Stelara (Ustekinumab) Side Effects, Cost, Dosage, Prescribing Information (Label) for Psoriasis | Sayeda Masruh, PharmD Intern | RxEconsult

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Stelara (ustekinumab) Side Effects, Cost, Dosage, Prescribing Information for Plaque Psoriasis and Psoriatic Arthritis Category: Dermatology by - February 7, 2015 | Views: 66913 | Likes: 2 | Comment: 0  

Stelara for plaque psoriasis and psoriatic arthritis

Brand Name:  Stelara
Generic Name: ustekinumab

Medication Class: Interleukin Antagonist
Manufacturer: Janssen Biotech
FDA Approval Date: September 25, 2009
Similar Drugs: Humira (adalimumab), Enbrel (etanercept), Actemra (Tocilizumab), Cosentyx (secukinumab)

What is Stelara and how does it works?

Stelara is an injectable biologic drug which affects the immune system. The active compound in Stelara is called ustekinumab. Stelara is used for the treatment of plaque psoriasis and psoriatic arthritis in adults. Plaque psoriasis is a chronic genetically inherited inflammatory condition that is caused by excessive production of skin cells. The disease is characterized by raised palpable patches of red skin, covered with silvery scales which are itchy and painful. In the USA, about 7 million people suffer from plaque psoriasis and up to 30% of people with psoriasis can develop psoriatic arthritis. Joint pain, stiffness and swelling are the main symptoms of psoriatic arthritis.

Stelara is a human monoclonal antibody which binds selectively to two cytokines called interleukin 12 (IL 12) and interleukin 23 (IL 23). Cytokines are naturally occurring proteins involved in immune reactions. These two cytokines cause an activation of T lymphocytes (white blood cells) that trigger inflammation of the skin which results in psoriasis. Stelara reduces symptoms of psoriasis such as inflammation and excessive production of skin cells by attaching to IL-12 and IL-23 thus preventing them from activating T-lymphocytes.

What does Stelara treat?

Stelara is approved for the treatment of patients 18 years or older with:

  • moderate to severe plaque psoriasis in patients eligible for treatment with phototherapy or systemic therapy (medication absorbed into the body)
  • Stelara can be used as monotherapy or in combination with methotrexate (MTX) to treat psoriatic arthritis

How effective is Stelara?


The efficacy of Stelara for treating psoriasis was evaluated in two randomized, double blind and placebo controlled studies. A total of 1996 patients 18 years of age and older with plaque psoriasis that involved a minimum body surface area of 10%, Psoriasis Area and Severity Index (PASI) score ≥12, and who were eligible for phototherapy or systemic therapy were included in the studies. Patients were randomized in equal groups to placebo or 45 mg or 90 mg of Stelara. 

The efficacy parameters in both studies were the proportion of subjects who achieved at least a 75% reduction in PASI score (PASI 75) from beginning of the study to Week 12 and treatment success was evaluated on the Physician’s Global Assessment (PGA) scale ranging from 0 to 5.

Study 1:  PASI 75 response was 3% for placebo compared to 67% and 66% for Stelara 45 mg and 90 mg group, respectively.

Study 2: PASI 75 response was 4% for placebo compared to 67% and 76% for Stelara 45 mg and 90 mg group, respectively.

Treatment success (PGA of cleared or minimal) at week 12 was achieved in 68% and 73% for Stelara 45 mg and 90 mg treated patients, respectively, versus 4% of placebo treated patients.

In these studies similar response rates were found with Stelara 45 mg and 90 mg doses for patients weighing  ≤100 kg, but higher response rates occurred from Stelara 90 mg compared to 45 mg doses when patients weighed >100 kg.

Psoriatic Arthritis Studies

Stelara was evaluated in a double blind, placebo controlled trial with 615 patients (18 years or older) with psoriatic arthritis (swollen joints ≥5 and tender joints≥5) regardless of treatment with NSAID or disease modifying antirheumatic (DMARD) therapy. Patients were randomized to receive Stelara 45 mg, 90 mg, or placebo. Around 50% patients continued their methotrexate (MTX doses).

The efficacy parameter was the percentage of patients obtaining ACR 20 response at Week 24. Higher response rates were observed on ACR 20 with Stelara 45 mg and 90 mg when compared with placebo. ACR 20 response rates were 42%, 50% and 23% with Stelara 45 mg, 90 mg and placebo, respectively. 




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