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Stelara (Ustekinumab) - Summary

 
 



STELARA 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 >>

NEWS HIGHLIGHTS

Media Articles Related to Stelara (Ustekinumab)

Brodalumab Beats Stelara in Psoriasis Trial, Sponsors Say
Source: MedPage Today Dermatology [2014.11.11]
(MedPage Today) -- More patients achieve total plaque clearance in topline results.

CHMP Backs Secukinumab, Apremilast for Psoriasis
Source: Medscape Medical News Headlines [2014.11.21]
The European Medicines Agency committee has recommended secukinumab and apremilast for moderate to severe plaque psoriasis and apremilast for active psoriatic arthritis.
International Approvals

Positive results from second pivotal Phase 3 study of Brodalumab in patients with moderate-to-severe plaque psoriasis announced
Source: Clinical Trials / Drug Trials News From Medical News Today [2014.11.13]
Amgen and AstraZeneca has announced that AMAGINE-3(TM), a pivotal, multi-arm Phase 3 trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis...

New research reveals true impact of psoriasis
Source: Dermatology News From Medical News Today [2014.11.03]
Innovative research published in the latest edition of the British Journal of Dermatology reveals the causes behind the emotional distress experienced by people with psoriasis.

Lesion-healing mechanism identified in psoriasis
Source: Dermatology News From Medical News Today [2014.10.29]
A UC Irvine-led study has revealed the underlying genetic factors that help repair skin lesions caused by psoriasis, which could engender new methods of controlling the lingering condition.Dr.

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Published Studies Related to Stelara (Ustekinumab)

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...

Long-term safety experience of ustekinumab in patients with moderate-to-severe psoriasis (Part I of II): results from analyses of general safety parameters from pooled Phase 2 and 3 clinical trials. [2012]
ustekinumab through 3 years of treatment... CONCLUSIONS: The safety profile of continued ustekinumab exposure through up to 3

Cost-efficacy of adalimumab, etanercept, infliximab and ustekinumab for moderate-to-severe plaque psoriasis. [2011.11.30]
Background Different biological agents are used for the treatment of psoriasis. Previous data have shown adalimumab to be the most efficient drug in terms of cost-efficacy... The robustness of this finding was confirmed by sensitivity analysis.

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Clinical Trials Related to Stelara (Ustekinumab)

A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis [Recruiting]
The purpose of this study is to evaluate the efficacy (good or bad effects) and safety of ustekinumab in the treatment of patients with moderate to severe psoriasis in China.

Safety and Efficacy of Ustekinumab in Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis [Recruiting]
This study will provide data on sasety and efficacy of Ustekinumab in patients suffering from Palmo-Plantar Pustular Psoriasis (PPPP) or Palmo-Plantar Pustulosis(PPP)

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

TRANSIT - A Safety and Efficacy Study of Ustekinumab in Patients With Plaque Psoriasis Who Have Had an Inadequate Response to Methotrexate [Recruiting]
This purpose of this study is to assess the safety of ustekinumab in psoriasis patients who receive ustekinumab following an inadequate response to methotrexate therapy. The study will provide information for doctors on how to manage the transfer from methotrexate to the biologic agent ustekinumab. The study is designed to compare two methods of transferring patients from methotrexate to ustekinumab. The two methods being compared are discontinuation of methotrexate with immediate initiation of ustekinumab versus initiation of ustekinumab with overlap and gradual dose reduction of methotrexate over 4 weeks.

A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid [Recruiting]
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.

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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: 2014-11-21

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