STELARA®

(ustekinumab)

Medical inquiries

Connect with my medical science liaison

Chat live

Available Monday - Friday 9AM - 4:30PM ET

Call me now

Available Monday - Friday 9AM - 7:30PM ET

Email your inquiry

Call 1-800-526-7736

Available Monday - Friday 9AM - 8PM ET

Live video

Available Monday - Friday 9AM - 4:30PM ET

This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

STELARA® (ustekinumab)

Medical Information

+ Save link

STELARA - Measuring Ustekinumab Drug Levels in Patients with Crohn’s Disease: UNITI Clinical Trial Program

Last Updated: 01/02/2025

Click on the following links to related sections within the document: Phase 3 UNITI Clinical Trial Program, IM-UNITI Long-Term Extension, and Post Hoc Analysis.
Abbreviations: AE, adverse event; Avg, average; CD, Crohn’s disease; Conc, concentration; CR, clinical remission; IV, intravenous; LTE, long-term extension; PK, pharmacokinetics; Q, quartiles; Q1, first quartile; Q2, second quartile; Q3, third quartile; Q4, fourth quartile; q4w, every 4 weeks; q8w, every 8 weeks; q12w, every 12 weeks; SC, subcutaneous; UST, ustekinumab.
^aAdedokun (2018).¹ ^bAdedokun (2017).² ^cAdedokun (2017).³ ^dAdedokun (2016).⁴ ^eAdedokun (2018).⁵ ^fSerum UST concentrations were evaluated at weeks 0, 3, 6, and 8 during induction and q4w during maintenance; UST concentration data were categorized into quartiles, and exposure-response relationships were assessed. ^gFeagan (2016).⁶ ^hFeagan (2016).⁷ ⁱUNITI-1: Q1, <3.19 µg/mL; Q2, ≥3.19 to <6.50 µg/mL; Q3, ≥6.50 to <9.73 µg/mL; Q4, ≥9.73 µg/mL; UNITI-2: Q1, <3.94 µg/mL, Q2, ≥3.94 to <6.47 µg/mL, Q3, ≥6.47 to <9.79 µg/mL, Q4, ≥9.79 µg/mL. ^jIM-UNITI: Q1, ≤0.5 µg/mL; Q2, >0.5 to ≤1.1 µg/mL; Q3, >1.1 to ≤2.5 µg/mL; Q4, >2.5 µg/mL. ^kAdedokun (2021).⁸ ^lIn patients receiving UST during the LTE, median steady-state trough UST concentrations were measured from weeks 44 to 252 to evaluate the consistency of UST levels; safety events by serum UST concentration were evaluated through week 272. ^mUST concentration quartiles: Q1, ≤0.70 µg/mL; Q2, >0.70 to ≤1.52 µg/mL; Q3, >1.52 to ≤2.78 µg/mL; Q4, >2.78 µg/mL; quartiles are based on combined data in UST 90 mg SC q12w and q8w dose groups. ⁿUST concentration quartiles: Q1, ≤0.63 µg/mL; Q2, >0.63 to ≤1.32 µg/mL; Q3, >1.32 to ≤2.51 µg/mL; Q4, >2.51 µg/mL; quartiles are based on combined data in UST 90 mg SC q12w and q8w dose groups.

Summary

Please refer to the local labeling for relevant information on STELARA and pharmacokinetics.
Summarized in this response are relevant data from the pivotal phase 3 UNITI clinical trial program,¹^-⁵ the IM-UNITI long-term extension (LTE) through 5 years,⁸ and a post hoc analysis of UNITI studies,⁹ which evaluated STELARA treatment in adult patients with moderately to severely active Crohn’s disease (CD). Analyses included the association of serum ustekinumab concentrations with efficacy and safety.

CLINICAL DATA

Phase 3 UNITI Clinical Trial Program

Feagan et al (2016)⁶^,⁷ evaluated the efficacy and safety of STELARA in 3 randomized, double-blind, placebo-controlled, phase 3 clinical studies in adult patients (≥18 years of age) with moderately to severely active CD (Crohn’s Disease Activity Index [CDAI] score of 220-450). 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.

Adedokun et al (2018)¹ collected data from these phase 3 clinical studies to determine STELARA’s pharmacokinetic features and relationship between exposure and response. Additionally, optimal ustekinumab cutoff values were also evaluated.

Study Design/Methods

UNITI-1 (741 randomized patients) evaluated the efficacy and safety of 2 STELARA IV induction regimens in adult patients with moderately to severely active CD who failed or were intolerant to 1 or more tumor necrosis factor (TNF) blockers. A total of 740 of the 741 randomized patients were included in the pharmacokinetic and exposure-response analyses.¹^,⁶^,⁷
UNITI-2 (628 randomized patients) evaluated the efficacy and safety of 2 STELARA IV induction regimens in adult patients with moderately to severely active CD who had failed or were intolerant to oral steroid and/or immunosuppressive therapy (ie, azathioprine, mercaptopurine, or methotrexate) but were not refractory to TNF blocker therapy. Patients were allowed to have previously received ≥1 TNF blocker but could not have been intolerant to the TNF blocker(s) and had not met the criteria for primary or secondary nonresponse to the treatment. A total of 626 of the 628 randomized patients were included in the pharmacokinetic and exposure-response analyses.
In the UNITI-1 and UNITI-2 studies, at week 0, patients were randomized in a 1:1:1 ratio to receive a single dose of placebo IV, STELARA 130 mg IV, or weight-based tiered STELARA IV dosing approximating 6 mg/kg (260 mg [weight ≤55 kg], 390 mg [weight >55 kg and ≤85 kg], 520 mg [weight >85 kg]).
IM-UNITI evaluated the efficacy and safety of 2 maintenance SC regimens of STELARA in patients with moderately to severely active CD who responded to IV treatment with STELARA in the UNITI-1 and UNITI-2 studies.
In the IM-UNITI study, patients who were in clinical response at week 8 to STELARA IV during the UNITI-1 or UNITI-2 induction studies (n=397, primary population) were randomly assigned in a 1:1:1 ratio to receive:
- Placebo SC (n=133)
- STELARA 90 mg SC every 8 weeks (q8w; n=132) through week 40
- STELARA 90 mg SC every 12 weeks (q12w; n=132) through week 36
A total of 387 of the 397 randomized patients in IM-UNITI were included in the pharmacokinetic and exposure-response analyses.
A total of 884 patients were in the nonrandomized population.⁶
Patients who received placebo or STELARA 90 mg SC q12w and met criteria of loss of response (defined as a CDAI score ≥220 and an increase from their baseline CDAI score of ≥100 points) between weeks 8 and 32 underwent dose adjustment and were allowed to cross over to receive STELARA 90 mg SC q8w. Patients who were already receiving STELARA 90 mg SC q8w continued to receive that regimen after loss of response.
The primary endpoint for both UNITI-1 and -2 induction studies was clinical response at week 6. Clinical response was defined as a reduction from baseline in the CDAI score of ≥100 points, although patients with a baseline CDAI score of ≥220 to ≤248 were considered to be in clinical response if a CDAI score of <150 was attained.¹^,⁶^,⁷
For the IM-UNITI maintenance study, the primary endpoint was clinical remission at week 44 (52 weeks after induction week 0). In all 3 studies, clinical remission was defined as a CDAI score <150.
Serum ustekinumab levels were evaluated at weeks 0, 3, 6, and 8 during induction and every 4 weeks (q4w) during maintenance.⁶
Ustekinumab concentration data were categorized into quartiles and exposure-response relationships were assessed. Specifically, the relationships between serum ustekinumab concentrations (based on induction week 8 concentrations, maintenance week 24 concentrations, or average trough concentrations through week 44) and clinical remission or serum C-reactive protein (CRP) were evaluated for the 3 UNITI studies, while the relationships between serum ustekinumab concentrations and endoscopic remission or response were evaluated in the endoscopic substudy.¹^,²
- The relationship between clinical remission and trough ustekinumab concentration quartiles during maintenance were examined at week 24 of IM-UNITI, as this was the timepoint where the STELARA q8w and q12w groups shared a preadministration trough.¹
For the endoscopic substudy analysis, endoscopic endpoints were assessed at week 44 (maintenance) using the Simple Endoscopic Score for Crohn’s Disease (SES-CD) in the subset of patients participating in the substudy (patients with a baseline SES-CD score ≥3 [indicating mucosal ulceration in at least 1 segment] were included).
Optimal ustekinumab concentration targets associated with clinical remission were estimated using receiver operating characteristic (ROC) curve analysis.

Results

Serum concentrations of ustekinumab over time were proportional to dose and did not differ significantly between the induction studies.
At week 8 of the UNITI-1 study, the median serum levels of ustekinumab in the groups receiving STELARA 130 mg IV and STELARA ~6 mg/kg IV were 2.1 µg/mL and 6.4 µg/mL, respectively.¹^,⁶
At week 8 of the UNITI-2 study, the median serum levels of ustekinumab in the groups receiving STELARA 130 mg IV and STELARA ~6 mg/kg IV were 2.0 µg/mL and 6.3 µg/mL, respectively.
Among STELARA IV induction responders randomized to placebo maintenance, median ustekinumab concentrations were undetectable by week 12 in patients receiving 130 mg and by week 16 in those receiving the ~6 mg/kg induction dose. In contrast, median ustekinumab concentrations were maintained above detectable levels through week 44 among patients randomized to either STELARA maintenance regimen.¹
Ustekinumab concentrations reached steady state by the second maintenance SC dose (ie, 16 weeks after induction for the q8w group and 20 weeks after induction for the q12w group).
The median trough concentrations in the STELARA 90 mg q8w group were approximately three-fold greater than in the 90 mg q12w group. Specifically, the median preadministration ustekinumab concentrations were consistent through week 44 for both 90 mg q8w group (range: 2.0 µg/mL to 2.2 µg/mL at IM-UNITI weeks 8, 16, 24, 32, and 40) and 90 mg q12w group (range: 0.6 µg/mL to 0.8 µg/mL at IM-UNITI weeks 12, 24, and 36).
Serum ustekinumab concentrations were similar between patients who were on azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX), compared with patients who were not on these treatments.
In both UNITI-1 and UNITI-2, higher remission rates (combined data for both 130 mg and ~6 mg/kg dose groups) were observed at week 8 in the 2 higher ustekinumab concentration quartiles compared with the 2 lower quartiles, although this pattern was more apparent in UNITI-2. For exposure-response results for the ~6 mg/kg group, please see Table: Remission Exposure-Response by Induction Dose (STELARA ~6 mg/kg) at Week 8: UNITI-1 and UNITI-2.

Remission Exposure-Response by Induction Dose (STELARA ~6 mg/kg) at Week 8: UNITI-1 and UNITI-2¹^,³^,⁵

Week 8	UNITI-1 STELARA ~6 mg/kg	UNITI-2 STELARA ~6 mg/kg
First ustekinumab concentration quartile^a
N	47	42
Proportion of patients in remission (%)	14.9	40.5
Second ustekinumab concentration quartile^a
N	47	42
Proportion of patients in remission (%)	38.3	47.6
Third ustekinumab concentration quartile^a
N	47	42
Proportion of patients in remission (%)	23.4	52.4
Fourth ustekinumab concentration quartile^a
N	48	43
Proportion of patients in remission (%)	27.1	53.5
P-value	0.225	0.101
^aUNITI-1: first quartile: <3.19 µg/mL, second quartile: ≥3.19 to <6.50 µg/mL, third quartile: ≥6.50 to <9.73 µg/mL, fourth quartile: ≥9.73 µg/mL; UNITI-2: first quartile: <3.94 µg/mL, second quartile: ≥3.94 to <6.47 µg/mL, third quartile: ≥6.47 to <9.79 µg/mL, fourth quartile: ≥9.79 µg/mL.

Ustekinumab concentration was reported to be inversely related to CRP concentration and positively correlated with normalization of CRP during both induction and maintenance. A trend toward lower CRP concentration with increasing ustekinumab concentration was seen at induction week 8 (P<0.001). During maintenance, similar patterns were observed with steady-state ustekinumab concentration and CRP at week 24 (P<0.001) and week 44 (P=0.008).¹
In the maintenance study, greater proportions of patients were in clinical remission at week 24 in the higher ustekinumab concentration quartiles (combined dosing groups).
For endoscopic endpoints at week 44 of maintenance, greater proportions of patients achieved a reduction in the SES-CD score of 3 points or more with increasing ustekinumab concentration (P=0.038). Additionally, greater endoscopic response and remission rates were observed in the top 3 concentration quartiles compared with the first quartile.
For further information related to clinical remission, CRP, and endoscopic endpoints, please see Table: Ustekinumab Concentration Association Analysis (Combined STELARA 90 mg SC q12w and q8w Groups) with Clinical Efficacy Outcomes and CRP Normalization: IM-UNITI and Table: Ustekinumab Concentration Exposure-Response Analysis (by Regimen) with Clinical Remission: IM-UNITI.

Ustekinumab Concentration Association Analysis (Combined STELARA 90 mg SC q12w and q8w Groups) with Clinical Efficacy Outcomes and CRP Normalization: IM-UNITI¹^-³

Efficacy Outcome	IM-UNITI Main Study^a (Week 24 Trough Concentration)
	Q1	Q2	Q3	Q4	P-value
	N=47	N=48	N=48	N=48	P-value
Clinical remission at week 24	55.3%	70.8%	77.1%	81.3%	0.002
CRP normalization at week 24	23.4%	27.1%	47.9%	56.3%	<0.001
	Endoscopy Substudy^b (Average Trough Concentration at Week 44)
	Q1	Q2	Q3	Q4	P-value
	N=26	N=25	N=26	N=25	P-value
≥3-point reduction in SES-CD score at week 44	34.6	48.0	50.0	60.0	0.038
Endoscopic response (50% decrease in SES-CD) at week 44	7.7%	40.0%	34.6%	44.0%	0.006
Endoscopic remission (SES-CD ≤2) at week 44	7.7%	24.0%	19.2%	28.0%	0.054
Abbreviations: CRP, C-reactive protein; Q, quartile; q12w, every 12 weeks; q8w, every 8 weeks; SC, subcutaneous; SES-CD, simple endoscopic score for Crohn's disease. ^aIM-UNITI Main Study: Q1: ≤0.5 µg/mL, Q2: >0.5 to ≤1.1 µg/mL, Q3: >1.1 to ≤2.5 µg/mL, Q4: >2.5 µg/mL. ^bEndoscopic Substudy: Q1: ≤0.5 µg/mL, Q2: >0.5 to ≤1.4 µg/mL, Q3: >1.4 to ≤2.7 µg/mL, Q4: >2.7 µg/mL.

Ustekinumab Concentration Exposure-Response Analysis (by Regimen) with Clinical Remission: IM-UNITI¹^-³

Efficacy Outcome	STELARA 90 mg SC q12w (At Week 24 Trough Concentration)^a
	Q1	Q2	Q3	Q4	P-value
	N=24	N=24	N=24	N=24	P-value
Clinical remission at week 24	62.5%	62.5%	70.8%	79.2%	0.084
	STELARA 90 mg SC q8w (At Week 24 Trough Concentration)^b
	Q1	Q2	Q3	Q4	P-value
	N=23	N=24	N=24	N=24	P-value
Clinical remission at week 24	47.8%	83.3%	79.2%	83.3%	0.006
Abbreviations: Q, quartile; q12w, every 12 weeks; q8w, every 8 weeks; SC, subcutaneous. ^aUstekinumab concentration quartiles (90 mg SC q12w): Q1: ≤0.3 µg/mL, Q2: >0.3 to ≤0.6 µg/mL, Q3: >0.6 to ≤1.2 µg/mL, Q4: >1.2 µg/mL. ^bUstekinumab concentration quartiles (90 mg SC q8w): Q1: ≤1.0 µg/mL, Q2: >1.0 to ≤2.2 µg/mL, Q3: >2.2 to ≤3.4 µg/mL, Q4: >3.4 µg/mL.

Overall, during maintenance using the ROC analyses, steady-state ustekinumab trough concentrations between 0.8 and 1.4 µg/mL or greater were associated with maintenance of clinical remission in a higher proportion of patients than patients with lower trough concentrations.¹^-³
There was no relationship seen between serum ustekinumab concentrations and the incidence of infections, serious infections, or serious adverse events (AEs) following induction or maintenance treatment with STELARA.¹^,⁴

IM-UNITI LTE

Adedokun et al (2021)⁸ assessed the immunogenicity and pharmacokinetics of 4 additional years of STELARA SC treatment in adult patients with moderately to severely active CD who completed the IM-UNITI maintenance study and continued treatment in the LTE.

Study Design/Methods

In patients receiving STELARA during the LTE, median steady-state trough ustekinumab concentrations were measured from week 44 through week 252 to evaluate the consistency of ustekinumab levels.
The associations between serum ustekinumab concentration and immunosuppressant use (6-MP, AZA, MTX) and clinical remission were assessed from week 44 through week 252.
Through week 272, safety events were evaluated by serum ustekinumab concentration.

Results

A total of 166 patients (q12w: n=84; q8w: n=82) randomized to STELARA continued treatment in the LTE and were not dose adjusted during maintenance therapy.
Among these patients, median serum trough ustekinumab concentrations from week 44 through week 252 ranged from 0.71 to 0.88 µg/mL and 2.18 to 3.13 µg/mL for the q12w and q8w groups, respectively. These concentrations were similar to those observed for week 8 through week 44 of the maintenance study (0.62-0.76 µg/mL and 2.04-2.37 µg/mL for the q12w group and q8w group, respectively).
Patients receiving immunosuppressants had similar median serum ustekinumab concentrations compared to patients who were not receiving these therapies.
For data regarding the association between serum ustekinumab concentration and clinical remission, please see Table: Clinical Remission by Average Ustekinumab Trough Concentration: IM-UNITI LTE.

Clinical Remission by Average Ustekinumab Trough Concentration: IM-UNITI LTE⁸

Efficacy Outcome	Average Trough Concentration Weeks 44-252^a
	Q1	Q2	Q3	Q4
	n=24/37	n=17/36	n=21/36	n=21/36
Clinical remission at week 252^b	64.9%	47.2%	58.3%	58.3%
Abbreviations: LTE, long-term extension; Q, quartile; q12w, every 12 weeks; q8w, every 8 weeks; SC, subcutaneous. ^aUstekinumab concentration quartiles: Q1: ≤0.70 µg/mL, Q2: >0.70 to ≤1.52 µg/mL, Q3: >1.52 to ≤2.78 µg/mL, Q4: >2.78 µg/mL. Quartiles are based on combined data in STELARA 90 mg SC q12w and q8w dose groups. ^bCombined STELARA dose groups (90 mg SC q8w and q12w) were used for the proportion of patients in clinical remission.

The proportion of patients who reported infection, serious infection, or serious AE during the LTE was generally similar across the serum ustekinumab concentration quartiles.
Please see Table: Selected Safety Events from Maintenance Week 0 through Week 272 of the IM-UNITI LTE by Serum Trough Concentration Quartiles through Week 252.

Selected Safety Events from Maintenance Week 0 through Week 272 of the IM-UNITI LTE by Serum Trough Concentration Quartiles through Week 252⁸

Safety Event	Average Trough Concentration Weeks 24-252^a
	Q1	Q2	Q3	Q4
	n=45	n=45	n=45	n=45
Average duration of follow-up (weeks)	179.4	206.6	210.6	205.9
Infection^b	75.6%	66.7%	86.7%	75.6%
Serious infection^b	17.8%	8.9%	8.9%	8.9%
Serious AE	28.9%	26.7%	26.7%	24.4%
Abbreviations: AE, adverse event; LTE, long-term extension; Q, quartile; q8w, every 8 weeks; q12w, every 12 weeks; SC, subcutaneous. ^aUstekinumab concentration quartiles: Q1: ≤0.63 µg/mL, Q2: >0.63 to ≤1.32 µg/mL, Q3: >1.32 to ≤2.51 µg/mL, Q4: >2.51 µg/mL. Quartiles are based on combined data in STELARA 90 mg SC q12w and q8w dose groups. ^bInfections as assessed by the investigator.

Post Hoc Analysis

Colombel et al (2024)⁹ conducted a post hoc analysis to evaluate the safety and efficacy of STELARA through week 16 among early and late responders using data from the UNITI studies.

Study Design/Methods

Patients were classified as the followings based on their response to the STELARA treatment:
- Week 8 responders: Patients who achieved clinical response 8 weeks after the STELARA 6 mg/kg IV induction infusion. These patients were then randomized to receive STELARA 90 mg SC q8w or q12w through week 44.
- Week 16 responders: Patients who did not achieve clinical response at week 8 following the STELARA 6 mg/kg IV induction infusion, but received STELARA 90 mg SC at week 8, and achieved clinical response at week 16. These patients continued receiving STELARA 90 mg SC q8w through week 44.
- Week 16 nonresponders: Patients who did not achieve clinical response neither at week 8 or week 16 after receiving the STELARA 6 mg/kg IV induction dose and STELARA 90 mg SC at week 8. These patients were discontinued.
Serum ustekinumab concentrations were obtained at induction baseline and weeks 3, 6, 8 and q4w during maintenance treatment.

Results

At weeks 8 and 16, trough serum ustekinumab concentrations did not differ meaningfully among week 8 responders, week 16 responders, and week 16 nonresponders.
At week 8, the median trough serum concentrations were slightly higher in week 16 responders (n=92) vs week 16 nonresponders (n=118): 6.83 µg/mL (Interquartile Range [IQR]: 3.38-9.93) vs 5.84 µg/mL (IQR: 3.12-9.12). These differences were not clinically meaningful.
Additionally, the pharmacokinetics of ustekinumab in week 8 nonresponders, did not reliably predict response potential at week 16.
In UNITI-1, among patients who had experienced biologic failure or intolerance, the highest proportion of week 16 responders (51.6%) was observed in the lowest serum ustekinumab quartile, whereas it was slightly lower (40.0%) in the highest quartile. See Table: Clinical Response at Week 16 by Week 8 Serum Ustekinumab Concentration Quartiles in UNITI-1.

Clinical Response at Week 16 by Week 8 Serum Ustekinumab Concentration Quartiles in UNITI-1⁹

	Ustekinumab Trough Concentration^a
	Q1	Q2	Q3	Q4
UNITI 1: Patients with a history of biologic failure or intolerance
n/N (%)	16/31 (51.6)	9/30 (30.0)	9/30 (30.0)	12/30 (40.0)
Abbreviations: IV, intravenous; Q, quartile; SC, subcutaneous. ^aUstekinumab concentration quartiles: Q1: <2.976 µg/mL, Q2: ≥2.976 to <6.496 µg/mL, Q3: ≥6.496 to <9.302 µg/mL, Q4: ≥9.302 µg/mL. Quartiles are based on the study for patients who received induction with STELARA IV 6 mg/kg, had no clinical response at week 8, and received STELARA 90 mg SC at that visit.

In UNITI-2, among biologic-nonfailure patients, the lowest proportion of week 16 responders (36.8%) was found in the lowest serum ustekinumab quartile, while the highest proportions (≥65.0%) were observed in the third and fourth quartiles. See Table: Clinical Response at Week 16 by Week 8 Serum Ustekinumab Concentration Quartiles in UNITI-2.

Clinical Response at Week 16 by Week 8 Serum Ustekinumab Concentration Quartiles in UNITI-2⁹

	Ustekinumab Trough Concentration^a
	Q1	Q2	Q3	Q4
UNITI 2: Biologic nonfailure patients
n/N (%)	7/19 (36.8)	10/20 (50.0)	14/19 (73.7)	13/20 (65.0)
Abbreviations: IV, intravenous; Q, quartile; SC, subcutaneous. ^aUstekinumab concentration quartiles: Q1: <3.837 µg/mL, Q2: ≥3.837 to <6.316 µg/mL, Q3: ≥6.316 to <9.32 µg/mL, Q4: ≥9.32 µg/mL. Quartiles are based on the study for patients who received induction with STELARA IV 6 mg/kg, had no clinical response at week 8, and received STELARA 90 mg SC at that visit.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 02 April 2024.

Summarized in this response are relevant data from the phase 3 UNITI clinical trial program, the LTE of IM-UNITI and post hoc analysis.

References

Show

1	Adedokun OJ, Xu Z, Gasink C, et al. Pharmacokinetics and exposure response relationships of ustekinumab in patients with Crohn’s disease. Gastroenterology. 2018;154(6):1660-1671.
2	Adedokun OJ, Xu Z, Gasink C, et al. Exposure-response to SC ustekinumab in moderate-severe Crohn’s disease: results from the IM-UNITI maintenance study. Abstract presented at: American College of Gastroenterology (ACG) Meeting; October 13-18, 2017; Orlando, FL.
3	Adedokun O, Xu Z, Gasink C, et al. Exposure-response to subcutaneous ustekinumab in moderate-to-severe Crohn’s disease: results from the IM-UNITI maintenance study. Poster presented at: American College of Gastroenterology (ACG) Meeting; October 13-18, 2017; Orlando, FL.
4	Adedokun OJ, Xu Z, Gasnik C, et al. Pharmacokinetics and exposure-response relationships of ustekinumab during IV induction and SC maintenance treatment of patients with Crohn’s disease with ustekinumab: results from the UNITI-1, UNITI-2, and IM-UNITI studies. Poster presented at: Digestive Disease Week; May 21-24, 2016; San Diego, CA.
5	Adedokun OJ, Xu Z, Gasnik C, et al. Supplement to: Pharmacokinetics and exposure response relationships of ustekinumab in patients with Crohn’s disease. Gastroenterology. 2018;154(6):1660-1671.
6	Feagan BG, Sandborn WJ, Gasink C, et al. Ustekinumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2016;375(20):1946-1960.
7	Feagan BG, Sandborn WJ, Gasink C, et al. Supplement to: Ustekinumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2016;375(20):1946-1960.
8	Adedokun OJ, Sands BE, Ghosh S, et al. The pharmacokinetics and immunogenicity of 5 years of treatment with ustekinumab: results from the IM-UNITI long-term extension [abstract]. Gastroenterology. 2021;160(6):S-354. Abstract Fr540.
9	Colombel JF, Sands BE, Gasink C, et al. Evolution of symptoms after ustekinumab induction therapy in patients with Crohn’s disease. Clin Gastroenterol Hepatol. 2024;22(1):144-153.