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STELARA® (ustekinumab)

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Use of STELARA in Adult Patients with Crohn's Disease Who are Biologic-Naïve

Last Updated: 01/03/2025

Summary

The efficacy and safety of STELARA in adults with moderately to severely active Crohn's disease (CD) was evaluated in the UNITI-IMUNITI clinical trial program, including the long-term extension (LTE) through 5 years. Clinical remission data at 5 years among patients naïve to tumor necrosis factor (TNF)-blockers are summarized below.¹
Relevant data from two phase 3b studies: the SEAVUE study,²^,³ which evaluated the STELARA treatment vs the adalimumab (ADA) treatment, and the STARDUST trial,⁴^,⁵ which compared a treat-to-target (T2T) maintenance strategy to a standard-of-care (SoC) approach, are summarized below.
Additionally, real-world studies evaluating the use of STELARA in adult patients with CD who are biologic-naïve are summarized below.⁶^-²⁰

CLINICAL DATA

Phase 3, Pivotal Clinical Trial Program

Sandborn et al (2022)¹ evaluated the long-term efficacy of STELARA in TNF-blocker naïve patients with CD through 5 years in the LTE of the IM-UNITI maintenance study.

The efficacy and safety of STELARA was evaluated in 3 randomized, double-blind, placebocontrolled phase 3 clinical studies in adult patients with moderately to severely active CD. There were two 8-week intravenous (IV) induction studies (UNITI 1 and UNITI 2), followed by a 44-week subcutaneous (SC) randomized withdrawal maintenance study (IM-UNITI), representing 52 weeks of therapy. All patients (randomized and nonrandomized) who completed the efficacy and safety assessment at week 44 of the IMUNITI maintenance study were eligible to participate in the IM-UNITI extension (up to 4 years; 5 years of treatment in total) and continued to receive the same treatment as they were receiving at week 44 of the IM-UNITI maintenance study.

Of the 397 patients who were randomized in the IM-UNITI trial, 298 patients entered the LTE.
Among patients who were randomized to STELARA maintenance therapy and entered the LTE, 52.3% (124/237) completed dosing through 5 years.

Results

Results through 5 years among randomized patients are summarized in Table: Clinical Remission through Week 252 Among TNF-blocker Naïve Patients (ITT Analysis) and Clinical Remission at Week 252 Among Randomized Patients Who Entered the LTE.

Clinical Remission through Week 252 Among TNF-blocker Naïve Patients (ITT Analysis)¹^,a,b

Proportion of Patients in Clinical remission^c (%)	STELARA 90 mg SC Q12W N=53	STELARA 90 mg SC Q8W N=52
Week 44	56.6	65.4
Week 92	54.7	55.8
Week 164	52.8	53.8
Week 252	28.3	44.2
Abbreviations: CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; ITT, intent-to-treat; IV, intravenous; LTE, long-term extension; Q12W, every 12 weeks; Q8W, every 8 weeks; SC, subcutaneous; TNF, tumor necrosis factor. ^aPatients who were in clinical response to STELARA IV induction dosing and were randomized to SC on entry into this maintenance study. ^bPatients who had a CD-related surgery due to lack of efficacy of study agent (with the exception of minor procedures such as drainage of a superficial abscess or seton placement), discontinuation of study agent due to lack of efficacy or due to an adverse event of worsening CD, loss of clinical response (from week 8 to week 32), or initiation of or increase in dose of corticosteroids or immunosuppressant (prior to week 44 only) prior to the designated analysis timepoint are subsequently considered not 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 are considered not to be in clinical remission. ^cClinical remission was defined as a CDAI score lower than 150 points.

Clinical Remission at Week 252 Among Randomized Patients Who Entered the LTE¹

Randomized Patients Who Entered the LTE (nonresponder imputation analysis)^a	Continuous 90 mg SC Q12W from Maintenance Baseline^b	Continuous 90 mg SC Q8W from Maintenance Baseline^b	Previous Dose Adjustment to 90 mg SC Q8W^c	Combined
Clinical remission^d among TNF-blocker naïve patients^d, n/N (%)	15/38 (39.5)	23/39 (59.0)	16/28 (57.1)	39/67 (58.2)
Abbreviations: CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; IV, intravenous; LTE, long-term extension; Q12W, every 12 weeks; Q8W, every 8 weeks; SC, subcutaneous; TNF, tumor necrosis factor. ^aIn this analysis, patients with missing data or those who met treatment failure rules were considered to be nonresponders or not in clinical remission regardless of their CDAI score. ^bPatients who were in clinical response to STELARA IV induction dosing, were randomized in the maintenance study, and did not meet loss of response criteria from week 8 through week 32. ^cPatients who were in clinical response to STELARA IV induction dosing, were randomized in the maintenance study, met loss of response criteria from week 8 through week 32, and initiated STELARA 90 mg SC Q8W (for patients initially randomized to placebo SC or STELARA 90 mg SC Q12W) or continued STELARA 90 mg SC Q8W (for patients initially randomized to STELARA 90 mg SC Q8W). ^dClinical remission was defined as a CDAI score lower than 150 points. ^ePatients who had a CD-related surgery due to lack of efficacy of study agent (with the exception of minor procedures such as drainage of a superficial abscess or seton placement), discontinuation of study agent due to lack of efficacy or due to an adverse event indicated to be of worsening CD prior to the designated analysis timepoint are considered not to be in clinical remission, regardless of their CDAI score. Patients who had insufficient data at the designated analysis timepoint were considered not to be in clinical remission.

Phase 3b Study

Sands et al (2022)² conducted a phase 3b, multicenter, randomized, double-blind, parallel-group, active‑comparator study (SEAVUE) evaluating the efficacy and safety of STELARA and ADA in adult patients with moderately to severely active CD who were biologic-naïve.

Study Design/Methods

For study design/methods, see Figure: SEAVUE - Study Design.

SEAVUE Study Design²

Abbreviations: ADA, adalimumab; CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; FDA, Food and Drug Administration; IV, intravenous; Q2W, every 2 weeks; Q8W, every 8 weeks; R, randomization; SC, subcutaneous; US, United States; UST, ustekinumab.
^aDosing regimens approved by the US FDA without dose modifications.

Endpoints

Primary and secondary endpoints were tested in a hierarchical fashion. If the primary endpoint did not show a significant difference between treatment groups, all subsequent major secondary endpoints were considered not significant, and P-Values were nominal. The remaining prespecified endpoints were not adjusted for multiplicity.

Primary Endpoint

Clinical remission (Crohn’s Disease Activity Index [CDAI] <150) at week 52.

Major Secondary Endpoints

Corticosteroid-free remission at week 52, defined as CDAI <150 and not taking corticosteroids ≥30 days before week 52.
Clinical response at week 52, defined as a decrease in CDAI score ≥100 from baseline or CDAI score <150.
Patient-reported outcome (PRO)-2 symptom remission at week 52, defined as abdominal pain mean daily score ≤1 and stool frequency mean daily score ≤3.
Clinical remission at week 16.
Endoscopic remission (ER) at week 52, defined as Simple Endoscopic Score for Crohn’s Disease (SES-CD; determined by central reading score) ≤3 or SES-CD=0 for patients who entered the study with SES-CD=3.
Health-related quality of life (HRQoL) was also evaluated using the Inflammatory Bowel Disease Questionnaire (IBDQ) and Patient-Reported Outcomes Measurement Information System (PROMIS)-29 questionnaire.²¹
- The PROMIS-29 assessment was conducted across 8 domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity. A clinically meaningful improvement was defined as:
  - A ≥5-point change from baseline in T-score domains
  - A decrease of ≥50% of 1 baseline standard deviation (SD) in the pain intensity score (0-10 numeric rating)

Results

A total of 386 patients were randomized (STELARA, n=191; ADA, n=195), of whom, 311 completed the study treatment through week 52 (STELARA, n=162; ADA, n=149).
Baseline demographics and diseases characteristics were balanced between the 2 treatment groups.

Efficacy

Primary Endpoint

At week 52, clinical remission was achieved in 65% (124 of 191) of patients treated with STELARA and 61% (119 of 195) of patients treated with ADA.
- No statistically significant difference was found between the treatment groups (4%; 95% confidence interval, -6% to 14%; P=0.42).
- Because there was no significant difference between the treatment groups in the primary endpoint, all major secondary and other endpoint P-Values were nominal and considered nonsignificant.

Major Secondary Endpoints

Data regarding major secondary endpoints are summarized in Table: Major Secondary Endpoints.

Major Secondary Endpoints²

Endpoints	STELARA (n=191)	ADA (n=195)	Treatment Difference % (95% CI)^a	Nominal P-value
Major secondary endpoints, %
Corticosteroid-free clinical remission at week 52	61	57	4 (-6 to 13)	NS
Clinical response at week 52	72	66	6 (-3 to 15)	NS
PRO-2 symptom remission at week 52	57	55	1 (-8 to 11)	NS
Clinical remission at week 16	57	60	-3 (-13 to 7)	NS
Endoscopic outcomes at week 52, %	n=179	n=179	-	-
Endoscopic remission at week 52	29	31	-2 (-12 to 7)	NS
Endoscopic response at week 52	42	37	5 (-5 to 15)	NS
≥25% SES-CD improvement at week 52	51	42	9 (-1 to 20)	NS
Other secondary endpoints, n/N (%)
Maintenance of clinical response at week 52 among patients in response at week 16	124/140 (89)	110/141 (78)	11 (2 to 19)	NS
Maintenance of clinical remission at week 52 among patients in remission at week 16	94/109 (86)	94/117 (80)	7 (-3 to 16)	NS
Note: Primary and secondary endpoints were tested in a hierarchical fashion. Because there was no significant difference between treatment groups in the primary endpoint, all major secondary and other endpoint P-Values were nominal and considered nonsignificant. Abbreviations: ADA, adalimumab; CI, confidence interval; NS, nonsignificant; PRO-2, patient-reported outcome-2; SES-CD, Simple Endoscopic Score for Crohn’s Disease. ^a95% CIs were based on the Wald statistic with Mantel-Haenszel weight.

For changes in C-reactive protein (CRP) or fecal calprotectin (FCP) levels, see Table: Proportions of Patients with Elevated CRP or FCP Levels at Baseline Who Achieved Normalization at Week 52.

Proportions of Patients with Elevated CRP or FCP Levels at Baseline Who Achieved Normalization at Week 52²²

	STELARA n/N (%)	ADA n/N (%)	Treatment Difference, % (95% CI)^a	Nominal P-value
Patients with CRP ≤3 mg/L at week 52^b,c,d	34 (44/130)	33 (43/130)	1 (-10 to 12)	NS
Patients with FCP ≤250 μg/g at week 52^b,c,e	38 (52/138)	43 (56/129)	-6 (-18 to 5)	NS
Note: Primary and secondary endpoints were tested in a hierarchical fashion. Because there was no significant difference between treatment groups in the primary endpoint, all major secondary and other endpoint P-values were nominal and considered nonsignificant. Abbreviations: ADA, adalimumab; AE, adverse event; CD, Crohn’s disease; CI, confidence interval; CRP, C-reactive protein; FCP, fecal calprotectin; NS, nonsignificant. ^a95% CIs were based on the Wald statistic with Mantel-Haenszel weight. ^bPatients who had a prohibited CD-related surgery, had prohibited concomitant medication changes, or discontinued the study agent due to lack of efficacy or an AE of worsening CD before the designated analysis timepoint were considered not to be normalized. ^cPatients who had insufficient data at the designated analysis timepoint had their last value carried forward. ^dAmong patients with CRP >3 mg/L at baseline. ^eAmong patients with FCP >250 μg/g at baseline.

For rates of clinical and biochemical remission, see Table: Clinical and Biomarker Remission from Week 8 through Week 52.

Clinical and Biomarker Remission^a from Week 8 through Week 52²²

Proportion of Patients (%)^b,c,d,e	STELARA (n=162)	ADA (n=162)
Week 8	36	41
Week 16	43	49
Week 52	51	45
Abbreviations: ADA, adalimumab; AE, adverse event; CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; CRP, C-reactive protein; FCP, fecal calprotectin. ^aClinical and biomarker remission was defined as CDAI <150, CRP level ≤3 mg/mL, and FCP level ≤250 μg/g among patients with CRP level >3 mg/L or FCP >250 μg/g at baseline. ^bPatients who had a prohibited CD-related surgery, had prohibited concomitant medication changes, or discontinued the study agent due to lack of efficacy or an AE of worsening CD before the designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score. ^cPatients who had insufficient data to calculate the CDAI score at the designated analysis timepoint were considered not to be in clinical remission. ^dPatients who had a prohibited CD-related surgery, had prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or an AE of worsening CD before the designated analysis timepoint had their baseline CRP or FCP level carried forward. ^ePatients who had insufficient CRP or FCP data at the designated analysis timepoint had their last value carried forward.

For HRQoL outcomes based on IBDQ, see Tables: IBDQ Response and Remission at Week 52 and Change from Baseline in IBDQ Scores through Week 52.

IBDQ Response and Remission at Week 52²²^,a,b

	STELARA (n=191)	ADA (n=195)	Treatment Difference, % (95% CI)^c	Nominal P-value
IBDQ response, %	67	63	4 (-6 to 13)	NS
IBDQ remission, %	53	52	2 (-8 to 11)	NS
Note: Primary and secondary endpoints were tested in a hierarchical fashion. Because there was no significant difference between treatment groups in the primary endpoint, all major secondary and other endpoint P-values were nominal and considered nonsignificant. Abbreviations: ADA, adalimumab; AE, adverse event; CD, Crohn’s disease; CI, confidence interval; IBDQ, Inflammatory Bowel Disease Questionnaire; NS, nonsignificant. ^aPatients who had a prohibited CD-related surgery, had prohibited concomitant medication changes, or discontinued the study agent due to lack of efficacy or an AE of worsening CD before the designated analysis timepoint were considered not to be in IBDQ response or remission. ^bPatients who had insufficient data to calculate the IBDQ score at the designated analysis timepoint were considered not to be in IBDQ response or remission. ^c95% Cis were based on the Wald statistic with Mantel-Haenszel weight.

Change from Baseline in IBDQ Scores through Week 52²²^,a,b

Median (IQR) Change in IBDQ Score	STELARA (n=192)	ADA (n=192)
Week 8	38.0	32.5
Week 16	40.0	36.0
Week 52	51.5	44.0
Abbreviations: ADA, adalimumab; AE, adverse event; CD, Crohn’s disease; IBDQ, Inflammatory Bowel Disease Questionnaire; IQR, interquartile range. ^aPatients who had a prohibited CD-related surgery, had prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or due to an AE of worsening CD before the designated analysis timepoint had their baseline value carried forward. ^bPatients who had insufficient data to calculate the IBDQ score at the designated analysis timepoint had their last value carried forward.

For HRQoL outcomes based on PROMIS-29, see Tables: Baseline PROMIS-29 Scores and Patients Achieving Clinically Meaningful Improvement in PROMIS-29 Scores at Week 52.

Baseline PROMIS-29 Scores²²^,a

Domains, Mean (SD)	STELARA (n=191)	ADA (n=195)
Physical function T-score	42.9 (7.6)	44.2 (8.1)
Anxiety T-score	60.3 (8.7)	59.5 (9.0)
Depression T-score	56.9 (9.7)	56.6 (9.2)
Fatigue T-score	62.1 (8.5)	60.5 (8.3)
Sleep disturbance T-score	53.6 (5.2)	52.6 (5.2)
Ability to participate in social roles and activities T-score	44.1 (7.4)	45.3 (8.3)
Pain interference T-score	61.3 (7.1)	60.5 (6.9)
Pain intensity score	5.6 (2.1)	5.2 (2.0)
Abbreviations: ADA, adalimumab. ^aA T-score of 50 is average for a healthy population. A higher T-score reflects more of the construct.

Patients Achieving Clinically Meaningful Improvement in PROMIS-29 Scores at Week 52²²

Domains, n (%)	STELARA (n=191)	ADA (n=195)	P-value
Physical function T-score	81 (42.4)	74 (37.9)	Nominal
Anxiety T-score	88 (46.1)	77 (39.5)	Nominal
Depression T-score	78 (40.8)	70 (35.9)	Nominal
Fatigue T-score	112 (58.6)	93 (47.7)	Nominal
Sleep disturbance T-score	43 (22.5)	42 (21.5)	Nominal
Ability to participate in social roles and activities T-score	112 (58.6)	93 (47.7)	Nominal
Pain interference T-score	101 (52.9)	106 (54.4)	Nominal
Pain intensity score	110 (57.6)	113 (57.9)	Nominal
Abbreviations: ADA, adalimumab; PROMIS-29, Patient-Reported Outcome Measurement Information System-29.

For corticosteroid-free remission ≥30 or ≥90 days Before Week 52, see Table: Corticosteroid-free Remission ≥30 or ≥90 days Before Week 52.

Corticosteroid-free Remission ≥30 or ≥90 days Before Week 52²³

Patients, n (%)	STELARA (n=191)	ADA (n=195)
Corticosteroid-free remission^a,b,c
≥30 days before week 52	116 (60.7)	112 (57.4)
≥90 days before week 52	113 (59.2)	112 (57.4)
Abbreviations: ADA, adalimumab. ^aCorticosteroid-free remission was defined as in clinical remission (CDAI<150) and not receiving steroids for ≥30 or ≥90 days prior to week 52. ^bPatients who had a prohibited CD-related surgery, had prohibited concomitant medication changes, or discontinued the study agent due to lack of efficacy or an AE of worsening CD before the designated analysis timepoint were considered not to be in corticosteroid-free remission. Patients who had insufficient data to calculate the CDAI score at the designated analysis timepoint were considered not to be in corticosteroid-free remission. ^cPatients who had a missing value in corticosteroids use at the designated analysis timepoint had their last value carried forward.

Safety

Safety results are summarized in Table: Summary of Safety Results through Week 52.
Opportunistic infections of active pulmonary tuberculosis and disseminated herpes zoster were reported in the ADA group and Paracoccidioides infection in the STELARA group.
Overall, 15% (29 of 191) of patients treated with STELARA and 24% (46 of 195) of patients treated with ADA discontinued study treatment before week 52.
- Reasons for discontinuation (STELARA vs ADA) were primarily adverse events (6% vs 11%), withdrawal of consent (6% vs 5%), and absence of improvement (2% vs 5%).

Summary of Safety Results through Week 52²

	STELARA (n=191)	ADA (n=195)^a
Mean (SD) duration of follow-up, weeks	47.6 (12.0)	45.8 (13.4)
Mean (SD) number of study treatment administrations	29.0 (5.8)	28.0 (6.4)
Any AE, n (%)	153 (80)	152 (78)
Serious AE, n (%)	25 (13)	32 (16)
Serious AEs of worsening CD	5 (3)	14 (7)
Infections, n (%)	65 (34)	79 (41)
Serious infections, n (%)	4 (2)	5 (3)
Malignancies, n (%)	0	1 (1)^b
Infusion-related AEs, n (%)	3 (2)	6 (3)^c
Injection-site reactions, n (%)
Active treatment injections	2 (1)	20 (10)
Placebo	4 (2)^d	-
AEs that led to discontinuation of the study drug, n (%)	11 (6)	21 (11)
Deaths, n (%)	0	0^e
Abbreviations: ADA, adalimumab; AE, adverse event; CD, Crohn’s disease; SD, standard deviation. ^aThe citrate-free 40 mg/0.4 mL ADA formulation was used. ^bBasal cell carcinoma. ^cInfusions in the ADA group were placebo. ^dOne additional patient had a reaction to placebo who also had a reaction to STELARA; the overall rate of injection-site reactions, combining both active treatment and placebo injections, was 3%. ^eOne sudden death, with pulmonary embolism as the suspected cause, occurred in the ADA group at approximately 4 weeks after week 52.

Post Hoc Analysis

Narula et al (2024)³ evaluated the long-term outcomes of ADA and STELARA among biologic-naïve adult patients with moderately to severely active CD who had early and delayed response.

Study Design/Methods

This was a post hoc analysis of patient-level data from the SEAVUE study. The data was obtained through the Yale University Open Data Access project (YODA; #2023-5158).
In this post hoc analysis, patients were classified based on their achievement of clinical response, defined as a reduction in CDAI score of at least 100 points from baseline or CDAI score <150.
- Early responders: Patients who achieved clinical response at week 8.
- Delayed responders: Patients who did not respond at week 8 but responded by week 16.
- Nonresponders: Patients who did not respond at week 8 or 16.

Endpoints

The primary outcome was clinical remission at week 56 (CDAI <150).
Secondary outcomes included corticosteroid-free remission (CDAI score <150 and no corticosteroids for at least the past 30 days), clinical response (CDAI reduction ≥100 points from baseline or CDAI score<150), ER (SES-CD ≤3 or SES-CD of 0 for patients with baseline SES-CD of 3 at week 56), and endoscopic healing (EH) (SES-CD of 0).

Results

This post hoc analysis included 373 patients (STELARA, n=187; ADA, n=186) with CDAI and SES-CD data available at baseline.
Of the 373 patients, 253 (67.8%) were classified as early responders, 49 (13.1%) as delayed responders, and 71 (19.0%) as nonresponders.

Comparison of 1-Year Outcomes Stratified by Response to STELARA

For all the outcomes assessed at 1 year, no statistically significant differences were observed between early and delayed responders, including endoscopic remission and endoscopic healing.
For comparison of 1-year outcomes between early and delayed responders, see Table: Outcomes at 1 Year Among Early, Delayed, and Nonresponders to STELARA.
For comparison of logistic regression models between early and delayed responders, see Table: Logistic Regression Models of Outcomes at 1 Year Among Early and Delayed Responders to STELARA.

Outcomes at 1 Year Among Early, Delayed, and Nonresponders to STELARA³

1-Year Outcome, n (%)	Early Responders (n=128)	Delayed Responders (n=21)	Nonresponders (n=38)	P-Value (Pairwise Early vs Delayed)
Clinical remission^a	103 (80.5)	13 (61.9)	5 (13.2)	0.058
Corticosteroid-free remission^b	102 (79.7)	13 (61.9)	5 (13.2)	0.072
Clinical response^c	112 (87.5)	15 (71.4)	9 (21.1)	0.054
Endoscopic remission^d	41 (32.0)	5 (23.8)	9 (23.7)	0.450
Endoscopic healing^e	31 (24.2)	3 (14.3)	4 (10.5)	0.315
Abbreviations: CDAI, Crohn’s Disease Activity Index; SES-CD, Simple Endoscopic Score for Crohn’s Disease. ^aCDAI <150. ^bCDAI score <150 and no corticosteroids for the past ≥30 days. ^cCDAI reduction ≥100 points from baseline or CDAI score <150. ^dSES-CD ≤3 or SES-CD of 0 for patients with baseline SES-CD of 3 at week 56. ^eSES-CD of 0.

Logistic Regression Models of Outcomes at 1 Year Among Early and Delayed Responders to STELARA³

1-Year Outcome, n (%)	Early vs Delayed Responders
1-Year Outcome, n (%)	aOR^a (95% CI)	P-Value
Clinical remission^b	2.66 (0.96-7.34)	0.060
Corticosteroid-free remission^c	2.57 (0.93-7.11)	0.069
Clinical response^d	2.79 (0.90-8.61)	0.075
Endoscopic remission^e	1.48 (0.51-4.35)	0.472
Endoscopic healing^f	1.88 (0.52-6.84)	0.339
Abbreviations: aOR, adjusted odds ratio; CDAI, Crohn’s Disease Activity Index; SES-CD, Simple Endoscopic Score for Crohn’s Disease. ^aAdjusted for disease duration and concomitant corticosteroid use. ^bCDAI <150. ^cCDAI score <150 and no corticosteroids for the past ≥30 days. ^dCDAI reduction ≥100 points from baseline or CDAI score <150. ^eSES-CD ≤3 or SES-CD of 0 for patients with baseline SES-CD of 3 at week 52. ^fSES-CD of 0.

Biomarker Trends Through Week 8 in Delayed Responders and Nonresponders to STELARA

Delayed responders experienced a significant decrease in CRP and FCP levels compared to nonresponders: P-Values (0.001 and <0.0001), respectively.

Danese et al (2022)⁴ reported efficacy and safety results from an open-label, phase 3b, multicenter, randomized study (STARDUST) in adult patients with moderately to severely active CD comparing a T2T maintenance strategy based on dose adjustment of STELARA at week 16 using endoscopy (followed by clinical and biomarker directed dose escalation) vs a SoC approach.

Study Design/Methods

• For the week 48 analysis, nonresponder imputation (NRI) and last observation carried forward (LOCF) analyses were used for missing dichotomous and continuous variables, respectively.
For study design/methods, see Figure: STARDUST - Study Design.

STARDUST - Study Design⁴

Abbreviations: CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; CRP, C-reactive protein; EU, European Union; FCP, fecal calprotectin; IL, interleukin; IV, intravenous; LOCF, last observation carried forward; LTE, long-term extension; NRI, non-responder imputation ; q4w, every 4 weeks; q8w, every 8 weeks; q12w, every 12 weeks; R, randomization; SC, subcutaneous; SES-CD, Simple Endoscopic Score for Crohn’s Disease; SmPC, Summary of Product Characteristics; SoC, standard of care; T2T, treat-to-treat; UST, ustekinumab.

Results

The randomized population included a total of 440 patients (T2T group, n=219; SoC group, n=221).
In the T2T and SoC groups, respectively, 85 (39%) and 84 (38%) patients were biologic-naïve.

Efficacy

For the NRI analysis of clinical outcomes at weeks 8 and 16, see Table: NRI Analysis of Clinical Response and Remission at Weeks 8 and 16 Among Biologic-Naïve Patients.

NRI Analysis of Clinical Response and Remission at Weeks 8 and 16 Among Biologic-Naïve Patients⁵

Proportion of Patients (%)	Week 8 (n=207)	Week 16 (n=291)
CDAI-70-point response^a	72.0	80.7
Clinical response^b	65.7	78.3
Clinical remission^c	55.1	68.1
Note: NRI patients with missing data at week 48 were considered to not have achieved their dichotomous endpoint. This was a post hoc analysis. Abbreviations: CDAI, Crohn’s Disease Activity Index; NRI, nonresponder imputation. ^aCDAI-70-point response was defined as an improvement of CDAI total score of ≥70 points vs baseline. ^bClinical response was defined as an improvement in CDAI total score of ≥100 points vs baseline. ^cClinical remission was defined as a CDAI score of <150 points.

Clinical outcomes between the treatment groups at week 48 in biologic-naïve patients are summarized in the Table: Clinical Outcomes Between the Treatment Groups at Week 48 in Biologic-Naïve Patients.

Clinical Outcomes Between the Treatment Groups at Week 48 in Biologic-Naïve Patients⁵

Outcomes	NRI Analysis		LOCF Analysis
Outcomes	T2T (n=85)	SoC (n=84)	T2T (n=85)	SoC (n=84)
CDAI-70 response^a, n (%) 95% CI	63 (74.1) (63.5-83.0)	67 (79.8) (69.6-87.7)	79 (92.9) (85.3-97.4)	78 (92.9) (85.1-97.3)
Clinical response^a, n (%) 95% CI	63 (74.1) (63.5-83.0)	66 (78.6) (68.3-86.8)	79 (92.9) (85.3-97.4)	76 (90.5) (82.1-95.8)
Clinical remission^b, n (%) 95% CI	60 (70.6) (59.7-80.0)	62 (73.8) (63.1-82.8)	73 (85.9) (76.6-92.5)	71 (84.5) (75.0-91.5)
Note: In NRI analysis, patients with missing data at week 48 were considered to not have achieved their dichotomous endpoint. In LOCF analysis, patients with missing data at week 48 visit had their last observation carried forward. Abbreviations: CDAI, Crohn’s Disease Activity Index; LOCF, last observation carried forward; NRI, nonresponder imputation analysis; SoC, standard of care; SES-CD, Simple Endoscopic Score for Crohn’s Disease; T2T, treat to target. ^aCDAI-70 responder is defined as showing an improvement of CDAI total score of ≥70 points vs baseline. Clinical response is defined as showing an improvement in CDAI total score of ≥100 points vs baseline. ^bClinical remission is defined as a CDAI score of <150 points.

Kucharzik et al (2023)²⁴^,²⁵ reported results from a substudy of the STARDUST trial assessing changes in IUS parameters, including the transmural response to STELARA therapy.

Study Design/Methods

Key IUS endpoints were assessed at weeks 0, 4, 8, 16, and 48 or upon early termination:
- Segmental IUS response was defined as a reduction of ≥25% in bowel wall thickness (BWT) of the target bowel segment.
- Transmural remission was defined as normalization of all IUS parameters in the target bowel segment.
- Segmental BWT: The mean of 4 measurements (2 in cross-section and 2 in longitudinal) of the most affected (ie, most inflamed) part of each segment. BWT was considered pathological if thickness was >2.0 mm in the terminal ileum and >3.0 mm in the colon.
For all IUS parameters, the most affected bowel segment at baseline was used.

Results

Of the 77 patients who had a baseline IUS assessment, 31 (40.3%) were biologicnaïve.
Changes in IUS response, transmural remission, and BWT per observed analysis in biologic-naïve patients are described in Table: IUS Response, Transmural Remission, and BWT Over Time in Biologic-Naïve Patients.

IUS Response, Transmural Remission, and BWT Over Time in Biologic-Naïve Patients²⁴^,²⁵^,a

Outcomes	Week 4 (n=24)	Week 8 (n=25)	Week 16 (n=27)	Week 48 (n=22)
IUS response^b (%)	25.0	28.0	29.6	59.1
Transmural remission^c (%)	0.0	4.0	18.5	31.8
Mean percentage change in BWT from baseline, mm	-11.05	-14.84	-17.06	-33.42
P-value^d	<0.05	<0.05	<0.01	<0.001
Abbreviations: BWT, bowel wall thickness; IUS, intestinal ultrasound. ^aOnly patients with nonmissing baseline value and ≥1 nonmissing postbaseline value during the main treatment period are included in the analysis. ^bIUS response was defined as a ≥25% reduction from baseline in BWT. ^cTransmural remission was defined as normalization of BWT, blood flow (color Doppler signal), bowel wall echostratification, and inflammatory mesenteric fat. The most affected (most thickened) bowel segment at baseline was used for IUS response/remission evaluation in the follow-up scans. If 3 out of the 4 IUS parameters were normalized and the fourth was ‘not assessed/not assessable’, transmural remission was considered ‘Yes’. ^dP-Values are based on the Wilcoxon signed-rank test.

Real-world data

Several real-world studies have reported the use of STELARA in biologic-naïve patients with CD. Please see Table: Summary of Real-World Data on the Use of STELARA in Biologic-Naïve Patients with CD. Results reported in the table are specific to patients treated with STELARA who were biologic-naïve.

Summary of Real-World Data on the Use of STELARA in Biologic-Naïve Patients with CD

Study Description and Select Baseline Characteristics	Results
Prospective Studies
Nagano et al (2023)⁶ evaluated the efficacy and safety of STELARA in Japanese patients with moderate to severe CD after 1-year of induction and maintenance therapy. STELARA was administered as an IV induction (~6mg/kg) followed by 90 mg SC 8 weeks after the first dosing and thereafter 90 mg SC once every 12 weeks. Outcomes evaluated at week 52 included clinical response (100-point reduction in CDAI score from the first STELARA administration), clinical remission (CDAI score of <150) and change in CRP from baseline. A total of 336 patients were included in the effectiveness analysis set.	Efficacy
	Clinical response in bio-naive patients at weeks 8, 24, 36, and 52 were 65.5% (N=29), 84% (N=25), 66.7% (N=24), and 70.8% (N=24), respectively.⁷ Clinical remission in bio-naive patients at weeks 8, 24, 36, and 52 were 75.9% (N=29), 88% (N=25), 70.8% (N=24), and 66.7% (N=24), respectively.⁶ Steroid-free clinical remission in bio-naive patients at weeks 8, 24, 36, and 52 were 45.5% (N=11), 80% (N=10), 87.5% (N=8), and 100% (N=8), respectively.⁶ Mean value of CRP (mg/dL) in bio-naive patients at weeks 0, 8, 24, 36, and 52 was 1.5, 0.5, 0.4, 0.8, and 0.7, respectively.⁶
Bokemeyer et al (2023)⁸ evaluated the efficacy of STELARA during induction phase in patients with CD in an observational study (RUN-CD) in Germany. STELARA was administered per the label-recommended dosing with necessary adjustments made at the treating physician’s discretion. The primary outcome was clinical remission (defined as HBI score of ≤4 points) at the end of the induction phase (week 1416). The secondary outcomes included steroidfree remission (defined as HBI score of ≤4 points without systemic steroids or oral budesonide within 8 weeks of the end of the induction phase) and clinical response (defined as improvement in HBI score of ≥3 points and/or remission achievement at the end of the induction phase). Of the 399 patients with CD, who were treated with STELARA, 34 were biologicnaïve.	Efficacy
	Primary outcome Clinical remission in biologic-naïve patients was 68.4%. Secondary outcomes Steroid-free remission in biologic-naïve patients was 48.9%. Clinical response in biologic-naïve patients was 77.6%.
Retrospective Studies
Bessissow et al (2024)⁹ evaluated the effectiveness and safety of STELARA in biologic-naïve patients with moderately to severely active CD in a multicenter cohort study (JUSTify). Data were collected retrospectively after STELARA initiation at months 4, 6, and 12. The primary outcome was clinical remission at month 6. Secondary outcomes included clinical remission at months 4 and 12, clinical response, corticosteroid-free remission, and biochemical and endoscopic response and remission at all study defined timepoints. A total of 158 patient charts were reviewed at 7 Canadian sites.	Efficacy
	Primary outcomes Clinical remission at month 6 was 67.7% (105/155). Secondary outcomes Clinical remission at months 4 and 12 was 50% (36/72) and 73.7% (84/114), respectively. Clinical response at months 4, 6, and 12 was 62.9% (44/70), 69.9% (107/153), and 72.1% (80/111), respectively. Corticosteroid-free clinical remission at months 4, 6, and 12 were 43.1% (N=72), 67.1% (N=155), and 71.9% (N=114), respectively. Biochemical remission at months 4, 6, and 12 were 65.2% (N=66), 71.6% (N=88), and 73.9% (N=92), respectively. Endoscopic remission at months 6 and 12 were 40.5% (N=37) and 56.3% (N=48), respectively.
	Safety
	In the first year following STELARA initiation, 8 ADRs were reported (pyrexia, dizziness, headache, dyspnea, acne, alopecia, and pruritus). By the end of the first year after STELARA initiation, 87.5% (7/8) of ADRs were resolved. No serious ADRs were reported.
Ferrante et al (2023)¹⁰ evaluated the effectiveness and safety of STELARA in biologic-naïve patients with CD in a multicenter cohort study (EVOLVE Expansion). The evaluated outcomes included cumulative rates of clinical response (defined as CDAI, positive change in category from baseline or HBI, overall decrease of ≥3 points from baseline or modified HBI, decrease of ≥3 points from baseline, or treatment response recorded in the medical chart as “complete response” or “partial response”), clinical remission (defined as CDAI score of <150 points or HBI score of <4 points or modified HBI score of <4 points, or remission status recorded in the medical chart as “in remission”), and mucosal healing (defined as endoscopic assessment score of 0 or 1 or SES-CD score of <3 points or lack of ulceration, or ≥1 endoscopic procedure findings indicating inactive disease [no findings/no active disease, no erosion, no ulcers, no inflammation or inflammatory activity, or no pathological findings]) at 12, 24, and 36 months SAEs, SIs, CD exacerbations, and CDrelated surgeries were also evaluated. Of the 623 patients with CD who were biologic-naïve, 276 were treated with STELARA.	Efficacy
	Cumulative clinical outcomes Clinical responseat 12, 24, and 36 months were 70.3%, 80.5%, and 84.1%, respectively. Clinical remissionat 12, 24, and 36 months were 74.8%, 84.6%, and 88.5%, respectively. Mucosal healingat 12, 24, and 36 months were 41.5%, 70.2%, and 87.4%, respectively.
	Safety
	Overall, 53 SAEs (including SIs) and 5 SIs were reported in 27/276 (9.8%) and 2/276 (0.7%) patients treated with STELARA, respectively.
Johnson et al (2023)¹¹ evaluated the effectiveness and safety of STELARA in patients with CD in a multinational, multicenter study (SUCCESS consortium). The primary outcomes were cumulative rates of clinical remission (defined as complete resolution of all CDrelated symptoms) and endoscopic remission (defined as absence of ulcers and/or erosions) at 6 and 12 months. The secondary outcomes included cumulative rates of corticosteroidfree remission (defined as tapering corticosteroids completely, achieving clinical remission, and having no documentation of repeat corticosteroid prescription within the first 4 weeks of completing the taper). Of the 1113 patients treated with STELARA, 106 were biologicnaïve.	Efficacy
	Primary outcomes Cumulative clinical remission among 106 biologic-naïve patients at 6 and 12 months were 25% and 63%, respectively. Cumulative endoscopic remissionamong 106 biologic-naïve patients at 6 and 12 months were 22% and 55%, respectively. Secondary outcomes Cumulative steroid-free remission among 106 biologic-naïve patients at 6 and 12 months were 19% and 62%, respectively.
Riviera et al (2023)¹² evaluated the efficacy of STELARA in biologic-naïve patients with luminal CD in a two-center study. STELARA was administered at a median dose of 5.6 mg/kg (IQR, 5.0-6.3) IV for induction and at 90 mg every 8 weeks for maintenance, except in 1 patient who received 90 mg every 12 weeks. The primary outcome was clinical response (defined as a 3point decrease in HBI score compared with inclusion or HBI score of <4 points without the use of steroids or the need for CDrelated surgery or treatment discontinuation due to failure or intolerance) at 3 months. The secondary outcomes included clinical remission (defined as HBI score of ≤4 points without the use of steroids or the need for CDrelated surgery or treatment discontinuation due to failure or intolerance) and biochemical remission (defined as clinical remission associated with CRP levels of ≤5 mg/L, corresponding to the upper limit of the normal range) at 3 and 12 months, time to drug withdrawal, and endoscopic healing (defined as SES-CD score of <4 points) at 6-18 months. Of the 206 biologic-naïve patients, 50 (24%) were treated with STELARA.	Efficacy
	Primary outcome Clinical response at 3 months was 66% (29/44). Secondary outcomes Clinical remission at 3 and 12 months were 57% (25/44) and 63% (31/49), respectively. Biochemical remission at 3 and 12 months were 33% (11/33) and 42% (18/43), respectively. Endoscopic healing at 6-18 months was 61% (17/28). Median (IQR) time to treatment discontinuation was 9 (7-11) months. A total of 6 (12%) patients discontinued STELARA due to treatment failure (n=5; 10%) or pregnancy (n=1; 2%).
	Safety
	AEs occurred in 7 (14%) patients; however, no SAEs were reported.
Sedano et al (2023)¹³ evaluated the efficacy of STELARA in patients with CD in Canada. STELARA was administered at a weight-based IV dosing for induction (≤55 kg, 260 mg; >55 kg, 390 mg; >85 kg, 520 mg) followed by 90 mg SC every 8 weeks for maintenance. The primary outcome was clinical response (assessed by PGA and defined as a ≥50% reduction in CDrelated symptom activity/severity) and clinical remission (defined as HBI score of ≤4 points) at 3, 6, and 12 months. The secondary outcomes included endoscopic response (defined as improvement in endoscopic appearance from baseline) and remission (defined as absence of mucosal ulcers), endoscopic healing (defined as endoscopic response or remission), imaging response (defined as improvement in ≥1 features, including BWT/mural hyperenhancement/fat stranding/other inflammatory features) and remission (defined as absence of any features of active mucosal inflammation on imaging), corticosteroid-free clinical response and remission (as per clinical response and remission, with no steroids for 4 weeks before the endpoint assessment), and biochemical or CRP response (defined as CRP levels decreased to ≤5 mg/L). Of the 229 patients treated with STELARA, 48 (21%) were biologic-naïve.	Efficacy
	Primary outcomes Clinical response and remission at 3 months were 39.6% (59/144) and 64% (89/139), respectively. Clinical response and remission at 6 months were 49.6% (60/121) and 59.4% (63/106), respectively. Clinical response and remission at 12 months were 51.7% (31/64) and 57.1% (28/49), respectively. Secondary outcomes Among biologic-naïve patients with an endoscopic assessment at some point during the follow-up period, endoscopic response was achieved in 41.2% (7/17) of patients and endoscopic remission was achieved in 35.3% (6/17) of patients. Endoscopic healing was achieved in 76.5% (13/17) of biologic-naïve patients; median time to endoscopic healing was 8.4 months. Among biologic-naïve patients with an imaging assessment at some point during the follow-up period, imaging response and remission were achieved in 60.0% (3/5) of patients, each. Imaging healing was achieved in 3 biologic-naïve patients; median time to endoscopic healing was 3.5 months. Proportion of biologic-naïve patients using corticosteroids at 3 and 6 months were 13.5% (5/37) and 21.7% (5/23), respectively; 52.4% (11/21) of biologic-naïve patients achieved CRP normalization at 3 months.
Teresa et al (2023)¹⁴ evaluated the effectiveness and safety of STELARA in biologic-naïve patients with CD in a multicenter study in Spain. STELARA was administered at a dose of 6 mg/kg IV for induction followed by 90 mg SC at week 8 and then every 8 or 12 weeks based on clinical judgement. The evaluated outcomes included corticosteroid-free clinical remission (defined as HBI score of ≤4 points), clinical response (defined as a decrease of ≥3 points in the HBI score from baseline, without remission), and biochemical remission and response evaluated using FCP and CRP (FCP and CRP normalization levels were <250 mg/kg and <5 mg/L, respectively). Overall, 84 biologic-naïve patients were treated with STELARA.	Efficacy
	Clinical outcomes In patients with clinical disease activity at baseline, corticosteroid-free clinical remission at 16, 24, 52, and 72 weeks were 80.0% (48/60), 77.4% (41/53), 80.0% (36/45), and 71.4% (30/42), respectively. In patients who were not in clinical remission at baseline, corticosteroidfree clinical response at 16, 24, 52, and 72 weeks were 13.3% (8/60), 9.4% (5/53), 2.2% (1/45), and 0% (0/42), respectively. Corticosteroid-free clinical remission or response at 16, 24, 52, and 72 weeks were 93.3% (56/60), 86.8% (46/53), 82.2% (37/45), and 71.4% (30/42), respectively. Biochemical outcomes Among 52.2% (42/82) of patients with abnormal CRP levels at baseline, CRP values returned to normal in 47.6% (20/42), 43.2% (16/37), 50% (14/28), and 52.4% (11/21) at 16, 24, 52, and 72 weeks, respectively. Among 82.3% (51/62) of patients with abnormal FCP levels at baseline, FCP values returned to normal in 45.5% (20/44), 45.5% (20/44), 48.6% (17/35), and 50% (13/26) at 16, 24, 52 and, 72 weeks, respectively. Median (IQR) CRP and FCP levels decreased significantly from baseline (CRP, 5.1 [1.5-12.6] mg/L; FCP, 851.5 [341.3-1800.0] mg/kg) to week 72 (CRP, 2.0 [0.6-4.0] mg/L; FCP, 91.5 [83.25-698.2] mg/kg; P<0.001 for both).
	Safety
	During the 72-week follow-up period, 10 AEs occurred in 9 (10.7%) patients, 4 of which led to treatment discontinuation (1 uveitis recurrence, 1 infection, 1 infusion reaction, and 1 adenocarcinoma of the ileum). The remaining 6 AEs that did not warrant treatment discontinuation were headache, infection, arthralgia, dyspnea, cutaneous rash, and odynophagia. Seven (8.2%) patients required surgery during the follow-up period. Two patients died during the follow-up period (1 was treated for 72 weeks and died of pneumonia secondary to COVID-19 infection and the other was treated for 24 weeks and died of acute mesenteric ischemia).
Moens et al (2022)¹⁵ evaluated the efficacy of STELARA and ADA in biologic-naïve patients with moderate to severe CD in a cohort study from a tertiary referral center in Belgium. STELARA was administered at a dose of ~6 mg/kg IV at week 0 followed by 90 mg SC maintenance doses every 8 weeks starting week 8 onwards. ADA was administered SC at an induction dose of 160 mg at week 0 and 80 mg at week 2 followed by a maintenance dose of 40 mg every other week from week 4 onwards. The primary outcome was endoscopic remission (defined as SES-CD score of <3 points) at 26-52 weeks. The secondary outcomes included steroid-free clinical remission (defined as HBI score of <5 points) at 26 and 52 weeks, endoscopic improvement (defined as 50% decrease in SES-CD score or SES-CD score of ≤3 points) at 2652 weeks, and corticosteroid-free endoscopic remission at 26-52 weeks. Of the 64 biologic-naïve patients included in the final matched cohort, 32 were treated with STELARA.	Efficacy
	Primary outcome Compared to STELARA, ADA was associated with significantly higher odds of reaching endoscopic remission at 26-52 weeks (aOR, 2.73; 95% CI, 1.12-7.36; P<0.05); the odds for endoscopic response were only nominally higher (aOR, 2.24; 95% CI, 0.94-5.71; P=0.07). Secondary outcomes Among patients with clinically active disease at baseline (n=47), clinical remission rates were not statistically different in the STELARA vs ADA group at 26 weeks (aOR, 1.26; 95% CI, 0.36-4.51; P=0.72) and 52 weeks (aOR, 1.58; 95% CI, 0.54-4.88; P=0.41). Among patients with clinically active disease at baseline, no difference was observed in the rates of steroid-free clinical remission between the 2 treatment groups at 26 weeks (aOR, 1.30; 95% CI, 0.40-4.50; P=0.72) and 52 weeks (aOR, 1.60; 95% CI, 0.50-4.90; P=0.41). Additionally, no difference was observed in the rates of steroid-free endoscopic remission (aOR, 2.51; 95% CI, 1.02-6.82; P=0.05) and endoscopic improvement (aOR, 1.93; 95% CI, 0.83-4.74; P=0.13) between the 2 treatment groups at 26-52 weeks. Three (9%) patients failed STELARA treatment and needed to undergo surgery.
	Safety
	During the first year, 24 AEs were reported in 17 patients treated with STELARA and during the entire follow-up period, 27 AEs (including SAEs) were reported in 18 patients treated with STELARA.
Parra et al (2022)¹⁶ evaluated the effectiveness and safety of STELARA in patients with CD who were either biologic-naïve or biologic-experienced in a multicenter study in Brazil. STELARA was administered at a weight-based induction dose of ~6 mg/kg IV followed by 90 mg SC induction dose at week 8 and then subsequent 90 mg SC maintenance doses every 8 or 12 weeks at the treating physician’s discretion. The primary outcome was clinical remission (defined as HBI score of ≤4 points in those with baseline HBI score of ≥8 points) at 8, 24, and 56 weeks. The secondary outcomes included biological response (defined as ≥50% reduction in CRP or FCP levels in patients with an elevated CRP or FCP levels at baseline) and remission (defined as normal CRP and FCP levels of ≤5 mg/L and <250 μg/g, respectively) up to 16 weeks. Of the 245 patients treated with STELARA, 33 (13.5%) were biologicnaïve.	Efficacy
	Clinical remission at weeks 8, 24, and 56 were 36.4%, 54.5%, and 39.4%, respectively. Biologic response and remission up to week 16 were 56.5% and 21.7%, respectively.
Shiga et al (2022)¹⁷ evaluated the efficacy of STELARA in biologic-naïve patients with CD using data form a nationwide anonymized Japanese database containing administrative medical claims data. Cumulative rates of hospitalization and surgery at 1 and 2 years were evaluated. After 1:1 propensity score matching, 1379 biologic-naïve patients were treated with STELARA.	Efficacy
	Cumulative hospitalization rates at 1 and 2 years were 26.5% and 39.8%, respectively. Cumulative surgery rates at 1 and 2 years were 5.1% and 8.4%, respectively.
Monin et al (2021)¹⁸ evaluated the effectiveness and safety of STELARA in biologic-naïve and biologic-experienced patients with CD in a single center study in Belgium. STELARA was administered as a weight-based IV infusion followed by 90 mg SC every 8 weeks. The evaluated outcomes included CRP and FCP levels and full biologic response (defined as CRP levels of <5 mg/L and FCP levels of <250 μg/g) after induction (824 weeks), during maintenance therapy (around 1 year), and at the last follow-up visit. Assessment was restricted to patients who reached week 16 after induction at the time of the analysis. Of the 148 patients treated with STELARA, 35 were biologic-naïve and the remaining failed biologic therapy (biologic-failure group).	Efficacy
	A statistically significant decrease was observed in CRP and FC levels at 8-24 weeks in biologic-naïve and biologic-failure patients (P<0.0001). CRP levels were significantly lower in biologic-naïve vs biologic-failure patients (P<0.05), and no significant decrease in FC levels was observed over time between the 2 patient groups. Among biologic-naïve patients, the proportion of patients with full biologic response at 8-24 weeks, 1 year, and the last follow-up visit were 60.6% (20/33), 85.7% (6/7), and 87.5% (8/9), respectively.
Miyazaki et al (2020)¹⁹ evaluated the efficacy of STELARA in patients with CD at a referral center in Japan. STELARA was administered as a weight-based IV infusion (~6 mg/kg) followed by 90 mg SC maintenance doses every 8 or 12 weeks per the treating physician’s discretion. Clinical remission (defined as CDAI score of <150 points) at 8 weeks was evaluated. Of the 47 patients treated with STELARA, 6 (12.8%) were biologic-naïve.	Efficacy
	Two biologic-naïve patients achieved clinical remission at 8 and 24 weeks.
Ahmed et al (2019)²⁰ evaluated the efficacy of STELARA in patients with moderate to severe CD in a cohort study at a tertiary inflammatory bowel disease referral center using data from EMR. The primary outcome was clinical response (defined as ≥2 point fall in HBI score, with a maximum HBI score of 7 points) at 416 weeks after induction. The secondary outcomes included clinical remission (defined as patients with clinical response and an overall HBI score of <4 points) at 4-16 weeks after induction. Of the 66 STELARA-treated patients, 10 were TNF-naïve.	Efficacy
	Clinical response and remission were achieved in 40.0% (4/10) and 33.3% (3/9) of TNF-naïve patients, respectively.
Abbreviations: ADA, adalimumab; ADR, adverse drug reaction; AE, adverse event; aOR, adjusted odds ratio; BWT, bowel wall thickness; CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; CI, confidence interval; COVID-19, coronavirus disease 2019; CRP, C-reactive protein; EMR, electronic medical record; FCP, fecal calprotectin; HBI, Harvey-Bradshaw index; HR, hazard ratio; IQR, interquartile range; IV, intravenous; PGA, Physician Global Assessment; SAE, serious adverse event; SC, subcutaneously; SES-CD, simple endoscopic score for Crohn's disease SI, serious infection; TNF, tumor necrosis factor.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 05 April 2024.

Summarized in this response are data evaluating the efficacy and safety of STELARA in biologic-naïve adult patients with CD.

References

Show

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