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STELARA®

(ustekinumab)

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STELARA® (ustekinumab)

Medical Information

STELARA - Occurrence of Herpes Zoster Infections in Adult Patients

Last Updated: 02/03/2026

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 phase 3b study, a subgroup analysis of phase 3b study, a prospective study, retrospective studies, a registry-based study, and case reports are summarized below.3-13

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.14

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
PBOa
STELARAb
PBOa
STELARAb
PBOa
STELARAb
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


Summary of Occurrence of HZ Infection in Adult Patients with CD, UC, and PsO3-11
Primary Author and Year
Study Design
UST Patient Population
UST Dosing Regimen
HZ Infection
Phase 3b Study
Peyrin-Biroulet et al (2024)3 
Phase 3b, open-label, randomized controlled trial (SEQUENCE)
265 adults with CD
Induction: STELARA IV
Maintenance:
90 mg SC q8w
  • HZ infection was reported in 1 (0.4%) patient
Lee et al (2019)4
Subgroup analysis of a phase 3b, randomized, double-blind, multicenter study (CLEAR)
62 adults of Asian origin with moderate to severe plaque PsO
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
Prospective Study
Gerdes
et al
(2025)5 
Prospective, non-interventional study (PERSIST)
313 adults with PsO
STELARA dosing not specified
  • Ophthalmic HZ occurred in 1 patient
Retrospective Studies
Almasri
et al (2025)6  
Retrospective, cohort study
11,576 adults with UC
STELARA dosing not specified
  • HZ occurred in 41 patients
Chaparro et al (2022)7
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)8
Retrospective, single-center, observational
30 adults 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)9
Retrospective, single-center, chart review
18 adults 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)10
Retrospective, single-center
40 adults with PsO
Dosing information not described
  • 1 case of HZ infection was reported to develop within 1 year of starting STELARA
Registry-Based Study
Shalom
et al (2019)11
Prospective, observational, international disease-based registry (PSOLAR)
2704 adults with PsO
Dosing information not described
  • HZ infections in the STELARA group was reported in 19 patients
    • HZ incidence rates (95% CI) per 100 PYs was 0.29 (0.18-0.46)
Abbreviations: CD, Crohn’s disease; CI, confidence interval; HR, hazard ratio; HZ, herpes zoster; IV, intravenous; PsO, psoriasis; PY, patient-year; q8w, every 8 weeks; q12w, every 12 weeks; SC, subcutaneous; 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 Infections12,13
Publication
Patient
Case Description
Bhalani et al (2020)12
  • 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)13
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 acyclovir (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.
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 20 January 2026.

 

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 Peyrin-Biroulet L, Chapman JC, Colombel JF, et al. Risankizumab versus ustekinumab for moderate-to-severe Crohn’s disease. N Engl J Med. 2024;391(3):213-223.  
4 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.  
5 Gerdes S, Hoffmann M, Asadullah K, et al. Effectiveness, safety and quality-of-life effects of guselkumab and ustekinumab in patients with psoriasis: week 104 results from the non-interventional, prospective, German multicentre PERSIST study. J Eur Acad Dermatol Venereol. 2025;39 (Suppl. 1):38-49.  
6 Almasri H, Ismail A, Khataniar H, et al. Ustekinumab versus vedolizumab and ustekinumab versus tumor necrosis factor alpha agent infectious adverse effects in patients with ulcerative colitis, a real-world data study. Expert Opin Pharmacother. 2025;26(13):1467-1471.  
7 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.  
8 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.  
9 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.  
10 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.  
11 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.  
12 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.  
13 Failla V, Nikkels AF. Ustekinumab and herpes zoster. Dermatology. 2011;222(2):119-122.  
14 Data on File. Ustekinumab Company Core Data Sheet (CCDS) v54. Janssen Research & Development, LLC. EDMS-ERI-22004273; 2025.