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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)

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STELARA - Occurrence of Herpes Zoster Infections in Adult Patients

Last Updated: 03/25/2025

Summary

Please refer to local labeling for relevant information on STELARA and herpes zoster (HZ) infection.
A pooled safety analysis reported incidences of HZ infection with STELARA treatment across all approved indications in adults for up to 5 years. The overall rate of HZ per 100 patient-years (PYs) of follow-up was 0.63 in STELARA-treated patients vs 1.21 in placebo-treated patients.¹
A pooled safety analysis reported incidences of HZ infection with STELARA treatment for adult patients through 5 years in Crohn’s disease (CD) and 4 years in ulcerative colitis (UC). The overall rate of HZ per 100 patient-years (PYs) of follow-up was 0.85 in STELARA-treated patients vs 1.27 in placebo-treated patients.²
Data on the incidences of HZ infection during STELARA treatment from a subgroup analysis of a phase 3b study, retrospective studies, a registry-based study, and case reports are summarized below.³^-¹¹

COMPANY CORE DATA SHEET

STELARA CLINICAL INFORMATION

Adverse Reactions

Infections and Infestations

In clinical studies, HZ was reported as an uncommon (infrequent) (≥1/1000, <1/100) adverse reaction.¹²

POOLED SAFETY ANALYSIS ACROSS ALL APPROVED INDICATIONS

Ghosh et al (2024)² published long-term safety data from pooled STELARA phase 2/3 clinical studies through 5 years in CD and 4 years in UC.

HZ (including disseminated opportunistic infections or other infection events) cases were systematically collected in each trial throughout the study until the last study visit.
Infection outcomes were presented as events per 100 PYs of follow-up.
The rates of HZ in the pooled IBD group were no higher in the STELARA arm vs placebo.
For the rate of HZ infections in patients with CD or UC, see Table: HZ Infections In Patients with CD or UC Treated with STELARA vs Placebo.

HZ infections in Patients with CD or UC Treated with STELARA vs Placebo

	CD		UC		IBD Pooled
	PBO^a	STELARA^b	PBO^a	STELARA^b	PBO^a	STELARA^b
Patients Treated (n)	943	1749	446	826	1389	2575
Average follow-up (weeks)	29.01	86.13	48.55	121.47	35.29	97.46
PYs of follow-up	526	2897	416	1930	943	4826
Number of patients with herpes zoster per 100 PYs (number of patients)	1.71 (9)	0.86 (25)	0.72 (3)	0.83 (16)	1.27 (12)	0.85 (41)
95% CI	(0.78, 3.25)	(0.56, 1.27)	(0.15, 2.11)	(0.47, 1.35)	(0.66, 2.22)	(0.61, 1.15)
Abbreviations: CD, Crohn’s disease; IBD, inflammatory bowel disease; PBO, placebo; PY, patient-year; SC, subcutaneous; UC, ulcerative colitis; q8w, every 8 weeks.^aUlcerative colitis and Crohn’s disease: 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. ^bUlcerative colitis and Crohn’s disease: 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 patients had a dose adjustment from placebo SC to STELARA 90 mg SC q8w.

Loftus et al (2022)¹reported HZ infections from a pooled analysis of long-term safety data from 13 phase 2/3 studies through 5 years of CD and psoriasis (PsO), 2 years of UC, and 1 year of psoriatic arthritis (PsA).

HZ (including disseminated or nondisseminated opportunistic infections) was evaluated separately and identified by Medical Dictionary for Regulatory Activities (MedDRA) preferred terms for “varicella” or “zoster” and indicated as infection per the investigator.
Concomitant use of immunomodulators/corticosteroids was allowed in studies involving CD, UC, and PsA.
Safety outcomes were presented as events per 100 PYs of follow-up.
The rates of HZ, including disseminated HZ, were low and comparable between treatment groups.
For the rate of HZ infections in all approved indications, see Table: HZ Infection in Patients Treated with STELARA vs Placebo.

HZ Infection in Patients Treated with STELARA vs Placebo¹

	CD/UC	Psoriatic Diseases	All Diseases Pooled
STELARA, N (total PY follow-up)	2575 (3960)	4135 (9847)	6710 (13,807)
Placebo, N (total PY follow-up)	1389 (916)	1112 (327)	2501 (1244)
Incidence of HZ infection, rate/100 PYs
STELARA	0.91	0.52	0.63
Placebo	1.42	0.61	1.21
Abbreviations: CD, Crohn’s disease; HZ, herpes zoster; PY, patient-year; UC, ulcerative colitis.

One case of HZ was considered to be disseminated and counted as an opportunistic infection:
- A 53-year-old patient with PsO treated with STELARA reported left-sided flank pain 1 day prior to the first dose of STELARA. Four days later, the patient was diagnosed with disseminated cutaneous HZ based on the presence of 19 cutaneous vesicles outside the primary dermatome which resolved with treatment.

CLINICAL DATA - CD, UC, and PsO

Data on the incidences of HZ infection are available through a subgroup analysis of a phase 3b study, several retrospective studies, and a registry-based study. Please see Table: Summary of Occurrence of HZ Infection in Adult Patients with CD, UC and PsO from Phase 3b, Retrospective, and Registry-Based Studies.

Summary of Occurrence of HZ Infection in Adult Patients with CD, UC, and PsO from Phase 3b, Retrospective, and Registry-Based Studies³^-⁹

Primary Author and Year	Study Design	Patient Population	Dosing Regimen	HZ Infection
Phase 3 Study
Lee et al (2019)³	Subgroup analysis of a phase 3b, randomized, double-blind, multicenter study (CLEAR)	62 adults of Asian origin with moderate to severe plaque PsO	Secukinumab (n=23): 300 mg at baseline; weeks 1, 2, and 3; and then q4w up to week 48; STELARA (n=39): 45 mg (≤100 kg) or 90 mg (>100 kg) at baseline and week 4, and then q12w from week 16 onwards	HZ infection was reported in 3 (7.7%) patients in the STELARA group vs none in the secukinumab group
Retrospective Studies
Cheng et al (2022)⁴	Nationwide, retrospective, observational	89,972,617 adults with CD or UC between 2008-2019	Patients received either anti-TNF agents (n=19,096), STELARA (n=2420), or tofacitinib (n=305); dosing information not described	Risk of HZ infections based on multivariable analysis: STELARA vs anti-TNF: HR, 1.01 (95% CI, 0.56-1.54); P=0.96 Tofacitinib vs anti-TNF: HR, 0.46 (95% CI, 0.00-1.11); P=0.14
Chaparro et al (2022)⁵	Retrospective, real-world, multicenter, noninterventional (SUSTAIN)	463 adults with active CD	Induction: STELARA 90 mg SC at week 8; Maintenance: STELARA 90 mg SC q8w to q12w	HZ infection was reported in 3 (0.6%) patients
Trujillano et al (2021)⁶	Retrospective, single-center, observational	30 patients with active CD	Induction: STELARA IV; Maintenance: STELARA IV/SC; dosing information not described	HZ infection was reported in 8% of patients
Batista et al (2014)⁷	Retrospective, single-center, chart review	18 patients with CD	Induction: 45 mg to 270 mg SC at week 0; Maintenance: 90 mg SC q8w	HZ infection was reported in 1 patient
Umezawa et al (2014)⁸	Retrospective, single-center	144 patients with PsO	Patients were treated with either STELARA (n=40), IFX (n=39), or ADA (n=65) for a year; dosing information not described	A total of 4 cases (1 patient was receiving STELARA, 2 were receiving ADA treatment and 1 patient was switching from IFX to ADA treatment) were reported to develop HZ infection within 1 year of starting biologic treatment
Registry-Based Study
Shalom et al (2019)⁹	Prospective, observational, international disease-based registry (PSOLAR)	10,469 adults (24,025 PYs) with PsO	Patients received either TNF-α inhibitors (n=5076), STELARA (n=2704), MTX (n=1201), or no biologics/no MTX control (n=1488); dosing information not described	Overall population: HZ infections in the TNF-α inhibitors, STELARA, MTX, and no biologics/no MTX groups were reported in 29, 19, 2, and 5 patients, respectively. HZ incidence rates (95% CI) per 100 PYs in the TNF-α inhibitors, STELARA, MTX, and no biologics/no MTX groups were 0.25 (0.17-0.36), 0.29 (0.18-0.46), 0.14 (0.02-0.49), and 0.11 (0.040.27), respectively Compared with the no biologics/no MTX group, the adjusted HRs (95% CI) for HZ infections per 100 PYs in the TNF-α inhibitors, STELARA, and MTX groups were 2.22 (0.82-5.97; P=0.116), 2.73 (0.98-7.58; P=0.054), and 1.04 (0.20-5.41; P=0.966), respectively
Abbreviations: ADA, adalimumab; CD, Crohn’s disease; CI, confidence interval; HR, hazard ratio; HZ, herpes zoster; IFX, infliximab; IV, intravenous; MTX, methotrexate; PsO, psoriasis; PY, patient-year; q4w, every 4 weeks; q8w, every 8 weeks; q12w, every 12 weeks; SC, subcutaneous; TNF-α, tumor necrosis factor-alpha; UC, ulcerative colitis.

Additional data on the occurrence of HZ infection is available through various case reports. Please see Table: Case Reports on the Occurrence of HZ Infections.

Case Reports on the Occurrence of HZ Infections¹⁰^,¹¹

Publication	Patient	Case Description
Bhalani et al (2020)¹⁰	36-year-old male with moderate to severe inflammatory, ileocolonic CD History of secondary loss of response to IFX and ADA, and no history of immunomodulator use	The patient received treatment with vedolizumab and was later switched to STELARA due to persistent symptoms with objective evidence of inflammation. The patient also concurrently received a short course of prednisone for hand eczema. The patient developed a typical HZ rash involving the C2, C3, and C4 dermatomes 2 days after the first loading dose of STELARA (and 20 days after the last dose of vedolizumab). A 10-day course of valacyclovir was given, and the rash resolved over the course of 1 week. On follow-up, the patient had not developed PHN, and the Zoster recombinant, adjuvanted vaccine (Shingrix) was administered.
Failla and Nikkels (2011)¹¹	Case 1 50-year-old male with severe PsO Patient failed previous treatments which included topical corticosteroids, PUVA therapy, MTX, and cyclosporin	The patient received treatment with STELARA 45 mg after 3 months of coal tar treatment. Following the second injection (on day 30), the patient developed severe HZ infection in the third and fourth lumbar right dermatomes, with lesions affecting more than 3/4th of the dermatomal surface. Oral aciclovir (800 mg, 5 times daily) was given for 7 days, which resulted in the gradual disappearance of cutaneous lesions over a 14-day period. On follow-up after 3 months, the patient had no residual PHN.
Failla and Nikkels (2011)¹¹	Case 2 60-year-old male with long-standing and extensive plaque PsO Patient failed previous treatments, which included topical steroids, PUVA therapy, coal tars, cyclosporin, and ADA	The patient received treatment with STELARA 45 mg after 9 months of ADA treatment. After 3 injections (at 3 months), the patient developed severe HZ affecting the entire left 10th and 11th thoracic dermatomes. There was no satellite lesions. The patient’s wife developed HZ infection 3 weeks before the patient’s eruption. Oral aciclovir (800 mg, 5 times daily) was given for 7 days, which resulted in fading of the eruption-related pain after 5 days of therapy. No residual skin lesions or scarring were present after 1 month. On follow-up, the patient did not develop PHN.
Abbreviations: ADA, adalimumab; C2, lower jaw, back of the head; C3, upper neck, back of the head; C4, lower neck, upper shoulders; CD, Crohn’s disease; CT, computed tomography; HZ, herpes zoster; IFX, infliximab; IV, intravenous; MTX, methotrexate; PHN, postherpetic neuralgia; PsO, psoriasis; PUVA, psoralen plus ultraviolet-A radiation.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 24 February 2025.

References

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1	Loftus EV, Long M, Ott E, et al. Active tuberculosis and opportunistic infections: pooled safety analysis of ustekinumab through up to 5 years across all approved indications. Poster presented at: American College of Gastroenterology; October 21-26, 2022; Charlotte, NC.
2	Ghosh S, Feagan B, Ott E, et al. Safety of ustekinumab in inflammatory bowel disease: pooled safety analysis through 5 years in Crohn’s disease and 4 years in ulcerative colitis. J of Crohn’s and Colitis. 2024;18(10):1091-1101.
3	Lee MG, Huang YH, Lee JH, et al. Secukinumab demonstrates superior efficacy and a faster response in clearing skin in Asian subjects with moderate to severe plaque psoriasis compared with ustekinumab: subgroup analysis from the CLEAR study. J Dermatol. 2019;46(9):752-758.
4	Cheng D, Kochar BD, Cai T, et al. Risk of infections with ustekinumab and tofacitinib compared to tumor necrosis factor α antagonists in inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2022;20(10):2366-2372.e6.
5	Chaparro M, Baston-Rey I, Fernández-Salgado E, et al. Long-term real-world effectiveness and safety of ustekinumab in Crohn’s disease patients: the SUSTAIN study. Inflamm Bowel Dis. 2022;28(11):1725-1736.
6	Trujillano A, Maestre MA, Galan N, et al. Ustekinumab in Crohn’s disease: experience in a regional hospital [abstract]. Int J Clin Pharm. 2021;43(3):815. Abstract PP835.
7	Batista DD, Yadav S, Harmsen WS, et al. Ustekinumab treatment for Crohn’s disease in clinical practice: experience at a tertiary medical center [abstract]. Gastroenterology. 2014;146(5):S-464-S-465.
8	Umezawa Y, Fukuchi O, Ito T, et al. Risk of herpes zoster in psoriatic patients undergoing biologic treatment. J Dermatol. 2014;41(2):168-170.
9	Shalom G, Naldi L, Lebwohl M, et al. Biological treatment for psoriasis and the risk of herpes zoster: results from the psoriasis longitudinal assessment and registry (PSOLAR). J Dermatolog Treat. 2019;30(6):534-539.
10	Bhalani N, Laput G, Prajapati D, et al. Herpes zoster eruption in a young patient with moderate to severe, inflammatory, ileo-colonic Crohn’s disease after switch from vedolizumab to ustekinumab. Poster presented at: ACG Annual Meeting; October 23-28, 2020; Virtual.
11	Failla V, Nikkels AF. Ustekinumab and herpes zoster. Dermatology. 2011;222(2):119-122.
12	Data on File. Ustekinumab Company Core Data Sheet (CCDS) v52. Janssen Research and Development, LLC. EDMS-ERI-22004273; 2024.