Summary

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• TREMFYA is indicated for the treatment of adults with moderately to severely active ulcerative colitis (UC).¹ The safety and efficacy of TREMFYA in adults with moderately to severely active Crohn’s disease (CD) is currently being investigated.²
• TREMFYA is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients.¹
• Serious hypersensitivity reactions, including anaphylaxis, have been reported with post market use of TREMFYA. Some cases required hospitalization. If a serious hypersensitivity reaction occurs, discontinue TREMFYA and initiate appropriate therapy.¹
• In phase 2b induction study of adult patients with moderately to severely active UC – QUASAR program, no adverse events (AEs) that occurred within 1 hour of infusion were considered serious or led to treatment discontinuation.³
• The rates of infusion related reactions through week 12 observed during the Phase 3 UC clinical trial program (QUASAR) and CD clinical trial program (GALAXI) are reported below.
• There were no anaphylactic or serum sickness-like reactions observed through 1 year based on an integrated safety analysis of data from the phase 2/3 clinical trials of TREMFYA in patients with moderately to severely active CD or UC.⁴ 

Clinical data

Infusion related reactions from GALAXI and QUASAR Programs

For the rate of infusion related reactions through week 12 of treatment with TREMFYA in the GALAXI or QUASAR Phase 3 clinical program, please see Table: Infusion Related Reactions During Induction Period (Through Week 12) in the Phase 3 Analysis Set.

Anaphylactic or Serum Sickness-like Reactions: Integrated Safety Analysis of Phase 2/3 Studies in CD and UC 

• Patients with moderately to severely active CD or UC through up to 1 year were included:⁴ 
  • UC: n=1514 from QUASAR induction study 1, 2 and the maintenance study
  • CD: n=1492 from GALAXI 1,2 and 3; GRAVITI (subcutaneous induction therapy with TREMFYA).
  • UC: VEGA study (Guselkumab plus golimumab combination therapy versus TREMFYA or golimumab monotherapy [VEGA]).
• TREMFYA studies were pooled for the induction period (GALAXI, GRAVITI, & QUASAR; Weeks 0-12 [VEGA excluded due to no PBO control]) and through 1 year (GALAXI, GRAVITI, QUASAR, & VEGA).
• Through 1 year, 2057 patients were treated with TREMFYA with 1752.1 PY of follow-up. No anaphylactic or serum sickness-like reactions were reported through 1 year of treatment. 

PHASE 2/3 CLINICAL PROTOCOLS

Phase 2b/3 Clinical Trial Program in Ulcerative Colitis (QUASAR)⁶

Management of Hypersensitivity Reactions

• In the clinical trial program for UC, before a subcutaneous (SC) injection or intravenous (IV) infusion, appropriately trained personnel and medications (e.g., injectable epinephrine) to treat hypersensitivity reactions, including anaphylaxis, were required to be available.
• All participants must be observed carefully for any signs and symptoms of a hypersensitivity reaction such as urticaria, pruritus, angioedema, wheezing, dyspnea, and/or hypotension.

Management of Adverse Events Temporarily Associated with Infusion

• Any AE (except laboratory abnormalities) that occurs during or within 1 hour after the IV infusion of the study intervention will carefully be evaluated.
• Minor infusion-related AEs may 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 the study intervention is interrupted because of an AE that, in the opinion of the investigator, is not severe or does not result in a serious adverse event (SAE), the infusion may be restarted with caution.

Phase 2/3 Clinical Trial Program in Crohn’s Disease (GALAXI)⁷

Management of Allergic Reactions

• In the clinical trial program for CD, before an SC injection or IV infusion, appropriately trained personnel and medications to treat allergic reactions, including anaphylaxis, were required to be available.
• All participants must be observed carefully for any signs and symptoms of an allergic reaction such as urticaria, itching, and/or hives.
• If a mild or moderate allergic reaction is observed, acetaminophen, nonsteroidal anti-inflammatory drugs, and/or diphenhydramine may be administered.
• In the case of a severe allergic reaction (e.g., anaphylaxis), SC 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 infusions or injections.
• Patients who experienced reactions following an injection or infusion that resulted in bronchospasm with wheezing and/or dyspnea that requires ventilatory support, or symptomatic hypotension with a decrease in systolic blood pressure greater than 40 mm Hg were not permitted to receive additional study intervention.
• Patients who experience reactions suggestive of serum sickness-like reactions (resulting in symptoms such as myalgia and/or arthralgia with fever and/or rash that are not representative of signs and symptoms of other recognized clinical syndromes) occurring 1 to 14 days after an injections of study intervention, should be discontinued from further study intervention administrations. Note that these symptoms may be accompanied by other events including pruritus, facial, hand, or lip edema, dysphagia, urticaria, sore throat, and/or headache.

Management of Adverse Events Temporally Related to Infusion

• Any AE (except laboratory abnormalities) that occurs during or within 1 hour after the IV infusion of the study intervention will carefully be evaluated.
• Minor infusion-related AEs may 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 the study intervention is interrupted because of an AE that, in the opinion of the investigator, is not severe or does not result in a SAE, the infusion may be restarted with caution.

literature search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 03 February 2025.