STELARA(R) Shows Significant Improvement in Quality of Life in Japanese Psoriasis PatientsBy Janssen Asia Pacific, PRNE
Wednesday, May 25, 2011
SEOUL, South Korea, May 26, 2011 -
- This Media Alert is Intended for Hong Kong, New Zealand, the
Philippines, Singapore and Thailand Only
- New Data Presented at World Congress of Dermatology
New data presented at the World Congress of Dermatology (WCD) have shown
treatment with STELARA(R) significantly improved the health-related quality
of life in Japanese psoriasis patients.
Psoriasis, a chronic, immune-mediated disease that results from the
overproduction of skin cells, affects 125 million people worldwide. The
disease symptoms can range from mild, to moderate, to severe and disabling.
"Psoriasis can have a significant and detrimental effect on a patient's
quality of life," said Dr Alexander Rodríguez Morales MD, Asia Pacific
Medical Affairs Associate Director for Janssen. "These results show that
treatment with STELARA can yield significant and positive results in patients
of Japanese ethnicity."
The impact of treatment with STELARA on health-related quality of life
was observed in a double-blind, placebo-controlled trial through 64 Weeks.
158 patients were randomized to receive STELARA 45 mg (n=64) or 90 mg (n=62)
at Weeks 0 and 4, then every 12 weeks, or placebo (n=32). At Week 12, the
placebo group crossed over to receive STELARA. Of these, 137 patients
completed the study.
Health-related quality of life was assessed using the Dermatology Life
Quality Index (DLQI), Psoriasis Disability Index (PDI), and the Short Form-36
(mental component summary [MCS] and physical component summary [PCS] scores).
At Week 12, patients treated with STELARA had a significantly greater
improvement in baseline DLQI scores, compared to the placebo group, with a
clinically meaningful improvement of 7.4-8.0 points in the STELARA treated
arms (p<0.0001). These results were maintained through Week 64 with
placebo-crossover patients showing a similar response.
Significant improvement in PDI scores was observed through Week 64 in
STELARA treated and placebo-crossover patients.
Clinically meaningful improvements in both the mean SF-36 physical
component summary (PCS) and mental component summary (MCS) scores were
observed through Week 64 for STELARA treated and placebo-crossover patients.
This analysis is one of a number of studies on the treatment of psoriasis
with STELARA being announced at WCD this week.
For more information contact: Ruth Fazakerley, Janssen Asia Pacific,
More information on STELARA can be found at www.stelarainfo.com or
Important Safety Information
STELARA is a prescription medicine that affects your immune system.
STELARA can increase your chance of having serious side effects including:
STELARA may lower your ability to fight infections and may increase your
risk of infections. While taking STELARA, some people have serious
infections, which may require hospitalization, including tuberculosis (TB),
and infections caused by bacteria, fungi, or viruses.
- Your doctor should check you for TB before starting STELARA and watch
you closely for signs and symptoms of TB during treatment with STELARA.
- If your doctor feels that you are at risk for TB, you may be treated
for TB before and during treatment with STELARA.
You should not start taking STELARA if you have any kind of infection
unless your doctor says it is okay.
Before starting STELARA, tell your doctor if you think you have an
infection or have symptoms of an infection such as:
- fever, sweats, or chills
- muscle aches
- shortness of breath
- blood in your phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning when you urinate or urinate more often than normal
- feel very tired
- are being treated for an infection
- get a lot of infections or have infections that keep coming back
- have TB, or have been in close contact with someone who has TB
After starting STELARA, call your doctor right away if you have any
symptoms of an infection (see above).
STELARA can make you more likely to get infections or make an infection
that you have worse. People who have a genetic problem where the body does
not make any of the proteins interleukin 12 (IL-12) and interleukin 23
(IL-23) are at a higher risk for certain serious infections that can spread
throughout the body and cause death. It is not known if people who take
STELARA will get any of these infections because of the effects of STELARA on
STELARA may decrease the activity of your immune system and increase your
risk for certain types of cancer. Tell your doctor if you have ever had any
type of cancer.
Reversible posterior leukoencephalopathy syndrome (RPLS)
RPLS is a rare condition that affects the brain and can cause death. The
cause of RPLS is not known. If RPLS is found early and treated, most people
recover. Tell your doctor right away if you have any new or worsening medical
problems including: headache, seizures, confusion, and vision problems.
Serious Allergic Reactions
Serious allergic reactions can occur. Get medical help right away if you
have any symptoms such as: feeling faint, swelling of your face, eyelids,
tongue, or throat, trouble breathing, throat or chest tightness, or skin
Before receiving STELARA, tell your doctor if you:
- have any of the conditions or symptoms listed above for
serious infections, cancer, or RPLS
- have recently received or are scheduled to receive an
immunization (vaccine). People who take STELARA should not receive live
vaccines. Tell your doctor if anyone in your house needs a vaccine. The
viruses used in some types of vaccines can spread to people with a
weakened immune system, and can cause serious problems. You should not
receive the BCG vaccine during the one year before taking STELARA or one
year after you stop taking STELARA. Non-live vaccinations received while
taking STELARA may not fully protect you from disease.
- are receiving or have received allergy shots, especially for
serious allergic reactions.
- ever had an allergic reaction to STELARA.
- receive phototherapy for your psoriasis.
- have any other medical conditions.
- are pregnant or plan to become pregnant. It is not known if STELARA
will harm your unborn baby. You and your doctor should decide if you will
- are breast-feeding or plan to breast-feed. It is thought that STELARA
passes into your breast milk. You should not breast-feed while taking STELARA
without first talking to your doctor.
Tell your doctor about all the medicines you take, including prescription
and non-prescription medicines, vitamins, and herbal supplements. Especially
tell your doctor if you take:
- other medicines that affect your immune system
- certain medicines that can affect how your liver breaks down other
Common side effects of STELARA include: upper respiratory infections,
headache, and tiredness. These are not all of the side effects with STELARA.
Tell your doctor about any side effect that bothers you or does not go away.
Ask your doctor or pharmacist for more information.
 Nakagawa H, et al. Long-term Impact of Ustekinumab on Health-related
Quality of Life in Japanese Patients with Moderate to Severe Plaque
Psoriasis. Proceedings of the 22nd World Congress of Dermatology; 2011 May
29-29; Seoul, Korea. P2501
For more information contact: Ruth Fazakerley, Janssen Asia Pacific, +852-9301-0413.
Tags: Janssen Asia Pacific, May 26, Seoul, South Korea