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Upa Induction and Maintenace studies, Adapted mayo score: exc. PGA …
Upa Induction and Maintenace studies
INDU - U-ACHIEVE
199 clinical centres - 39 countries -
2:1, 45mg/Placebo
Clinical remission: 26% vs 5%
Achieved all secondary endpoints
Clinical response: 60%
More patients achieve lower than 150mg/kg FC at week 2 and 8 vs placebo
U-ACCOMPLISH
204 centres and 40 countries
2:1, 45 mg/placebo
Clinical Remission: 33% vs 4%
Achieved all secondary endpoints
Clinical response: 63%
U-ACHIEVE maintenance
195 centres and 35 centers
1:1:1 - 30mg; 15mg or placebo for 52 weeks
Clinical Remission: 42% (15mg); 52% (30mg); 12% placebo
All secondary endpoints achieved in 15mg + 30mg groups
Steroid free remission: 57%; 68%; 12% p=<0.0001
Mucosal healing: 18%; 19% and 5%
Design
16-75 years old
mod -severe UC
Adapted Mayo 5-9
Endoscopic subscore 2- 3
Primary endpoints:
Clinical Remission
per adapted mayo score at
8 and 52 weeks
Efficacy analysis in the 2x inductions studies based on ITT population (min. 1 dose). Maintenance study the primary efficacy analysis based on
first 450 clinical responders to 8-week induction
Definitions:
Clinical Response: Decrease in
Adapted Mayo by 2
or more +
30% or more from baseline
+ rectal
bleeding
score decrease of
at least
1
Clinical Remission:
Adapted Mayo of
2 or less
,
SFS of 1
or less and not greater than baseline,
RBS=0
and
ES of 1
or less without friability
MUCOSAL HEALING:
Endo score=0 + Genoese score of less than 2
STEROID-FREE CLINICAL REMISSION: clinical remission per adapted mayo score + steroid-free for 90+ days prior to week 52 in those who achieve clinical remission at the end of induction studies
Inadequate, intolerance or loss of response to at least one of: Aminosalicylates, steroids, immunosuppressants, or biological therapy.
At least 3 biological failures limited to less than 30%
Patients that discontinued biological due to other reasons e.g. insurance coverage provided their exposure was less than 1 year, were limited to 20% of the population
TNF and Veda
wash out - 8 weeks
Ustekinumab -
12 weeks wash out
Exclusions:
CD
Rectum limited disease
Active infection
Previous JAK
non responders at 8 weeks continued to receive until 16 weeks; if still not responding then they were discontinued
Concomitant UC related medications were kept the same (steroid prednisone less than 31mg daily)
Concomitant biological were prohibited
At week 0 of Maintenance. Steroids were tapered
Adapted mayo score: exc. PGA
Partial Mayo score: exc. Endoscopy