Wednesday, June 18, 2014

UpdatesPlus - EULAR - Integrated safety analysis from Xeljanz treated RA patients suggests that serious AE rate does not increase with time

    The alert below is from our EULAR 2014 coverage.  We have captured most of the key oral and poster presentations delivered at EULAR and will be analyzing these more comprehensively in upcoming issues of our UpdatesPlus service.UpdatesPlus is a service comprising alerts and monthly reports including pipeline and trial updates plus analysis of key information.  The service is designed for industry and academics across the Immunology & Inflammation spectrum.  To register for UpdatesPlus or to get further information please contact

    • In our previous alert we reported on long-term PRO data for Xeljanz from ORAL Start.  A second oral presentation at EULAR on Pfizer's JAK inhibitor described  an integrated safety analysis from cumulative exposure of 12,664 patient-years
    • Data were derived from 5671 patients in Phase 2 and 3 RA studies as well as OLEs.  555 patients received treatment for at least 3yrs
    • Rates of serious infection were constant over time (overall rate of 2.93/100 pt yrs) with the most frequent pathogens being herpes zoster, UTIs and TB.  TB events were predominantly in regions of high prevalence
    • 107 malignancies were reported (excl NMSC) with a stable rate (overall 0.85/100 pt yrs)
    • MACE events were reported with an overall rate of 0.46/100 pt yrs.  Rates, when stratified into 6m periods was remarkably variable

    Comments:  During the Q&A session it was remarked that some AEs may be expected to increase with treatment exposure with the example of serious infection given.  This was not observed.  Conversely an increase in MACE events may be expected due to background aging and against a relatively high risk seen with RA patients.  This was not the case and indeed a trend towards reduced events after 2 years is apparent.  Whether this trend is significant remains to be determined and if so better understood.  One possibility is that the dataset was enriched for healthier patients with time - far more interesting is the possibility that prolonged treatment and reduced inflammatory load reduced CV  risk.  With this in mind adjusting the data for baseline characteristics and stratifying for disease activity may be of use, especially as data continue to accumulate


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