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(ustekinumab)

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STELARA® (ustekinumab)

Medical Information

Retreatment of Crohn’s Disease with STELARA After a Drug Free Interval

Last Updated: 08/05/2025

Summary

  • The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
  • Please refer to the local labeling for relevant information on dosage and administration for STELARA.
  • Clinical studies and case reports have described STELARA retreatment after a drug-free interval in Crohn’s disease (CD).1-7

CLINICAL DATA

Phase 3 UNITI Clinical Trials

Overall Study Design/Methods

  • The efficacy and safety of STELARA was evaluated in 3 randomized, double-blind, placebo-controlled phase 3 clinical studies in adult patients (≥18 years of age) with moderately to severely active CD (Crohn’s Disease Activity Index [CDAI] score of 220 to 450). 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.1
  • In the UNITI-1 and UNITI-2 induction studies, at week 0, patients were randomized in a 1:1:1 ratio to receive a single dose of IV placebo, or IV STELARA 130 mg, or weight-based tiered IV STELARA dosing approximating 6 mg/kg (260 mg [weight ≤55 kg], 390 mg [weight >55 kg and ≤85 kg], 520 mg [weight >85 kg]). In UNITI-1, a total of 741 patients were randomized, and in UNITI-2, a total of 628 patients were randomized.1
  • In the IM-UNITI maintenance study, patients who were in clinical response at week 8 to IV STELARA during the induction studies (n=397, primary population) were randomly assigned in a 1:1:1 ratio to receive (through week 40) placebo SC (n=133), or STELARA 90 mg SC every 8 weeks (q8w), (n=132), or STELARA 90 mg SC every 12 weeks (q12w), (n=132).1
  • During IM-UNITI, patients in clinical response with STELARA during an induction study who subsequently lost response during the maintenance study were eligible, beginning at week 8, for a single dose adjustment through week 32. There were 3 possible scenarios for dose adjustment for patients who met the criteria for loss of response (LOR; defined as a CDAI score ≥220 and an increase from their maintenance baseline CDAI score of ≥100 points)1:
    • Patients randomized to maintenance treatment with placebo SC dose-adjusted to STELARA 90 mg SC q8w.
    • Patients randomized to maintenance treatment with STELARA 90 mg SC q12w dose-adjusted to STELARA 90 mg SC q8w.
    • Patients randomized to STELARA 90 mg SC q8w continued to receive the same dose regimen after LOR (no dose adjustment).
  • Patients who had their dose adjusted were assessed 16 weeks after the visit where the LOR criteria was met to determine if there was a benefit from dose adjustment (eg, clinical response [a ≥100 point decrease in CDAI] and clinical remission [CDAI <150]).2

Results

Efficacy
  • For the patients in the primary population who were randomized to placebo SC in the IM-UNITI study after responding to STELARA IV induction, the resumption of STELARA treatment after meeting LOR criteria (dose adjustment of placebo SC→STELARA 90 mg SC q8w) occurred in 51 patients. At the assessment, 16 weeks after dose adjustment2:
    • 39.2% of these patients were in clinical remission.
    • 70.6% of these patients had regained clinical response.
    • The median change in CDAI score from time of dose adjustment was -121.0.

Case Reports

Case reports of patients with CD who were retreated with STELARA after a drug-free interval are summarized in Table: Case Reports on Retreatment with STELARA After a Drug-Free Interval.


Case Reports on Retreatment with STELARA After a Drug-Free Interval3-7
Case
Patient/Disease Characteristics
Discontinuation, Retreatment, and Outcomes
Gonzalez et al (2024)3 reported a case of a 44-year-old female patient with complicated perianal CD.
  • The patient had a history of allergic rhinitis and asthma and was diagnosed with complicated perianal CD.
  • The patient was treated with STELARA and achieved disease remission.
  • Years later, the patient presented with anal fissures with luminal activity, and STELARA was restarted.
  • Ten minutes after starting STELARA infusion, the patient developed severe HSR with generalized urticaria, nausea, vomiting, oxygen desaturation, and hypotension.
  • A dose of epinephrine, hydrocortisone, diphenhydramine, and supplemental oxygen were administered. Remission of symptoms was achieved.
  • A desensitization protocol with STELARA was successfully performed without HSR using a 3-bag, 12-step method and premedication with dexamethasone, diphenhydramine, aspirin, and montelukast.
  • Desensitization protocol was subsequently performed 3 times without HSR.
Keating et al (2024)4 reported a case of a 34-year-old pregnant patient with ileocolonic CD.
  • The patient was diagnosed with ileocolonic CD 8 years prior, and the disease was well controlled with STELARA 90 mg q8w.
  • The baseline CRP level was <1 mg/L, and FCP level was 31 μg/g.
  • The prenatal course was uncomplicated, with no abnormality detected on fetal ultrasonography at 20 weeks.
  • The patient self-discontinued STELARA during the first trimester.
  • STELARA was restarted at 16 weeks following a flare of her CD and a peak calprotectin level of 5792 μg/g.
  • Improvement in symptoms was observed within a week of retreatment, and a reduction in calprotectin levels (2222 μg/g) was observed within 3 weeks.
  • The last dose of STELARA was administered at 32 weeks of gestation.
  • The patient had a spontaneous vaginal delivery of a female infant at 38 weeks (weight, 3.4 kg; APGAR score, 9 at both 1 minute and 5 minutes).
  • STELARA was reinitiated on day 5 postpartum and on day 9, the patient was readmitted with mastitis that improved with IV antibiotics.
  • Both the mother and infant were doing well at 3 months postpartum. No severe infections occurred in the infant.
Barahimi et al (2021)5 reported a case of a 51-year-old male with CD.
  • The patient initially presented with a pustular rash on his hands, body, face, extremities, and scalp starting 5 weeks after the initial weight-based STELARA induction (520 mg IV).
  • The rash resolved spontaneously and then recurred on both palms 4 weeks after the first STELARA maintenance dose (90 mg SC).
  • Biopsy of the affected area (left and right palms) revealed SPD.
  • STELARA was discontinued, and the rash resolved spontaneously.
  • The patient experienced a clinical recurrence of CD and arthritis, and STELARA was reinitiated at a weight-based induction dose (520 mg IV) with premedication (acetaminophen 650 mg and diphenhydramine 25 mg administered prior to infusion and prednisone 40 mg administered prior to, on the day, and on the day after STELARA infusion).
  • Two weeks later, the pustular rash recurred on the patient’s back; however, the presentation was less severe.
  • STELARA was continued, given improvement in the refractory CD symptoms, and the rash was managed with topical corticosteroids.
Chugh et al (2021)6 reported a case of an 18-year-old male with a 4-year history of small bowel CD.
  • The patient developed new, blanching, red violaceous papules bilaterally on his medial insteps 31 days after the initial STELARA induction dose.
  • Biopsy revealed medium caliber vessel vasculitis with mixed neutrophilic and eosinophilic infiltrates, indicating cPAN.
  • STELARA was discontinued.
  • Two years later, the patient developed duodenal and jejunal strictures, and STELARA was reinitiated in combination with MTX.
  • At the time of this report, the patient had been on STELARA therapy for 22 months without recurrence.
Borrás-Blasco et al (2017)7 reported a case of a 57-year-old male with CD.
  • The patient presented with a 4-day history of high fever, dyspnea, asthenia, productive cough, left pleuritic pain, and recent weight loss of >6 kg, approximately 6 weeks after STELARA initiation (90 mg SC weekly for 4 weeks).
  • Chest X-ray revealed left upper lobar consolidation, and a urine antigen test was positive for Legionella pneumophila.
  • STELARA was discontinued and the patient was treated for pneumonia, and his clinical condition improved over the next 48 hours.
  • One month later, following a severe relapse of CD, STELARA was reinitiated at a dose of 45 mg SC q2w.
  • Oral prednisone therapy was maintained at a dose of 40 mg daily (decreased by 5 mg weekly). Parenteral nutrition was continued for a month.
  • STELARA treatment was continued for the next 16 months. The patient was able to wean off prednisone, recover lost weight, and remain in clinical remission of CD symptoms.
Abbreviations: APGAR, Appearance, Pulse, Grimace, Activity, and Respiration; CD, Crohn’s disease; cPAN, cutaneous polyarteritis nodosa; CRP, C-reactive protein; FCP, fecal calprotectin; HSR, hypersensitivity reaction; IV, intravenous; MTX, methotrexate; q2w, every 2 weeks; q8w, every 8 weeks; SC, subcutaneous; SPD, subcorneal pustular dermatosis.

LITERATURE SEARCH

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

 

References

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1 Feagan BG, Sandborn WJ, Gasink C, et al. Ustekinumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 375(20):1946-1960.  
2 Feagan BG, Sandborn WJ, Gasink C, et al. Supplement to: Ustekinumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2016;375(20):1946-1960.  
3 Gonzalez RV, Martinez-Vazquez M, Cadenas-García D, et al. Hypersensitivity reaction to ustekinumab desensitization after severe anaphylaxis in Crohn’s disease [abstract]. Ann Allergy Asthma Immunol. 2024;133(6):S102. Abstract M003.  
4 Keating N, Walker C, Lally D, et al. Elevated cord levels of ustekinumab following its use in the treatment of Crohn’s disease in pregnancy. Obstet Med. 2024;17(1):47-49.  
5 Barahimi M, Lee S, Clark-Snustad K. Pustular rash in Crohn’s patient on ustekinumab raises concern for drug-induced paradoxical psoriasis. Case Reports Gastroenterology. 2021;15(2):662-666.  
6 Chugh R, Proctor DD, Little A, et al. Cutaneous Vasculitis After Ustekinumab Induction in Crohn’s Disease. Inflamm Bowel Dis. 2020;27(3):e30-e31.  
7 Borrás-Blasco J, Cortes X, Fernandez-Martinez S, et al. Legionella pneumophila pneumonia possibly due to ustekinumab therapy in a patient with Crohn’s disease. Am J Heal-Syst Pharm. 2017;74(4):209-212.