Efficacy - Post-hoc Analyses

UC Patients can benefit from a rapid and significant reduction in symptoms with XELJANZ, seen as early as 3 days1
For patients with moderately to severely active ulcerative colitis, onset of action is an important consideration when choosing appropriate therapy to provide timely symptomatic relief1

Based on post hoc analyses of daily patient diary data from the OCTAVE induction studies:

  • Significant reductions in rectal bleeding vs placebo were seen as early as 3 days: 
    mean change from baseline rectal bleeding subscore of -0.30 vs -0.14; p<0.01

  • Significant reductions in stool frequency vs placebo were seen as early as 3 days:
    mean change from baseline stool frequency subscore of -0.27 vs -0.11; p<0.01

*Relates to results from a post hoc analysis, consideration should be made for multiple testing and inclusion of unadjusted p-values when interpreting data.
Post-hoc analysis of pooled data from Induction 1 and 2 trials. Daily Mayo stool frequency and rectal bleeding subscores were calculated using patient diary data collected daily during the first 15 days of induction therapy. Partial Mayo Score subscore data were first collected at Day 15.

With XELJANZ, rapid reduction in symptoms, seen within 3 days are irrespective of prior TNFi therapy failure status, baseline steroid use, or baseline C-reactive protein level1

Percentage of patients with reduction from baseline Mayo rectal bleeding subscore >1 excludes patients with baseline Mayo rectal bleeding subscore = 0
§Percentage of patients with reduction from baseline Mayo stool frequency subscore of >1 excludes patients with baseline Mayo stool frequency subscore = 0

 

XELJANZ Risk Minimisation Programme (RMP) materials, including a Patient Alert Card, Prescriber Checklists and a Prescriber Brochure are available from https://www.medicines.org.uk/emc/. Patients treated with XELJANZ should be given the Patient Alert Card.

XELJANZ Summary of Product Characteristics    XELJANZ Prescribing Information

1Hanauer S et al. Clin Gastroenterol Hepatol 2019;17:139-47
2. Hanauer S et al Clin Gastroenterol Hepatol 2019;17(Suppl):139-47
 

PP-XEL-GBR-2152 March 2020