For the treatment of adult patients with moderately to severely active CD

INDUCTION STUDY

STELARA^®^**DELIVERED* RAPID RESPONSE AS EARLY AS WEEK 6 (CLINICAL RESPONSE) AND WEEK 3 (70-POINT RESPONSE)

Primary Endpoint at Week 6 Induction Study^†
Secondary Endpoint at Week 3 + 6 Induction Study^†

Primary Endpoint

Clinical response at Week 6 (100-point reduction) Patient population: predominantly TNF blocker naïve^‡

Clinical response at Week 6 (100-point reduction) Patient population: TNF blocker failure

Clinical response at Week 6 (100-point reduction)
Patient population: predominantly TNF blocker naïve^‡

56%

of patients receiving STELARA^®^* IV induction dose
(n=116/209)

29%

of patients receiving placebo
(n=60/209)

Clinical response at Week 6 (100-point reduction) Patient population: TNF blocker failure

34%

of patients receiving STELARA^®^* IV induction dose
(n=84/249)

21%

of patients receiving placebo
(n=53/247)

Clinical response was defined as reduction in CDAI score of ≥100 points or CDAI score of <150¹

Secondary Endpoint

Significantly greater proportion of predominantly TNF blocker–naïve patients achieved 70-point response^§ at Week 3

Significantly greater proportion of predominantly TNF blocker–naïve patients achieved 70-point response^§ at Week 3 (N=627; P<0.001)

51%

of patients receiving STELARA^®^* IV induction dose
(n=106/209)

32%

of patients receiving placebo
(n=66/209)

Significant response in predominantly TNF blocker–naïve patients at Week 6 (70-point response^§) (N=627; P<0.001)

65%

of patients receiving STELARA^®^* IV induction dose
(n=135/209)

39%

of patients receiving placebo
(n=81/209)

CD=Crohn’s disease; CDAI=Crohn’s Disease Activity Index; IV=intravenous; TNF=tumor necrosis factor.

^*Weight-based induction dosage regimen: STELARA^® 260 mg (weight ≤55 kg), STELARA^® 390 mg (weight >55 kg to 85 kg), STELARA^® 520 mg (weight >85 kg).¹

^‡The induction studies each included a third randomized arm where patients received a single 130-mg IV administration dose of STELARA^®. The 130-mg IV dose is not an approved induction dose.^1,2

^†69% of patients were TNF blocker naïve. Remaining population were patients previously exposed to, but who did not fail, treatment with TNF blockers. All patients in the study failed or were intolerant to conventional treatment (eg, azathioprine, 6-mercaptopurine, methotrexate, or corticosteroids).^1,2

^§70-point response was defined as reduction in CDAI score of ≥70 points.¹

For the treatment of adult patients with moderately to severely active CD

SYMPTOM IMPROVEMENT: ABDOMINAL PAIN/STOOL FREQUENCY SCORE

MEAN CHANGE IN ABDOMINAL PAIN AND STOOL FREQUENCY FROM BASELINE WITHIN THE FIRST 2 WEEKS⁴

(POST HOC ANALYSIS OF ABDOMINAL PAIN AND STOOL FREQUENCY SUBSCORE: UNITI-1 TNF BLOCKER–FAILURE PATIENTS)

Over the course of Week 2 (Days 8-14), 29.3% of patients had a ≥50-point reduction in the CDAI subscore, based solely on abdominal pain and stool frequency, compared with baseline

Abdominal Pain
Stool Frequency

MEAN CHANGE IN ABDOMINAL PAIN FROM BASELINE (RATED 0-3)^* AS REPORTED BY PATIENTS^2,4

MEAN CHANGE IN STOOL FREQUENCY FROM BASELINE (NUMBER PER DAY)^* AS REPORTED BY PATIENTS^2,4

WEEK 2 (DAYS 8-14)⁴

29.3%

of patients had a ≥50-point reduction in the CDAI subscore, based solely on abdominal pain and stool frequency, compared with baseline^II

Methodology: In the UNITI-1 IV induction study, patients with moderately to severely active CD (CDAI 220-450) who were intolerant or refractory (as either primary or secondary nonresponders) to TNF blocker biologics. Patient CDAI daily data (Day –7 to +14) were compiled and analyzed post hoc for the patient-reported CDAI components, where patient diary cards were available. The mean change in daily CDAI component scores with STELARA^® IV was compared with placebo. The CDAI subscore was calculated as the sum of the SF and AP scores over the 7 days (SFx2, APx5) and assessed as the proportion of patients with ≥50-point improvement in this CDAI subscore.⁴

AP=abdominal pain; CD=Crohn’s disease; CDAI=Crohn’s Disease Activity Index; IV=intravenous; SF=stool frequency; TNF=tumor necrosis factor.

*Abdominal pain was graded from 0 (none) to 3 (severe) on severity per day; Stool frequency was determined by the number of liquid or soft stools per day.

For the treatment of adult patients with moderately to severely active CD

MAINTENANCE STUDY

STELARA^®: LASTING REMISSION AT 1 YEAR

A Majority of Patients in the Maintenance Study Were in Clinical Remission at 1 Year After Induction Dose¹^*^†

Primary Endpoint

Clinical remission at 1 year after induction dosePatient population: Combined TNF blocker naïve^‡ and TNF blocker failure

53%

of patients receiving STELARA^® 90 mg subQ every 8 weeks
(n=68/128^§;
P<0.01)

36%

of patients receiving placebo (induction responders)^||
(n=47/131)

Clinical remission was defined as a CDAI score of
<150 points.¹

More Than Two-thirds of Patients in Clinical Remission at the Start of the Maintenance Study Were Still in Remission at 1 Year¹^*^†

Secondary Endpoint

Clinical remission at 1 year among patients in remission at the start of maintenance therapyPatient population: Combined TNF blocker naïve and TNF blocker failure

Combined predominantly TNF Blocker–naïve patients and TNF blocker–failure populations

Clinical remission was defined as a CDAI score of
<150 points.¹ Patients in clinical remission at the end of maintenance therapy who were in remission at the start of maintenance therapy. This does not account for any other time point during maintenance therapy.

A Majority of TNF Blocker–naïve Patients in the Maintenance Study Were in Clinical Remission at 1 Year After Induction Dose¹^*^†

Other endpoint

Clinical remission in TNF blocker–naïve subgroup at 1 year after induction

65%

of patients receiving
STELARA^® 90 mg subQ every 8 weeks
(n=34/52^§)

49%

of patients receiving placebo (induction responders)^||
(n=25/51)

Clinical remission was defined as a CDAI score of
<150 points.¹

CD=Crohn's disease; CDAI=Crohn's Disease Activity Index; IV=intravenous; subQ=subcutaneous; TNF=tumor necrosis factor.

^*Data through 1 year of maintenance or 52 weeks after induction dose.²

^†Week 44 of the maintenance study was defined as 1 year from initiation of the induction dose (8-week induction + 44-week maintenance study=1 year). Patients randomized in the maintenance study were those who had a clinical response to STELARA^® IV at Week 8 during either induction study.¹

^‡69% of patients were TNF blocker naïve. Remaining population were patients previously exposed to, but who did not fail, treatment with TNF blockers. All patients in the study failed or were intolerant to conventional treatment (eg, azathioprine, 6-mercaptopurine, methotrexate, or corticosteroids).¹

^§Patients randomized to the STELARA^® 90 mg every-8-weeks group.¹

^||All patients randomized to placebo in the maintenance study had a single STELARA^® IV induction dose.¹

For the treatment of adult patients with moderately to severely active CD

Maintenance Study and Open-label LTE
STELARA^®: LASTING Remission Through ≈5 Years^1,2^*^†

Studies That Assessed Efficacy and Safety From Week 3 to ≈5 Years^1,2*

STELARA® Clinical Trial Design: Phase 3 Studies (COMPLETED) and Open-label LTE (COMPLETED)

BACKGROUND AND ANALYSIS RULES FOR STELARA^® OPEN-LABEL LTE STUDY²

Background

Objective: To evaluate the efficacy and safety of STELARA® through 5 years of maintenance treatment. The final efficacy assessment was performed at Week 252 and the final safety assessment was performed at Week 272.

75% (298/397) of randomized patients who started maintenance phase entered open-label LTE

All patients completing Week 44 (1 year after induction dose) were eligible to enter the open-label LTE

Database lock was performed after the final patient completed the first, second, and fourth years of the 4-year, open-label LTE of the Maintenance Study (ie, Week 96, Week 156, and Week 272 Maintenance Study visits)

This represents 5 years of treatment with STELARA®

Study was unblinded after ﬁnal Week 44 maintenance analysis was completed (August 2015)

Patients randomized to placebo were discontinued after study unblinding and are not included in the open-label LTE eﬃcacy analyses, but were included in the safety analysis

Analysis Rules

Analyses shown are intent-to-treat:

For the open-label LTE efficacy analysis, any patient who met the criteria for treatment failure prior to Week 44 continued to be considered as a treatment failure through the open-label LTE

Patients who discontinued or had missing data were assumed not to be in response or remission. Patients undergoing CD‑related surgeries or initiating prohibited medications were considered treatment failures

In the open-label LTE, patients were not allowed to dose adjust upon loss of response but could make changes in steroids or immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate) if medically appropriate. Otherwise, all treatment failure rules were the same as they had been prior to Week 44 (during maintenance trial)

CLINICAL REMISSION: OVERALL POPULATION (TNF BLOCKER NAÏVE AND TNF BLOCKER FAILURE)

Blinded Maintenance Phase: Remission at 1 year (primary endpoint)

53%

of patients receiving STELARA^® were in remission 1 year after induction dose^§§
(n=68/128^||||;
P<0.01)

36%

of patients receiving placebo^††
(n=47/131)

Open-label LTE: Remission at 3 years
(These data are uncontrolled with no placebo comparator arm after 1 year)

43%

of patients receiving STELARA^® were in remission 152 weeks after induction dose
(n=55/128)

Open-label LTE: Remission at ≈5 years
(These data are uncontrolled with no placebo comparator arm after 1 year)

34%

of patients receiving STELARA^® were in remission 252 weeks after induction dose
(n=44/128)

At the ≈Year 5 visit, 95% (n=42/44) of STELARA^® patients in clinical remission were also steroid free²^¶¶##^***^†††(Post hoc analysis)

53% of patients who responded to the induction dose were in clinical remission at 1 year and 34% at ≈5 years^1,2

SubQ placebo group (8 weeks to 1 year after induction dose) (n=131)²
STELARA^® 90 mg every 8 weeks (8 weeks to 1 year after induction dose) and open-label LTE (1 year to 160 weeks after induction dose) (n=128)²
Efficacy analysis for the open-label LTE included patients who received STELARA^® 90 mg every 8 weeks (n=128)²
In the LTE, steroids or immunomodulators could be added if medically appropriate and not considered a treatment failure

TNF BLOCKER–NAÏVE SUBGROUP

Blinded Maintenance Phase: Remission at 1 year (other endpoint)

65%

of patients receiving STELARA^® were in remission 1 year after induction dose^§§
(n=34/52^||||)

49%

of patients receiving placebo^††
(n=25/51)

Open-label LTE: Remission at 3 years
(These data are uncontrolled with no placebo comparator arm after 1 year)

54%

of patients receiving STELARA^® were in remission 152 weeks after induction dose
(n=28/52)

Open-label LTE: Remission at ≈5 years
(These data are uncontrolled with no placebo comparator arm after 1 year)

44%

of patients receiving STELARA^® were in remission 252 weeks after induction dose
(n=23/52)

At the ≈Year 5 visit, 100% (n=23/23) of TNF blocker–naïve patients in clinical remission with STELARA^® were also steroid free²^¶¶##^***^†††(Post hoc analysis)

65% of TNF blocker–naïve patients who responded to the induction dose were in clinical remission at 1 year and 44% at ≈5 years^1,2

SubQ placebo group (8 weeks to 1 year after induction dose) (n=51)²
STELARA^® 90 mg every 8 weeks (8 weeks to 1 year after induction dose) and open-label LTE (1 year to 160 weeks after induction dose) (n=52)²
Efficacy analysis for the open-label LTE included TNF blocker–naive patients who received STELARA^® 90 mg every 8 weeks (n=52)²
In the LTE, steroids or immunomodulators could be added if medically appropriate and not considered a treatment failure

CD=Crohn's disease; CDAI=Crohn's Disease Activity Index; IV=intravenous; LTE=long-term extension; subQ=subcutaneous; TNF=tumor necrosis factor.

^*Data through 5 years of maintenance or 260 weeks after induction dose.² Open-label LTE is completed.

^†Efficacy assessments done every 12 weeks until study unblinding (then at dosing visits). Clinical remission defined as CDAI score of <150.^1,2

^‡In both induction studies, patients were randomized to receive STELARA^® weight-based dosage regimen (approximately 6 mg/kg), STELARA^® 130-mg IV, or placebo. The 130-mg IV dose is not an approved induction dose and therefore is not shown. Clinical response was defined as reduction in CDAI score of ≥100 points or CDAI score of <150.¹

^§69% of patients were TNF blocker naïve. Remaining population were patients previously exposed to, but who did not fail, treatment with TNF blockers. All patients in the study failed or were intolerant to conventional treatment (eg, azathioprine, 6-mercaptopurine, methotrexate, or corticosteroids).¹

^||Weight-based induction dosage regimen: STELARA^® 260 mg (weight ≤55 kg), STELARA^® 390 mg (weight >55 kg to 85 kg), STELARA^® 520 mg (weight >85 kg).¹

^¶Patients were intolerant to or failed TNF blocker therapy.¹

^#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 either induction study.^1,2

^**Clinical remission was defined as a CDAI score of <150. Week 44 of the maintenance study was defined as 1 year from the initiation of the induction dose (8-week induction + 44-week maintenance study=1 year).¹

^††All patients randomized to placebo in the maintenance study had a single STELARA^® IV induction dose.¹

^‡‡Patients in the open-label LTE study included those from the nonapproved STELARA^® 90 mg subQ every-12-week maintenance arm, which is not represented in the figure above.²

^§§Week 44 of the maintenance study was defined as 1 year from initiation of the induction dose (8-week induction + 44-week maintenance study=1 year). Patients randomized in the maintenance study were those who had a clinical response to STELARA^® IV at Week 8 during either induction study.¹

^||||Patients randomized to the STELARA^® 90 mg every-8-weeks group.¹

^¶¶Patients who had a prohibited CD-related surgery and had a loss of response (from Week 8 to Week 32) or discontinued study agent due to lack of efficacy or due to an adverse event indicated to be of worsening CD after Week 44 and prior to the designated analysis timepoint were not considered to be in clinical remission, regardless of their CDAI score.

^##Patients who had insufficient data to calculate the CDAI score at the designated analysis timepoint were not considered to be in clinical remission.

^***Patients who had a missing value in corticosteroid use at designated analysis timepoint had their last value carried forward.

^†††Steroid free is defined as not taking steroids during the 7-day period that the CDAI was being collected.

References: 1. STELARA^® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc. 3. Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn’s disease activity index. National cooperative Crohn’s disease study. Gastroenterology. 1976;70(3):439-443. 4. Sandborn WJ, Yeager B, Gasink C, et al. Ustekinumab IV induction results in Crohn's disease symptoms improvement within the first week in anti-TNF refractory patients. Presented at: World Congress of Gastroenterology at ACG 2017; October 13-18, 2017; Orlando, Florida. Poster 2145.

BACKGROUND AND ANALYSIS RULES FOR STELARA^® OPEN-LABEL LTE STUDY²

BACKGROUND

75% (298/397) of randomized patients who started maintenance phase entered open-label LTE

All patients completing Week 44 (1 year after induction dose) were eligible to enter the open-label LTE

Database lock was performed after the final patient completed the first, second, and fourth years of the 4-year, open-label LTE of the Maintenance Study (ie, Week 96, Week 156, Week 272 Maintenance Study visits)

This represents 5 years of treatment with STELARA^®

Study was unblinded after ﬁnal Week 44 maintenance analysis was completed (August 2015)

Patients randomized to placebo were discontinued after study unblinding and are not included in the open-label LTE eﬃcacy analyses, but were included in the safety analysis

ANALYSIS RULES

Analyses shown are intent-to-treat:

For the open-label LTE efficacy analysis, any patient who met the criteria for treatment failure prior to Week 44 continued to be considered as a treatment failure through the open-label LTE

CD=Crohn's disease; LTE=long-term extension.

Studies THAT ASSESSED Efficacy and Safety From Week 3 to ≈5 YEARS^1,2

STELARA® Clinical Trial Design: Phase 3 Studies (COMPLETED) and Open-label LTE (COMPLETED)

STELARA^® (ustekinumab) is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients.

Infections

STELARA^® may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections requiring hospitalization or otherwise clinically significant infections were reported. In patients with psoriasis, these included diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections. In patients with psoriatic arthritis, this included cholecystitis. In patients with Crohn’s disease, these included anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and Listeria meningitis. In patients with ulcerative colitis, these included gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis.

Treatment with STELARA^® should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of STELARA^® in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with STELARA^® and consider discontinuing STELARA^® for serious or clinically significant infections until the infection resolves or is adequately treated.

Theoretical Risk for Vulnerability to Particular Infections

Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria, Salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with STELARA^® may be susceptible to these types of infections. Appropriate diagnostic testing should be considered (eg, tissue culture, stool culture) as dictated by clinical circumstances.

Pre-Treatment Evaluation of Tuberculosis (TB)

Evaluate patients for TB prior to initiating treatment with STELARA^®. Do not administer STELARA^® to patients with active tuberculosis infection. Initiate treatment of latent TB before administering STELARA^®. Closely monitor patients receiving STELARA^® for signs and symptoms of active TB during and after treatment.

Malignancies

STELARA^® is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among patients who received STELARA^® in clinical studies. The safety of STELARA^® has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving STELARA^® who had risk factors for developing non-melanoma skin cancer (NMSC). All patients receiving STELARA^®, especially those >60 years or those with a history of PUVA or prolonged immunosuppressant treatment, should be monitored for the appearance of NMSC.

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with STELARA^®. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STELARA^®.

Posterior Reversible Encephalopathy Syndrome (PRES)

Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab.

Monitor all patients treated with STELARA^® for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue STELARA^®.

Immunizations

Prior to initiating therapy with STELARA^®, patients should receive all age-appropriate immunizations recommended by current guidelines. Patients being treated with STELARA^® should not receive live vaccines. BCG vaccines should not be given during treatment or within one year of initiating or discontinuing STELARA^®. Exercise caution when administering live vaccines to household contacts of STELARA^® patients, as shedding and subsequent transmission to STELARA^® patients may occur. Non-live vaccinations received during a course of STELARA^® may not elicit an immune response sufficient to prevent disease.

Concomitant Therapies

The safety of STELARA^® in combination with other biologic immunosuppressive agents or phototherapy was not evaluated in clinical studies of psoriasis. Ultraviolet-induced skin cancers developed earlier and more frequently in mice. In psoriasis studies, the relevance of findings in mouse models for malignancy risk in humans is unknown. In psoriatic arthritis studies, concomitant methotrexate use did not appear to influence the safety or efficacy of STELARA®. In Crohn’s disease and ulcerative colitis induction studies, concomitant use of 6-mercaptopurine, azathioprine, methotrexate, and corticosteroids did not appear to influence the overall safety or efficacy of STELARA^®.

Noninfectious Pneumonia

Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of STELARA^®. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and, in certain cases, administration of corticosteroids. If diagnosis is confirmed, discontinue STELARA^® and institute appropriate treatment.

Allergen Immunotherapy

STELARA^® may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.

Most Common Adverse Reactions

The most common adverse reactions (≥3% and higher than that with placebo) in adults from psoriasis clinical studies for STELARA^® 45 mg, STELARA^® 90 mg, or placebo were: nasopharyngitis (8%, 7%, 8%), upper respiratory tract infection (5%, 4%, 5%), headache (5%, 5%, 3%), and fatigue (3%, 3%, 2%), respectively. The safety profile in pediatric patients with plaque psoriasis was similar to that of adults with plaque psoriasis. In psoriatic arthritis (PsA) studies, a higher incidence of arthralgia and nausea was observed in patients treated with STELARA^® when compared with placebo (3% vs 1% for both). In Crohn’s disease induction studies, common adverse reactions (3% or more of patients treated with STELARA^® and higher than placebo) reported through Week 8 for STELARA^® 6 mg/kg intravenous single infusion or placebo included: vomiting (4% vs 3%). In the Crohn’s disease maintenance study, common adverse reactions (3% or more of patients treated with STELARA^® and higher than placebo) reported through Week 44 for STELARA^® 90 mg subcutaneous injection or placebo were: nasopharyngitis (11% vs 8%), injection site erythema (5% vs 0%), vulvovaginal candidiasis/mycotic infection (5% vs 1%), bronchitis (5% vs 3%), pruritus (4% vs 2%), urinary tract infection (4% vs 2%) and sinusitis (3% vs 2%). In the ulcerative colitis induction study, common adverse reactions (3% or more of patients treated with STELARA® and higher than placebo) reported through Week 8 for STELARA^® 6 mg/kg intravenous single infusion or placebo included: nasopharyngitis (7% vs 4%). In the ulcerative colitis maintenance study, common adverse reactions (3% or more of patients treated with STELARA^® and higher than placebo) reported through Week 44 for STELARA^® 90 mg subcutaneous injection or placebo included: nasopharyngitis (24% vs 20%), headache (10% vs 4%), abdominal pain (7% vs 3%), influenza (6% vs 5%), fever (5% vs 4%), diarrhea (4% vs 1%), sinusitis (4% vs 1%), fatigue (4% vs 2%), and nausea (3% vs 2%).

Please click to see the full Prescribing Information and Medication Guide for STELARA^®. Provide the Medication Guide to your patients and encourage discussion.

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CHOOSE INDICATIONCrohn’s Disease

STELARA®*DELIVERED RAPID RESPONSE AS EARLY AS WEEK 6 (CLINICAL RESPONSE) AND WEEK 3 (70-POINT RESPONSE)

Primary Endpoint

Primary Endpoint

Clinical response at Week 6 (100-point reduction) Patient population: predominantly TNF blocker naïve‡

Clinical response at Week 6 (100-point reduction) Patient population: TNF blocker failure

Clinical response at Week 6 (100-point reduction)Patient population: predominantly TNF blocker naïve‡

Clinical response at Week 6 (100-point reduction) Patient population: TNF blocker failure

Secondary Endpoint

Secondary Endpoint

Significantly greater proportion of predominantly TNF blocker–naïve patients achieved 70-point response§ at Week 3

Significantly greater proportion of predominantly TNF blocker–naïve patients achieved 70-point response§ at Week 3 (N=627; P<0.001)

Significant response in predominantly TNF blocker–naïve patients at Week 6 (70-point response§) (N=627; P<0.001)

STELARA® PIVOTAL STUDIES

MEAN CHANGE IN ABDOMINAL PAIN AND STOOL FREQUENCY FROM BASELINE WITHIN THE FIRST 2 WEEKS4

Over the course of Week 2 (Days 8-14), 29.3% of patients had a ≥50-point reduction in the CDAI subscore, based solely on abdominal pain and stool frequency, compared with baseline

MEAN CHANGE IN ABDOMINAL PAIN FROM BASELINE (RATED 0-3)* AS REPORTED BY PATIENTS2,4

MEAN CHANGE IN STOOL FREQUENCY FROM BASELINE (NUMBER PER DAY)* AS REPORTED BY PATIENTS2,4

WEEK 2 (DAYS 8-14)4

STELARA®: LASTING REMISSION AT 1 YEAR

A Majority of Patients in the Maintenance Study Were in Clinical Remission at 1 Year After Induction Dose1*†

Primary Endpoint

Clinical remission at 1 year after induction dosePatient population: Combined TNF blocker naïve‡ and TNF blocker failure

More Than Two-thirds of Patients in Clinical Remission at the Start of the Maintenance Study Were Still in Remission at 1 Year1*†

Secondary Endpoint

Clinical remission at 1 year among patients in remission at the start of maintenance therapyPatient population: Combined TNF blocker naïve and TNF blocker failure

A Majority of TNF Blocker–naïve Patients in the Maintenance Study Were in Clinical Remission at 1 Year After Induction Dose1*†

Other endpoint

Clinical remission in TNF blocker–naïve subgroup at 1 year after induction

STELARA® PIVOTAL STUDIES

For the treatment of adult patients with moderately to severely active CD

Maintenance Study and Open-label LTESTELARA®: LASTING Remission Through ≈5 Years1,2*†

Studies That Assessed Efficacy and Safety From Week 3 to ≈5 Years1,2*

BACKGROUND AND ANALYSIS RULES FOR STELARA® OPEN-LABEL LTE STUDY2

Background

Analysis Rules

CLINICAL REMISSION: OVERALL POPULATION (TNF BLOCKER NAÏVE AND TNF BLOCKER FAILURE)

Blinded Maintenance Phase: Remission at 1 year (primary endpoint)

Open-label LTE: Remission at 3 years(These data are uncontrolled with no placebo comparator arm after 1 year)

Open-label LTE: Remission at ≈5 years(These data are uncontrolled with no placebo comparator arm after 1 year)

TNF BLOCKER–NAÏVE SUBGROUP

Blinded Maintenance Phase: Remission at 1 year (other endpoint)

Open-label LTE: Remission at 3 years(These data are uncontrolled with no placebo comparator arm after 1 year)

Open-label LTE: Remission at ≈5 years(These data are uncontrolled with no placebo comparator arm after 1 year)

CROHN’S DISEASE ACTIVITY INDEX (CDAI) CONSISTS OF THE WEIGHTED SUM TOTAL OF THE FOLLOWING3:

Important Context About the Placebo Arm1

This publication includes information about STELARA® that is not found in the full Prescribing Information.

BACKGROUND AND ANALYSIS RULES FOR STELARA® OPEN-LABEL LTE STUDY2

BACKGROUND

ANALYSIS RULES

Studies THAT ASSESSED Efficacy and Safety From Week 3 to ≈5 YEARS1,2

STELARA® Clinical Trial Design: 3 Pivotal Studies With a Combined 1 Year1,2

STELARA^®^**DELIVERED* RAPID RESPONSE AS EARLY AS WEEK 6 (CLINICAL RESPONSE) AND WEEK 3 (70-POINT RESPONSE)

Clinical response at Week 6 (100-point reduction) Patient population: predominantly TNF blocker naïve^‡

Clinical response at Week 6 (100-point reduction)
Patient population: predominantly TNF blocker naïve^‡

Significantly greater proportion of predominantly TNF blocker–naïve patients achieved 70-point response^§ at Week 3

Significantly greater proportion of predominantly TNF blocker–naïve patients achieved 70-point response^§ at Week 3 (N=627; P<0.001)

Significant response in predominantly TNF blocker–naïve patients at Week 6 (70-point response^§) (N=627; P<0.001)

STELARA^® PIVOTAL STUDIES

MEAN CHANGE IN ABDOMINAL PAIN AND STOOL FREQUENCY FROM BASELINE WITHIN THE FIRST 2 WEEKS⁴

MEAN CHANGE IN ABDOMINAL PAIN FROM BASELINE (RATED 0-3)^* AS REPORTED BY PATIENTS^2,4

MEAN CHANGE IN STOOL FREQUENCY FROM BASELINE (NUMBER PER DAY)^* AS REPORTED BY PATIENTS^2,4

WEEK 2 (DAYS 8-14)⁴

STELARA^®: LASTING REMISSION AT 1 YEAR

A Majority of Patients in the Maintenance Study Were in Clinical Remission at 1 Year After Induction Dose¹^*^†

Clinical remission at 1 year after induction dosePatient population: Combined TNF blocker naïve^‡ and TNF blocker failure

More Than Two-thirds of Patients in Clinical Remission at the Start of the Maintenance Study Were Still in Remission at 1 Year¹^*^†

A Majority of TNF Blocker–naïve Patients in the Maintenance Study Were in Clinical Remission at 1 Year After Induction Dose¹^*^†

STELARA^® PIVOTAL STUDIES

Maintenance Study and Open-label LTE
STELARA^®: LASTING Remission Through ≈5 Years^1,2^*^†

Studies That Assessed Efficacy and Safety From Week 3 to ≈5 Years^1,2*

BACKGROUND AND ANALYSIS RULES FOR STELARA^® OPEN-LABEL LTE STUDY²

Open-label LTE: Remission at 3 years
(These data are uncontrolled with no placebo comparator arm after 1 year)

Open-label LTE: Remission at ≈5 years
(These data are uncontrolled with no placebo comparator arm after 1 year)

Open-label LTE: Remission at 3 years
(These data are uncontrolled with no placebo comparator arm after 1 year)

Open-label LTE: Remission at ≈5 years
(These data are uncontrolled with no placebo comparator arm after 1 year)

CROHN’S DISEASE ACTIVITY INDEX (CDAI) CONSISTS OF THE WEIGHTED SUM TOTAL OF THE FOLLOWING³:

Important Context About the Placebo Arm¹

This publication includes information about STELARA^® that is not found in the full Prescribing Information.

BACKGROUND AND ANALYSIS RULES FOR STELARA^® OPEN-LABEL LTE STUDY²

Studies THAT ASSESSED Efficacy and Safety From Week 3 to ≈5 YEARS^1,2

STELARA^® Clinical Trial Design: 3 Pivotal Studies With a Combined 1 Year^1,2