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. Safety data were pooled across four Phase II/III randomized controlled trials. 66 – N 4S1 – p. AB195 – Infection rates in the ustekinumab psoriasis clinical trial program: Update with up to 4 years of follow-up – EMconsulte.
Ustekinumab: 5 Years Of Follow-Up From The Psoriasis Clinical Development Program Including Patients With Psoriatic Arthritis. IL, 4Mount Sinai Medical Center, New York, NY, 5Janssen Research & Development, LLC. Results up to week 16 were presented today at the EADV congress. The primary endpoint of the TRANSIT study was the proportion of patients experiencing at least 1 treatment-emergent adverse event through week 12 in arm 1 versus arm 2. Infection rates in the ustekinumab psoriasis clinical trial program: Update with up to 4 years of follow-up. Poster presented at the European Association of Dermatology & Venereology (EADV) Annual Meeting, Lisbon, October 2011. Concepts about long-term follow-up have evolved as experience with biologic therapies has increased. Today, extension studies often continue for 4 years after completion of a 1-year clinical trial. The principal limitation of the data was short-term follow-up for detection of cancer and determining infection rates. Update on the cumulative safety experi ence of ustekinumab: Result from the ustekinumab psoriasis clinical development program with up to 4 years of follow-up.
Rates of SI in ustekinumab-treated patients per 100-PY were 1.37 (95 CI:0. Infection rates in the ustekinumab psoriasis clinical trial program: Update with up to 4 years of follow-up. 5-year safety analysis representing 8,998 patient-years of follow-up1,6. Cumulative rates of serious infections over time in psoriasis clinical trials1,3. Last updated Feb 15, 2016. The four year safety analysis, which includes the Phase 2, PHOENIX 1, PHOENIX 2 and ACCEPT trials, evaluated a large psoriasis-focused clinical trial safety database. Epidemiology and End Results (SEER) Database.1 Rate of non-fatal myocardial infarction (MI) or stroke was not elevated when compared with the general U. Serious infections have been observed in patients receiving ustekinumab in clinical trials. Ustekinumab Psoriasis Clinical Development Program with Up to 4 Years of Follow-up: Proceeding of the 22nd World Congress of Dermatology; 2011 May 29-29; Seoul, Korea. Follow on Google+ 0.
Long-term Safety Of Ustekinumab: 5 Years Of Follow-up From The Psoriasis Clinical Development Program Including Patients With Psoriatic Arthritis
All topics are updated as new evidence becomes available and our peer review process is complete. The epidemiology, clinical manifestations, and diagnosis of psoriatic skin disease are discussed in detail separately, as are psoriatic arthritis and the management of psoriasis in pregnant women and special populations. Pregnancy is contraindicated for three years following acitretin therapy. In this article, we review large-scale randomized clinical trials addressing the efficacy and safety profile of ustekinumab for the treatment of psoriatic arthritis. Learn about drug side effects and interactions for the drug Stelara Injection (Ustekinumab). 1Surveillance, Epidemiology, and End Results (SEER) Program (www. Updated & New. This release is intended for media in Hong Kong, New Zealand, The Philippines, Singapore and Thailand only. New findings to be presented from pooled analyses of the STELARA (ustekinumab) psoriasis clinical development program showed that the safety profile of STELARA and rates of adverse events remained consistent and stable over time in adults with moderate to severe plaque psoriasis receiving up to four years of treatment. Follow Us. Each pre-filled syringe contains 45 mg ustekinumab in 0.5 ml. In clinical studies, serious bacterial, fungal, and viral infections have been observed in patients receiving STELARA (see section 4. The rate of infection was 0.86 per patient-year of follow-up in ustekinumab-treated patients, and the rate of serious infections was 0. For apremilast (Otezla) and for ustekinumab (Stelara), member is 18 years of age or older. Risk factors for TB include: persons with close contact to people with infectious TB disease; persons who have recently emigrated from areas of the world with high rates of TB (e., Africa, Asia, Eastern Europe, Latin America, and Russia); children less than 5 years of age who have a positive TB test; groups with high rates of TB transmission (e. The author stated that longer follow-up studies and safety databases, for each of the biologicals used in psoriasis, are needed to ensure both prolonged effectiveness and minimal risk of harm.
Infection Rates In The Ustekinumab Psoriasis Clinical Trial Program: Update With Up To 4 Years Of Follow-up
When assessing the disease severity, the following should be recorded:. A large cohort study did not show any increase in cancer (both skin and non-skin malignancies) associated with the past use of topical tar treatments. Keywords: Psoriasis, Biologics, Monoclonal antibodies, Cytokines, Clinical trials, Efficacy, Safety, Quality of life. The pivotal trials evaluated etanercept in 2 well-controlled clinical trials that included more than 1200 patients. The extended trial was calculated to span 3104 patient-years of follow-up, with rates of overall AEs, SAEs, serious infections, malignancies, and major adverse cardiovascular events that were generally consistent over time and comparable between doses.