TREMFYA® (guselkumab) was approved in 2017 for use in adult patients with moderate to severe plaque psoriasis and who are candidates for systemic therapy or phototherapy, and was approved in 2020 for use in adult patients with active psoriatic arthritis.
At Week 24 in adult patients with active PsA:
Primary endpoint in pivotal studies: TREMFYA® showed a greater clinical response in ACR20 vs placebo, in both the DISCOVER 1 (52% vs 22%) and DISCOVER 2 (64% vs 33%) trials, respectively (P<0.0001).1
Major secondary endpoint in DISCOVER 2: TREMFYA® showed a reduction in structural damage progression (LS mean change from baseline in total mvdH-S score) vs placebo (0.52 vs 0.95; P=NS).2
Primary endpoint in a phase 3b study (APEX): TREMFYA® showed a greater clinical response in ACR20 vs placebo (68% vs 47%; P<0.001).3,4*†
Major secondary endpoint in a phase 3b study (APEX): TREMFYA® showed a greater reduction in structural damage progression (LS mean change from baseline in total mvdH-S score) vs placebo (0.54 vs 1.35; P<0.001).3,4†‡§
Study Designs
DISCOVER 1 and DISCOVER 2 were two phase 3, multicenter, randomized, double-blind, placebo-controlled studies evaluating the efficacy and safety of TREMFYA® administered subcutaneously in patients with active PsA (fulfilling CASPAR), despite standard therapies (nonbiologic disease-modifying antirheumatic drugs [DMARDs], apremilast, and nonsteroidal anti-inflammatory drugs [NSAIDs]). A stable dose of one selected nonbiologic DMARD, corticosteroids, and NSAIDs was permitted, but not required. The primary endpoint in both DISCOVER 1 and DISCOVER 2 was ACR20 response at Week 24.1,2,5
APEX is a phase 3b, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy of TREMFYA® administered subcutaneously in biologic-naïve patients with active PsA (fulfilling CASPAR) despite previous conventional synthetic DMARD, apremilast, and/or NSAID therapy, and who are at risk of radiographic progression. The primary endpoint in APEX is ACR20 response at Week 24, and the major secondary endpoint is the LS mean change from baseline in mvdH-S score at Week 24.3,6,7
ACR20=20% improvement in American College of Rheumatology composite measures of arthritis; ANCOVA=analysis of covariance; CASPAR=ClASsification criteria for Psoriatic ARthritis; CMH=Cochran-Mantel-Haenszel; LS=least squares; mFAS=modified full analysis set; mvdH-S=modified van der Heijde-Sharp; ND/MD=natural disaster/major disruption; NS=not significant; PsA=psoriatic arthritis.
*The primary endpoint P value is multiplicity controlled using a fixed sequence testing procedure and can be used to determine statistical significance. Statistics are based on the CMH test across multiply imputed datasets.
†Efficacy analyses are from the mFAS, which included all randomized patients, excluding those from Ukraine sites rendered unable to support key study operations due to major disruptions.
‡Statistics are based on ANCOVA. Missing data and data impacted by ND/MD were imputed using multiple imputation.
§Major secondary endpoint P value is multiplicity controlled using a fixed sequence testing procedure and can be used to determine statistical significance. Statistics are based on ANCOVA across multiply imputed datasets.
References: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naïve patient with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1126-1136. 3. Mease PJ, Ritchlin CT, Coates LC, et al. Inhibition of structural damage progression with guselkumab, a selective IL-23i, in participants with active PsA: results through Week 24 of the phase 3b, randomized, double-blind, placebo-controlled APEX study. Oral presentation at: European Alliance of Associations for Rheumatology (EULAR) 2025 Congress; June 11-14, 2025; Barcelona, Spain. 4. Mease PJ, Ritchlin CT, Coates LC, et al. Inhibition of structural damage progression with guselkumab, a selective IL-23i, in participants with active PsA: results through Week 24 of the phase 3b, randomized, double-blind, placebo-controlled APEX study. Abstract presented at: European Alliance of Associations for Rheumatology (EULAR) 2025 Congress; June 11-14, 2025; Barcelona, Spain. Late-Breaking Abstracts Session II. 5. Deodhar A, Helliwell PS, Boehncke W-H, et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naïve or had previously received TNFα inhibitor treatment (DISCOVER 1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1115-1125. 6. Ritchlin CT, Coates LC, Mease PJ, et al. The effect of guselkumab on inhibiting radiographic progression in patients with active psoriatic arthritis: study protocol for APEX, a phase 3b, multicenter, randomized, double-blind, placebo-controlled trial. Trials. 2023;24(1):22. 7. A study of guselkumab in participants with active psoriatic arthritis (APEX). ClinicalTrials.gov. Updated October 10, 2025. Accessed October 10, 2025. https://clinicaltrials.gov/ct2/show/NCT04882098
INDICATIONS
TREMFYA® (guselkumab) is indicated for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate to severe plaque psoriasis and who are candidates for systemic therapy or phototherapy.
TREMFYA® is indicated for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis.
TREMFYA® is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
TREMFYA® is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
TREMFYA® is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of TREMFYA®. Some cases required hospitalization. If a serious hypersensitivity reaction occurs, discontinue TREMFYA® and initiate appropriate therapy.
Infections
TREMFYA® may increase the risk of infection. Treatment with TREMFYA® should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Consider the risks and benefits of treatment prior to prescribing TREMFYA® in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving TREMFYA® to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and discontinue TREMFYA® until the infection resolves.
Tuberculosis (TB)
Evaluate patients for TB infection prior to initiating TREMFYA® treatment. Do not administer TREMFYA® to patients with active TB infection. Initiate treatment of latent TB prior to administering TREMFYA®. Consider anti-TB therapy prior to initiating TREMFYA® in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor all patients for signs and symptoms of active TB during and after TREMFYA® treatment.
Hepatotoxicity
A serious adverse reaction of drug-induced liver injury was reported in a clinical trial subject with Crohn’s disease following three doses of a higher than recommended induction regimen.
In patients with Crohn’s disease or ulcerative colitis, evaluate liver enzymes and bilirubin at baseline, for at least 16 weeks of treatment, and periodically thereafter according to routine patient management. In patients with plaque psoriasis or psoriatic arthritis, if clinically indicated, evaluate liver enzymes and bilirubin at baseline, and periodically thereafter according to routine patient management.
Consider other treatment options in patients with evidence of acute liver disease or cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.
Immunizations
Prior to initiating TREMFYA®, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid use of live vaccines in patients treated with TREMFYA®.
ADVERSE REACTIONS
Most common adverse reactions associated with TREMFYA® include: plaque psoriasis and psoriatic arthritis adverse reactions (≥1%): upper respiratory infections, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections. Ulcerative colitis adverse reactions (≥3%): injection site reactions, arthralgia, upper respiratory tract infections, headache, gastroenteritis, fatigue, pyrexia, and rash. Crohn’s disease adverse reactions (≥3%): respiratory tract infections, abdominal pain, injection site reactions, headache, fatigue, arthralgia, diarrhea, and gastroenteritis.
The safety profile observed in pediatric patients 6 years of age and older treated with TREMFYA® up to 52 weeks was consistent with the safety profile observed in adult patients with moderate to severe plaque psoriasis.
The overall safety profile observed in adult patients with psoriatic arthritis is generally consistent with the safety profile in adult patients with plaque psoriasis, with the addition of bronchitis and neutrophil count decreased.
Please read the full Prescribing Information and Medication Guide for TREMFYA®. Provide the Medication Guide to your patients and encourage discussion.
Dosage Forms and Strengths: TREMFYA® is available as 100 mg/mL and 200 mg/2 mL for subcutaneous injection and as a 200 mg/20 mL
(10 mg/mL) single-dose vial for intravenous infusion.
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