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Prescribing Information

ACR20=20% improvement in American College of Rheumatology composite measures of arthritis; ANCOVA=analysis of covariance; CMH=Cochran-Mantel-Haenszel; IGA=Investigator's Global Assessment; IGA 0/1=proportion of patients who achieved an IGA score of cleared (0) or minimal (1) using a 5-point scale where psoriatic lesions are graded by the investigator for induration, erythema, and scaling on a scale of 0 to 4: cleared, except for discoloration (0), minimal (1), mild (2), moderate (3), or severe (4); IL-23=interleukin 23; IL-23i=interleukin-23 inhibitor; LS=least squares; mFAS=modified full analysis set; mvdH-S=modified van der Heijde-Sharp; ND/MD=natural disaster/major disruption; NRI=nonresponder imputation; PASI 90=proportion of patients who achieved 90% or more reduction (or improvement) in Psoriasis Area and Severity Index (PASI) score from baseline.

IIThe 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.

#LS mean change from baseline in total PsA-mvdH-S score.

**Statistics are based on ANCOVA. Missing data and data impacted by ND/MD were imputed using multiple imputation.

††The 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.

Go beyond the skin.* Proven to preserve the joint.†

*TREMFYA® was approved in 2017 for use in adult patients with moderate to severe plaque psoriasis, and was approved in 2020 for use in adult
patients with active psoriatic arthritis.

Proven skin clearance in PsO and joint preservation in PsA

At Week 16 in adult patients with moderate to severe plaque PsO:
VOYAGE co-primary endpoints (NRI): VOYAGE 1—PASI 90: TREMFYA® 73% (241/329) vs placebo 3% (5/174) (P<0.001); IGA 0/1: TREMFYA® 85% (280/329) vs placebo 7% (12/174) (P<0.001); VOYAGE 2—PASI 90: TREMFYA® 70% (347/496) vs placebo 2% (6/248) (P<0.001); IGA 0/1: TREMFYA® 84% (417/496) vs placebo 8% (21/248) (P<0.001).1,5,6

†At Week 24 in adult patients with active PsA:
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).2-4‡§||

See skin clearance data

See structural damage data

Safety demonstrated across PsO and PsA

TREMFYA® has a proven safety profile across psoriatic disease with 5 years of data in adult patients with moderate to severe plaque PsO and 2 years of data in adult patients with active PsA.7,8

If clinically indicated, evaluate liver enzymes and bilirubin at baseline, and periodically thereafter according to routine patient management.1

See safety profile

Only# fully human, dual-acting** IL-23i to target the source of inflammation

Selective IL-23 inhibitors like TREMFYA® block IL-23 and regulate IL-17A/F and IL-22 cytokines.1††

TREMFYA® is the only# selective, dual-acting** IL-23 inhibitor designed also to neutralize inflammation at its cellular source by binding to CD64.9††‡‡

#"Only" based on approved IL-23 inhibitors for active PsA as of June 2026.

**Dual-acting is defined as blocking IL-23 and binding to CD64.

††The clinical significance is unknown.

‡‡Findings are limited to in vitro studies.

See MOA details

Outstanding§§ access

Once you've made the decision to prescribe, TREMFYA® has access and support you can count on.

TREMFYA® has nearlyIIII 100% commercial coverage and preferred¶¶ coverage for >90% Medicare Part D lives.

Source: Managed Markets Insight & Technology, LLCTM, a trademark of MMIT, as of April 2026. Collected as of 04/26 and may change. These percentages may not represent 100% of formulary lives due to data limitations.

See access

CD64=cluster of differentiation 64; IGA=Investigator's Global Assessment; IL-17A=interleukin-17A; IL-17F=interleukin-17F; IL-22=interleukin 22; IL-23=interleukin 23; MOA=mechanism of action.

‡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.

||The 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.

2 years represents Week 112.

§§”Outstanding” means >90% number of covered lives.

||||“Nearly” means absolute difference less than +/- 2% of the actual number. Within 2% of the access being stated.

¶¶“Preferred” means TREMFYA® can be accessed first-line (ie, step therapy is not required) and its formulary status is better than or equivalent to other products in the class.

References: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. 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. 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. Abstract presented at: European Alliance of Associations for Rheumatology (EULAR) 2025 Congress; June 11-14, 2025; Barcelona, Spain. Late-Breaking Abstracts Session II. 4. Mease PJ, Ritchlin CT, Coates LC, et al. Inhibition of structural damage progression with the selective interleukin-23 inhibitor guselkumab in participants with active PsA: results through week 24 of the phase 3b, randomised, double-blind, placebo-controlled APEX study. Ann Rheum Dis. 2025;84(12):1983-1994. 5. Blauvelt A, Papp KA, Griffiths CEM, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76(3):405-417. 6. Reich K, Armstrong AW, Foley P, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017;76(3):418-431. 7. Data on file. Janssen Biotech, Inc. 8. McInnes IB, Rahman P, Gottlieb AB, et al. Long-term efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through two years: results from a phase III, randomized, double-blind, placebo-controlled study conducted in biologic-naïve patients with active psoriatic arthritis. Arthritis Rheumatol. 2022;74(3):475-485. 9. Krueger J, Eyerich K, Greving C, et al. Differentiation of therapeutic antibodies targeting IL-23. Poster presented at: 2022 Society for Investigative Dermatology; May 18-21, 2022; Portland, OR.

See results across patient types