Tremfya contains the active drug guselkumab. It’s a humanized monoclonal antibody that binds to Interleukin-23 and neutralizes the effect of it ^[1].

IL-23 is a natural cytokine associated with inflammatory and immune responses; guselkumab inhibits the proinflammatory actions of IL-23, thereby reducing the inflammation and swelling associated with it.

Guselkumab can help lessen the red, scaly, itchy patches of skin caused by plaque psoriasis and lessen the pain and swelling in the joints caused by psoriatic arthritis.

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Pharmaceutical forms of Guselkumab (Tremfya)

1. Tremfya 100 mg solution for injection in pre-filled syringe

Each pre-filled syringe contains 100 mg of guselkumab in 1 mL solution.

1. Tremfya 100 mg solution for injection in pre-filled pen

Each pre-filled pen contains 100 mg of guselkumab in 1 mL solution.

 

 

Route of Administration: Subcutaneous route of administration.

 

Purpose/Indications to use Tremfya

Tremfya acts on the immune system (immuno-modulator) and is used to treat the following conditions:

 

Moderate to Severe Plaque Psoriasis

Indicated for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy (treatment using ultraviolet or UV light).

 Psoriasis is the most prevalent autoimmune disorder in the United States, affects approximately 7.5 million people ^[3]. The most common form of psoriasis is plaque psoriasis, in which patients develop thick, red skin with flaky, silver-white scales.

 

Psoriatic Arthritis

Guselkumab (Tremfya), an immune-modulator is also indicated for patients with psoriatic arthritis (inflammation of the joints associated with arthritis) in adults where DMARDs (disease-modifying anti-rheumatic drugs) don’t work sufficiently.

In Psoriatic Arthritis, your immune system (your body’s defense against infections) is overactive. It attacks healthy tissues and cells, causing joint pain and inflammation. It also causes your body to make too many skin cells, leading to a buildup of cells and areas called plaques. These plaques are flushed, itchy patches on your skin.

It is used alone or in combination with methotrexate for active psoriatic arthritis. It improves joint pain and swelling from arthritis and rash from psoriasis.

 

 

Off-Label Use of Guselkumab

Tremfya may be used off-label for the treatment of Crohn’s disease, which is a type of inflammatory bowel disease. Janssen Biotech, Inc., the manufacturer of Tremfya, is currently studying Tremfya in people with Crohn’s disease

 

Manufacturer of Taltz

Tremfya is marketed by Janssen Biotech, Inc.

 

 

Safety and Efficacy Profile

 A main measure of effectiveness was a reduction of at least 90% in PASI scores. PASI is a measure of disease severity and area of skin affected.

The first two studies compared Tremfya with adalimumab (another medicine used for treating psoriasis) and placebo (a dummy treatment). After 16 weeks, about 71% of patients (588 out of 825) receiving Tremfya had a reduction of at least 90% in PASI scores, compared with 48% (282 out of 582) of those receiving adalimumab and under 3% (11 out of 422) receiving placebo.

 

 

Side effects associated with Tremfya

Tremfya is a medicine that affects your immune system. Tremfya may lower the ability of your immune system to fight infections and may increase your risk of infections, which can sometimes become serious.

The most common side effects of TREMFYA are upper respiratory tract infections, headache, injection site reactions, and joint pain.

 

Contraindications

Tremfya is contraindicated in patients with past hypersensitivity reactions to the drug or any components of the formulation. As Tremfya can increase the risk of infection, it must not give to patients with serious infections such as tuberculosis.

 

 

Cost-Effective Analysis of Guselkumab

Guselkumab was less costly but less effective when compared with ixekizumab. The incremental cost per QALY gained for ixekizumab versus guselkumab was $121,255.

 

References

Drug Trials Snapshots: TREMFYA. (n.d.). Retrieved from U.S Food and Drug: https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-tremfya

guselkumab (Rx). (n.d.). Retrieved from Medscape: https://reference.medscape.com/drug/tremfya-guselkumab-1000164#0

Information on the Pharmacoeconomic Submission. (n.d.). Retrieved from NCBI: https://www.ncbi.nlm.nih.gov/books/NBK533390/

Ixekizumab (Taltz). (n.d.). Retrieved from American College of Rheumatology: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Treatments/Ixekizumab-Taltz

Matthew Richard Cawson, S. A. (2015). A systematic review, network meta-analysis and economic evaluation of biological therapy for the management of active psoriatic arthritis. PubMed.Gov, 15-26.

Tremfya. (n.d.). Retrieved from European Medicines Agency: https://www.ema.europa.eu/en/medicines/human/EPAR/tremfya

 

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