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STELARA® (ustekinumab)
Medical Information
STELARA - Occurrence of Hypersensitivity or Infusion Reactions in Adult Patients with Crohn’s Disease or Ulcerative Colitis
Last Updated: 07/28/2026
SUMMARY
- Please refer to the local labeling for relevant information regarding STELARA and the occurrence of hypersensitivity or infusion reactions in adult patients with Crohn’s disease (CD) or ulcerative colitis (UC).
- STELARA is contraindicated in patients with severe hypersensitivity to ustekinumab or to any of the excipients.1
Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported postmarketing. If an anaphylactic or other serious hypersensitivity reaction occurs, institute appropriate therapy and administration of STELARA should be discontinued.1 - Infusion reactions, injection site reactions, and hypersensitivity reactions are defined below, according to the phase 3 clinical programs for CD and UC.2
- 5 - In CD and UC intravenous (IV) induction studies, no events of anaphylaxis or other serious infusion reactions with STELARA were reported; 2.2% of 785 patients receiving placebo (PBO) and 1.9% of 790 patients treated with the recommended dose of STELARA reported adverse events (AEs) occurring during or within an hour of the infusion.1
- A safety analysis was conducted using data from the phase 3 CD trials to analyze the tolerability of STELARA and found no difference in infusion reactions or injection site reactions between PBO- and STELARA-treated patients.6
- A pooled safety analysis of clinical trial data through 5 years of CD and 4 years in UC reported no serious anaphylactic reactions or serum sickness-like reactions to STELARA.7
- Additional data are available through phase 3 studies, a phase 3b study, a retrospective study, registry-based studies, case series, and several case reports.8
-18
Section 4.0 Contraindications
- STELARA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients in STELARA.19
Section 5.5 Serious Hypersensitivity Reactions
- Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with STELARA in clinical trials and postmarketing. Some serious hypersensitivity reactions have occurred during the first IV dose of STELARA.19
- If a severe or clinically significant hypersensitivity reaction occurs, discontinue STELARA immediately and initiate appropriate medical treatment.19
Section 6.2 Postmarketing Experience
- The following adverse reactions have been reported during postapproval use of STELARA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to STELARA exposure.19
- Immune system disorders: Hypersensitivity reactions (e.g., anaphylaxis, angioedema, dyspnea, rash, urticaria), including a fatal case that presented with chest tightness and dyspnea during infusion of the first dose. Some cases of serious hypersensitivity reactions have been reported in patients with a history of alpha-gal syndrome, allergy to mammalian meat or meat products, or anti-alpha-gal IgE. In most of these cases the reactions occurred at the time of initial administration.
CLINICAL DATA
Phase 3 Controlled Trials - Crohn’s Disease and Ulcerative Colitis
Infusion Reactions
- In the clinical trial programs for CD and UC, an infusion reaction was defined as an AE that occurs during or within 1 hour following the infusion of a study agent, with the exception of laboratory abnormalities.2-5
- Minor infusion reactions could be managed by slowing the rate of the IV infusion and/or treating with antihistamines and/or acetaminophen as clinically indicated.
- If an IV infusion of study agent was stopped because of an infusion reaction and the reaction, in the opinion of the investigator, was not severe or did not result in a serious AE, the infusion could be restarted with caution.
Injection Site Reactions
Hypersensitivity Reactions
- In the clinical trial programs for CD and UC, before an SC injection or IV infusion, appropriately trained personnel and medications to treat allergic reactions, including anaphylaxis, were required to be available. Appropriate medical personnel were required to be in attendance at the time of the infusion and for at least 30 minutes after the SC injection or for at least 1 hour after the start of the infusion.2-5
- Appropriate medical personnel were required to be in close proximity to the infusion center for the remaining duration of the infusion, and for 1 hour after the end of the infusion in the event that emergency resuscitation was required. All patients were required to be observed carefully for symptoms of an allergic reaction (eg, urticaria, itching, hives).
- If a mild or moderate allergic reaction was observed, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or diphenhydramine could have been administered.
- In the case of a severe allergic reaction (eg, anaphylaxis), SC aqueous epinephrine, corticosteroids, respiratory assistance, and other proper resuscitative measures were required to be available at the study site where the infusions were being given.
- Patients who experienced serious adverse reactions related to either an injection or infusion were discontinued from further study injections. For severe reactions related to the injection or infusion, the patient could have been permanently discontinued from further study injections at the discretion of the investigator.
Crohn’s Disease
STELARA was evaluated in 3 randomized, double-blind, PBO-controlled clinical studies in adult patients with moderately to severely active CD. There were two 8-week IV induction studies (UNITI-1 and UNITI-2) followed by a 44-week SC maintenance study (IM-UNITI) representing 52 weeks of therapy.20
Loftus et al (2017)6 assessed the tolerability of STELARA as measured by infusion-related reactions, delayed hypersensitivity, or injection site reactions in the phase 3 studies. The results of this study demonstrated that, overall, infusion-related reactions were reported in 4.0% and 1.9% of all patients in UNITI-1 and UNITI-2, respectively.
- Between PBO and STELARA and between STELARA doses, there were no differences in infusion-related reactions. In nonrandomized patients who received an IV infusion during IM-UNITI, infusion-related reactions to PBO and STELARA 130 mg IV were similar.
- There were no anaphylactic or delayed hypersensitivity reactions to any IV dose.
- See Table: Infusion-Related Reactions: Phase 3 UNITI Studies in Crohn’s Disease.
| Population | PBO | STELARA 130 mg IV | STELARA ~6 mg/kg IV | STELARA IV Combined |
|---|---|---|---|---|
| UNITI-1 | 5/245 (2.0%) | 11/246 (4.5%) | 9/249 (3.6%) | 20/495 (4.0%) |
| UNITI-2 | 6/208 (2.9%) | 5/212 (2.4%) | 3/207 (1.4%) | 8/419 (1.9%) |
| IM-UNITI (combined) | 12/476 (2.5%) | 5/285 (1.8%) | N/A | N/A |
| All infusions combined | 23/929 (2.5%) | 21/743 (2.8%) | 12/456 (2.6%) | N/A |
| Abbreviations: AE, adverse event; IV, intravenous; N/A, not applicable; PBO, placebo. aAn infusion reaction was defined as any AE that occurred during or within 1 hour of the administration of the study agent infusion, with the exception of laboratory abnormalities. | ||||
- Following SC administration, injection site reactions were infrequent and did not differ between treatment arms.
- In the combined population (randomized and nonrandomized), injection site reactions occurred in 1.7% of patients receiving PBO and 3% of patients receiving STELARA.
- No serious injection site reactions were reported.
- Erythema was the most common injection site reaction reported (1.1%, PBO; 1.7%, STELARA).
- No anaphylactic or delayed hypersensitivity reactions occurred to any SC dose.
- One patient in the phase 3 program for CD discontinued therapy due to an injection site reaction.
Crohn’s Disease and Ulcerative Colitis
Ghosh et al (2024)7 evaluated the cumulative safety of STELARA from 6 phase 2/3 CD and UC studies (5 CD studies and 1 UC study) through 5 and 4 years of treatment, respectively.
- All patients receiving ≥1 dose of STELARA were included in the analysis.
- Concomitant immunomodulators and corticosteroids were permitted.
- The pooled analysis included 2575 and 1389 patients who received STELARA and PBO with 4826 and 943 years of follow-up, respectively.
- There were no serious anaphylactic reactions or serum sickness-like reactions to STELARA reported through 5 years.
- Through 5 years of CD and 4 years of UC treatment, antibodies to STELARA remained low.
- Overall, 5.8% of patients with CD and 5.5% of patients with UC who received continuous STELARA from induction through the final safety visit of the long-term maintenance study were positive for antibodies to STELARA.
Clinical Trials, Retrospective Study, Registry-based Study and Case Series/Case Reports
Additional data are available through clinical trial studies, a retrospective study and case reports. See Table: Summary of the Occurrence of Hypersensitivity or Infusion Reactions to STELARA in Adult Patients.
| Author and Year | Patient Characteristics and UST Dose | Description of Reaction | ||||
|---|---|---|---|---|---|---|
| GALAXI 2&3 (phase 3 studies) | ||||||
| Panaccione et al (2025)8 | UST weight-based infusion (N=300) | Anaphylactic or serum sickness reactions: 2 (1%) Injection site reaction: 1 (0.1%) | ||||
| VIVID-1 study (phase 3 study) | ||||||
| Ferrante et al (2024)9 | UST weight-based infusion (N=309) | Infusion site reaction: 4 (1.3%) Injection site reaction: 17 (5.8%) Hypersensitivity reaction on day of study treatment administration: 7 (2.3%) Hypersensitivity reaction after day of study treatment administration: 18 (5.8%) | ||||
| SEQUENCE study (phase 3b study) | ||||||
| Peyrin‑Biroulet et al (2024)10 | UST weight-based infusion (N=265) | Hypersensitivity reaction: 24 (9.1%) Injection-site reaction: 6 (2.3%) | ||||
| Author and Year | Patient Characteristics and UST Dose | Description of Reaction | Medications Administered and Outcome | Rechallenge Information | ||
| Retrospective study | ||||||
| Spencer et al (2020)11 | 16 patients experienced infusion reactions over ~2-year period: 14 patients at infusion center 1, (3% rate of infusion reactions) and 2 patients at infusion center 2 (0.8% rate of infusion reactions) 3/16 patients had history of infusion reactions to infliximab and/or adalimumab UST weight-based infusion No pretreatment was administered | Median time to infusion reaction: 2 (IQR, 2-4.5) minutes Majority were classified as moderate (50%) or severe (38%) Reactions reported in ≥10%: dyspnea 62.5%, flushing 56%, bronchospasm (acute onset of cough) 12.5%, angioedema (“throat closing”) 25%, stomach pain/nausea 31.3% | Diphenhydramine (87.5%), IV hydrocortisone (75%), famotidine (63%), ondansetron (12.5%), loratadine (12.5%), acetaminophen (12.5%), albuterol/atrovent (12.5%) | 15 patients (94%) restarted UST IV after treatment for infusion reactions (1 patient did not due to personal preference). All 15 patients completed infusions with no further issues. 13/14 patients who received UST SC tolerated injection without issues. Pretreatment used in 3 patients: Patient 1: Received prednisone 40 mg 2 days prior and diphenhydramine/acetaminophen right before injection. Patient 2: Received fexofenadine 30 minutes prior to injection and continues to receive prior to each injection per allergist recommendations. Patient 3: Received acetaminophen and diphenhydramine prior to injection. Patient experienced chest discomfort and was given IV hydrocortisone, which resolved symptoms. Reactions also occurred during second and third injection, which the patient elected to discontinue UST. | ||
| Author and Year | Patient Characteristics | Frequency of Adverse Events at the Patient Level for UST | ||||
| Registry-based study | ||||||
| Xu et al (2025)16 | 22,687 adverse event reports were collected from the FAERS database | |||||
| 596 reported cases of infusion-related reactions for USTa | The reporting odds ratio (95% CI) was 2.19 (2.02-2.39) | |||||
| 149 reported cases of hypersensitivity for UST | The reporting odds ratio (95% CI) was 1 (0.85-1.18) | |||||
| Author and Year | Patient Characteristics and UST Dose | Description of Initial Reaction | Medications Administered and Outcome | Rechallenge Information | ||
| Case series/case reports | ||||||
| Venkat et al (2026)18 | 6 patients experienced acute infusion reactions and tested positive for alpha-gal IgE | All patients went on to tolerate subsequent SC administration. Some patients were pretreated prior to the first SC injection. | ||||
| Patient 1: 58-year-old female with prior exposure to UST but UST was stopped 18 months prior due to insurance | Urticarial rash | Methylprednisolone, diphenhydramine, famotidine | Pretreatment ×2 injections | |||
| Patient 2: 55-year-old male with no prior exposure to UST and no prior medication reactions | Urticarial rash | Methylprednisolone, diphenhydramine, famotidine | No pretreatment before the first SC injection | |||
| Patient 3: 55-year-old male with no prior exposure to UST but had papular dermatitis while on adalimumab | Pruritus, generalized erythema | Diphenhydramine | No pretreatment before the first SC injection | |||
| Patient 4: 29-year-old male with no prior exposure to UST but had a serum sickness reaction to adalimumab | Urticarial rash, pruritus, flushing | Methylprednisolone, diphenhydramine, famotidine | Pretreatment ×2 injections | |||
| Patient 5: 35-year-old male with no prior exposure to UST and no prior medication reactions | Urticarial rash, pruritus, chest tightness | Methylprednisolone, diphenhydramine, famotidine | Pretreatment cetirizine 10 mg | |||
| Patient 6: 61-year-old female with no prior exposure to UST and no prior medication reactions | Urticarial rash, pruritus, throat tightness | Methylprednisolone, diphenhydramine, famotidine | Pretreatment cetirizine 10 mg | |||
| Thomas et al (2021)12 | Case 1: 41-year-old female with CD and a history of an infusion reaction to infliximab UST 390 mg IV | 10 minutes into UST IV infusion, developed SOB, difficulty breathing, chest discomfort, flushing and dizziness | UST IV infusion stopped and IV line was flushed; symptoms resolved within 10 minutes No treatment was given | 2 weeks later, patient received UST 90 mg SC injection; 4 hours after, reported erythema, warm sensation, and pruritus at injection site; desloratadine was administered with subsequent symptom resolution. Days 2-4 after SC dose, patient reported progressing symptoms, including dyspnea and edema at injection site. Oral prednisone 20 mg was given for 3 days with resolution in symptoms. UST was discontinued. | ||
| Case 2: 23-year-old female with CD and a history of an infusion reaction to infliximab UST 390 mg IV | 15 minutes into UST IV infusion, developed dyspnea, tingling of lips, and trouble swallowing | UST IV infusion stopped and prednisone 25 mg IV was administered. Symptoms resolved. | Restarted UST IV at lower infusion rate and after 5 minutes, similar symptoms occurred; UST was discontinued. 2 hours post UST IV infusion, UST 90 mg SC was administered. Patient developed SOB, flushing and was treated with an antihistamine and prednisone 25 mg IV. Oral prednisone and antihistamine were continued for 7 days with complete resolution of symptoms. UST was discontinued. | |||
| Case 3: 54-year-old female with CD and a history of infusion reactions to vedolizumab UST 390 mg IV | 40 minutes into UST IV infusion, patient developed swollen throat, cough, headache, and fatigue | UST IV infusion was stopped and an antihistamine was administered. Symptoms resolved. | UST IV infusion was reinitiated at a lower infusion rate. Similar symptoms occurred within 5 minutes. UST was discontinued. | |||
| Crosby et al (2021)13 | 61-year-old female with CD UST 520 mg IV | 17 minutes into UST IV infusion developed skin redness, itchiness, and urticaria; vital signs were stable with no respiratory compromise | Diphenhydramine was administered, and urticaria resolved. | 1 month post UST IV infusion, patient was pretreated with prednisone 40 mg BID the day before and 40 mg 1× on the day of UST 90 mg SC injection. Patient received diphenhydramine 25 mg and acetaminophen 650 mg 30 minutes prior to UST SC injection. Patient was monitored for 60 minutes and discharged with no reaction. After third UST SC injection, developed transient erythema and redness at injection site. | ||
| Yabumoto et al (2020)14 | 42-year-old male with CD UST dose not stated in the publication | 2 days after administration of UST, patient developed a pruritic erythematous blistering skin rash on neck, arms, trunk without mucus membrane involvement or fever; skin biopsy revealed hypersensitivity skin reaction | No medications were administered. Skin reaction resolved in 10 days. | Patient received 4 days of premedication with acetaminophen, famotidine, prednisone, and diphenhydramine prior to UST 90 mg SC. No reaction to UST SC was reported. | ||
| Krugliak Cleveland et al (2020)15 | 26-year-old female with CD and a history of anaphylaxis to infliximab UST 260 mg IV | At time of UST IV infusion, patient developed tachycardia, flushing, throat tightness, and difficulty breathing | Diphenhydramine 50 mg IV and methylprednisolone 100 mg IV were administered. Symptoms resolved. | No reaction was observed to UST SC. | ||
| Abbreviations: BID, twice a day; CD, Crohn’s disease; CI, confidence interval; FAERS, Food and Drug Administration Adverse Event Reporting System; IgE, immunoglobulin E; IQR, interquartile range; IV, intravenous; SC, subcutaneous; SOB, shortness of breath; UST, ustekinumab. aStatistically significant signals in the algorithm. | ||||||
LITERATURE SEARCH
A literature search of MEDLINE®
References
| 1 | Data on File. Ustekinumab Company Core Data Sheet (CCDS) v55. Janssen Research & Development, LLC. EDMS-ERI-22004273; 2026. |
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