Navigation Links
Ustekinumab Phase 3 data show long-term improvement of chronic plaque psoriasis
Date:2/2/2008

SAN ANTONIO, TX, February 2, 2008 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 bodys 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<0.001 for each comparison versus placebo). Furthermore, 42 percent of patients in the 45 mg ustekinumab dosing group and 37 percent of patients in the 90 mg ustekinumab dosing group achieved PASI 90, or nearly complete clearance of psoriasis, compared with 2 percent of patients receiving placebo (P<0.001). Primary endpoint study findings from PHOENIX 1 were consistent with the week 12 primary endpoint findings reported at the World Congress of Dermatology in October 2007 from another study, 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 2 (PHOENIX 2).

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≤0.001 for 45 mg comparison; P<0.001 for 90 mg comparison). Also at week 40, 66 percent and 73 percent of patients achieved PASI 90 after receiving either 45 mg ustekinumab or 90 mg ustekinumab, respectively, and response rates remained stable through week 52 with continued treatment, compared with 37 percent and 38 percent of patients switched to placebo.

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.


'/>"/>

Contact: Brian Kenney
BKenney1@cntus.jnj.com
215-325-2107
Centocor, Inc.
Source:Eurekalert

Related medicine news :

1. Medarex to Receive Milestone Payment for Submission of Regulatory Applications Requesting Approval of Ustekinumab (CNTO 1275) for Treatment of Psoriasis
2. Promising Phase 3 trial results show biologic therapy ustekinumab significantly improved psoriasis
3. Kiadis Pharma Announces Successful Completion of Rhitol(TM) Phase II Clinical Study
4. Medivation Plans to Initiate Pivotal Confirmatory Phase 3 Trial of Dimebon(TM) for Alzheimers Disease in Second Quarter of 2008
5. MDS Pharma Services Opens Largest Phase I Clinic on U.S. West Coast
6. Immunosyn Announces the Successful Completion of First Phase Proof of Concept Trial in Europe for Treatment of Diabetic Ulcers With Biopharmeceutical SF-1019
7. MAP Pharmaceuticals Reaches Agreement with FDA on Special Protocol Assessment for MAP0004 Phase 3 Clinical Trial in Patients With Migraine
8. Bisexuality not a transitional phase among women, according to new research
9. Cadence Pharmaceuticals Announces Topline Results of Two Phase III Clinical Trials of Acetavance(TM)
10. Kosan Opens TIME-1 Pivotal Phase 3 Trial in Multiple Myeloma
11. Ardea Biosciences Lead NNRTI for HIV, RDEA806, to Enter Phase 2a Proof-of- Concept Clinical Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating to ... of individuals in the United States and Canada wear eyeglasses. Once considered to be ... vision and make a fashion statement. Even celebrities use glasses as a way of ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a Media ... give their videos a whole new perspective by using the title layers in ... Studios. , ProSlice Levels contains over 30 Different presets to choose from. ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women ... diagnosed with endometriosis. These women need a treatment plan to not only alleviate ... that can help for preservation of fertility and ultimately achieving a pregnancy. The ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library ... City Observer , brings up a new, often overlooked aspect of head lice: the parasite’s ... for fumigation is not a common occurrence, but a necessary one in the event that ...
(Date:6/25/2016)... , ... June 25, 2016 , ... As a lifelong ... Cum Laude and his M.D from the David Geffen School of Medicine at UCLA. ... to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... June 23, 2016 Any dentist who has made ... the current process. Many of them do not even offer ... difficulties and high laboratory costs involved. And those who ARE ... at such a high cost that the majority of today,s ... Dr. Parsa Zadeh , founder of Dental Evolutions Inc. ...
(Date:6/23/2016)... , June 23, 2016 Roche (SIX: RO, ... clearance for its Elecsys BRAHMS PCT (procalcitonin) assay as ... or septic shock. With this clearance, Roche is the ... fully integrated solution for sepsis risk assessment and management. ... bacterial infection and PCT levels in blood can aid ...
(Date:6/23/2016)... -- Research and Markets has announced the addition ... to their offering. The ... commercial environment for MedImmune to enter. The US ageing population ... to drive considerable growth for effective anti-influenza medications. The introduction ... considerably, but development is still in its infancy. ...
Breaking Medicine Technology: