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IN ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA) OR MODERATE TO SEVERE PLAQUE PSORIASIS (PsO)

TREMFYA® has optimized 8-week dosing and the One-Press patient-controlled injector

TREMFYA® is administered as a 100-mg subcutaneous injection once every 8 weeks, after 2 starter doses at Weeks 0 and 41

Icon of 6, representing the number of injections per year

injections per year*

TREMFYA® (guselkumab) dosing schedule: one 100-mg injection on Day 1, 1 injection 4 weeks later, 1 injection every 8 weeks thereafter
TREMFYA® (guselkumab) dosing schedule: one 100-mg injection on Day 1, 1 injection 4 weeks later, 1 injection every 8 weeks thereafter

Download the full Instructions for Use (IFU)

Watch TREMFYA® injection demonstration

The TREMFYA® 8-week dosing schedule was researched in clinical trials1,2

PsA/PsO dosage forms

  • Prefilled syringe 100 mg/mL (NDC: 57894-640-01)
  • One-Press patient-controlled injector 100 mg/mL (NDC: 57894-640-11)

Pretreatment Evaluation: Evaluate for tuberculosis (TB) infection, evaluate liver enzymes and bilirubin levels (in UC and CD); if clinically indicated, evaluate liver enzymes and bilirubin levels (in PsO and PsA). Complete all age-appropriate vaccinations according to current immunization guidelines.

Monitor: For signs and symptoms of active TB during and after treatment with TREMFYA®. For the treatment of CD or UC, evaluate liver enzymes and bilirubin levels for at least 16 weeks of treatment, and periodically thereafter according to routine patient management. In patients with PsO or PsA, if clinically indicated, evaluate liver enzymes and bilirubin levels periodically according to routine patient management.

TREMFYA® is intended for use under the guidance and supervision of a healthcare professional. After proper training in subcutaneous injection technique, adults may self-inject. Pediatric self-administration is not recommended. Administration of TREMFYA® to pediatric patients should be performed by a healthcare provider or by a caregiver who has received training and demonstrated proper subcutaneous injection technique.

In active PsA, TREMFYA® can be used alone or in combination with a conventional DMARD (eg, methotrexate).

Download the full Instructions for Use (IFU)

Watch TREMFYA® injection demonstration

CD=Crohn's disease; DMARD=disease-modifying antirheumatic drug; NDC=National Drug Code; UC=ulcerative colitis.

*Frequency of maintenance injections for TREMFYA® after the first year.

References: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.

IN ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)

Consistent response rates from dose to dose1

Icon indicating 94% - 99% clinical improvement
Icon indicating 94% - 99% clinical improvement

of patients maintained clinical improvement at each 8-week dosing interval, assessed through Week 52

DISCOVER 2: Maintenance of cDAPSA MCII* at each dosing interval†

TREMFYA® (guselkumab) DISCOVER 2 response rate data at 8-week dosing intervals
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TREMFYA® (guselkumab) DISCOVER 2 response rate data at 8-week dosing intervals

These endpoints were not adjusted for multiplicity. Therefore, statistical significance has not been established.

This post hoc analysis evaluated consistency of improvement at start and end of each 8-week dosing interval in bio-naïve patients (n=248).§

cDAPSA is the sum of 4 domain scores that reflect PsA disease activity: swollen joint count, tender joint count, patient assessment of pain severity, and patient global assessment of arthritis.

cDAPSA=clinical Disease Activity Index for PsA; MCII=minimal clinically important improvements; PsA=psoriatic arthritis; PsO=psoriasis; q8w=every 8 weeks.

*MCII is defined as the smallest change in measurement that signifies an important improvement at the individual patient level.

†The same patients may not have responded at each time interval.

‡After Week 52, efficacy assessments of DISCOVER 2 were scheduled for visits >8 weeks apart.

§Proportion of patients who achieved MCII at previous visit and maintained MCII at the subsequent TREMFYA® q8w dosing visit (eg, achieved at Week 4 and maintained at Week 12). Only patients with available data in the outcome of interest for each pair of visits were included in the analysis of that outcome.

Reference: 1. Mease PJ, Baraliakos X, Chandran V, et al. Effect of guselkumab administered every 8 weeks in patients with active psoriatic arthritis persists between consecutive doses and is durable: post-hoc analysis of a phase 3, randomized, double-blind, placebo-controlled study. Poster presented at European Alliance of Associations for Rheumatology (EULAR) Congress; Milan; June 2-5, 2023.

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