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I AM A:
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    • RHEUMATOLOGY SPECIALIST
    • DERMATOLOGY SPECIALIST
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A SUPPORT PROGRAM THAT PARTNERS PATIENTS WITH A DEDICATED TREMFYA withMe GUIDE*†

*Eligible patients over 18 with a prescription for approved on-label use. Eligibility criteria for some program components may vary.

†Guides do not provide medical advice. Please ask your doctor any questions you might have about your disease and treatment.

PARTNERING PATIENTS WITH DEDICATED SUPPORT

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Learn more about how TREMFYA withMe Guides can help make it easier for patients as they begin, and continue, their TREMFYA® treatment journey.*†

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Answer questions about prescription fulfillment and cost support

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Help with treatment expectations

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Connect patients to injection support

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Provide regular updates and reminders at patient’s request

*Eligible patients over 18 with a prescription for approved on-label use. Eligibility criteria for some program components may vary.

†Guides do not provide medical advice. Please ask your doctor any questions you might have about your disease and treatment.

For more information, visit tremfyawithme.com 

 
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  1. Medical Information Center

Medical Information Center

Thank you for your interest in contacting Janssen Biotech, Inc.  Please note that we can only provide information about products marketed within the United States, and must refer international inquiries to our affiliates. For additional information, please contact Janssen Medical Information by using one of the following methods:

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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 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.

cp-82625v3

 

INDICATIONS

TREMFYA® is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

TREMFYA® is indicated for the treatment of adults with active psoriatic arthritis.

DOSAGE AND ADMINISTRATION

TREMFYA® is administered as a 100 mg subcutaneous injection once every 8 weeks, after starter doses at weeks 0 and 4. In active psoriatic arthritis, TREMFYA® may be administered alone or in combination with a cDMARD (e.g., methotrexate).

TREMFYA® is intended for use under the guidance and supervision of a physician. Patients may self-inject with TREMFYA® after physician approval and proper training.

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© Janssen Biotech, Inc. 2021. All rights reserved.

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This site is published by Janssen Biotech, Inc., which is solely responsible for its contents. This site is intended for use by healthcare professionals of the United States and Puerto Rico. Janssen Biotech, Inc., recognizes that the Internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico.

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Last Updated January 2022

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© Janssen Biotech, Inc. 2021. All rights reserved.

cp-137947v4

This site is published by Janssen Biotech, Inc., which is solely responsible for its contents. This site is intended for use by healthcare professionals of the United States and Puerto Rico. Janssen Biotech, Inc., recognizes that the Internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico.

Third party trademarks used herein are trademarks of their respective owners.

Legal Notice | Privacy Policy | Medical Information Center  

Do not sell my personal information

Last Updated January 2022

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DISCOVER 1 AND 
DISCOVER 2 
STUDY DESIGNS

Phase 3 Multicenter, Double-blind Trials1,2

DISCOVER 1 and DISCOVER 2 were 2 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 criteria) 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 were permitted, but not required. The primary endpoint in both DISCOVER 1 and DISCOVER 2 was ACR20 response at Week 24.

Selected Inclusion and Exclusion Criteria
DISCOVER 11
  • >18 years of age
  • Active PsA (swollen/tender joints ≥3, C-reactive protein [CRP] ≥0.3 mg/dL) for at least 6 months
  • Biologic experience: ≤2 tumor necrosis factor (TNFα) inhibitors (31%)
  • Patients with other inflammatory diseases and those who had previously received Janus kinase (JAK) inhibitors or biologics other than TNFα inhibitors were excluded
DISCOVER 22
  • >18 years of age
  • Active PsA (swollen/tender joints ≥5, CRP ≥0.6 mg/dL) for at least 6 months
  • No prior biologic experience
  • Previous exposure to biologics or JAK inhibitors precluded participation

*In DISCOVER 1, 128 patients and in DISCOVER 2, 245 patients were randomized to a q4w dosing regimen. TREMFYA® dosed every 4 weeks is not an FDA-approved dosing regimen.
†After Week 24, patients and doctors knew that all patients were on TREMFYA® (open label with a blinded dosing interval), which may have affected the results.
‡At Week 24 patients taking placebo crossed over to receive TREMFYA® 100 mg at Week 24, then every 4 weeks thereafter.
§At Week 16, subjects in all treatment groups who had <5% improvement from baseline in both swollen and tender joint counts were considered as meeting early escape criteria and were allowed to initiate or increase the dose of one of the permitted concomitant medications up to the maximum dose allowed.

References: 1. Deodhar A, Helliwell PS, Boehncke WH, 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. 2. Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naïve patients with active psoriatic arthritis (DISCOVER 2): a double-blind, randomized, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1126-1136.

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VOYAGE 1 AND VOYAGE 2 STUDY DESIGNS

PHASE 3 Multicenter, Double-blind Trials1,2

PATIENT ELIGIBILITY
  • ≥18 years of age
  • Moderate to severe plaque psoriasis (IGA score ≥3; PASI score ≥12, BSA involvement ≥10%) for at least 6 months
  • Candidates for phototherapy and/or systemic treatment
VOYAGE 1 (n=837)1,2,4

VOYAGE 2 (n=992)1,3,4

Before Week 48, patients who discontinued study agent because of lack of efficacy or an adverse event (AE) of psoriasis worsening, or who started a protocol-prohibited medication including conventional and biologic systemic therapy, phototherapy, and/or topical therapies for psoriasis were considered nonresponders (binary endpoints). Other patients with missing data were considered nonresponders for binary endpoints and nonresponder imputation (NRI) was applied. After Week 48, with the exception of ultra–high-potency corticosteroids, other topical agents for psoriasis were permitted.

*After Week 48, an open-label treatment period began where patients initially randomized to TREMFYA® or placebo at Week 0 continued to receive TREMFYA® 100 mg q8w at Week 52 through the extension period. Patients initially randomized to Humira® entered a washout period after their final dose of Humira® at Week 47 and initiated TREMFYA® I00 mg at Week 52 and then q8w thereafter.

†After Week 48, patients who discontinued study agent due to lack of efficacy or an AE or worsening of psoriasis, or who started a protocol-prohibited medication including conventional and biologic systemic therapy, phototherapy, and/or ultra–high-potency corticosteroids were considered treatment failures. Other topical agents for psoriasis were permitted.

‡At Week 28, patients treated with TREMFYA® achieving PASI 90 (responders) were re-randomized in a 1:1 ratio to continue TREMFYA® 100 mg q8w or placebo. Patients treated with placebo were re-treated with TREMFYA® and received another dose 4 weeks later, then q8w thereafter upon loss of 50% or more of Week 28 PASI response. TREMFYA® nonresponders continued TREMFYA® treatment.

§PlaceboTREMFYA® responders received placebo q8w beginning at Week 28. Upon loss of ≥50% Week 28 PASI response, patients were re-treated with TREMFYA®, another dose 4 weeks later, then q8w thereafter. PlaceboTREMFYA® nonresponders at Week 28 continued TREMFYA® q8w.

‖Humira® responders received placebo and upon loss of 50% or more of Week 28 PASI response, initiated TREMFYA®, then received another dose 4 weeks later, then q8w thereafter. Humira® nonresponders initiated TREMFYA® at Week 28, then received another dose 4 weeks later, then q8w thereafter.

References: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. 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. 3. 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. 4. Data on file. Janssen Biotech, Inc.