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Stelara (Ustekinumab) - Summary



STELARA™ is a human IgG1k monoclonal antibody against the p40 subunit of the IL-12 and IL-23 cytokines. Using DNA recombinant technology, STELARA™ is produced in a well characterized recombinant cell line and is purified using standard bio-processing technology. The manufacturing process contains steps for the clearance of viruses. STELARA™ is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. STELARA™ is available as: 45 mg of ustekinumab in 0.5 mL and 90 mg of ustekinumab in 1 mL.

STELARA™ is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

See all Stelara indications & dosage >>


Media Articles Related to Stelara (Ustekinumab)

CHMP Recommends Brodalumab (Kyntheum) for Plaque Psoriasis
Source: Medscape Dermatology Headlines [2017.05.19]
The EMA's CHMP has recommended granting marketing authorization for brodalumab (Kyntheum, LEO Pharma, A/S) for the treatment of adults with moderate to severe plaque psoriasis.
International Approvals

Guselkumab for Moderate-to-Severe Plaque Psoriasis
Source: Medscape Allergy & Clinical Immunology Headlines [2017.05.17]
Guselkumab, an interleukin-23 inhibitor currently in Phase III trials, is a promising new therapy for moderate-to-severe plaque psoriasis. What do we know so far?
Skin Therapy Letter

Adalimumab Effective in Children and Adolescents With Severe Psoriasis
Source: Medscape Orthopaedics Headlines [2017.05.15]
Adalimumab offers benefits over methotrexate in children and adolescents with severe chronic plaque psoriasis, according to a phase 3 trial.
Reuters Health Information

Psoriasis on the face: Symptoms, causes, and treatments
Source: Immune System / Vaccines News From Medical News Today [2017.04.28]
Psoriasis is a chronic autoimmune disease that effects the skin, causing itchy and painful patches to form. Learn more about how it can affect the face.

Can I get a tattoo if I have psoriasis?
Source: Immune System / Vaccines News From Medical News Today [2017.04.27]
Tattoos are common in the United States, but they can pose significant health risks to someone with psoriasis. Find out more in this article.

more news >>

Published Studies Related to Stelara (Ustekinumab)

Update on ustekinumab for the treatment of Crohn's disease. [2014]
Despite the success of antitumor necrosis factor (TNF) therapy in Crohn's disease, there remains a need for biologic therapy that targets other immune pathways of disease... This article reviews the clinical efficacy and safety data of ustekinumab in Crohn's disease in anticipation of the final results of the phase III development program in moderate to severe Crohn's disease.

Efficacy and safety of ustekinumab in Chinese patients with moderate to severe plaque-type psoriasis: results from a phase 3 clinical trial (LOTUS). [2013]
moderate to severe plaque-type psoriasis... CONCLUSIONS: Consistent with results previously reported in global phase 3

An update on the long-term safety experience of ustekinumab: results from the psoriasis clinical development program with up to four years of follow-up. [2012]
severe psoriasis treated for up to four years... CONCLUSION: The safety profile of long-term ustekinumab treatment with up to four

Long-term safety experience of ustekinumab in patients with moderate to severe psoriasis (Part II of II): results from analyses of infections and malignancy from pooled phase II and III clinical trials. [2012]
exposed up to 3 years... CONCLUSIONS: The emerging safety profile of ustekinumab remains favorable and

Efficacy and safety of ustekinumab in Japanese patients with moderate-to-severe plaque-type psoriasis: long-term results from a phase 2/3 clinical trial. [2012]
This phase 2/3, double-blind, placebo-controlled study was designed to assess the safety and efficacy of ustekinumab in Japanese patients with moderate-to-severe plaque-type psoriasis. Overall, 158 patients were randomized to receive ustekinumab 45 or 90 mg at weeks 0, 4, and every 12 weeks, or placebo with cross-over to ustekinumab at week 12...

more studies >>

Clinical Trials Related to Stelara (Ustekinumab)

A Study to Assess the Effect of Ustekinumab (Stelara�) and Etanercept (Enbrel�) in Participants With Moderate to Severe Psoriasis (MK-0000-206) [Completed]
This is a two-part study. The purpose of the pilot study (Part 1) is to optimize the acquisition, handling and shipping procedure for skin biopsies obtained from participants with plaque psoriasis. No treatment will be administered. Part 2 will include 2 cohorts. In Cohort 1, the effects of 16 weeks of treatment with either ustekinumab or etanercept on biomarkers in lesional skin in participants with moderate to severe psoriasis will be evaluated. In Cohort 2, biomarkers of lesional skin from participants with moderate to severe psoriasis who are not treated with biologic therapy will be evaluated over 16 weeks. The primary hypothesis is that treatment with ustekinumab reduces messenger RNA (mRNA) expression of genes in the interleukin 12 (IL-12) pathway that are modulated by interferon gamma (IFN-γ).

A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations [Completed]
The purpose of this study is to evaluate the pharmacokinetic (PK) (blood levels) comparability of 2 different formulations of ustekinumab, 90 milligram per milliliter (mg/mL) liquid in vial (LIV) and 5 mg/mL LIV, following a single intravenous administration of 6 milligram per kilogram (mg/kg) ustekinumab, diluted in saline, in healthy participants.

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis [Not yet recruiting]
The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.

A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS) [Completed]
This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.

Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease [Active, not recruiting]
To determine whether treatment with ustekinumab will alter the ratio of Treg/total CD4+ cells in peripheral blood at day 30 post-hematopoietic cell transplantation (HCT).

more trials >>

Reports of Suspected Stelara (Ustekinumab) Side Effects

Psoriasis (128)Myocardial Infarction (71)Pneumonia (69)Drug Ineffective (67)Headache (60)OFF Label USE (41)Arthralgia (40)Drug Dose Omission (34)Dizziness (34)Psoriatic Arthropathy (34)more >>

Page last updated: 2017-05-19

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