STELARA® clinical efficacy data in adult patients with moderately to severely active UC

INDUCTION STUDY: CLINICAL RESPONSE AND CLINICAL REMISSION AT WEEK 8

STELARA®DELIVERED RAPID RESPONSE AND REMISSION IN JUST 8 WEEKS1

CLINICAL RESPONSE*

Overall Population

Major Secondary Endpoint (P<0.001)

58%

of patients receiving STELARA®(n=186/322)

31%

of patients receiving placebo (n=99/319)

Bio-naïve Patients

Other Secondary Endpoint Prespecified Subgroup Analysis
Not Adjusted for Multiplicity

64%

of patients receiving STELARA®(n=94/147)

36%

of patients receiving placebo (n=55/151)

 

CLINICAL REMISSION

Overall Population

Primary Endpoint (P<0.001)

19%

of patients receiving STELARA®(n=62/322)

7%

of patients receiving placebo (n=22/319)

≈3X more patients

Bio-naïve Patients

Other Secondary Endpoint Prespecified Subgroup Analysis
Not Adjusted for Multiplicity

24%

of patients receiving STELARA®(n=36/147)

9%

of patients receiving placebo (n=14/151)

Bio-failure Patients

Other Secondary Endpoint Prespecified Subgroup Analysis
Not Adjusted for Multiplicity

14%

of patients receiving STELARA®(n=24/166)

4%

of patients receiving placebo (n=7/161)

View rapid response achieved at Week 6 with STELARA® in CD

Bio-failure=failed biologic treatment; Bio-naïve=naïve to biologic treatment; CD=Crohn's disease; UC=ulcerative colitis.

 

*Clinical response was defined as a decrease from baseline in the Mayo score by ≥30% and ≥2 points, with either a decrease from baseline in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1.

†An additional 7 patients receiving placebo and 9 patients receiving STELARA® (6 mg/kg) had been exposed to, but had not failed, biologics.

‡Clinical remission was defined as Mayo stool frequency subscore of 0 or 1, Mayo rectal bleeding subscore of 0, and Mayo endoscopy subscore of 0 or 1 (modified so that 1 does not include friability).

STELARA® clinical efficacy data in adult patients with moderately to severely active UC

MAINTENANCE STUDY: CLINICAL REMISSION AT 1 YEAR

STELARA® DELIVERED LASTING REMISSION AT 1 YEAR1

45% of the overall population receiving STELARA® were in clinical remission after 1 year of treatment

CLINICAL REMISSION*

Overall Population

Primary Endpoint (P≤0.001)

45%

of patients receiving STELARA® 90 mg subQ every 8 weeks (n=79/176)

26%

of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=46/175)

Among the patients in clinical remission at 1 year with STELARA®, 96% (n=76/79) were steroid free (post hoc analysis)

Bio-naïve Patients

Prespecified Subgroup Analysis of Primary Endpoint
Not Adjusted for Multiplicity

49%

of patients receiving STELARA® 90 mg subQ every 8 weeks (n=39/79)

36%

of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=30/84)

Bio-failure Patients

Prespecified Subgroup Analysis of Primary Endpoint
Not Adjusted for Multiplicity

41%

of patients receiving STELARA® 90 mg subQ every 8 weeks (n=37/91)

18%

of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=16/88)

View lasting remission demonstrated at 1 year with STELARA® in CD

Bio-failure=failed biologic treatment; Bio-naïve=naïve to biologic treatment; CD=Crohn's disease; IV=intravenous; subQ=subcutaneous; UC=ulcerative colitis.

 

*Clinical remission was defined as Mayo stool frequency subscore of 0 or 1, Mayo rectal bleeding subscore of 0, and Mayo endoscopy subscore of 0 or 1 (modified so that 1 does not include friability).

†An additional 3 patients receiving placebo and 6 patients receiving STELARA® had been exposed to, but had not failed, biologics.

STELARA® clinical efficacy data in adult patients with moderately to severely active UC

MAINTENANCE STUDY: STEROID-FREE CLINICAL REMISSION

STELARA® PROVIDED STEROID-FREE REMISSION1*

43% of the overall population—and nearly half of bio-naïve patients—were in steroid-free clinical remission with STELARA® at 1 year

STEROID-FREE
CLINICAL REMISSION

Overall Population

Major Secondary Endpoint (P≤0.001)

43%

of patients receiving STELARA® 90 mg subQ every 8 weeks (n=76/176)

26%

of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=45/175)

Bio-naïve Patients

Prespecified Subgroup Analysis of Major Secondary Endpoint
Not Adjusted for Multiplicity

48%

of patients receiving STELARA® 90 mg subQ every 8 weeks (n=38/79)

36%

of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=30/84)

View efficacy data for STELARA® in CD

Bio-naïve=naïve to biologic treatment; CD=Crohn's disease; IV=intravenous; subQ=subcutaneous; UC=ulcerative colitis.

 

*Steroid-free clinical remission was defined as patients in clinical remission and not receiving corticosteroids at 1 year.

†An additional 3 patients receiving placebo and 6 patients receiving STELARA® had been exposed to, but had not failed, biologics.

STELARA® clinical efficacy data in adult patients with moderately to severely active UC

STELARA® IS THE FIRST AND ONLY FDA-APPROVED UC TREATMENT TO ACHIEVE HISTO-ENDOSCOPIC MUCOSAL IMPROVEMENT (HEMI)1*

Endoscopic Improvement

+

Histologic Improvement

=

Histo-Endoscopic 
Mucosal Improvement

HEMI is a combined measure that assesses improvement of the colon at the cellular level through histologic examination PLUS images observed during colonoscopy

STELARA®ACHIEVED HISTO-ENDOSCOPIC MUCOSAL IMPROVEMENT (HEMI)1*

HEMI RESULTS1

Overall Population

Multiplicity-controlled Other Secondary Endpoint (P<0.001)

17%

of patients receiving STELARA®(n=54/322)

8%

of patients receiving placebo (n=26/319)

Bio-naïve Patients

Prespecified Subgroup Analysis of Other Secondary Endpoint

20%

of patients receiving STELARA®(n=30/147)

13%

of patients receiving placebo (n=19/151)

HEMI RESULTS1,2

Overall Population

Prespecified Other Endpoint (P<0.001)‡

44%

of patients receiving STELARA® 90 mg subQ every 8 weeks (n=75/172)

23%

of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=40/172)

Bio-naïve Patients

Prespecified Subgroup Analysis of Other Endpoint

49%

of patients receiving STELARA® 90 mg subQ every 8 weeks (n=38/77)

31%

of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=25/81)

The relationship of HEMI to long-term outcomes was not studied in the clinical trials.

‡The P  value is nominal. It represents a summary statistic and cannot be used to conclude statistical significance.

View efficacy data for STELARA® in CD

Bio-naïve=naïve to biologic treatment; CD=Crohn's disease; IV=intravenous; subQ=subcutaneous; UC=ulcerative colitis.

 

*HEMI was defined as combined endoscopic improvement (Mayo endoscopy subscore of 0 or 1) and histologic improvement of the colon tissue (neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue).

†An additional 7 patients receiving placebo and 9 patients receiving STELARA® (6 mg/kg) had been exposed to, but had not failed, biologics.

References: 1. STELARA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.