Posts tagged "Patients"

Certain Drugs Lower Risk Of Diabetes For Patients With Rheumatoid Arthritis Or Psoriasis

Main Category: Diabetes
Also Included In: Arthritis / Rheumatology;  Eczema / Psoriasis
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In a study that included nearly 14,000 patients with rheumatoid arthritis or psoriasis, the use of certain disease-modifying antirheumatic drugs was found to lower the risk of diabetes, according to a study in the June 22/29 issue of JAMA.

Two common systemic inflammatory conditions, rheumatoid arthritis (RA) and psoriasis, predispose patients to insulin resistance and may place patients at risk for diabetes mellitus (DM). The treatment of psoriasis and RA includes disease-modifying antirheumatic drugs (DMARDs) such as tumor necrosis factor (TNF) inhibitors, which are directed against the inflammatory response, according to background information in the article. The relationship between these conditions and DM suggests that systemic immunosuppression may also reduce the risk for DM.

Daniel H. Solomon, M.D., M.P.H., of Brigham and Women’s Hospital, Boston, and colleagues examined the relationship between DMARD medications and the risk of newly diagnosed DM among participants with RA or psoriasis. The researchers conducted a retrospective cohort study among 121,280 patients with a diagnosis of either RA or psoriasis on at least 2 visits. The analyses were conducted in the context of 2 large health insurance programs, 1 in Canada and 1 in the United States, using administrative data. The average follow-up was 5.8 months and began with the first prescription for a DMARD after study eligibility was met. Drug regimens were categorized into 4 mutually exclusive groups: (1) TNF inhibitors with or without other DMARDs; (2) methotrexate without TNF inhibitors or hydroxychloroquine; (3) hydroxychloroquine without TNF inhibitors or methotrexate; or (4) other nonbiologic DMARDs without TNF inhibitors, methotrexate, or hydroxychloroquine.

The final study cohort consisted of 13,905 participants with 22,493 new treatment episodes starting 1 of the categories of DMARD regimens between January 1996 and June 2008. The researchers found 267 newly diagnosed cases of DM: 55 cases among 3,993 treatment episodes with nonbiologic DMARD users; 80 cases among 4,623 treatment episodes with TNF inhibitor users; 82 cases among 8,195 treatment episodes with methotrexate users; and 50 cases among 5,682 treatment episodes with hydroxychloroquine users. The incidence rates for DM were highest for individuals who switched to other nonbiologic DMARDs and lowest for TNF inhibitor users. “The fully adjusted models suggest a reduced relative risk of DM for TNF inhibitor and hydroxychloroquine compared with other nonbiologic DMARDs,” the authors write.

According to the authors, “The findings from this epidemiologic study should be considered hypothesis-generating. However, considering these results in light of prior findings regarding improved insulin and glucose metabolism and reduced DM risk with hydroxychloroquine and TNF inhibitors, there is evidence suggesting a possible role for DMARDs and immunosuppression in DM prevention. A randomized controlled trial testing the ability of these agents to prevent DM among participants with systemic inflammatory disorders should be considered.”

JAMA. 2011;305[24]2525-2531.

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Of course, in regard to autoimmune etiology of DMII, BUT the effect of corticosteroids, widely used in treatment until recently, was different.

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Varicose Vein Laser Treatment Video for Patients

Beyond Biologics: Psoriasis Patients Can Still Benefit From Traditional Treatments :- Eczema.

Main Category: eczema / Psoriasis
Also Included In: Dermatology
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For patients with severe psoriasis, a new class of intravenous and injectable biological medicines known as “biologics” has brought about a near revolution in treatment.

But doctors at the University of Michigan Health System note that patients and their doctors should also consider long-established treatment alternatives. These can be far cheaper and avoid some of the risk factors associated with the immune system-suppressing biologics, such as increased risk of serious infection and lymphoma.

One of the oldest treatments for psoriasis is known as Goeckerman therapy. The process involves applying ointment made from coal tar to a patient’s skin and exposing the patient to ultraviolet radiation with light therapy, which work together to clear the patients’ skin.

The U-M Dermatology Day Treatment Center is among a small number of places in the country to offer a modernized version of the treatment, which dates back to the 1920s.

“Sometimes when new treatments come along, everyone jumps on the bandwagon,” says Thomas Anderson, M.D., medical director of the Day Treatment Center and associate professor of dermatology at the U-M Medical School. “But Goeckerman has a lot of advantages over biologics. One of the biggest ones is that you’re not on it forever.”

Cost can also be an important factor in deciding whether to use biologics or seek alternatives. The average course of biologics is $22,000 to $59,700 per year, according to a recent article in the International Journal of Dermatology, while Goeckerman therapy costs $10,000 to $12,000.

“The modified Goeckerman treatment has some advantages and we see good remissions,” says Allen Bruce, M.D., Ph.D., a psoriasis researcher and lecturer in the Department of Dermatology at the U-M Medical School. “It can be good for people who have certain risk factors, such as multiple sclerosis, cancer or a history of chronic infections. It’s also a good option for people who would prefer, for a number of reasons, not to be on biologics.”

The three-week tar and light therapy is intensive, but provides quick relief for many patients, allowing them to don shorts and participate in summer activities without being self-conscious about skin plaques. Remissions can last up to 10 years, but many patients require treatment every year or two.

According to a 2010 article in Pediatric Dermatology, Goeckerman therapy is unfairly considered a “lost art.” Given its record of safety and effectiveness, the authors recommended “the current trend toward abandonment of this treatment should be reversed.”

Psoriasis affects 7.5 million Americans, according to the National Psoriasis Foundation. Up to 30 percent of patients may also develop psoriatic arthritis, a painful joint condition.

Biologics can provide relief for patients with psoriatic arthritis, while Goeckerman treatment does not. Some patients pursue a combination of treatments that includes both biologics and Goeckerman.

Therapy at U-M’s Day Treatment Center is done on an outpatient basis. Patients who live within 30 miles can return home at night and in many cases hotel stays for patients from farther away are provided as part of the treatment cost.

Along with psoriasis, the center also treats rare skin conditions including chronic atopic dermatitis, eczema, chronic contact dermatitis and cutaneous t-cell lymphoma.

Source:
University of Michigan Health System

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I had the Goeckerman treatment in 1977. At that time it involved a hospital stay of over two weeks. A very smelly greasy tar and Vaseline based ointment was applied to my entire body daily and I wore the same pajamas the entire time. I had a light treatment once a day. My Psoriasis was about 80% cleared but that lasted only about six weeks and came back with a vengeance. Unless the treatment is a lot more effective and less awful to endure, I absolutely would not do it again and would not recommend it to any other Psoriasis sufferer.

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Synexus Delivers Fast Phase II Study Patients For Creabilis | Eczema.

Main Category: eczema / Psoriasis
Also Included In: Clinical Trials / Drug Trials;  Dermatology
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Synexus has completed a phase II study for the European biotech, Creabilis, recruiting 26 patients in the UK to the psoriasis trial of its CT327 lead product in just 2 weeks, as part of an international proof-of-concept study. The company delivered the targeted number of patients well within the agreed timelines and budget.

Chief Executive of Synexus, Dr Christophe Berthoux believes his company has a great deal to offer smaller pharma and biotech companies: “The Synexus model works particularly well with companies like Creabilis who need to get their early phase studies underway fast. Each of our 26 Dedicated Research Centres has access to large patient pools and use of our patient database with in excess of 450,000 pre-registered patients, to help recruit the right subjects very rapidly. We are talking to more and more biotechs already this year with many beginning to see that Synexus makes an ideal partner for their faster moving drug development pipelines.”

Dr Eliot Forster, Chief Executive of Creabilis acknowledged the advantages of working with a company like Synexus: “There remain significant unmet medical needs in treating dermatological diseases. Creabilis strives to make a difference to the way these diseases are treated. To do this effectively we need to partner with like-minded companies that can support our efforts to bring drugs to market more quickly. Synexus is one such company.”

Source:
Synexus

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New Four Year STELARA® Data Show Consistent Safety Profile Over Time In Patients With Moderate To Severe Plaque Psoriasis :- Eczema.

Main Category: eczema / Psoriasis
Also Included In: Clinical Trials / Drug Trials;  Dermatology
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New findings 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. Investigators also reported findings from an analysis of four placebo-controlled Phase 3 trials across patient populations on three continents and found that the efficacy and safety of STELARA in patients of Japanese and Korean-Taiwanese descent were consistent with findings previously reported in North American and European populations. Both sets of data were presented at the 22nd World Congress of Dermatology in Seoul, Korea.

Psoriasis, a chronic, immune-mediated disease that results from the overproduction of skin cells, affects 125 million people worldwide. Plaque psoriasis often results in patches of thick, red or inflamed skin covered with silvery scales known as plaques. These plaques usually itch or feel sore, can crack and bleed, and can occur anywhere on the body. The disease symptoms can range from mild, to moderate, to severe and disabling. STELARA is currently approved in 57 countries for the treatment of moderate to severe plaque psoriasis.

“These findings are promising and support a favorable benefit-to-risk profile for STELARA with up to four years of treatment,” said Kristian Reich, MD, Department of Dermatology of Dermatolgikum, Hamburg, Germany, and lead trial investigator for the PHOENIX 2 study. “Ongoing studies in psoriasis and psoriatic arthritis will continue to define the safety profile of STELARA in the psoriatic population.”

Pooled safety data from a total of 3,117 patients who participated in a Phase 2 STELARA trial and the Phase 3 PHOENIX 1, PHOENIX 2 and ACCEPT studies showed rates of adverse events (AEs) to be generally stable over time through up to four years of treatment with STELARA, with the most commonly reported AEs [greater than 5 per 100 patient years (PY)] including nasopharyngitis, upper respiratory tract infection, arthralgia, sinusitis, headache and back pain and influenza. Observed occurrences of AEs of interest, including serious infections (0.8 and 1.32 for 45 mg and 90 mg STELARA patient groups, respectively, per 100 PY), non-melanoma skin cancer (0.70; 0.53 per 100 PY, respectively), other malignancies (0.63; 0.61 per 100 PY, respectively) and major adverse cardiovascular events (MACE) (0.42; 0.36 per 100 PY, respectively) remained generally stable during the time periods evaluated. The observed rate of malignancies (excluding non-melanoma skin cancers) was consistent with that expected in the general U.S. population, derived from the Surveillance, Epidemiology and End Results (SEER) Database. Rate of non-fatal myocardial infarction (MI) or stroke was consistent with or lower than that expected in the general U.S. population and psoriasis populations, derived from the Framingham Database and General Practice Research Database (GPRD), respectively.

Consistency of Responses across Different Ethnic Populations with Moderate to Severe Plaque Psoriasis: Results from the STELARA Psoriasis Clinical Development Program

Additional findings from a separate analysis found STELARA efficacy and safety across Asian populations with moderate to severe plaque psoriasis to be consistent with those observed in North American and European populations, according to data from PHOENIX 1 (n=766) and PHOENIX 2 (n=1230) compared with Japanese and Korean-Taiwanese populations evaluated in the JPN-02 (n=158) and PEARL (n=121) trials, respectively.

“Psoriasis is an autoimmune disease that affects millions of people worldwide from all ethnic backgrounds,” said Reich. “These data show the consistency of response with STELARA in the treatment of psoriasis across ethnic populations. These findings are important considerations for the dermatology community.”

In the four analyzed studies, patients received subcutaneous injections of STELARA 45 mg or 90 mg, or placebo at weeks 0 and 4, although only the STELARA 45 mg dose was evaluated in the PEARL trial. STELARA patients received a third dose at week 16, while placebo-treated patients crossed over to receive active treatment at weeks 12 and 16. At week 12, the primary endpoint, a 75 percent improvement as measured by the Psoriasis Area Severity Index (PASI 75), was achieved by a significantly greater proportion of patients across all studies when compared with the placebo group (P > 0.001). Among patients receiving STELARA 45 mg, 66.9 percent, 59.4 percent and 67.2 percent achieved PASI 75 in the North American/European, Japanese and Korean-Taiwanese patient populations, respectively. In patients receiving 90 mg, 72.1 percent and 67.7 percent of patients achieved PASI 75 in the North American/European and Japanese populations. Placebo rates of response were 3.5 percent, 6.5 percent and 5.0 percent in the PHOENIX 1 & 2, Japanese and PEARL trials, respectively. These responses continued to improve through week 28 across groups, with similar responses seen in placebo-treated patients following cross over to treatment with STELARA.

Rates of AEs and serious AEs through week 12 were comparable overall between STELARA and placebo groups in the North American/European, Japanese and Korean-Taiwanese trials. Among patients receiving STELARA 45 mg (or 90 mg), 54.8 (49.7) percent, 65.6 (59.7) percent and 65.6 percent of patients across patient populations reported at least one AE, compared with 49.2 percent, 65.6 percent and 70.0 percent of placebo patients, respectively. Similar safety results were seen through week 28 of each trial. Please read the Important Safety Information for STELARA below.

About Psoriasis

Psoriasis is a chronic, immune-mediated disease that results from the overproduction of skin cells, which accumulate on the surface of the skin and cause red, scaly plaques that may crack and bleed. It is estimated that nearly three percent of the world’s population are living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe.

About the Phase 2 Study

The 36-week, double-blind, placebo-controlled trial, evaluated 320 patients with plaque psoriasis who were randomized to receive one of four dose regimens of STELARA (a single dose of 45 mg or 90 mg or four weekly doses of 45 mg or 90 mg) or placebo. Patients randomized to receive STELARA, whose PGA scores were less than excellent, received a single additional dose at week 16. Patients in the placebo group crossed over to receive 90 mg of STELARA at week 20. Safety data was collected through week 52 of the study.

About the PHOENIX 1 Trial

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) evaluated the efficacy and safety of STELARA in the treatment of 766 patients with chronic plaque psoriasis. Patients were randomized to receive subcutaneously administered STELARA or placebo. Patients randomized to receive STELARA 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 STELARA at weeks 12 and 16 and every 12 weeks thereafter. Some patients inadequately responding to STELARA at weeks 28 and 40 were eligible to switch to every 8 week dosing. The primary endpoint of the study was the proportion of patients achieving PASI 75 at week 12. Patients responding to STELARA through week 40 were randomized to continue treatment with STELARA or were switched to placebo with potential retreatment after loss of response. The long-term extension of this trial is ongoing and is expected to be completed in June 2011; PHOENIX 1 will provide up to five years of safety and efficacy data.

About the PHOENIX 2 Trial

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) evaluated the efficacy and safety of STELARA in 1,230 patients with moderate to severe plaque psoriasis. At baseline, patients were randomized to receive STELARA 45 mg or 90 mg at weeks 0, 4 and every 12 weeks thereafter, or placebo at weeks 0 and 4. Patients initially randomized to placebo at baseline were assigned to cross over to either STELARA 45 mg or 90 mg at weeks 12, 16 and every 12 weeks thereafter. The primary endpoint of the study was the proportion of patients achieving PASI 75 at week 12. Patients partially responding to STELARA at week 28 were randomized to continue treatment with STELARA every 12 weeks or were switched to every 8 week dosing. Patients inadequately responding to STELARA at week 40 and during the long-term extension were eligible to switch to every 8 week dosing. Patients inadequately responding to STELARA 45 mg every 8 weeks during the long-term extension were eligible to switch to 90 mg dosing. For patients who underwent dose-escalation from STELARA 45 mg to 90 mg, pooled safety results were based on the dose received at the time an adverse event occurred. The long-term extension of this trial is ongoing and is expected to be completed in November 2011; PHOENIX 2 will provide up to five years of safety and efficacy data.

About the ACCEPT Trial

The Phase 3, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Ustekinumab Compared to Etanercept (Enbrel®) in the Treatment of Subjects with Moderate to Severe Plaque Psoriasis (ACCEPT) included 903 patients with chronic plaque psoriasis (etanercept=347, STELARA 45 mg=209, STELARA 90 mg=347). Patients were randomized to receive subcutaneously administered STELARA or etanercept. Patients randomized to receive STELARA received 45 mg or 90 mg doses at weeks 0 and 4. Patients in the etanercept group received twice-weekly doses of 50 mg for 12 weeks. The primary endpoint of the study was the proportion of patients who achieved PASI 75 at week 12. At week 12, patients in the etanercept group who were classified as non-responders (i.e., had moderate, marked or severe psoriasis) received 90 mg of STELARA at weeks 16 and 20. STELARA non-responders received one additional dose of STELARA at week 16. Treatment was interrupted for all patients who had cleared, minimal or mild psoriasis at the end of week 12, and all patients were retreated with 45 or 90 mg STELARA when their disease worsened to moderate or worse.

About the PEARL Trial

PEARL was a Phase 3, multicenter, randomized study of subcutaneous injections of placebo and STELARA 45 mg for the treatment of moderate to severe plaque psoriasis in Korean and Taiwanese patients. Those patients who were randomized to STELARA received 45 mg doses at weeks 0, 4 and 16, and a placebo injection at week 12 to maintain the blind. Patients randomized to receive placebo at weeks 0 and 4 crossed over to receive STELARA 45 mg at weeks 12 and 16. All patients were followed through week 36. The primary endpoint of the study was the proportion of patients achieving PASI 75 at week 12.

About the Japanese (JPN02) Trial

JPN-02 was a Phase 2/3, multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study to evaluate the efficacy and safety of STELARA in Japanese patients with moderate to severe plaque-type psoriasis. STELARA was to be administered at either 45 mg or 90 mg subcutaneous at weeks 0 and 4 and then once every 12 weeks through week 52; or placebo at weeks 0 and 4 and cross over to receive either 45 mg or 90 mg STELARA at weeks 12 and 16 and then once every 12 weeks through week 52. The primary endpoint of the study was the proportion of patients achieving PASI 75 at week 12.

About STELARA

STELARA, a human interleukin (IL)-12 and IL-23 antagonist, is approved for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. IL-12 and IL-23 are naturally occurring proteins that are believed to play a role in psoriasis.

Centocor Ortho Biotech Inc. discovered STELARA and has exclusive marketing rights to the product in the United States. Janssen companies have exclusive marketing rights outside of the United States.

Important Safety Information

STELARA® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects including:

Serious Infections

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

– cough

– 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 these proteins.

Cancer

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 rash.

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 take STELARA®.

– 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 medicines

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.

Source: Centocor Ortho Biotech Inc

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.

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New Four Year Stelara(R) (Ustekinumab) Data Show Consistent Safety Profile Over Time In Patients With Moderate-To-Severe Plaque Psoriasis | Eczema.

Main Category: eczema / Psoriasis
Also Included In: Dermatology
Article Date: 25 May 2011 – 4:00 PDT window.fbAsyncInit = function() { FB.init({ appId: ‘aa16a4bf93f23f07eb33109d5f1134d3′, status: true, cookie: true, xfbml: true, channelUrl: ‘http://www.medicalnewstoday.com/scripts/facebooklike.html’}); }; (function() { var e = document.createElement(‘script’); e.async = true; e.src = document.location.protocol + ‘//connect.facebook.net/en_US/all.js’; document.getElementById(‘fb-root’).appendChild(e); }()); email to a friend   printer friendly   opinions  

New findings presented today from pooled analyses of the ongoing STELARA® (ustekinumab) psoriasis clinical development program showed that the safety profile of ustekinumab 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.1

Psoriasis is a chronic, immune-mediated disease that results from the overproduction of skin cells. It affects 1.5 million2,3 people in the United Kingdom, of whom 20 – 30% are estimated to have moderate-to-severe disease,4 and can have a significant physical and psychological impact on those affected.5Plaque psoriasis often results in patches of thick, red or inflamed skin covered with silvery scales (known as plaques). These plaques usually itch or feel sore, can crack and bleed, and can occur anywhere on the body. The disease symptoms can range from mild, to moderate, to severe and disabling.6

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. More than 1100 patients had been treated for at least three years with ustekinumab and more than 600 patients had been treated for at least four years, representing a total of nearly 6800 patient years (PY).1

“These findings are promising and support a favourable benefit-to-risk profile for ustekinumab with up to four years of treatment,” said Professor Kristian Reich, MD, Department of Dermatology of Dermatolgikum, Hamburg, Germany, and lead trial investigator for the PHOENIX 2 study. “Ongoing studies in psoriasis will continue to define the safety profile of ustekinumab in the psoriatic population.”

The pooled safety data, from a total of 3117 patients, showed rates of adverse events (AEs) to be generally stable over time up to four years of treatment with ustekinumab.1The most commonly reported AEs [at least 5 per 100 PY] included nasopharyngitis, upper respiratory tract infection, arthralgia, headache, back pain and influenza.1 Cumulative rates of AEs of interest, including serious infections (0.8 and 1.32 per 100 PY for 45 mg and 90 mg ustekinumab patient groups, respectively), non-melanoma skin cancer (0.70; 0.53 per 100 PY, respectively), other malignancies (0.63; 0.61 per 100 PY, respectively) and major adverse cardiovascular events (MACE) (0.42; 0.36 per 100 PY, respectively) remained generally stable during the time periods evaluated.1

Important Safety Information7

Ustekinumab is a selective immunosuppressant and may have the potential to increase the risk of infections and reactivate latent infections. Serious infections have been observed in patients receiving ustekinumab in clinical trials. Do not start ustekinumab during an active infection. If a serious infection develops, monitor patients carefully and stop ustekinumab until the infection resolves. Patients should be evaluated and monitored closely for signs and symptoms of active tuberculosis (TB) infection before, during and after initiating treatment with ustekinumab.

Ustekinumab is a selective immunosuppressant. Immunosuppressive agents have the potential to increase the risk of malignancy. Malignancies have been observed in patients receiving ustekinumab in clinical trials. Caution should be exercised when considering the use of ustekinumab in patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy.

Serious allergic reactions have been reported in the post-marketing setting, in some cases several days after treatment. Anaphylaxis and angioedema have occurred. If an anaphylactic or other serious allergic reaction occurs, administration of ustekinumab should be discontinued immediately and appropriate therapy instituted.

About the Phase 2, PHOENIX 1, PHOENIX 2 and ACCEPT ustekinumab psoriasis trials

For further information on the clinical trials included in this release, please refer to the Clinical Trial Backgrounder or contact liz.wyatt@resolutecommunications.com.

References

1. Reich K, Leonardi C, Griffiths CEM et al. Update on the Cumulative Safety Experience of Ustekinumab: Result from the 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. FC07-03.

2. National Statistics Online. Population Estimates. Available here. Accessed on 4 May 2011.

3. National Psoriasis Foundation. About Psoriasis: Statistics. Available here. Accessed 14 April 2011.

4. Smith CH, Anstey AV, Barker JN, et al. British Association of Dermatologists guidelines for use of biological interventions in psoriasis 2005. Br J Dermatol. 2005;153(3):486-497.

5. International Federation of Psoriasis Associations. Psoriasis is a Serious Disease Deserving Global Attention. Available here. Accessed on 14 April 2011.

6. National Institute of Arthritis and Musculoskeletal and Skin Disorders. Questions and Answers About Psoriasis. U.S. Department of Health and Human Services, National Institutes of Health; 2003. NIH Publication No. 03-5040.

7. Janssen-Cilag Ltd. STELARA Summary of Product Characteristics (SPC). Published on European Medicines Agency (EMA) website on 3 March 2011.

Source:
Janssen Pharmaceutical Companies of Johnson & Johnson

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Data Presented At Two Global Medical Congresses Reinforce Significant Benefit Of Enbrel(R) For Patients With Chronic Inflammatory Conditions :- Eczema.

Main Category: Arthritis / Rheumatology
Also Included In: eczema / Psoriasis;  Dermatology
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Pfizer (NYSE: PFE) today announced new results from multiple studies of ENBREL (etanercept), further expanding the body of evidence supporting the efficacy and safety profile of ENBREL, the most prescribed biologic by rheumatologists worldwide. Eighteen abstracts across four indications, including moderate-to-severe rheumatoid arthritis (RA), ankylosing spondylitis (AS), moderate-to-severe plaque psoriasis (PsO), and psoriatic arthritis (PsA), will be published at two global medical congresses, the European League Against Rheumatism (EULAR) and World Congress of Dermatology (WCD), this week.

“The breadth of data being presented at these congresses underscores our ongoing commitment to the rigorous study of these conditions where treatment has been shown to improve patient outcomes,” said Yvonne Greenstreet, Senior Vice President of Clinical Development and Medical Affairs, Pfizer Inc. “With its first approval for RA in 1998 in the US and 2000 in Europe, ENBREL has 2.5 million patient-years of collective clinical experience, and we continue to gain important knowledge about these conditions and the potential benefits of treating patients with certain chronic inflammatory diseases.”

Rheumatoid Arthritis
Impact of Etanercept-Methotrexate (MTX) Therapy on Disease Activity and Radiographic Progression in Moderately Active Rheumatoid Arthritis: Interim Results of the PRESERVE Trial
Persistent inflammation and associated joint damage may play a critical role in causing impairment in joint function in RA. Previous studies exploring treatment with biologics focused primarily on patients with severe disease. The radiographic data are an exploratory endpoint and represent results from Period 1 of a 2-period study from the initial open-label portion of the PRESERVE trial examining patients with moderately active rheumatoid arthritis. The results demonstrated that treatment with ENBREL added to MTX led to radiographic nonprogression in 82 percent (modified Total Sharp Score [mTSS] change =0.5) of these patients, all of whom had an inadequate response to MTX alone. Results also showed that 86 percent of patients achieved Disease Activity Score (DAS) 28 low disease activity and 67 percent achieved DAS28 clinical remission with continuous treatment with ENBREL plus MTX.

Improvement in Patient-Reported Outcomes with Etanercept-Methotrexate (MTX)
Therapy in Moderately Active Rheumatoid Arthritis: Interim Results of the PRESERVE Trial
Patients with RA often experience impairment in physical function, health-related quality of life (HR-QOL) and productivity at work. Patient-reported outcomes from the initial open-label portion of the PRESERVE trial examining patients with moderate rheumatoid arthritis showed clinically important improvements in measures of physical function, disease activity, pain, fatigue, HR-QOL and work productivity after 36 weeks of ENBREL added to MTX.

Psoriatic Arthritis
Psoriasis Patients with Psoriatic Arthritis and Axial Involvement Have a Higher Disease Burden than Those without Axial Involvement but Similar Treatment Outcomes: Results from PRESTA Trial
Patients who have PsO and PsA with axial disease (disease involvement in the spine) have a higher burden of disease than those without axial disease (patients who have disease in the peripheral joints only). Data from an exploratory analysis of the PRESTA trial examining patients with moderate-to-severe PsO and PsA found that patients presenting with and without axial disease showed benefit from treatment with ENBREL compared with baseline.

Psoriasis
Effects of Etanercept on Cardiometabolic Biomarkers in Subjects with Moderate-to-Severe Plaque Psoriasis: The PRISTINE Trial

Psoriasis patients may have an increased incidence of co-morbid conditions, such as diabetes and cardiovascular disease. Data from this exploratory endpoint from the PRISTINE trial studying patients with moderate-to-severe plaque psoriasis found at week 12, ENBREL 50mg once or twice weekly did not negatively impact various biomarkers of cardiometabolic disease like apolipoprotein B/apolipoprotein A1 ratio, hsCRP, and NT-proBNP. The clinical significance of these findings needs to be studied further, but the results are important for consideration as the medical community continues to explore the potentially broader effects of inflammatory disease in the body.

About Rheumatoid Arthritis

Rheumatoid arthritis is a chronic inflammatory disease that affects millions of people worldwide, and may get worse over time if not treated effectively, causing permanent damage to joints, deformity, loss of independence and work disability.

About Psoriasis

Plaque psoriasis is a long-term1 immune disorder characterized by patches of thickened and red skin covered by silvery white scales. The patches are called plaques.2 There are other forms of psoriasis, but plaque psoriasis is the most common.

About Psoriatic Arthritis

Psoriatic arthritis is an auto-immune disease that causes pain, stiffness and swelling in and around the joints. In addition, psoriatic arthritis patients may experience skin lesions similar to those seen in plaque psoriasis.

Up to 30 percent of people diagnosed with plaque psoriasis may actually have psoriatic arthritis.

About Ankylosing Spondylitis

Ankylosing spondylitis (AS) is a debilitating condition that affects approximately two to three times as many men as women, and typically presents in patients during the second and third decades of life. AS typically causes inflammation, stiffness and pain in the spine (known as axial disease), but can also affect the peripheral joints. As a result of the disease, patients with symptomatic AS lose productivity owing to work disability and unemployment, have substantial use of healthcare resources and an overall reduced quality of life.3

About Enbrel

For full information about ENBREL go here.

References

1. Lebwohl M. Psoriasis. Lancet. 2003;361(9364): 1197-1204. Doi:10.1016/S0140-6736(03)12954-6.

2. Gottlieb AB. Psoriasis: Emerging therapeutic therapies. Nat Rev Drug Discov. 2005;4:19-34.

3. Sieper J. et al. Ankylosing spondylitis: an overview. Ann Rheum Dis. 2002;61(Suppl III):iii8-iii18.

Source:
Pfizer Inc

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New Four Year STELARA(R) Data Show Consistent Safety Profile Over Time In Patients With Moderate To Severe Plaque Psoriasis | Eczema.

Main Category: eczema / Psoriasis
Also Included In: Dermatology
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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.1 Investigators also reported findings from an analysis of four placebo-controlled Phase 3 trials across patient populations on three continents and found that the efficacy and safety of STELARA in patients of Japanese, Korean and Taiwanese descent were consistent with findings previously reported in North American and European populations.2 Both sets of data were presented at the 22nd World Congress of Dermatology in Seoul, Korea.

Psoriasis, a chronic, immune-mediated disease that results from the overproduction of skin cells, affects 125 million people worldwide. Plaque psoriasis often results in patches of thick, red or inflamed skin covered with silvery scales known as plaques. These plaques usually itch or feel sore, can crack and bleed, and can occur anywhere on the body. The disease symptoms can range from mild, to moderate, to severe and disabling. STELARA is currently approved in 57 countries for the treatment of moderate to severe plaque psoriasis.

“These findings are promising and support a favorable benefit-to-risk profile for STELARA with up to four years of treatment,” said Kristian Reich, MD, Department of Dermatology of Dermatolgikum, Hamburg, Germany, and lead trial investigator for the PHOENIX 2 study. “Ongoing studies in psoriasis and psoriatic arthritis will continue to define the safety profile of STELARA in the psoriatic population.”

Pooled safety data from a total of 3,117 patients who participated in a Phase 2 STELARA trial and the Phase 3 PHOENIX 1, PHOENIX 2 and ACCEPT studies showed rates of adverse events (AEs) to be generally stable over time through up to four years of treatment with STELARA, with the most commonly reported AEs [greater than 5 per 100 patient years (PY)] including nasopharyngitis, upper respiratory tract infection, arthralgia, sinusitis, headache and back pain and influenza. Observed occurrences of AEs of interest, including serious infections (0.8 and 1.32 for 45 mg and 90 mg STELARA patient groups, respectively, per 100 PY), non-melanoma skin cancer (0.70; 0.53 per 100 PY, respectively), other malignancies (0.63; 0.61 per 100 PY, respectively) and major adverse cardiovascular events (MACE) (0.42; 0.36 per 100 PY, respectively) remained generally stable during the time periods evaluated. The observed rate of malignancies (excluding non-melanoma skin cancers) was consistent with that expected in the general U.S. population, derived from the Surveillance, Epidemiology and End Results (SEER) Database. Rate of non-fatal myocardial infarction (MI) or stroke was consistent with or lower than that expected in the general U.S. population and psoriasis populations, derived from the Framingham Database and General Practice Research Database (GPRD), respectively.1

Consistency of Responses across Different Ethnic Populations with Moderate-to-Severe Plaque Psoriasis: Results from the STELARA Psoriasis Clinical Development Program

Additional findings from a separate analysis found STELARA efficacy and safety across Asian populations with moderate to severe plaque psoriasis to be consistent with those observed in North American and European populations, according to data from PHOENIX 1 (n=766) and PHOENIX 2 (n=1230) compared with Japanese, Korean and Taiwanese populations evaluated in the JPN-02 (n=158) and PEARL (n=121) trials, respectively.2

“Psoriasis is an autoimmune disease that affects millions of people worldwide from all ethnic backgrounds,” said Dr Jai-Il Youn, Department of Dermatology, Seoul National University, Seoul, Korea and study investigator. “These data show the consistency of response with STELARA in the treatment of psoriasis across ethnic populations. These findings are important considerations for the dermatology community.”

In the four analyzed studies, patients received subcutaneous injections of STELARA 45 mg or 90 mg, or placebo at weeks 0 and 4, although only the STELARA 45 mg dose was evaluated in the PEARL trial. STELARA patients received a third dose at week 16, while placebo-treated patients crossed over to receive active treatment at weeks 12 and 16. At week 12, the primary endpoint, a 75 percent improvement as measured by the Psoriasis Area Severity Index (PASI 75), was achieved by a significantly greater proportion of patients across all studies when compared with the placebo group (P > 0.001). Among patients receiving STELARA 45 mg, 66.9 percent, 59.4 percent and 67.2 percent achieved PASI 75 in the North American/European, Japanese, Korean and Taiwanese patient populations, respectively. In patients receiving 90 mg, 72.1 percent and 67.7 percent of patients achieved PASI 75 in the North American/European and Japanese populations. Placebo rates of response were 3.5 percent, 6.5 percent and 5.0 percent in the PHOENIX 1 & 2, Japanese and PEARL trials, respectively. These responses continued to improve through week 28 across groups, with similar responses seen in placebo-treated patients following crossover to treatment with STELARA. STELARA-treated patients also demonstrated clinically meaningful improvements in quality of life, as measured by the Dermatology Life Quality Index (DLQI), at weeks 12 and 28 across the four trials.

Rates of AEs and serious AEs through week 12 were comparable overall between STELARA and placebo groups in the North American/European, Japanese, Korean and Taiwanese trials. Among patients receiving STELARA 45 mg (or 90 mg), 54.8 (49.7) percent, 65.6 (59.7) percent and 65.6 percent of patients across patient populations reported at least one AE, compared with 49.2 percent, 65.6 percent and 70.0 percent of placebo patients, respectively. Similar safety results were seen through week 28 of each trial. Please read the Important Safety Information for STELARA below.

About Psoriasis

Psoriasis is a chronic, immune-mediated disease that results from the overproduction of skin cells, which accumulate on the surface of the skin and cause red, scaly plaques that may crack and bleed. It is estimated that nearly three percent of the world’s population are living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe.

About STELARA

STELARA is currently approved in 57 countries, including Japan, Thailand, Hong Kong, Philippines, Singapore, Australia, New Zealand, Canada, Europe, the United States, Brazil and Mexico for the treatment of moderate to severe plaque psoriasis. STELARA, a human interleukin (IL)-12 and IL-23 antagonist, is approved for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. IL-12 and IL-23 are naturally occurring proteins that are believed to play a role in psoriasis.

Centocor Ortho Biotech Inc. discovered STELARA and has exclusive marketing rights to the product in the United States. Janssen companies have exclusive marketing rights outside of the United States.

Important Safety Information

STELARA is a prescription medicine that affects your immune system. STELARA can increase your chance of having serious side effects including:

Serious Infections

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
- cough
- 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 these proteins.

Cancer

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 rash.

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 take STELARA.

- 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 medicines

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.

1. Reich K, Leonardi C, Griffiths CEM, Szapary PO, Wasfi Y , Hsu MC, Gordon K. Update on the Cumulative Safety Experience of Ustekinumab: Result from the Ustekinumab Psoriasis Clinical Development Program with Up to 4 Years of Follow-up, Proceedings of the 22nd World Congress of Dermatology; 2011 May 29-29; Seoul, Korea. FC07-03

2. Youn J, Tsai TF, Reich K, Ho V, Yamauchi P, Song M, Kato T. Consistency of responses across different ethnic populations with moderate-to-severe psoriasis: Results from the ustekinumab psoriasis clinical development program. Proceedings of the 22nd World Congress of Dermatology; 2011 May 29-29; Seoul, Korea. P2504

Source:
Janssen Asia Pacific

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.

Please note that we publish your name, but we do not publish your email address. It is only used to let you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

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