The main focus of my presentation at AD/PD was on safety outcomes with gantenerumab and the GRADUATE program. And basically, it showed that there was ARIA, sort of at predicted rates that we’ve seen in other trials and that the pattern of the ARIA was similar to what we’ve seen as well. So typically asymptomatic and transient, and manageable in the clinical trial setting. There were no deaths that were clearly related to ARIA or to treatment with gantenerumab...
The main focus of my presentation at AD/PD was on safety outcomes with gantenerumab and the GRADUATE program. And basically, it showed that there was ARIA, sort of at predicted rates that we’ve seen in other trials and that the pattern of the ARIA was similar to what we’ve seen as well. So typically asymptomatic and transient, and manageable in the clinical trial setting. There were no deaths that were clearly related to ARIA or to treatment with gantenerumab. So overall it looked like the medication was well tolerated or at least as expected given this class of amyloid lowering antibodies. There were some infusion reactions or site injection reactions which again we had seen in prior trials as well. So no major new safety concerns.
Now unfortunately, the main focus of the trial, the primary outcome was on the clinical outcome and although there was some numerical benefits for gantenerumab in both GRADUATE I and GRADUATE II, it didn’t really reach significance. And I think the company has decided not to take this version of gantenerumab forward based on that.
