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
¡°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!
Physics of bubbles could explain language patterns
25.07.2017 | University of Portsmouth
Obstructing the ‘inner eye’
07.07.2017 | Friedrich-Schiller-Universität Jena
Strong light-matter coupling in these semiconducting tubes may hold the key to electrically pumped lasers
Light-matter quasi-particles can be generated electrically in semiconducting carbon nanotubes. Material scientists and physicists from Heidelberg University...
Fraunhofer IPA has developed a proximity sensor made from silicone and carbon nanotubes (CNT) which detects objects and determines their position. The materials and printing process used mean that the sensor is extremely flexible, economical and can be used for large surfaces. Industry and research partners can use and further develop this innovation straight away.
At first glance, the proximity sensor appears to be nothing special: a thin, elastic layer of silicone onto which black square surfaces are printed, but these...
3-D shape acquisition using water displacement as the shape sensor for the reconstruction of complex objects
A global team of computer scientists and engineers have developed an innovative technique that more completely reconstructs challenging 3D objects. An ancient...
Physicists have developed a new technique that uses electrical voltages to control the electron spin on a chip. The newly-developed method provides protection from spin decay, meaning that the contained information can be maintained and transmitted over comparatively large distances, as has been demonstrated by a team from the University of Basel’s Department of Physics and the Swiss Nanoscience Institute. The results have been published in Physical Review X.
For several years, researchers have been trying to use the spin of an electron to store and transmit information. The spin of each electron is always coupled...
What is the mass of a proton? Scientists from Germany and Japan successfully did an important step towards the most exact knowledge of this fundamental constant. By means of precision measurements on a single proton, they could improve the precision by a factor of three and also correct the existing value.
To determine the mass of a single proton still more accurate – a group of physicists led by Klaus Blaum and Sven Sturm of the Max Planck Institute for Nuclear...
26.07.2017 | Event News
21.07.2017 | Event News
19.07.2017 | Event News
26.07.2017 | Physics and Astronomy
26.07.2017 | Life Sciences
26.07.2017 | Earth Sciences