Median time to treatment failure
was 226 days in the oral antipsychotic group and nearly twice as long at 416 days in the injectable paliperidone palmitate group.
Study met primary endpoint of 50% prolongation of time to treatment failure
over that expected for standard RCHOP alone; estimated 73% 5-year overall survival with ZEVALIN
The PRIDE trial looked at time to treatment failure
in 444 schizophrenia patients over 15 months--226 were treated with IM paliperidone (Invega Sustenna) and 218 were treated with one of seven oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, or risperidone).
El-Nashar reported that there were no significant differences in the time to treatment failure
between the two groups, with a 3-year cumulative failure rate of 9% in the RFA group, compared with 12% in the TBA group.
The primary outcome was time to treatment failure
, strictly defined as failure to enter prednisone-free remission at week 14 and failure to maintain remission through week 50.
The trial's primary outcome was time to treatment failure
, which the investigators defined in seven ways, including physician judgment.
0380) LTLD dose response effect: median time to treatment failure
for patients receiving at least the maximum tolerated dose of 50 mg/m2was 374 days while that for patients receiving less than 50 mg/ m2 was 80 days.
PRIDE assessed as its primary endpoint time to treatment failure
, which is a subset of relapse.
1 years' follow-up, there was no difference in overall survival, although the primary analysis showed a statistically significant rise in time to treatment failure
in the 352 patients on maintenance therapy.
Secondary endpoints included overall survival, response rate, time to treatment failure
, quality of life and safety.
Secondary endpoints included overall survival, time to treatment failure
We are hopeful that these data will be persuasive to the FDA and European regulatory authorities even though we missed our primary endpoint of median time to treatment failure
at study day 50.