in LUNAR and ALMS ( it is 2 in AURORA). 3) you can use rescue medication if you stay under 2 weeks in LUNAR and you can increase Steroid (in AURORA you can use up to a total of 1 week only and no more than 3 consecutive days and steroid use can not go over 10 mg / day) 3) in AURORA GFR reduction of < 20% makes you NR ( this does not exist in ALMS or LUNAR). 4) the Average daily Steroid dose for LUNAR after week 16 was 12.5 mg / daily when it is 2.5 mg in AURORA.
so this is just to tell you that numbers vary between one trial and another depending on how difficult are the trial conditions and CR conditions. I believe the AURORA (same as AURA) conditions are very strict and this explains why ZERO out of 5 blacks and 5 mixed Raced made any CR at 52 weeks in AURA . I don't know how VCS will perform with the Black category (no data in AURA for that) and same for Hispanic (even though we had 44% CR over 9 patients, which is still not enough but sure hell better than ZERO over 10 encountered in the MMF arm)
I am still extremely positive with the study result, it may not be higher than AURA due to the fact that Blacks / Hispanic are harder to treat than others but MMF too will be lower so that the P value between VCS and MMF will be statistically significant
As for safety, I already mentioned that the quality of the sites ?countries in AURORA is better than AURA. more safety measures were invested on the study sites, and since most of the death (9/13) happened in the first 2 months, AUPH team know that patients with AE will be thoroughly followed up in the first 2 months of the study (lessons learned)
