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STELARA® (ustekinumab)

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STELARA - Occurrence of Major Adverse Cardiovascular Events (MACE)

Last Updated: 05/04/2025

Summary

Please refer to your local labeling for further information regarding STELARA and adverse reactions.
To evaluate the occurrence of major adverse cardiovascular events (MACE) in the overall STELARA plaque psoriasis (PsO) clinical development program, safety data were pooled across 4 clinical studies (phase 2 and phase 3) and included results from adult patients with up to 5 years of treatment with STELARA (2011 Safety Analysis).¹
Adjudication of serious cardiovascular (CV) events was performed in a retrospective, independent, and blinded fashion, to determine events that might represent either MACE (including CV death, myocardial infarction [MI], and stroke) or other ischemic CV events.²
A pooled analysis from a phase 2 (n=146) and two phase 3 (PSUMMIT I [n=615], PSUMMIT II [n=312]) studies evaluated the occurrence of MACE in adult patients with active psoriatic arthritis (PsA) exposed to STELARA for up to 2 years.³
In a phase 3 clinical study of STELARA in 110 adolescent patients (age 12 to 17 years) with moderate to severe plaque PsO and in a phase 3 clinical study of STELARA in 44 pediatric patients (age 6 to 11 years) with moderate to severe plaque PsO, there were no reports of MACE through week 60 and week 56, respectively.⁴^-⁶
Analyses of MACE were performed for pooled data from phase 2 and 3 clinical trials through 4 years in ulcerative colitis (UC) and 5 years in Crohn’s disease (CD).⁷^,⁸
An integrated safety analysis of data from phase 2/3 and phase 3b studies in CD and UC showed that through up to 1 year of treatment, the rate of MACE (events per 100 patient-years [PY]) was 0.00 in bio-naïve patients treated with STELARA and 0.89 in bio-naïve patients treated with placebo. Through up to 5 years of treatment, the rate of MACE (events per 100 PY) was 0.07 in bio-naïve patients treated with STELARA and 0.53 in bio-naïve patients treated with placebo.⁹ Through up to 5 years of treatment in patients with a history of prior biologic failure, the rate of MACE (events per 100 PY) was 0.25 in patients treated with STELARA and 0.21 in patients treated with placebo.¹⁰

CLINICAL DATA IN adult PLAQUE PSORIASIS

Reich et al (2011)² reported the results of STELARA on CV events (MACE: MI, stroke, or CV death) from a retrospective, independent, and blinded fashion of phase 2 and phase 3 studies in adult patients with moderate to severe PsO.

Controlled Portions of PsO Clinical Studies

A pooled analysis of the placebo-controlled period in the PsO phase 2 and phase 3 (PHOENIX 1 and PHOENIX 2) clinical studies showed the risk differences observed in MACE between patients treated with placebo and STELARA for each individual study, and for data combined from these PsO studies. See Figure: Risk Difference in MACE During the Placebo-Controlled Period in PsO Studies.
In the placebo-controlled portions of the phase 2 and phase 3 PsO studies, 5 MACE were reported in 1582 patients treated with STELARA at week 2, 6, 10, 14, and 17 (0.3%; 95% confidence interval [CI], 0.1-0.7%) in patients with at least 3 established CV risk factors compared with no events in 732 patients treated with placebo (0.0%; 95% CI, 0.0-0.5%).
No clustering of MACE was observed during the 12- and 20-week controlled periods of the phase 2 and phase 3 studies.

Risk Difference in MACE During the Placebo-Controlled Period in PsO Studies²^,¹¹

Note: Treatment allocation defined as placebo: STELARA.
Abbreviations: CI, confidence interval; MACE, major adverse cardiovascular events; PsO, psoriasis.
^aMeta-analysis of 3 PsO studies listed.

Cumulative Safety Experience: Results from PsO Clinical Studies

2011 Safety Analysis

Papp et al (2013)¹ evaluated the cumulative safety experience of STELARA in adult patients with up to 5 years of treatment across phase 2 (n=301/320) and phase 3 (PHOENIX 1 [n=753/766], PHOENIX 2 [n=1212/1230], and ACCEPT [n=851/903]) PsO clinical studies (referred to as the 2011 Safety Analysis).

Study Design/Methods

Patients with moderate to severe PsO from 4 randomized, blinded, phase 2 and 3 STELARA studies were included. All studies were placebo-controlled, except for the ACCEPT study with etanercept as the active-comparator.
The 2011 Safety Analysis included 3117 patients receiving at least 1 dose of STELARA with 8998 PY of follow-up, including 1855 exposed up to 1 year, 1653 exposed up to 2 years, 1569 exposed up to 3 years, 1482 exposed up to 4 years, 1435 exposed up to 4.5 years, and 838 exposed up to 5 years.

Results

Through the 2011 Safety Analysis, the numbers of events of MACE per 100 PY with 95% CIs were 0.56 (0.35-0.85) for the 45 mg, 0.36 (0.22-0.57) for the 90 mg, and 0.44 (0.32-0.61) for the combined groups. The overall rate of MACE was comparable between the 45 mg and 90 mg groups. Individual event rates were 0.08 and 0.06 (CV death), 0.40 and 0.31 (MI), 0.08 and 0.00 (stroke) for the 45 mg and 90 mg groups, respectively.
Forty MACE (45 mg [n=21] and 90 mg [n=19]) were reported in 37 patients treated with STELARA; most were MIs, accounting for 77.5% (31/40) of all MACE reported. There was year-to-year variability, but no trend toward increasing events over time was noted. The proportion of patients with CV risk factors was similar at year 5 compared with baseline. All patients with MACE in this analysis had at least 2 established CV risk factors.

The 2011 Safety Analysis is the final summary from the STELARA PsO clinical development program. The long-term safety profile of STELARA remained stable over time, and is consistent with the previous reports after 3 and 4 years of follow-up.¹²^,¹³^,¹⁴

Clinical data in pediatric (ages 6 to 17) plaque psoriasis

Landells et al (2015)⁴ assessed the safety of STELARA in 110 adolescent patients (12 to 17 years of age) with moderate to severe plaque PsO in CADMUS, a phase 3, multicenter, randomized, double blind, placebo-controlled, parallel study.

Patients received treatment through week 40.⁴
Through week 60 of the CADMUS study, there were no reports of MACE.⁵

Phillipp et al (2020)⁶ evaluated the safety of STELARA in 44 pediatric patients (6 to 11 years of age) with moderate to severe plaque PsO in CADMUS Jr, a phase 3, multicenter, open-label, single-arm study.

Patients received treatment through week 40.
Through week 56 of the CADMUS Jr study, there were no reports of MACE defined as CV death, MI, or nonfatal stroke.

CLINICAL DATA IN PSORIATIC ARTHRITIS

McInnes et al (2013)¹⁵^,¹⁶ reported results from PSUMMIT I, a phase 3, multicenter, double-blind, placebo-controlled study to assess the efficacy and safety of STELARA in reducing signs and symptoms of active PsA in adult patients.

No MACE occurred during the placebo-controlled study period through week 16.
The average duration of follow-up through week 108 was 91.9 weeks for the combined STELARA treatment groups.
Three MACE were reported after the placebo-controlled period in patients receiving STELARA 45 mg, including MI (1 case at 8 weeks after placebo-controlled period, 1 case at 22 weeks after placebo-controlled period), and 1 stroke at 29 weeks after placebo-controlled period.
MACE occurred at a rate of 0.66 per 100 PY of follow-up through week 108.

Ritchlin et al (2014)¹⁷ evaluated the efficacy and safety of STELARA in PSUMMIT II, a phase 3, multicenter, double-blind, placebo-controlled study in adult patients with active PsA with and without previous anti-tumor necrosis factor (anti-TNF) agent experience.

No MACE occurred during the placebo-controlled study period through week 16.
Through week 60, 3 MACE were reported, 2 in patients receiving STELARA 45 mg and 1 in a patient receiving STELARA 90 mg. Two of these cases were adjudicated as MIs (rate, 0.74 per 100 PY). All 3 patients had a history of CV risk factors (history of stroke, hypertension, smoking, and/or symptoms of metabolic syndrome) and had been previously treated with an anti-TNF agent.

Kavanaugh et al (2014)³ reported the pooled safety of STELARA from the phase 2 and 3 studies in adult patients with active PsA exposed to STELARA for up to 2 years.

For this analysis, safety data from a phase 2 study of STELARA in 146 patients with active PsA (36-week study with a 12-week placebo-controlled period) were included with PSUMMIT I and PSUMMIT II.
The rates of MACE per 100 PY were 0.69 for placebo, 1.04 for STELARA 45 mg, 0.32 for STELARA 90 mg, and 0.71 for STELARA-combined groups through 2 years of follow-up.

additional clinical data in Plaque Psoriasis

MACE reports in plaque PsO comparator studies are summarized in Table: MACE in Phase 3 Comparator Studies. Refer to individual publications for additional detail on how MACE is defined in each study.¹⁸^-²⁶

MACE in Phase 3 Comparator Studies ¹⁸^-²⁶

Studies	Agent(s)	Number of Patients	MACE	Controlled Period	Reporting Period
AMAGINE-2^a,¹⁸^,¹⁹	STELARA^h	300	0	12 weeks
	Brodalumab 140 mg	607	1
	Brodalumab 210 mg	612	0
	Placebo	309	0
AMAGINE-3^a,¹⁸^,¹⁹	STELARA^h	313	0	12 weeks
	Brodalumab 140 mg	626	2
	Brodalumab 210 mg	622	0
	Placebo	313	0
UltIMMa-1²⁰^,²¹	STELARA^h	100	0	16 weeks
	Risankizumab 150 mg	304	0
	Placebo	102	0
UltIMMa-2²⁰^,²¹	STELARA^h	99	0	16 weeks
	Risankizumab 150 mg	294	0
	Placebo	98	0
BE VIVID^b,²²	STELARA^h	163	0	16 weeks
	Bimekizumab 320 mg	321	1
	Placebo	83	0
	STELARA^h	163	0	52 weeks
	Bimekizumabⁱ 320 mg	395	5	52 weeks
NAVIGATE^c,d,e,²³^,	STELARA^h	871	0		16 weeks
CLEAR^d,f,²⁴	STELARA^h	336	1		52 weeks
CLEAR^d,f,²⁴	Secukinumab 300 mg	335	1		52 weeks
CLARITY^c,d,²⁵	STELARA^h	552	2		52 weeks
CLARITY^c,d,²⁵	Secukinumab 300 mg	550	1		52 weeks
IXORA-S^d,g,²⁶	STELARA^h	166	1		52 weeks
IXORA-S^d,g,²⁶	Ixekizumab 80 mg	135	1		52 weeks
Abbreviations: CV, cardiovascular; MACE, major adverse cardiovascular events; MI, myocardial infarction. ^aDefined as stroke, MI, or CV death. ^bIdentified as cardiac arrest. All MACE occurred in patients with ≥2 pre-existing CV factors. ^cDefined as MI, stroke, or CV death. ^dStudy did not include a placebo group. ^eData presented for 16 week open-label run-in only. ^fIdentified as MI for STELARA and stroke for secukinumab; both patients had concomitant hypertension and hyperlipidemia. ^gIdentified as MI for STELARA and unstable angina for ixekizumab. ^h45 mg for patients with a body weight ≤100 kg and 90 mg for patients >100 kg. ⁱIncludes patients switching from placebo to bimekizumab 320 mg every 4 weeks at week 16; only events occurring after switching are included.

Rungapiromnan et al (2020)²⁷ performed a prospective cohort study to determine the comparative risk of MACE in adults with chronic PsO receiving anti-TNF therapies (adalimumab, etanercept) and STELARA.

Study Design/Methods

Patients with moderate to severe PsO and adult patients ≥18 years of age with chronic PsO who were biologic-naïve with no prior history of MACE enrolled in the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) were included in this 11-year analysis.
MACE was defined as acute coronary syndrome, unstable angina, MI, and stroke.
The risk of MACE was studied over 2 periods:
- Drug exposure
- Drug exposure and an extension period (90 days after the last dose)
Number of events and incident rates per 1000 PY of follow-up were selected outcomes in this analysis.

Results

A total of 5468 patients were included in the main analysis.
- Among these patients, 4517 and 951 patients were taking anti-TNF and STELARA therapy, respectively.
For incidence rates among patients receiving anti-TNF and STELARA therapy, see Tables: Incidence Rates Among STELARA and Anti-TNF Therapy: Outcomes During Drug Exposure and Incidence Rates Among STELARA and Anti-TNF Therapy: Outcomes During Drug Exposure and Extension.

Incidence Rates Among STELARA and Anti-TNF Therapy: Outcomes During Drug Exposure²³

Outcomes During Drug Exposure
Agents	PY of Follow-Up^a	Number of MACE	Incidence Rate^b	95% CI
STELARA	1.76 (0.92-2.96)	7	3.61	1.72-7.58
Anti-TNF therapy	1.69 (0.81-3.10)	24	2.46	1.65-3.67
Abbreviations: CI, confidence interval; MACE, major adverse cardiovascular events; PY, patient-years; TNF, tumor necrosis factor. ^aMedian, p25-p75 (25th percentile to 75th percentile). ^bPer 1000 PY.

Incidence Rates Among STELARA and Anti-TNF Therapy: Outcomes During Drug Exposure and Extension²³

Outcomes During Drug Exposure and Extension^a
Agents	PY of Follow-Up^b	Number of MACE^c	Incidence Rate^d	95% CI
STELARA	2.01 (1.16-3.21)	7	3.23	1.54-6.77
Anti-TNF therapy	1.93 (1.05-3.34)	29	2.67	1.86-3.84
Abbreviations: CI, confidence interval; MACE, major adverse cardiovascular events; PY, patient-years; TNF, tumor necrosis factor. ^aOutcomes were analyzed during drug exposure plus 90 days after the last dose. ^bMedian, p25-p75 (25th percentile to 75th percentile). ^cThere were 7 patients in the STELARA group that reported MACE during treatment exposure; there were no additional MACE reported in patients within 90 days after the last dose. ^dPer 1000 PY.

There was no statistically significant difference found in the risk of MACE in either treatment period assessed.

CLINICAL DATA IN CROHN’S DISEASE and Ulcerative colitis

Ghosh et al (2024)⁷ reported long-term safety data (up to 5 years in CD and 4 years in UC) from the cumulative analysis of six phase 2/3 studies (5 CD studies and 1 UC study) in patients with CD and UC.

Patients who received ≥1 dose of STELARA were included in the analysis. Concomitant immunomodulators and corticosteroids were permitted.
The PY of follow-up on inflammatory bowel disease (IBD) for STELARA and placebo were 4826 and 943, respectively. A total of 2575 patients received STELARA and 1389 patients received placebo.
The rate of MACE (per 100 PY) was 0.25 (95% CI, 0.13-0.43) in the STELARA group and 0.32 (95% CI, 0.07-0.93) in the placebo group.
The rates of deep vein thrombosis and pulmonary embolism (DVT/PE) events per 100 PY were infrequently reported across IBD, and they are as follows (STELARA vs placebo, respectively):
- DVT: 0.35 (95% CI, 0.21-0.56) vs 0.11 (95% CI, 0.00-0.59)
- PE: 0.08 (95% CI, 0.02-0.21) vs 0.42 (95% CI, 0.12-1.09)
The overall rates of DVT and PE for STELARA and placebo were 0.44 (95% CI, 0.27-0.67) and 0.53 (95% CI, 0.17-1.24), respectively.
For data across the overall study population, see Table: MACE Across Overall Population.

MACE Across Overall Population⁷

	CD		UC		Inflammatory Bowel Disease
	STELARA^a	Placebo^b	STELARA^a	Placebo^b	STELARA^a	Placebo^b
Patients treated	1749	943	826	446	2575	1389
Safety event, rate per 100 PYs (N)
MACE^c	0.28 (8)	0.19 (1)	0.21 (4)	0.48 (2)	0.25 (12)	0.32 (3)
95% CI^d	0.12-0.54	0.00-1.06	0.06-0.53	0.06-1.73	0.13-0.43	0.07-0.93
Abbreviations: CD, Crohn’s disease; CI, confidence interval; MACE, major adverse cardiovascular event; PY, patient-years; q8w, every 8 weeks; UC, ulcerative colitis. ^aUC and CD: includes data up to 16 weeks from the first STELARA dose for patients who were crossed over or re-randomized to placebo, and from the dose adjustment onward if had a dose adjustment from subcutaneous placebo to subcutaneous STELARA 90 mg q8w ^bUC and CD: includes data up to the first STELARA dose for patients who were initially treated with placebo; includes data at or after 16 weeks from the first STELARA dose onward, up to the dose adjustment if patients had a dose adjustment, for patients who were crossed over or re-randomized to placebo maintenance. ^cFor UC, MACE were identified by clinical review and were not independently adjudicated. ^dCIs based on an exact method assuming that the observed number of events follows a Poisson distribution.

Ghosh et al (2021)⁸ reported rates of MACE observed during the STELARA phase 2 and 3 clinical studies for CD and UC. The analysis included data through 5 years in CD and 2 years in UC.

Study Design/Methods

Data from 6 phase 2 and 3 clinical studies were analyzed which included all patients who received at least 1 dose of STELARA.
The populations included in this analysis were:
- All patients randomized to induction (weeks 0-8; phase 3 only)
- Randomized maintenance (weeks 0-44, phase 3 only; including placebo patients who were responders to STELARA intravenous induction dose)
- Patients in phase 2/3 clinical trials treated through 1 year
- Long-term pooled safety dataset through 2020 (5 years in CD and 2 years in UC)
Number of events and events per 100 PY of follow-up were outcomes included in this analysis.

Results

No MACE was identified in patients treated with STELARA in phase 3 CD/UC studies throughout induction and randomized maintenance. In UC, 1 MACE of nonfatal stroke during induction and 1 MACE of nonfatal MI during randomized maintenance were reported in patients treated with placebo.
Throughout 1 year of treatment in phase 2/3 CD and UC studies, 2 events of MACE were reported in the STELARA and placebo groups constituting rates of 0.12 (95% CI, 0.01-0.42) and 0.34 (95% CI, 0.04-1.21), respectively.
In the long-term pooled 2020 safety dataset, 2575 patients were treated with STELARA with 3960 PY of follow-up with 12 (0.30 events per 100 PY) events and 3 (0.33 events per 100 PY) events in the STELARA and placebo group, respectively.
For MACE data through 1 year in CD and UC, see Tables: MACE in the Induction/Randomized Maintenance Population and All-Treated Patients through 1 Year for Crohn’s Disease and MACE in the Induction/Randomized Maintenance Population and All-Treated Patients through 1 Year for Ulcerative Colitis.

MACE in the Induction/Randomized Maintenance Population and All-Treated Patients through 1 Year for Crohn’s Disease⁸

Crohn’s Disease
Patient Population	Agents	Number of Patients	PY of Follow-up	MACE	Event Rate per 100 PY	95% CI
Induction^a	Placebo	466	73	0	0	0.00-4.09
Induction^a	STELARA	941	148	0	0	0.00-2.02
Randomized maintenance^b	Placebo	133	82	0	0	0.00-3.66
Randomized maintenance^b	STELARA	314	237	0	0	0.00-1.27
All-treated patients through 1 year	Placebo	943	347	0	0.00	0.00-0.86
All-treated patients through 1 year	STELARA	1749	1106	1	0.09	0.00-0.50
Abbreviations: CI, confidence interval; MACE, major adverse cardiovascular events; PY, patient-years. ^aPlacebo controlled through up to week 8; phase 3 only. ^bThrough up to week 44; phase 3 only.

MACE in the Induction/Randomized Maintenance Population and All-Treated Patients through 1 Year for Ulcerative Colitis⁸

Ulcerative Colitis
Patient Population	Agents	Number of Patients	PY of Follow-up	MACE	Event Rate per 100 PY	95% CI
Induction^a	Placebo	319	49	1	2.05	0.05-11.41
Induction^a	STELARA	641	100	0	0	0.00-2.99
Randomized maintenance^b	Placebo	175	142	1	0.7	0.02-3.91
Randomized maintenance^b	STELARA	348	281	0	0	0.00-1.07
All-treated patients through 1 year	Placebo	446	250	2	0.80	0.10-2.89
All-treated patients through 1 year	STELARA	825	627	1	0.16	0.00-0.89
Abbreviations: CI, confidence interval; MACE, major adverse cardiovascular events; PY, patient-years. ^aPlacebo controlled through up to week 8; phase 3 only. ^bThrough up to week 44; phase 3 only.

For MACE data in the CD and UC long-term pooled safety dataset, see Tables: MACE in the Long-Term Pooled Safety Dataset for Crohn’s Disease and MACE in the Long-Term Pooled Safety Dataset for Ulcerative Colitis.

MACE in the Long-Term Pooled Safety Dataset for Crohn’s Disease⁸

Crohn’s Disease
Agents	Number of Patients	PY of Follow-up	MACE	Event Rate per 100 PY	95% CI
Placebo	943	526	1	0.19	0.00-1.06
STELARA	1749	2897	8	0.28	0.12-0.54
Abbreviations: CI, confidence interval; MACE, major adverse cardiovascular events; PY, patient-years.

MACE in the Long-Term Pooled Safety Dataset for Ulcerative Colitis⁸

Ulcerative Colitis
Agents	Number of Patients	PY of Follow-up	MACE	Event Rate per 100 PY	95% CI
Placebo	446	390	2	0.51	0.06-1.85
STELARA	826^a	1063	4	0.38	0.10-0.96
Abbreviations: CI, confidence interval; MACE, major adverse cardiovascular events; PY, patient-years. ^aOne patient who was only supposed to receive placebo incorrectly received a dose of STELARA, therefore is counted in both columns.

Danese et al (2022)⁹ conducted an integrated safety analysis incorporating data from phase 2/3 and phase 3b studies in CD and UC for bio-naïve patients (up to 5 years in CD and up to 2 years in UC).

Bio-naïve was defined as patients who were never treated with biologics. Concomitant immunomodulators and corticosteroids were permitted.
Through up to 1 year, the median duration of follow-up for placebo and STELARA was 27.61 and 39.26 weeks, respectively. The total PY of follow-up was 226 for placebo and 582 for STELARA.
Through up to 5 years, the median duration of follow-up was 45.96 weeks for placebo and 101.90 weeks for STELARA. The total PY of follow-up for placebo and STELARA was 376 and 1511, respectively.
MACE are presented as event rates per 100 PY of follow-up.
Through up to 5 years, there were 425 bio-naïve patients who received placebo and 771 bio-naïve patients who received STELARA.
Through up to 1 year of treatment, the rate of MACE (events per 100 PY) was 0.00 (95% CI, 0.00-0.51) in bio-naïve patients treated with STELARA (n=771) and 0.89 (95% CI, 0.11-3.20) in bio-naïve patients treated with placebo (n=425).
Through up to 5 years of treatment, the rate of MACE (events per 100 PY) was 0.07 (95% CI, 0.00-0.37) in bio-naïve patients treated with STELARA (n=771) and 0.53 (95% CI, 0.06-1.92) in bio-naïve patients treated with placebo (n=425).

Loftus et al (2022)¹⁰ reported long-term safety data (up to 5 years in CD and up to 2 years in UC) from an integrated analysis of five phase 2/3 and phase 3 studies in CD and UC patients with a history of prior biologic failure.

All patients who received ≥1 dose of STELARA and were identified to have a history of prior biologic failure were included in this analysis.
Through up to 5 years, the average duration of follow-up for placebo and STELARA was 29.06 and 64.18 weeks, respectively. The total PY of follow-up was 473 for placebo and 1970 for STELARA.
Through up to 5 years of treatment, the rate of MACE (events per 100 PY) in patients with a history of prior biologic failure are presented below:
- Patients treated with placebo (n=847): 0.21 (95% CI, 0.01-1.18)
- Patients treated with STELARA (n=1596): 0.25 (95% CI, 0.08-0.59)

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 20 February 2025.

Summarized in this response are relevant clinical data from phase 2 and phase 3 studies, and pooled analyses of data from phase 2/3 clinical trials.

References

Show

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2	Reich K, Langley RG, Lebwohl M, et al. Cardiovascular safety of ustekinumab in patients with moderate to severe psoriasis: results of integrated analyses of data from phase II and III clinical studies. Br J Dermatol. 2011;164(4):862-872.
3	Kavanaugh A, McInnes B, Ritchlin C, et al. Integrated safety of ustekinumab in psoriatic arthritis: 2 year follow-up from the psoriatic arthritis clinical development program. Poster presented at: American College of Rheumatology 78th Annual Scientific Meeting; November 14-19, 2014; Boston, MA.
4	Landells I, Marano C, Hsu MC, et al. Ustekinumab in adolescent patients age 12 to 17 years with moderate-to-severe plaque psoriasis: results of the randomized phase 3 CADMUS study. J Am Acad Dermatol. 2015;73(4):594-603.
5	Landells I, Marano C, Hsu MC, et al. Safety and efficacy of ustekinumab in adolescent patients with moderate to severe plaque psoriasis: results through 1 year of the phase 3 CADMUS trial. Poster presented at: The 73rd Annual Meeting of the American Academy of Dermatology; March 20-24, 2015; San Francisco, CA.
6	Philipp S, Menter A, Nikkels A, et al. Ustekinumab for the treatment of moderate-to-severe plaque psoriasis in pediatric patients (≥6 to <12 years of age): efficacy, safety, pharmacokinetic, and biomarker results from the open-label CADMUS Jr study. Br J Dermatol. 2020;183(4):664-672.
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8	Ghosh S, Ott E, Gasink C, et al. Safety of ustekinumab in IBD: a comprehensive analysis of major cardiovascular events (MACE) through 5 years in CD and 2 years in UC [abstract]. Gastroenterology. 2021;160(6, Suppl. 37):S37. Abstract 131.
9	Danese S, Hanauer SB, Jairath V, et al. Long-term cumulative safety of ustekinumab in bionaive patients with Crohn’s disease and ulcerative colitis [abstract]. J Crohns Colitis. 2022;16(Suppl 1):i434. Abstract P457.
10	Loftus EV, Lee SD, Panaccione R, et al. Long-term safety of ustekinumab in IBD patients with a history of biologic failure: pooled safety analysis through 5 years in Crohn’s disease and 2 years in ulcerative colitis. Poster presented at: Digestive Disease Week; May 21-24, 2022; San Diego, CA.
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