Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Ustekinumab Phase 3 data show long-term improvement of chronic plaque psoriasis

05.02.2008
New findings from a second pivotal Phase 3 study show subjects receiving infrequently administered ustekinumab maintained improvement from psoriasis through 1 year

One-year data from a second double-blind, placebo-controlled Phase 3 study showed therapy with ustekinumab given every 12 weeks provided sustained, clinically meaningful improvement in the treatment of moderate to severe plaque psoriasis through one year.

According to findings presented at the Annual Meeting of the American Academy of Dermatology, 87 percent of patients responding to ustekinumab 45 mg maintenance therapy and 91 percent of patients responding to ustekinumab 90 mg maintenance therapy sustained at least a 75 percent improvement in psoriasis through one year, as measured by the Psoriasis Area and Severity Index (PASI 75).

Ustekinumab is a new human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in the body¡¯s regulation of immune responses and that are also believed to play a role in immune-mediated inflammatory disorders, including psoriasis.

In December 2007, Centocor announced that a Biologics License Application (BLA) had been submitted to the U.S. Food and Drug Administration (FDA) and Janssen-Cilag International NV announced its submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA).

¡°These findings show that ustekinumab may control plaque psoriasis with as few as four injections a year,¡± says lead study investigator Kenneth Gordon, MD, associate professor, Feinberg School of Medicine, Northwestern University, and Head of Dermatology, Evanston Northwestern Healthcare, Skokie, IL. ¡°We are encouraged by the results seen in clinical trials to date and the hope that ustekinumab may hold for patients and the dermatology community.¡±

The primary endpoint of the Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis Followed by Long-term Extension (PHOENIX 1) study examined the proportion of patients achieving at least a 75 percent improvement from baseline at week 12. Investigators reported findings from PHOENIX 1 that showed at week 12, after two doses, 67 percent of patients receiving 45 mg ustekinumab and 66 percent of patients receiving 90 mg ustekinumab achieved PASI 75 compared with 3 percent of patients receiving placebo (P
In the PHOENIX 1 study, subjects who received 45 mg or 90 mg of ustekinumab and consistently achieved a 75 percent improvement from baseline were randomized at week 40 to either continue treatment or switch to placebo, with levels of response to maintenance therapy measured at week 52. Of those patients who continued treatment with ustekinumab 45 mg and ustekinumab 90 mg dosing, 87 percent and 91 percent, respectively, had a sustained PASI 75 response compared with 64 percent and 62 percent of patients switched to placebo (P¡Ü0.001 for 45 mg comparison; P

¡°The Phase 3 efficacy and safety data for ustekinumab are extremely promising and offer hope to a patient population in need of additional therapeutic options,¡± says Kim Papp, MD, PhD, Probity Medical Research, Waterloo, Ontario, and lead study investigator.

About the PHOENIX 1 Trial

PHOENIX 1 evaluated the efficacy and safety of ustekinumab in the treatment of 766 patients with chronic plaque psoriasis. Patients were randomized to receive subcutaneously administered ustekinumab or placebo. Patients randomized to receive ustekinumab received 45 mg or 90 mg doses at weeks 0 and 4 followed by the same dose every 12 weeks. Patients in the placebo group crossed over to receive either 45 mg or 90 mg doses of ustekinumab at weeks 12 and 16 and every 12 weeks thereafter. The primary endpoint of the study was the proportion of patients achieving PASI 75 at week 12. Patients responding to ustekinumab through week 40 were randomized to either continue treatment with ustekinumab or were switched to placebo.

Through week 12 (the placebo-controlled portion of the study) the percentages of study participants experiencing at least one adverse event (AE) were comparable between the placebo group (48 percent) and the ustekinumab 45 mg group (57 percent) and 90 mg group (51 percent). Those patients experiencing at least one serious AE were reported as follows: 1 percent and 2 percent of patients receiving 45 mg or 90 mg ustekinumab, respectively, compared with 2 percent of patients receiving placebo. After the randomization at week 40, 46 percent and 49 percent of patients continuing treatment with 45 mg and 90 mg ustekinumab, respectively, experienced at least one AE, compared with 56 and 48 percent of patients switched to placebo. Serious AEs were observed in 0 and 1 percent of patients continuing treatment with 45 mg and 90 mg ustekinumab, compared with 0 and 2 percent of patients switched to placebo.

Brian Kenney | EurekAlert!
Further information:
http://www.psoriasis.org/about/stats

More articles from Studies and Analyses:

nachricht Smart Data Transformation – Surfing the Big Wave
02.12.2016 | Fraunhofer-Institut für Angewandte Informationstechnik FIT

nachricht Climate change could outpace EPA Lake Champlain protections
18.11.2016 | University of Vermont

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Novel silicon etching technique crafts 3-D gradient refractive index micro-optics

A multi-institutional research collaboration has created a novel approach for fabricating three-dimensional micro-optics through the shape-defined formation of porous silicon (PSi), with broad impacts in integrated optoelectronics, imaging, and photovoltaics.

Working with colleagues at Stanford and The Dow Chemical Company, researchers at the University of Illinois at Urbana-Champaign fabricated 3-D birefringent...

Im Focus: Quantum Particles Form Droplets

In experiments with magnetic atoms conducted at extremely low temperatures, scientists have demonstrated a unique phase of matter: The atoms form a new type of quantum liquid or quantum droplet state. These so called quantum droplets may preserve their form in absence of external confinement because of quantum effects. The joint team of experimental physicists from Innsbruck and theoretical physicists from Hannover report on their findings in the journal Physical Review X.

“Our Quantum droplets are in the gas phase but they still drop like a rock,” explains experimental physicist Francesca Ferlaino when talking about the...

Im Focus: MADMAX: Max Planck Institute for Physics takes up axion research

The Max Planck Institute for Physics (MPP) is opening up a new research field. A workshop from November 21 - 22, 2016 will mark the start of activities for an innovative axion experiment. Axions are still only purely hypothetical particles. Their detection could solve two fundamental problems in particle physics: What dark matter consists of and why it has not yet been possible to directly observe a CP violation for the strong interaction.

The “MADMAX” project is the MPP’s commitment to axion research. Axions are so far only a theoretical prediction and are difficult to detect: on the one hand,...

Im Focus: Molecules change shape when wet

Broadband rotational spectroscopy unravels structural reshaping of isolated molecules in the gas phase to accommodate water

In two recent publications in the Journal of Chemical Physics and in the Journal of Physical Chemistry Letters, researchers around Melanie Schnell from the Max...

Im Focus: Fraunhofer ISE Develops Highly Compact, High Frequency DC/DC Converter for Aviation

The efficiency of power electronic systems is not solely dependent on electrical efficiency but also on weight, for example, in mobile systems. When the weight of relevant components and devices in airplanes, for instance, is reduced, fuel savings can be achieved and correspondingly greenhouse gas emissions decreased. New materials and components based on gallium nitride (GaN) can help to reduce weight and increase the efficiency. With these new materials, power electronic switches can be operated at higher switching frequency, resulting in higher power density and lower material costs.

Researchers at the Fraunhofer Institute for Solar Energy Systems ISE together with partners have investigated how these materials can be used to make power...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

ICTM Conference 2017: Production technology for turbomachine manufacturing of the future

16.11.2016 | Event News

Innovation Day Laser Technology – Laser Additive Manufacturing

01.11.2016 | Event News

#IC2S2: When Social Science meets Computer Science - GESIS will host the IC2S2 conference 2017

14.10.2016 | Event News

 
Latest News

UTSA study describes new minimally invasive device to treat cancer and other illnesses

02.12.2016 | Medical Engineering

Plasma-zapping process could yield trans fat-free soybean oil product

02.12.2016 | Agricultural and Forestry Science

What do Netflix, Google and planetary systems have in common?

02.12.2016 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>