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A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis

A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis 1

A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis. This study has been completed. Sponsor:. Efficacy and safety of ustekinumab in Chinese patients with moderate to severe plaque-type psoriasis: results from a phase 3 clinical trial (LOTUS). Consistent with results previously reported in global phase 3 studies, ustekinumab was highly effective and generally well tolerated in Chinese patients with moderate to severe psoriasis through 36 weeks. Ustekinumab is a human monoclonal antibody. It is manufactured in the Netherlands. It was found not effective for multiple sclerosis. III trial, ACCEPT, compared the efficacy and safety of ustekinumab with etanercept in the treatment of moderate to severe plaque psoriasis. Three studies were focused on patients with psoriasis, one on psoriatic arthritis, and one on multiple sclerosis.

A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis 2Gov Data_NCT01059773A Safety and Efficacy Study of Ustekinumab in Patients With Plaque Psoriasis Who Have Had an Inadequate Response to MethotrexateClinicalThis purpose of this study is to assess the safety of ustekinumab in psoriasis patients who receive ustekinumab following an inadequate response to methotrexate therapy. AMAGINE-3 is a Phase 3 study that assessed the safety and efficacy of brodalumab given at two doses every two weeks via subcutaneous injection compared with placebo and Stelara in patients with moderate-to-severe plaque psoriasis. AMAGINE-3 Study DesignAMAGINE-3 is a Phase 3 study that assessed the safety and efficacy of brodalumab given at two doses every two weeks via subcutaneous injection compared with placebo and Stelara in patients with moderate-to-severe plaque psoriasis. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. Study endpoints were the proportion of all patients using ustekinumab according to label-recommended intervals and the proportion of Korean patients who achieved a psoriasis area severity index 75 response at week 16.

Prescribing InFormation for Stelara, Janssen Biotech, Horsham, UK, 2012., A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction, British Journal of Dermatology, vol., A randomized, double-blind, placebo-controlled study of ustekinumab in Chinese patients with moderate to severe plaque psoriasis: LOTUS trial results, Journal of Dermatology, vol. In one such recent study, a cohort of 173 patients with psoriasis (409 patient-years of follow-up) on biologics was prospectively followed for 5 years between February 2005 and April 2010. In this cohort, only the safety of the biological therapies was evaluated and deemed favorable with a low incidence of therapy-related SAEs. 60 and 61More recently, a cross-sectional study of 1182 patients with moderate to severe psoriasis in the Dermatology Clinical Effectiveness Research Network in the United States showed highest overall satisfaction scores for patients receiving biological monotherapies, biologic-methotrexate combinations, or phototherapy (83. Ltd, Shanghai, China. In this 52-week, double-blind study (NCT02074982), 676 subjects were randomized 1:1 to subcutaneous injection of secukinumab 300 mg or ustekinumab per label. Ustekinumab (Stelara) package insert, Janssen Biotech, Inc, Horsham, PA (2014).

Efficacy And Cost-efficacy Of Biologic Therapies For Moderate To Severe Psoriasis: A Meta-analysis And Cost-efficacy Analysis Using The Intention-to-treat Principle

A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis 3In January 2009, ustekinumab (Stelara; Janssen Cilag) was granted marketing authorization by the European Commission for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other therapies including cyclosporine, methotrexate and phototherapy. Traditional treatments, such as topical corticosteroids, are generally effective in managing mild psoriasis. Keywords: Crohn’s disease, ustekinumab, clinical trials, inflammatory bowel disease. In particular, patients with psoriasis respond to treatment interfering with lymphocyte activation, the tumor necrosis factor (TNF) pathway, agents blocking interleukin (IL)-17 or the IL-12/23p40 subunit. In January 2009, UST (CNTO 1275, Stelara; Janssen Cilag) was granted marketing authorization by the European Commission for the treatment of moderate to severe chronic plaque psoriasis in adults who failed to respond to, who have a contraindication to or who are intolerant of systemic oral immunosuppressants. 40 replicated the Italian study in Chinese patients with psoriasis. Safety and efficacy of ustekinumab or golimumab in patients with chronic sarcoidosis. Patients with nail psoriasis can develop a wide variety of nail ch. Some studies suggest that psoriatic arthritis is more tightly associated with psoriatic nail involvement than cutaneous psoriasis alone 6. However, because many systemic treatments used for psoriasis and psoriatic arthritis are also effective for nail psoriasis, patients with mild nail psoriasis who receive systemic treatment for other manifestations may experience improvement in nail disease. 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. As for infliximab, randomized, double-blind, placebo-controlled multicenter trials of psoriasis have been conducted in Japan and China. Three phase 3 randomized placebo-controlled studies for ustekinumab have been conducted, PEARL (in Korea and Taiwan), Jpn-02 (in Japan) and LOTUS (in China). Taiwan with a total number of 49 patients participated in the study 15. A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis. Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis.

Efficacy And Cost-efficacy Of Biologic Therapies For Moderate To Severe Psoriasis: A Meta-analysis And Cost-efficacy Analysis Using The Intention-to-treat Principle

Now, a new drug called ustekinumab (Stelara) appears to be more effective than the old standby, etanercept (Enbrel),. For the study, Griffiths and colleagues randomly assigned 903 patients with moderate-to-severe psoriasis to two different doses of Stelara injected 30 days apart or to high-dose Enbrel injections twice a week for 12 weeks. The safety of the two biologics appeared similar, Griffiths said. Navy Commander: South China Sea Not a US-Versus-China Battle. A number of new treatment options for patients with psoriasis and related conditions have been recently approved or are nearing approval for us by the NHS in England and Scotland. In addition, NICE has backed ustekinumab (Stelara) as a treatment option for patients with active psoriatic arthritis, when the response to previous non-biological disease-modifying anti-rheumatic drug therapy has been inadequate. Psoriasis drug suspended by regulators over patient safety concerns. A skin ointment based on a traditional Chinese medicine is effective in treating plaque-type psoriasis, according to a study. Higher Drug Survival Rates in Patients with Psoriasis Utilizing Etanercept Compared to Adalimumab a Nationwide Population-Based Cohort Study in Sweden. Sun Exposure in Mexico: an Observational Study on Population Habits and Knowledge of Risks Associated with Such Exposure. Cost Effectiveness Analysis of Ranibizumab Compared to Aflibercept and Laser Intervention In Treatment of Diabetic Macular Edema (Dme) In The Czech Republic. For The Treatment of Age-Related Macular Degeneration In China.