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TREMFYA® IS INDICATED FOR ADULT PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS (PsO) WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY
For patients who suffer from ITCHING, STINGING, AND BURNING PLAQUES, help them...
In VOYAGE 1 and VOYAGE 2 at Week 16, the majority of patients with moderate to severe plaque PsO achieved the co-primary endpoints of PASI 90 and IGA 0/1. Patients had greater improvements in symptoms of psoriasis (itch, pain, stinging, burning, and skin tightness) compared to placebo as measured by the Psoriasis Symptoms and Signs Diary (PSSD).1-3
PASI=Psoriasis Area and Severity Index; IGA=Investigator's Global Assessment.
Click the pivotal studies button above to explore more about the TREMFYA® story for moderate to severe plaque psoriasis.
Click on the PIVOTAL STUDIES pillar to explore the TREMFYA® story for moderate to severe plaque psoriasis or the ACTIVE PsA pillar to explore the TREMFYA® story for active PsA.
IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PsO WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY
IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PsO WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY
FOR THE TREATMENT OF ADULTS WITH MODERATE TO SEVERE PLAQUE PsO WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY
FOR TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)
VOYAGE 1/VOYAGE 2
Based on the results of an analysis of 101 global sites from VOYAGE 1 and 115 global sites from VOYAGE 2 (including North American sites [ie, United States and Canada]).
Nonresponder imputation (NRI) methods were used for analysis.
NRI methods were used for analysis.
†US-licensed adalimumab.
‡Subjects from sites in the United States and Canada.
Humira is a registered trademark of AbbVie Inc.
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 111, 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 Ill, 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.
VOYAGE 1
Patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may increase the response rate in an as-observed analysis.
Data shown include patients randomized at Week 0 to TREMFYA® arm and placebo arm patients who crossed over to receive TREMFYA® at Weeks 16, 20, and q8w thereafter.
†The same patients may not have responded at each time point.
TFR methods: Patients who discontinued study agent due to lack of efficacy or an adverse event of 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.
Based on the results of an analysis of 101 global sites from VOYAGE 1 (including North American sites [ie, United States and Canada]).
*Year 5 represents Week 252.
‡Available data at each visit were used; missing data were not included in the analysis.
Reference: 1. Data on file. Janssen Biotech, Inc.
ECLIPSE TRIAL
- PASI 75: TREMFYA® 89% (477/534), Cosentyx® 92% (471/514)
- IGA 0/1: TREMFYA® 86% (457/534), Cosentyx® 86% (444/514)
Due to the results of the step-down approach to control for multiple testing, the nominal P value for PASI 75 at Week 12 is not presented and efficacy comparisons cannot be made.
IGA 0/1 at Week 12 was a prespecified exploratory endpoint that was not adjusted for multiplicity; P value was considered nominal.
Results based on ECLIPSE: a single study of TREMFYA® vs Cosentyx®.
Nonresponder imputation (NRI) methods were used for analysis.
There were no new safety findings observed for either TREMFYA® or Cosentyx® in this study.
References: 1. Data on file. Janssen Biotech, Inc. 2. Reich K, Armstrong AW, Langley RG, et al. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet. 2019;
394(10201):831-839.
394(10201):831-839.
DISCOVER 1/DISCOVER 2
†Through Week 24, patients were considered to be nonresponders after meeting treatment failure criteria: discontinued study agent due to any reason, terminated study participation for any reason, initiated or increased the dose of 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.
‡Patients with missing data were considered to be nonresponders.
References: 1. Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER 2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;20(30263):1-11. 2. Deodhar A, Helliwell PS, Boehncke WH, et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFα inhibitor treatment (DISCOVER 1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;20(30265):1-11.
IN ADULTS WITH MODERATE TO SEVERE PLAQUE PsO
TREMFYA®: ESTABLISHED SAFETY PROFILE THROUGH 5 YEARS
In clinical trials, 1823 patients with moderate to severe plaque psoriasis received TREMFYA®. Of these, 1393 were exposed to TREMFYA® for at least 6 months and 728 were exposed for at least 1 year.1
IN THE 16-WEEK, PLACEBO-CONTROLLED PERIOD OF THE VOYAGE 1 AND VOYAGE 2 POOLED CLINICAL TRIALS:
- In clinical trials, infections occurred in 23% of patients in the TREMFYA® group vs 21% of patients in the placebo group through 16 weeks of treatment. The rate of serious infections for the TREMFYA® group and the placebo group was ≤0.2%. A similar risk of infection was seen in the placebo-controlled trials in patients with psoriatic arthritis
- The most common (≥1%) infections were upper respiratory infections, gastroenteritis, tinea infections, and herpes simplex infections; all cases were mild to moderate in severity and did not lead to discontinuation of TREMFYA®
IN THE 24-WEEK PLACEBO-CONTROLLED PERIOD OF THE COMBINED DISCOVER 1 AND DISCOVER 2 CLINICAL TRIALS1:
-
The overall safety profile observed in patients with psoriatic arthritis treated with TREMFYA® is generally consistent with the safety profile in patients with plaque psoriasis, with the addition of bronchitis and neutrophil count decrease. In the 24-week, placebo-controlled period combined across the 2 studies:
- Bronchitis occurred in 1.6% of patients in the TREMFYA® q8w group and in 1.1% of patients in the placebo group
- Neutrophil count decreased occurred in 0.3% of patients in the TREMFYA® q8w group compared with 0% of patients in the placebo group. The majority of events of neutrophil count decreased were mild, transient, not associated with infection, and did not lead to discontinuation
TREMFYA® is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients. Warnings and precautions include hypersensitivity, infections, TB, and immunizations.
NO LABELED WARNINGS OR PRECAUTIONS FOR MALIGNANCY OR INFLAMMATORY BOWEL DISEASE.1
Initially evaluate for TB and monitor patients for signs and symptoms of TB infection during and after treatment.
NO ROUTINE LAB MONITORING REQUIRED
DURING TREATMENT.
References: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.
AFTER CONSIDERING THE EFFICACY AND SAFETY OF TREMFYA® FOR YOUR ADULT PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY
NATIONALLY, 9 OUT OF 10 COMMERCIALLY INSURED PATIENTS HAVE FIRST-LINE, PREFERRED* ACCESS TO TREMFYA®
National, Preferred, First-line Formulary Coverage for TREMFYA®
The information provided does not imply comparable safety or efficacy between products and only represents access information. Indicated trademarks are the registered trademarks of their respective owners. Please refer to each product’s Prescribing Information for indication(s), recommended dosing, and administration.
IL=interleukin.
*“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.
†“Best-in-class” means the number of first-line covered lives is greater for TREMFYA® than for other products in the IL-23 inhibitor class [Skyrizi® (risankizumab-rzaa), Ilumya® (tildrakizumab-asmn)].
‡“Superior” means the number of first-line covered lives is at least 10% greater for TREMFYA® than for products in the IL-17 inhibitor class [Cosentyx® (secukinumab), Taltz® (ixekizumab), Siliq® (brodalumab)].
Collected in February 2022 and is subject to change. This information does not provide advice or guarantee coverage or payment. Legal requirements and plan information can be updated frequently. We strongly recommend contacting the plan for more information about current coverage, restrictions, or prerequisites that may apply.
This may not represent 100% of formulary lives due to data limitations.
Source: Managed Markets Insight and Technology, LLC™, a trademark of MMIT, as of February 2022.
Visit TremfyaBioCoordiNATION.com to access the Commercial Formulary Coverage tool to look up preferred first-line access to TREMFYA® for your local area.
When commercial insurance coverage is delayed >5 business days or denied, Janssen Link offers eligible patients TREMFYA® (guselkumab) at no cost until their commercial insurance covers the medication. See program requirements at JanssenCarePath.com/Tremfya/Janssen-Link.