IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)

TREMFYA^® IS THE FIRST IL-23 INHIBITOR TO INCLUDE FACIT-F IN THE LABEL FOR ACTIVE PsA^1,2

Treatment With TREMFYA^® Resulted in Improvement in Fatigue as Measured by FACIT-F

FACIT-F

DISCOVER 2: MEAN CHANGE FROM BASELINE IN FACIT-F SCORE AT WEEK 24 (NRI)*^†‡

View Study Design

IN DISCOVER 1 AT WEEK 24

The mean change from baseline in FACIT-F score was 5.76 for patients receiving TREMFYA^® q8w (n=127) vs 2.15 for patients receiving placebo (n=126)¹*^†‡

The FACIT-F endpoints in DISCOVER 1 and DISCOVER 2 were not adjusted for multiplicity. Therefore, statistical significance has not been established.

FACIT-Fatigue (FACIT-F) measures a patient's level of fatigue and tiredness over the last 7 days through a questionnaire consisting of 13 questions. Lower scores reflect more severe fatigue.²

FACIT-F=Functional Assessment of Chronic Illness Therapy-Fatigue; NRI=nonresponder imputation.

*Through Week 24, patients were considered to have no improvement (change=0) after meeting treatment failure criteria: discontinued study agent for any reason, terminated study participation for any reason, initiated or increased the dose of disease-modifying antirheumatic drugs (DMARDs) or oral corticosteroids over baseline for PsA, or initiated protocol-prohibited medications/therapies for PsA. After Week 24, treatment failure rules were not applied.

^†Change from baseline, if missing, was considered to have no improvement (change=0) after patients discontinued study treatment due to any reason.

^‡Patients with data missing were considered nonresponders.

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

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 a 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.

Pre-Treatment Evaluation for Tuberculosis (TB)
Evaluate patients for TB infection prior to initiating treatment with TREMFYA^®. Initiate treatment of latent TB prior to administering TREMFYA^®. Monitor patients for signs and symptoms of active TB during and after TREMFYA^® treatment. Do not administer TREMFYA^® to patients with active TB infection.

Immunizations
Prior to initiating TREMFYA^®, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with TREMFYA^®.

ADVERSE REACTIONS
Most common (≥1%) adverse reactions associated with TREMFYA^® include upper respiratory infections, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.

The overall safety profile observed in patients with psoriatic arthritis is generally consistent with the safety profile in 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.

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TREMFYA^® IS THE FIRST IL-23 INHIBITOR TO INCLUDE FACIT-F IN THE LABEL FOR ACTIVE PsA^1,2

IMPORTANT SAFETY INFORMATION

INDICATIONS

DOSAGE AND ADMINISTRATION

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TREMFYA® IS THE FIRST IL-23 INHIBITOR TO INCLUDE FACIT-F IN THE LABEL FOR ACTIVE PsA 1,2

DOSAGE AND ADMINISTRATION

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TREMFYA^® IS THE FIRST IL-23 INHIBITOR TO INCLUDE FACIT-F IN THE LABEL FOR ACTIVE PsA^1,2