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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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Occurrence of Cytomegalovirus in Adult Patients Receiving STELARA

Last Updated: 01/02/2025

SUMMARY

Summarized in this response are relevant data from integrated safety analyses, which included the occurrence of cytomegalovirus (CMV), from the pivotal phase 3 clinical trial programs in adult patients with active psoriatic arthritis (PsA) and moderately to severely active Crohn’s disease (CD) or ulcerative colitis (UC) treated with STELARA.¹^-⁹
Additionally, several retrospective studies describe the occurrence of CMV in adults treated with STELARA for CD or UC and are summarized below.¹⁰^-¹²

clinical data in psoriatic arthritis

The efficacy and safety of STELARA in adult patients with active PsA were assessed through 2 phase 3, randomized, multicenter, placebo-controlled clinical studies (PSUMMIT I and PSUMMIT II) through week 24.⁴^,⁵

For data regarding the occurrence of CMV in adult patients with PsA treated in the PsA phase 3 studies (PSUMMIT I and PSUMMIT II), see Table: Number of Patients with 1 or More Treatment-Emergent Adverse Events through the End of the Reporting Period by MedDRA System-Organ Class and Preferred Term; Patients Treated in PsA Phase 3 Studies.

Number of Patients with 1 or More Treatment-Emergent Adverse Events through the End of the Reporting Period by MedDRA System-Organ Class and Preferred Term; Patients Treated in PsA Phase 3 Studies¹

	Placebo STELARA 45 mg^a	STELARA 45 mg^b	STELARA 90 mg^b	Combined
Patients treated, n	269	308	308	885
Average duration of follow-up, weeks	32.00	51.65	51.17	45.51
CMV syndrome, n (%)	0	1 (0.3)	0	1 (0.1)
Abbreviations: CMV, cytomegalovirus; MedDRA, Medical Dictionary for Regulatory Activities; PsA, psoriatic arthritis. ^aPatients who early escaped at week 16 or crossed over at week 24. ^bIncludes all treated patients irrespective of early escape.

Through week 24 of PSUMMIT I (placebo-controlled period), the occurrence of CMV syndrome in patients receiving placebo vs STELARA was 0 and 1 (0.2%), respectively.²

CLINICAL DATA IN CROHN’S DISEASE AND ULCERATIVE COLITIS

The safety and efficacy of STELARA in adults with moderate to severe CD were evaluated in the pivotal, phase 3, randomized, double-blind, placebo-controlled, multicenter clinical program (UNITI & IM-UNITI). The program consisted of 2 induction studies and 1 maintenance study.⁶

A case of CMV colitis occurred in a 32-year-old who received STELARA induction followed by placebo maintenance (440 days after the last exposure to STELARA). The patient was treated with ganciclovir with resolution of the infection.⁷

Additionally, the safety and efficacy of STELARA in adult patients with moderate to severe UC were evaluated in the pivotal, phase 3, randomized, double-blind, placebo-controlled, multicenter clinical program (UNIFI). The program consisted of 1 induction study and 1 maintenance study followed by an open-label long-term extension.⁸

CMV infection was reported in 2 patients who received STELARA during the open-label long-term extension (week 44 of the maintenance study through the final safety visit [at week 220 or at the discontinuation visit if the patient stopped treatment before week 220]).⁹

For the occurrence of CMV in adult patients with CD or UC, see Table: Number of Patients with 1 or More Treatment-Emergent Adverse Events on Induction and Maintenance Therapy (up to 52 Weeks Total) by MedDRA System-Organ Class and Preferred Term; Treated Patients Who Were Randomized in UC and CD Phase 3 Maintenance Studies.

Number of Patients with 1 or More Treatment-Emergent Adverse Events on Induction and Maintenance Therapy (up to 52 Weeks Total^a) by MedDRA System-Organ Class and Preferred Term; Treated Patients Who Were Randomized in UC and CD Phase 3 Maintenance Studies³

	Placebo SC Maintenance^b	STELARA 90 mg SC Every 12 Weeks^c	STELARA 90 mg SC Every 8 Weeks^c	Combined STELARA Group (Every 8 and 12 Weeks)^c
Patients treated, n	308	304	307	611
Average duration of follow-up, weeks	47.27	49.00	48.60	48.80
CMV colitis, n (%)	0	2 (0.7)	0	2 (0.3)
Abbreviations: CD, Crohn’s disease; CMV, cytomegalovirus; IV, intravenous; MedDRA, Medical Dictionary for Regulatory Activities; SC, subcutaneous; UC, ulcerative colitis. ^aUp to 60 weeks for patients who entered maintenance at week 16 of the induction study in UC. ^bPatients who were in clinical response to STELARA IV induction dosing and were randomized to placebo SC on entry into this maintenance study. ^cIncludes data up to the time of meeting loss of response criteria for patients who had a dose adjustment in CD.

Retrospective Studies

Additional data regarding the occurrence of CMV in adults treated with STELARA are available through several retrospective studies; see Table: Occurrence of CMV in Retrospective Studies in Adult Patients Receiving STELARA.

Occurrence of CMV in Retrospective Studies in Adult Patients Receiving STELARA¹⁰^-¹²

Primary Author and Year	Study Design	Patient Population	Dosing Regimen	Occurrence of CMV
Ecker et al (2021)¹⁰	Retrospective analysis	26 adults with UC	Induction: IV UST ~5.7 mg/kg Maintenance: 90 mg SC^a	1 patient had a colonic reactivation of CMV but continued UST maintenance treatment
Kopylov et al (2020)¹¹	Retrospective, multicenter	142 adults with CD	Induction: IV UST ~6 mg/kg Maintenance: 90 mg SC at week 8, then Q8W then dose-escalated^b	CMV colitis occurred in 1 patient following UST dose escalation
Hoffman et al (2019)¹²	Retrospective, single center	57 adults with CD	Induction: IV UST ~6 mg/kg Maintenance: 90 mg SC at week 8, then Q8W or Q12W	CMV occurred in 1 patient at week 12 of UST treatment
Abbreviations: CD, Crohn’s disease; CMV, cytomegalovirus; IV, intravenous; Q4W, every 4 weeks; Q6W, every 6 weeks; Q8W, every 8 weeks; SC, subcutaneous; UC, ulcerative colitis; UST, ustekinumab. ^a46.2% of patients received 90 mg UST Q8W, 30.5% of patients received UST 90 mg Q6W, and 23.1% received UST 90 mg Q4W. ^bDose escalation included 90 mg Q4W or Q6W SC or patients received an IV reinduction dose (~6 mg/kg) or a combination of IV reinduction and SC dose escalation.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 18 July 2024.

References

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1	Data on File. Ustekinumab. Integrated Summary of Safety. Janssen Research and Development, LLC. EDMS-ERI-166475058; 2018.
2	Data on File. Clinical Study Report. Janssen Research and Development, Inc. EDMS-ERI-31929474; 2013.
3	Data on File. Ustekinumab. Integrated Summary of Safety. Janssen Research and Development, LLC. EDMS-ERI-60793268; 2018.
4	McInnes IB, Kavanaugh A, Gottlieb AB, et al. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet. 2013;382(9894):780-789.
5	Ritchlin C, Rahman P, Kavanaugh A, et al. Efficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial. Ann Rheum Dis. 2014;73(6):990-999.
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	Sandborn WJ, Rutgeerts P, Gasink C, et al. Long‐term efficacy and safety of ustekinumab for Crohn’s disease through the second year of therapy. Aliment Pharmacol Ther. 2018;48(1):65-77.
8	Sands BE, Sandborn WJ, Panaccione R, et al. Ustekinumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2019;381(13):1201-1214.
9	Afif W, Arasaradnam RP, Abreu MT, et al. Efficacy and safety of ustekinumab for ulcerative colitis through 4 years: final results of the UNIFI long-term maintenance study. Am J Gastroenterol. 2024;119(5):910-921.
10	Ecker D, Fuchssteiner H, Gregus M. Ustekinumab for ulcerative colitis a real-world experience-retrospective data analysis of the IBD cohort Ordensklinikum Linz [abstract]. United European Gastroenterol J. 2021;9 (Suppl 8):Abstract P0395.
11	Kopylov U, Hanzel J, Liefferinckx C, et al. Effectiveness of ustekinumab dose escalation in Crohn’s disease patients with insufficient response to standard-dose subcutaneous maintenance therapy. Aliment Pharmacol Ther. 2020;52(1):135-142.
12	Hoffmann P, Krisam J, Wehling C, et al. Ustekinumab: “real-world” outcomes and potential predictors of nonresponse in treatment-refractory Crohn’s disease. World J Gastroenterol. 2019;25(31):4481-4492.