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Adverse events reporting | Prescribing information ( This product is under additional monitoring)

Lasting, consistent relief[1] - Because Life is non-stop

Sustained joint symptom relief proven for 2 years in PsA[1]

Fast[2][3] and sustained complete clearance proven for 2 years in PsA[1]

Most patients who started on TREMFYA® stayed on TREMFYA® long-term[1][4][5]

Durability*, also known as patient retention or drug survival is a combination of efficacy, safety, tolerability and patient satisfaction or preference.

DISCOVER-2 was a Phase 3, double-blind, multi-centre, placebo-controlled study that evaluated the efficacy and safety of TREMFYA® in bio-naive patients with active PsA.[1]

TREMFYA® is the first IL-23 inhibitor approved for both PsA and PsO in Europe[6]

Image (required) people-1approved-in-psoriatic-arthritis
TREMFYA® is indicated in psoriatic arthritis and psoriasis[6]

TREMFYA®, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.[6]

TREMFYA® is indicated for adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy.[6]

Access the TREMFYA® SmPC

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If you would like to watch a video on the role of IL23 in inflammation please visit our medical education hub

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TREMFYA® One-Press: convenient dosing with high levels of patient satisfaction[6][7]

Dosing and administration chart
For PsA patients at high risk for joint damage according to clinical judgement, a dose of 100 mg every 4 weeks may be considered[6]
HCP support materials

Watch videos of key opinion leaders and download details of clinical studies.

Patient support materials

Resources and tools to help you provide your psoriatic arthritis patients with the information they need to understand their disease and treatment.

Medical Education

Keep up to the date with the ongoing events organised by our medical team.

Explore TREMFYA® in psoriasis on Janssen Medical Cloud
Explore TREMFYA® in psoriasis on Janssen Medical Cloud
REACH Downstream Communication Requirements for SVHCs

Article 33 of Regulation (EC) No 1907/2006 REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) As required by Article 33 of REACH, Janssen, the Pharmaceutical Companies of Johnson & Johnson, informs that recipients of our articles are informed when our articles contain Substances of Very High Concern (SVHC) included in the Candidate List of REACH, in a concentration above 0.1 % weight by weight (w/w).

The following REACH SVHCs are present in the device constituent of Janssen products:

Product
Article containing Substance of Very High Concern
Substance of Very High Concern
Product

Tremfya 100 mg solution for injection in pre-filled pen guselkumab

Article containing Substance of Very High Concern

pre-filled pen – mid housing, needle guard and syringe retainer overmold

Substance of Very High Concern

2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)- CAS# 25973-55-1

More information on REACH can be found on the following websites:

Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Healthcare professionals are asked to report any suspected adverse events via: HPRA Pharmacovigilance Website: www.hpra.ie. Adverse events should also be reported to Janssen Sciences Ireland UC on 1800 709 122 or at dsafety@its.jnj.com.

References

McInnes IB, et al. Efficacy and Safety of Guselkumab, a Monoclonal Antibody Specific to the p19-Subunit of Interleukin-23, Through 2 Years: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Study Conducted in Biologic-naïve Patients with Active Psoriatic Arthritis. Presented at Innovations in Dermatology Conference, March 16-20, 2021. Online.
Blauvelt A et al. J Am Acad Dermatol 2017;76(3):405–417.
Mease PJ,et al. Lancet 2020;395:1126-1136.
McInnes IB, Rahman P, Gottlieb AB, Hsia EC, KollmeierAP, Chakravarty SD, et al. Efficacy and safety of guselkumab, an interleukin-23p19-specific monoclonal antibody, through 1 year in biologic-naive psoriatic arthritis patients. Arthritis Rheumatol 2021. Apr;73(4):604-616.
Ritchlin CT, Helliwell PS, Boehncke W- H, et al. Guselkumab, an inhibitor of the IL- 23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic- naïve or TNFα inhibitor- experienced. RMD Open 2021;7:e001457.
FerrisL, et al. J Dermatology Treat 2020 :31;152-159
CP-243578 - February 2022