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STELARA®

(ustekinumab)

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STELARA® (ustekinumab)

Medical Information

STELARA – Occurrence of Arthralgia in Adults Patients with Crohn’s Disease

Last Updated: 02/24/2026

SUMMARY  

  • The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
  • Summarized in this response are the relevant data of adult patients with moderate to severe Crohn’s disease (CD) enrolled in the phase 3 and 3b studies who were treated with STELARA and experience arthralgia.
  • Additional data from retrospective studies are summarized below.

CLINICAL DATA

UNITI Trial Program

Feagan et al (2016)1 reported the efficacy and safety of STELARA through 3 randomized, double-blind, placebo controlled, clinical trials in adult patients with moderate to severe CD. 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. 

Proportions of randomized patients in the Crohn’s disease phase 3 pivotal maintenance study who reported arthralgia1      

UNITI-1
UNITI-2
IM-UNITI
STELARA
STELARA
STELARA
130 mg
6 mg/kg
130 mg
6 mg/kg
90 mg/12 week
90 mg/8 week
Patients treated, N
246
249
212
207
132
131
Arthralgia, n (%)
26 (10.6)
15 (6.0)
8 (3.8)
9 (4.3)
22 (16.7)
18 (13.7)

STARDUST Trial 

Danese et al (2022)2 conducted an open-label, phase 3b, multicenter, randomized study in adult patients with moderately to severely active CD comparing a treat-to-target (T2T) maintenance strategy based on dose adjustment of STELARA at week 16 (90 mg SC every 8 weeks or every 4 weeks) using endoscopy (followed by clinical and biomarker directed dose escalation) vs a standard of care (SoC) approach (90 mg SC every 12 weeks). All patients received an IV induction dose of ~6 mg/kg.

Results - Safety

  • Arthralgia occurred in 24/188 (11%) patients in the T2T group and 19/221 (9%) patients in the SoC group.

SEAVUE

Sands et al (2022)3 conducted a phase 3b, randomized, double-blind, parallel, active-comparator study to evaluate the efficacy and safety of monotherapy with STELARA vs adalimumab in biologic-naïve adults with moderately to severely active CD. Patients in the STELARA group received an IV induction dose of ~6 mg/kg followed by 90 mg SC every 8 weeks.

Results - Safety

  • Among STELARA-treated patients, arthralgia occurred in 12/191 (6%) patients.

Retrospective Studies

Additional data regarding the occurrence of arthralgia in adults treated with STELARA are available through several retrospective studies. See Table: Reports of Arthralgia in Adult Patients with CD from Retrospective Studies.


Reports of Arthralgia in Adult Patients with CD from Retrospective Studies4-7 
Primary Author and Year
Study Design
UST Patient Population
Dosing Regimen
Occurrence of Arthralgia
Livne-Margolin et al (2022)4 
Single-center
53 adult patients
Exact dosing not reported
At baseline, 7 patients had an arthralgia related disease, and 50 patients reported arthralgia as an EIM
  • New occurrences of arthralgia were reported in 2 patients receiving STELARA
    • One of two patients had a history of arthralgia and known sacroiliitis related complaints at treatment initiation. During follow-up, she suffered from recurrence of arthralgia with no improvement
    • The second patient developed de novo arthralgia during the time of follow-up
Sedano et al (2022)5  
Single-center
229 adult patients
Induction: STELARA IV weight-baseda
Maintenance: 90 mg SC q8w
At baseline, a history of arthralgia as an EIM was reported in 51/95 patients
Four cases of arthralgia were reported as adverse events
Plevris et al (2020)6 
Multicenter
216 adult patients
Induction: STELARA IV weight-based
Maintenance: 90 mg SC q8w
Arthralgia was reported in 4 patients with an incidence rate of 2.9 per 100 PYF
Iborra et al (2020)7 
Multicenter, ENEIDA registry (Nationwide study on genetic and environmental determinates of inflammatory bowel disease)
407 adult patients
Induction: UST IV weight-based
Maintenance: 90 mg SC q8w at week 8, then 90 mg q12w or 90 mg q8w
Arthralgia was reported in 21 patients as an EIM at baseline
Five cases of arthralgia were reported as AE
Abbreviations: AE, adverse event; EIM, extraintestinal manifestations; IV, intravenous; PYF, patient-years of follow-up; q8W, every 8 weeks; SAE, serious adverse event; SC, subcutaneousaSingle IV weight-based dose (for 260mg ≤55 kg; 390 mg for > 55–85 kg; 520 mg for >85 kg).

Literature Search

A literature search MEDLINE®, EMBASE®, BIOSIS Previews®, DERWENT® (and other resources, including internal/external databases) was conducted on 23 February 2026.

 

References

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1 Feagan BG, Feagan BG, Gasink C, et al. Ustekinumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2016;375(20):1946-1960.  
2 Danese S, Vermeire S, D’Haens G, et al. Treat to target versus standard of care for patients with Crohn’s disease treated with ustekinumab (STARDUST): an open-label, multicentre, randomised phase 3b trial. Lancet Gastroenterology Hepatology. 2022;7(4):294-306.  
3 Sands BE, Irving PM, Hoops T, et al. Ustekinumab versus adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn’s disease: a multicentre, randomised, double-blind, parallel-group, phase 3b trial. Lancet. 2022;399(10342):2200-2211.  
4 Livne-Margolin M, Ling D, Konyo SA, et al. Ustekinumab and vedolizumab for extraintestinal manifestations in inflammatory bowel disease [abstract]. J Crohns Colitis. 2022;16(Suppl. 1):i429-i430.  
5 Sedano R, Guizzetti L, McDonald C, et al. Clinical, endoscopic, and radiological effectiveness of ustekinumab in bio-naïve versus bio-experienced patients with Crohn’s disease: real-world experience from a large Canadian center. Inflamm Bowel Dis. 2022;29(6):866-874.  
6 Plevris N, Fulforth J, Siakavellas S, et al. Real-world effectiveness and safety of ustekinumab for the treatment of Crohn’s disease: the Scottish ustekinumab cohort. J Gastroenterol Hepatol. 2021;36(8):2067-2075.  
7 Iborra M, Beltrán B, Fernández-Clotet A, et al. Real-world long-term effectiveness of ustekinumab in Crohn’s disease: results from the ENEIDA registry. Aliment Pharmacol Ther. 2020;52(6):1017-1030.