FDA Approves New Biologic Treatment for Psoriasis
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People living with moderate to severe plaque psoriasis have a new treatment option: on July 13, 2017 the U.S. Food and Drug Administration (FDA) approved Tremfya™ (guselkumab) for the treatment of adults with moderate to severe psoriasis who are candidates for systemic therapy or phototherapy. Tremfya is the first biologic therapy approved that selectively blocks interleukin (IL)-23, a cytokine (chemical messenger) that is involved in the inflammatory process of the immune system.1,2

How Tremfya works

Biologics are drugs that have been genetically engineered to act on specific immunological targets. Unlike other immune therapies that have an overall, systemic suppressing effect on the immune system, biologics create far less interference with other biological functions. Common proteins targeted include tumor necrosis factor (TNF) and various interleukins (IL).3

In autoimmune diseases like psoriasis, the inflammatory response is abnormally activated, causing damage to tissues and creating the plaques on the skin. By blocking IL-23, Tremfya interrupts the abnormal inflammatory process.2

What is the evidence that Tremfya works in psoriasis?

The FDA based their approval on the results of three Phase III clinical trials that included more than 2,000 patients. After treatment for 16 weeks, at least seven out of ten patients who were treated with Tremfya saw at least 90% clearer skin, and more than 80% of them experienced cleared or almost cleared skin. The patients who received Tremfya also had improvements in their symptoms of psoriasis, including itch, pain, stinging, burning, and skin tightness.

In some clinical trials, Tremfya was compared to other biologic treatments for psoriasis. After 24 weeks of treatment, more than seven out of ten patients treated with Tremfya experienced at least 90% clearer skin compared to four out of ten patients treated with Humira® (adalimumab). Another trial evaluated the use of Tremfya in people whose psoriasis didn’t respond to Stelara® (ustekinumab). Patients treated with Stelara who didn’t have a good response were randomly chosen to either continue treatment with Stelara or receive Tremfya. After 28 weeks of treatment, 31% of the patients receiving Tremfya were considered cleared or almost cleared of their psoriasis versus 14% of those who continued to receive Stelara.1,2

How is Tremfya given?

Tremfya is delivered as an injection that is given subcutaneously (under the skin) at the beginning of treatment (week 0), again at week 4, and then every 8 weeks from then on. Tremfya comes in a single-dose prefilled syringe that contains 100 mg/mL of guselkumab, the active ingredient.2

What are the possible side effects of Tremfya?

The most common side effects experienced by patients taking Tremfya in clinical trials are upper respiratory infections, headache, pain or irritation at the site of the injection, joint pain, diarrhea, gastroenteritis (inflammation of the stomach and intestines that can cause diarrhea, vomiting, or pain), ear infections, and herpes simplex infections (like cold sores and genital herpes). Because Tremfya works by interrupting the inflammatory response of the immune system, it may increase the risk of infection. Patients should be tested for tuberculosis (TB) before starting treatment with Tremfya.2

How expensive will it be?

Like other biologics, Tremfya will be expensive: its list price will be $9,684 per dose, which comes out to about $58,100 per year. The manufacturer, Janssen Biotech (part of Johnson & Johnson), says it will work with payers, providers, and pharmacy benefit managers to ensure Tremfya is accessible and affordable. They also have a number of patient support programs to reduce an individual’s out-of-pocket expenses.1,4

view references
  1. Johnson & Johnson. Accessed online on 7/14/17 at https://www.jnj.com/media-center/press-releases/janssen-announces-us-fda-approval-of-tremfya-guselkumab-for-the-treatment-of-moderate-to-severe-plaque-psoriasis.
  2. Tremfya prescribing information. Accessed online on 7/14/17 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761061s000lbl.pdf
  3. Gottlieb A, Korman NJ, Gordon KB, Feldman SR, Lebwohl M, Koo JY, Van Voorhees AS, Elmets CA, Leonardi CL, Beutner KR, Bhushan R, Menter A. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol. 2008 May;58(5):851-64.
  4. First Word Pharma. Accessed online on 7/14/17 at https://www.firstwordpharma.com/node/1487938.
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