IN ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)

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

Consistent response rates from dose to dose1

clinical improvement
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 consistency data at 8-week dosing intervals
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dose graph
dose graph

Indicates when TREMFYA® doses were administered. In DISCOVER 2, TREMFYA® doses were administered via prefilled syringe.

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; 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.

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

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 Evaluations: Evaluate patients for tuberculosis (TB) infection, obtain liver enzymes and bilirubin levels (in UC and CD), and complete all age-appropriate vaccinations according to current immunization guidelines.

Monitoring: For signs and symptoms of active TB during and after treatment with TREMFYA®. For the treatment of UC and CD, monitor liver enzymes and bilirubin levels for at least 16 weeks of treatment, and periodically thereafter according to routine patient management.

TREMFYA® is intended for use under the guidance and supervision of a healthcare professional. TREMFYA® may be administered by a healthcare professional, or a patient/caregiver may inject after proper training on correct subcutaneous injection technique.

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

DMARD=disease-modifying antirheumatic drug; NDC=National Drug Code.

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