Clinical Response & Remission | RINVOQ CD

INITIATION GUIDE

PRODUCT INFORMATION

PATIENT BOOKLET

A Phase 3 RINVOQ clinical trial program in Crohn's disease

A Phase 3 clinical trial program involving 3 studies: 2 replicate induction studies (U-EXCEED and U-EXCEL) and 1 maintenance study (U-ENDURE) evaluated RINVOQ 45 mg vs placebo for induction, and RINVOQ 15 mg and 30 mg vs placebo for maintenance treatment. The co-primary endpoints of disease control were endoscopic response (per simple endoscopic score for Crohn’s disease [SES-CD]) and clinical remission (per stool frequency and abdominal pain score [SF/APS]) at Week 12 and Week 52.^1,2*

*Patients who achieved clinical response (SF/APS) with the 12-week RINVOQ 45 mg QD induction treatment entered the maintenance phase. Clinical non-responders (per SF/APS) entered extended induction with RINVOQ 30 mg QD for a further 12 weeks. EMA protocol.¹

Study design

as early as Week 2 with RINVOQ^1,2

Clinical response (CR-100) = Decrease of at least 100 points in CDAI from baseline at Week 2 and 12; secondary endpoints (NRI-C).¹

*P<0.001; **P=0.002; RINVOQ vs placebo. Multiplicity-controlled analysis at Week 2 and 12.
All other timepoints are non-ranked and not controlled for multiplicity; p-values not reported.

with extended induction^1,3

Open-label extension (+12 weeks).

Week 52 maintenance outcomes among induction Week 24 responders to RINVOQ 30 mg QD

Maintained clinical response per SF/APS* with RINVOQ 30 mg (41.2%).³
Clinical remission per CR-100^‡ with RINVOQ 30 mg (35.3%).³

*Clinical response (SF/APS) = ≥30% decrease in average daily very soft or liquid SF and/or ≥30% decrease in average daily APS and neither greater than baseline (NRI-C).¹
^†RINVOQ patients who did not achieve clinical response at Week 12 in U-EXCEL and U-EXCEED continued in an additional 12-week, open-label, induction extension period with RINVOQ 30 mg QD. Clinical responders following extended induction continued to U-ENDURE Maintenance, however they were not included in the primary analysis.³
^‡Clinical remission (CR-100) = Decrease of at least 100 points in CDAI from baseline at Week 2 and 12; secondary endpoints (NRI-C).^1,3
Open-label extended induction endpoints were not pre-specified and not controlled for multiplicity.³

^1,2

Clinical remission (SF/APS) = Average daily SF ≤2.8 and APS ≤1.0 and neither greater than baseline at Week 12 and Week 52; co-primary endpoint (NRI-C).¹

*P<0.001; RINVOQ vs placebo. Multiplicity-controlled analysis at Week 4, 12 and 52.
All other timepoints are non-ranked and not controlled for multiplicity; p-values not reported.
RINVOQ induction and maintenance studies achieved the co-primary endpoints of clinical remission and endoscopic response (decrease in SES-CD >50% from baseline of the induction study [or for patients with an SES-CD of 4 at baseline of the induction study, at least a 2-point reduction from baseline of the induction study]) at Week 12 and Week 52.^1,2

Subgroup analysis at Week 12 and Week 52

All comparisons are non-ranked and not controlled for multiplicity; p-values not reported.
With biologic failure: Inadequate response or intolerance to one or more biologic therapies.
Without biologic failure: Inadequate response or intolerance to conventional therapies but not biologic therapy.

CDAI^1,2

Clinical remission (CDAI) = CDAI < 150 at Week 12 and Week 52; secondary endpoints (NRI-C).¹

*P<0.001; RINVOQ vs placebo. Multiplicity-controlled analysis at Week 4, 12 and 52.

Sustained²

Steroid-free remission = Discontinuation of steroid and achievement of clinical remission (average daily SF ≤2.8 and APS ≤1.0 and neither greater than baseline) at Week 12 among patients on steroids at baseline; secondary endpoint (NRI-C).¹