Media Articles Related to Stelara (Ustekinumab)
New Phase 3 study findings show Stelara maintained clinical remission after one year of treatment in patients with moderate to severe Crohn's disease
Source: Clinical Trials / Drug Trials News From Medical News Today [2016.05.24]
Janssen Research & Development, LLC (Janssen) Phase 3 data presented for the first time at Digestive Disease Week® 2016 showed that a significantly greater proportion of adult patients with...
FDA Panel Backs Approval of Psoriasis Drug Brodalumab
Source: Medscape Allergy & Clinical Immunology Headlines [2016.07.20]
The panelists said that patients should be given proper informed consent about the risk for suicide.
Medscape Medical News
FDA Panel Backs Psoriasis Drug With Caveats
Source: MedPage Today Dermatology [2016.07.20]
(MedPage Today) -- Says suicide risk means brodalumab needs careful management
Valeant Psoriasis Drug's Suicide Risk Hard to Assess -FDA Staff
Source: Medscape Dermatology Headlines [2016.07.18]
Valeant Pharmaceuticals International Inc's experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said on Friday.
Reuters Health Information
Suicide Risk Jeopardizes Promising New Psoriasis Drug
Source: MedPage Today Dermatology [2016.07.16]
(MedPage Today) -- Six completed suicides among brodalumab trial participants
Published Studies Related to Stelara (Ustekinumab)
Update on ustekinumab for the treatment of Crohn's disease. 
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). 
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. 
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. 
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. 
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...
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
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).
Reports of Suspected Stelara (Ustekinumab) Side Effects
Myocardial Infarction (71),
Drug Ineffective (67),
OFF Label USE (41),
Drug Dose Omission (34),
Psoriatic Arthropathy (34), more >>