STELARA® clinical efficacy data in adult patients with moderately to severely active UC
INDUCTION STUDY: CLINICAL RESPONSE AND CLINICAL REMISSION AT WEEK 8
CLINICAL RESPONSE*Major Secondary Endpoint (P<0.001)
of patients receiving STELARA® (n=186/322)
of patients receiving placebo (n=99/319)
Other Secondary Endpoint Prespecified Subgroup Analysis
Not Adjusted for Multiplicity
of patients receiving STELARA® (n=94/147)
of patients receiving placebo (n=55/151)
CLINICAL REMISSION‡Primary Endpoint (P<0.001)
of patients receiving STELARA® (n=62/322)
of patients receiving placebo (n=22/319)
Other Secondary Endpoint Prespecified Subgroup Analysis
Not Adjusted for Multiplicity
of patients receiving STELARA® (n=36/147)
of patients receiving placebo (n=14/151)
Other Secondary Endpoint Prespecified Subgroup Analysis
Not Adjusted for Multiplicity
of patients receiving STELARA® (n=24/166)
of patients receiving placebo (n=7/161)
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
CLINICAL REMISSION*Primary Endpoint (P≤0.001)
of patients receiving STELARA® 90 mg subQ every 8 weeks (n=79/176)
of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=46/175)
Prespecified Subgroup Analysis of Primary Endpoint
Not Adjusted for Multiplicity
of patients receiving STELARA® 90 mg subQ every 8 weeks (n=39/79)
of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=30/84)
Prespecified Subgroup Analysis of Primary Endpoint
Not Adjusted for Multiplicity
of patients receiving STELARA® 90 mg subQ every 8 weeks (n=37/91)
of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=16/88)
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
STEROID-FREEMajor Secondary Endpoint (P≤0.001)
of patients receiving STELARA® 90 mg subQ every 8 weeks (n=76/176)
of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=45/175)
Prespecified Subgroup Analysis of Major Secondary Endpoint
Not Adjusted for Multiplicity
of patients receiving STELARA® 90 mg subQ every 8 weeks (n=38/79)
of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=30/84)
STELARA® PIVOTAL STUDIES IN ULCERATIVE COLITIS
Get details about the pivotal trials of STELARA® as induction and maintenance therapy for the treatment of adults with moderately to severely active ulcerative colitis featured in The New England Journal of Medicine.
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
+
=
HEMI is a combined measure that assesses improvement of the colon at the cellular level through histologic examination PLUS images observed during colonoscopy
HEMI RESULTS1Multiplicity-controlled Other Secondary Endpoint (P<0.001)
of patients receiving STELARA® (n=54/322)
of patients receiving placebo (n=26/319)
Prespecified Subgroup Analysis of Other Secondary Endpoint Not Adjusted for Multiplicity
of patients receiving STELARA® (n=30/147)
of patients receiving placebo (n=19/151)
HEMI RESULTS1,2of patients receiving STELARA® 90 mg subQ every 8 weeks (n=75/172)
of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=40/172)
Prespecified Other Endpoint Not Adjusted for Multiplicity
Prespecified Subgroup Analysis of Other Endpoint Not Adjusted for Multiplicity
of patients receiving STELARA® 90 mg subQ every 8 weeks (n=38/77)
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.
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.
STELARA® study design in adult patients with moderately to severely active UC
UNIFI CLINICAL TRIAL DESIGN
MAJOR SECONDARY ENDPOINTS INCLUDED:
MAJOR SECONDARY ENDPOINTS INCLUDED:
All patients completing the Maintenance Study were eligible to enter the LTE. Placebo subQ patients were discontinued after unblinding at 1 year after induction dose. Efficacy measures were collected every 12 weeks thereafter. Safety was evaluated throughout.
OTHER SECONDARY ENDPOINTS IN THE INDUCTION AND MAINTENANCE STUDIES INCLUDED:
Adult patients with moderately to severely active UC who had an inadequate response to or failed to tolerate biologic (ie, TNF blocker and/or vedolizumab) or conventional (ie, corticosteroids and/or the immunomodulators 6-MP or AZA) therapy.
6-MP=6-mercaptopurine; AZA=azathioprine; IV=intravenous; subQ=subcutaneous; TNF=tumor necrosis factor; UC=ulcerative colitis.
*In the Induction Study, patients were randomized to receive STELARA® weight-based dosage regimen (approximately 6 mg/kg), STELARA® 130-mg IV dose, or IV placebo. The 130-mg IV dose is not an approved induction dose and therefore is not shown.
†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).
‡Weight-based induction dosage regimen: STELARA® 260 mg (weight 55 kg or less), STELARA® 390 mg (weight >55 kg to 85 kg), and STELARA® 520 mg (weight >85 kg).
§The Maintenance Study included a third randomized arm where patients received STELARA® 90 mg subQ every 12 weeks. STELARA® 90 mg subQ every 12 weeks is not an approved maintenance dose and therefore is not shown. Patients randomized in the Maintenance Study were those who had a clinical response to STELARA® IV at Week 8 during the Induction Study.
IISymptomatic remission was defined as no rectal bleeding (Mayo rectal bleeding subscore of 0) and normal to near-normal stool frequency (Mayo stool frequency subscore of 0 or 1); no endoscopic assessment was performed.
¶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.
#Endoscopic improvement was defined as Mayo endoscopy subscore of 0 or 1 (modified so that 1 does not include friability).
**Patients who achieved clinical response to STELARA® at the end of the Induction Study.
††Steroid-free clinical remission was defined as patients in clinical remission and not receiving corticosteroids at 1 year.
‡‡Maintenance of clinical remission at 1 year was defined as remission at Week 44 in patients who achieved clinical remission 8 weeks after induction.
§§HEMI was defined as combined endoscopic improvement (Mayo endoscopy subscore of 0 or 1) and histologic improvement of the colon tissue (neutrophil infiltration <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue).
||||Week 44 of the Maintenance Study was defined as 1 year from initiation of the induction (8-week Induction Study + 44-week Maintenance Study=1 year).
References: 1. STELARA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.
STELARA® open-label LTE study design in adult patients with moderately to severely active UC
UNIFI CLINICAL TRIAL DESIGN
MAJOR SECONDARY ENDPOINTS INCLUDED:
MAJOR SECONDARY ENDPOINTS INCLUDED:
All patients completing the Maintenance Study were eligible to enter the LTE. Placebo subQ patients were discontinued after unblinding at 1 year after induction dose. Efficacy measures were collected every 12 weeks thereafter. Safety was evaluated throughout.
OTHER SECONDARY ENDPOINTS IN THE INDUCTION AND MAINTENANCE STUDIES INCLUDED:
Adult patients with moderately to severely active UC who had an inadequate response to or failed to tolerate biologic (ie, TNF blocker and/or vedolizumab) or conventional (ie, corticosteroids and/or the immunomodulators 6-MP or AZA) therapy.
6-MP=6-mercaptopurine; AZA=azathioprine; IV=intravenous; LTE=long-term extension; subQ=subcutaneous; TNF=tumor necrosis factor; UC=ulcerative colitis.
*In the Induction Study, patients were randomized to receive STELARA® weight-based dosage regimen (approximately 6 mg/kg), STELARA® 130-mg IV dose, or IV placebo. The 130-mg IV dose is not an approved induction dose and therefore is not shown.
†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 included friability).
‡Weight-based induction dosage regimen: STELARA® 260 mg (weight 55 kg or less), STELARA® 390 mg (weight >55 kg to 85 kg), and STELARA® 520 mg (weight >85 kg).
§The Maintenance Study included a third randomized arm where patients received STELARA® 90 mg subQ every 12 weeks. STELARA® 90 mg subQ every 12 weeks is not an approved maintenance dose and therefore is not shown. Patients randomized in the Maintenance Study were those who had a clinical response to STELARA® IV at Week 8 during the Induction Study.
IISymptomatic remission was defined as no rectal bleeding (Mayo rectal bleeding subscore of 0) and normal to near-normal stool frequency (Mayo stool frequency subscore of 0 or 1); no endoscopic assessment was performed.
¶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.
#Endoscopic improvement was defined as Mayo endoscopy subscore of 0 or 1 (modified so that 1 does not include friability).
**Patients who achieved clinical response to STELARA® at the end of the Induction Study.
††Steroid-free clinical remission was defined as patients in clinical remission and not receiving corticosteroids at 1 year.
‡‡Maintenance of clinical remission at 1 year was defined as remission at Week 44 in patients who achieved clinical remission 8 weeks after induction.
§§HEMI was defined as combined endoscopic improvement (Mayo endoscopy subscore of 0 or 1) and histologic improvement of the colon tissue (neutrophil infiltration <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue).
IIIIWeek 44 of the Maintenance Study was defined as 1 year from initiation of the induction (8-week Induction Study + 44-week Maintenance Study=1 year).
References: 1. STELARA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.
STELARA® open-label LTE study design and background and analysis rules in adult patients with moderately to severely active UC
UNIFI CLINICAL TRIAL DESIGN
MAJOR SECONDARY ENDPOINTS INCLUDED:
MAJOR SECONDARY ENDPOINTS INCLUDED:
All patients completing the maintenance study were eligible to enter the LTE. Placebo subQ patients were discontinued after unblinding at 1 year after induction dose. Efficacy measures were collected every 12 weeks thereafter. Safety was evaluated throughout.
OTHER SECONDARY ENDPOINTS IN THE INDUCTION AND MAINTENANCE STUDIES INCLUDED:
Adult patients with moderately to severely active UC who had an inadequate response to or failed to tolerate biologic (ie, TNF blocker and/or vedolizumab) or conventional (ie, corticosteroids and/or the immunomodulators 6-MP or AZA) therapy.
Objective: To evaluate the efficacy and safety data of STELARA® through 3 years of LTE after the maintenance treatment through Week 44. The final efficacy assessments will be performed at Week 200 and the final safety assessments at Week 220.
75% (588/783) of patients who started the maintenance phase entered the open-label LTE
In the open-label LTE, if a patient's UC symptoms worsen per investigator judgment, the patient is allowed one dose adjustment. Patients randomized to the 90 mg every 8 weeks group received a sham escalation and stayed at 90 mg every 8 weeks.
The final database lock will occur when all patients have completed or terminated before Week 220 the open-label LTE of the Maintenance Study
Study was unblinded after final Week 44 maintenance analysis was completed
Analyses shown are intent-to-treat:
Patients who had a prohibited change in UC medication, an ostomy or colectomy, used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an adverse event of worsening of UC prior to the Week 44 visit were considered not to be in symptomatic remission. Additionally, patients who had an ostomy or colectomy, or discontinued study agent due to lack of therapeutic effect or due to an adverse event of worsening of UC after Week 44 and prior to the designated visit, were considered not to be in symptomatic remission.
Patients who are receiving any of the UC-specific medical therapies (oral 5-ASA, AZA, 6-MP, or MTX) at the time of entry into the Maintenance Study and do not lose response must keep their prescribed dosage stable through completion of the Week 44 assessment. During the LTE, discontinuation of immunomodulators was allowed as determined by the investigator.
6-MP=6-mercaptopurine; AZA=azathioprine; IV=intravenous; LTE=long-term extension; subQ=subcutaneous; TNF=tumor necrosis factor; UC=ulcerative colitis.
*In the Induction Study, patients were randomized to receive STELARA® weight-based dosage regimen (approximately 6 mg/kg), STELARA® 130-mg IV dose, or IV placebo. The 130-mg IV dose is not an approved induction dose and therefore is not shown.
†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).
‡Weight-based induction dosage regimen: STELARA® 260 mg (weight ≤55 kg), STELARA® 390 mg (weight >55 kg to 85 kg), and STELARA® 520 mg (weight >85 kg).
§The Maintenance Study included a third randomized arm where patients received STELARA® 90 mg subQ every 12 weeks. STELARA® 90 mg subQ every 12 weeks is not an approved maintenance dose and therefore is not shown. Patients randomized in the Maintenance Study were those who had a clinical response to STELARA® IV at Week 8 during the Induction Study.
IIWeek 44 of the Maintenance Study was defined as 1 year from initiation of the induction (8-week Induction Study + 44-week Maintenance Study=1 year).
¶Clinical response was defined as a decrease from baseline in 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.
#Endoscopic improvement was defined as Mayo endoscopy subscore of 0 or 1 (modified so that 1 does not include friability).
**Patients who achieved clinical response to STELARA® at the end of the Induction Study.
††Steroid-free clinical remission was defined as patients in clinical remission and not receiving steroids at 1 year.
‡‡Maintenance of clinical remission at 1 year was defined as remission at Week 44 in patients who achieved clinical remission 8 weeks after induction.
§§HEMI was defined as combined endoscopic improvement (Mayo endoscopy subscore of 0 or 1) and histologic improvement of the colon tissue (neutrophil infiltration <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue).
IIIISymptomatic remission was defined as no rectal bleeding (Mayo rectal bleeding subscore of 0) and normal to near-normal stool frequency (Mayo stool frequency subscore of 0 or 1); no endoscopic assessment was performed.
References: 1. STELARA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.
STELARA® clinical efficacy data in adult patients with moderately to severely active UC
OPEN-LABEL LTE: 4-YEAR SYMPTOMATIC REMISSION
68%
STELARA® 90 mg subQ
every 8 weeks
(n=119/176)
45%
of patients
receiving placebo
(Note: STELARA® IV
Induction Responders
randomized to placebo)
(n=79/175)
Includes efficacy data from 40/176 patients who experienced UC worsening per investigator’s judgment during Weeks 56 to 200 but remained on STELARA® 90 mg q8w
68%
STELARA® 90 mg subQ
every 8 weeks
(n=119/176)
56%
STELARA® 90 mg subQ
every 8 weeks
(n=99/176)
55%
STELARA® 90 mg subQ
every 8 weeks
(n=96/176)
Among patients in symptomatic remission at ≈4 years with STELARA®, 95% (n=91/96) were steroid-free (post hoc analysis)
Includes efficacy data from 40/176 patients who experienced UC worsening per investigator’s judgment during Weeks 56 to 200 but remained on STELARA® 90 mg q8w
MAINTENANCE OF SYMPTOMATIC REMISSION
MAINTENANCE OF SYMPTOMATIC REMISSION* AT ≈4 YEARS1
The majority of patients in clinical remission† at 1 year maintained symptomatic remission at ≈4 years‡§II
(Dose adjustment not considered as treatment failure: randomized patients in maintenance who were treated in LTE)
LTE=long-term extension; q8w=every-8-weeks; subQ=subcutaneous.
*Symptomatic remission was defined as no rectal bleeding (Mayo rectal bleeding subscore of 0) and normal to near-normal stool frequency (Mayo stool frequency subscore of 0 or 1); no endoscopic assessment was performed.
†Clinical remission is defined as a Mayo score ≤2 points, with no individual subscore >1.
‡Denominator is the number of patients who had achieved clinical remission at Week 44. Includes treatment failure and missing data nonresponder imputation.
§Randomized group at maintenance Week 0 regardless of whether or not patients had a dose adjustment during the long-term extension. Starting at Week 56, randomized patients with UC worsening could adjust to q8w dosing schedule.
IIPatients who had an ostomy or colectomy, or discontinued study agent due to lack of therapeutic effect or due to an adverse event of worsening of UC after Week 44 and prior to the designated visit, were considered not to be in symptomatic remission. Patients who had both stool frequency and rectal bleeding subscores missing at a visit were considered not to be in symptomatic remission for that visit.
*Symptomatic remission was defined as a Mayo stool frequency subscore of 0 or 1 and a Mayo rectal bleeding subscore of 0.
†Patients who had a prohibited change in UC medication, an ostomy or colectomy or used a rescue medication after clinical flare, or discontinued study agent due to the lack of therapeutic effects or due to an AE of worsening UC prior to the Week 44 visit were considered not to be in symptomatic remission. Patients who had an ostomy or colectomy, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC after Week 44 and prior to the designated visit, were considered not to be in symptomatic remission.
‡Patients who had both stool frequency and rectal bleeding subscores missing at a visit were considered not to be in symptomatic remission for that visit.
References: 1. Data on file. Janssen Biotech, Inc. 2. Abreu M, Danese S, Sandborn WJ, et al. Efficacy and safety of ustekinumab for ulcerative colitis through 3 years: UNIFI long-term extension. Presented at: 16th Congress of ECCO; July 2021; Virtual; DOP83.
