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New Data Demonstrate Stelara® (Ustekinumab) Is Effective, Well-Tolerated And Improved QOL In Patients With Moderate To Severe Plaque Psoriasis

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AppId is over the quota AppId is over the quota Article adapted by Medical News Today from original press release. Click ‘references’ tab above for source.
Visit our eczema / psoriasis section for the latest news on this subject. Study Design and Results

TRANSIT study
Design: A 52 week, open-label, Phase 4 study of 489 patients designed to compare two methods of transitioning patients from methotrexate to ustekinumab. The first was discontinuation of methotrexate with immediate initiation of ustekinumab and the second was initiation of ustekinumab with overlap and gradual dose reduction of methotrexate over four weeks. Results: Ustekinumab was well tolerated, with 8% of patients in each transition arm experiencing a serious adverse event (AE), and associated with sustained efficacy;http://www.eczemablog.net/  76% and 77% of patients, in the methotrexate immediate cessation arm and the methotrexate gradual withdrawal arm respectively, achieved at least a 75% improvement from baseline in their Psoriasis Area and Severity Index score (PASI 75) at Week 52. The data showed there was no difference in terms of the number and types of AE or efficacy outcomes, whether given ustekinumab after immediate cessation of methotrexate or if methotrexate is gradually withdrawn over 4 weeks.1


PHOENIX 2
Design: 1,230 patients with moderate-to-severe plaque psoriasis were randomised to receive ustekinumab 45 mg or 90 mg at weeks 0, 4 and every 12 weeks thereafter, or placebo at weeks 0 and 4. Patients initially randomised to placebo at baseline were assigned to cross over to either ustekinumab 45 mg or 90 mg at weeks 12, 16 and every 12 weeks thereafter. Investigators were permitted to adjust ustekinumab dosing based on clinical judgment after Week 52 of the study.* Results: With up to five years of ustekinumab treatment, high levels of clinical responses were achieved and maintained in the overall population; 76.5% and 78.6% of patients who received STELARA 45 mg and 90 mg, respectively, achieved a PASI 75 response at the end of the treatment period. The safety profile of ustekinumab was generally comparable between patients who received 45 mg or 90 mg, with or without dose adjustments.3


*PHOENIX 2 study design involved a revised dosing schedule for partial responders which is not included in the approved EMA Summary of Product Characteristics for STELARAR.


Clinical Trial Safety Database Analysis


Design: Safety data were pooled from four ustekinumab psoriasis studies (one Phase 2 and three Phase 3 [PHOENIX 1, PHOENIX 2, and ACCEPT]) in which patients were treated for up to five years. Rates of overall and targeted adverse events were analysed by ustekinumab dose received (45 mg or 90 mg) and by year of follow-up (Year 1 to 5) to evaluate potential dose-response or impact of increasing duration of exposure.
Results: Analyses included 3,117 patients with a total of 8.998 PY of follow-up. Rates of safety events were generally comparable between patients who received 45 mg and 90 mg; and generally consistent over time from Year 1 through 5. The overall safety profile of ustekinumab remained stable in adults with moderate-to-severe plaque psoriasis receiving up to five years of ustekinumab treatment. No effect of dose and no effect of increasing duration of exposure were observed.4


PSOLAR
Design: A disease-based registry study that captures multiple forms of psoriasis therapy that is planned to enroll approximately 12,000 patients. In August 2011, 9,495 patients were available in the last annual data extract reflecting 13,733 PY of exposure. Patients that are eligible for systemic therapies, including ustekinumab and infliximab, are enrolled and followed biannually.
Results: Preliminary findings on rates of infection, malignancy (excluding non-melanoma skin cancers) and major adverse cardiovascular events (MACE) observed since the registry opened in 2007 were reported.5-7 In patients exposed to ustekinumab and infliximab, no new safety signals for malignancy, MACE or infection were identified in patients undergoing actual clinical use in more than 250 centres internationally.5-7


About Psoriasis


Psoriasis is a chronic disease caused when the immune system mistakenly attacks healthy skin cells, speeding up skin cell production.10 Plaque psoriasis, the most common type of psoriasis,11 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.


Psoriasis affects 125 million people worldwide and around 11 million people in Europe.12,13 The type, symptoms and severity of psoriasis may differ from one person to another, with its effects ranging from mild or moderate, to severe. Nearly one-quarter of people with psoriasis have cases that are considered moderate to severe.14


Biological therapies represent an advancement in the treatment of moderate to severe plaque psoriasis. Long-term data on available treatment options is important to support healthcare professionals in their decision-making about the most appropriate treatment option for patients.


For more information about psoriasis, available treatment options and tools to assess the medical severity of psoriasis please visit http://www.psoriasis360.com


About STELARA (Ustekinumab)


Ustekinumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (psoralen plus UVA).15


The recommended dosing regimen for ustekinumab is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter. For patients with a body weight of greater than 100 kg the recommended dose is 90 mg administered subcutaneously, followed by a 90 mg dose 4 weeks later, then every 12 weeks thereafter. (In these patients, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy). Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.15 Ustekinumab is the only subcutaneous treatment for psoriasis available with every 12-week (quarterly) dosing, or as few as four injections per year, following two initial doses.15-17


STELARA is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy.


Janssen Biotech, Inc. discovered and developed ustekinumab and has exclusive marketing rights to the product in the United States. Janssen pharmaceutical companies have exclusive marketing rights in all countries outside of the United States.


Important Safety Information14


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 for tuberculosis (TB) infection prior to 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 treatment instituted.


It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guerin [BCG]) should not be given concurrently with STELARA.


No overall differences in efficacy or safety in patients age 65 and older who received STELARA were observed compared to younger patients. Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.


Special Warnings and Precautions for Use14


Concomitant immunosuppressive therapy: Caution should be exercised when considering concomitant use of other immunosuppressants and ustekinumab or when transitioning from other immunosuppressive biologics.


References


1. Paul C et al. Long-term safety and efficacy of ustekinumab in patients with psoriasis inadequately responding to methotrexate: Week 52 TRANSIT results. Presented at the 21st European Association of Dermatology & Venereology (EADV) congress, Prague 27–30 September 2012. Oral session FC02.1.


2. Reich K et al. Long-term improvement in patient-reported outcomes after transition from methotrexate to ustekinumab in moderate to severe psoriasis: TRANSIT Week 52 results. Poster presented at the 21st European Association of Dermatology & Venereology (EADV) congress, Prague 27–30 September 2012. Poster 955.


3. Langley R et al. Long term efficacy and safety of ustekinumab in patients with moderate to severe psoriasis through 5 years of follow-up: results from the PHOENIX 2 long-term extension. Poster presented at the 21st European Association of Dermatology & Venereology (EADV) congress, Prague 27–30 September 2012. Poster 976.


4. Papp K et al. Long term safety of ustekinumab in patients with moderate to severe psoriasis through up to 5 years of continuous follow-up. Poster presented at the 21st European Association of Dermatology & Venereology (EADV) congress, Prague 27–30 September 2012. Poster 965.


5. Naldi L et al. Major adverse cardiovascular events in the Psoriasis Longitudinal Assessment and Registry (PSOLAR) study: current status of observations. Presented at the 21st European Association of Dermatology & Venereology (EADV) congress, Prague 27–30 September 2012. Oral session FC02.7.


6. Leonardi C et al. Serious infection events in the Psoriasis Longitudinal Assessment and Registry (PSOLAR) study: current status of observations. Poster presented at the 21st European Association of Dermatology & Venereology (EADV) congress, Prague 27–30 September 2012. Poster 977.


7. Langley R et al. Malignancy events in the Psoriasis Longitudinal Assessment and Registry (PSOLAR) study: current dtatus of observations. Poster presented at the 21st European Association of Dermatology & Venereology (EADV) congress, Prague 27–30 September 2012. Poster 973.


8. National Psoriasis Foundation. Related Health concerns: Psoriasis comorbidities. Available at: http://www.psoriasis.org/about-psoriasis/related-conditions. Last accessed September 2012


9. Augustin M et al. A framework for improving the quality of care for people with psoriasis. JEADV 2012; 26 (Supplement 4):1–16.


10. The Psoriasis Association. Available at: http://www.psoriasis-association.org.uk/pages/view/about-psoriasis. Last accessed September 2012.


11. National Psoriasis Foundation. Psoriasis types. Available at: http://www.psoriasis.org/about-psoriasis/types. Last accessed September 2012.


12. National Psoriasis Foundation. About Psoriasis: Statistics. Available at: http://www.psoriasis.org/about/stats. Last accessed September 2012.


13. Lecluse LL et al. National registries of systemic treatment for psoriasis and the European ‘Psonet’ initiative. Dermatology. 2009;218 (4):347-56.


14. Ustekinumab European Summary of Product Characteristics. Date: March 2012.


15. Wyeth Pharmaceuticals. Enbrel Summary of Product Characteristics.


16. Abbott Laboratories Ltd. Humira Summary of Product Characteristics.


17. Schering-Plough Ltd. Remicade Summary of Product Characteristics.


To view a film of experts discussing the data, please visit:
http://www.brainshark.com/janssencns/PsoriasisInterviews


Janssen

Please use one of the following formats to cite this article in your essay, paper or report:

MLA

Janssen. “New Data Demonstrate StelaraR (Ustekinumab) Is Effective, Well-Tolerated And Improved QOL In Patients With Moderate To Severe Plaque Psoriasis.” Medical News Today. MediLexicon, Intl., 2 Oct. 2012. Web.
7 Apr. 2013. APA
Janssen. (2012, October 2). “New Data Demonstrate StelaraR (Ustekinumab) Is Effective, Well-Tolerated And Improved QOL In Patients With Moderate To Severe Plaque Psoriasis.” Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/250915.php.

Please note: If no author information is provided, the source is cited instead.


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Eczema Blog

Beat Eczema with Improved Skin Care

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This will probably come as a shock to you but many people affected by eczema are unaware that with improved skin care procedures may be all that lies between constant suffering and an improved healthier skin condition. Some easy changes to your skin care regimen can make massive improvement to the condition of your skin which is one of the first steps to beat eczema with improved skin care.

Here are some steps to take that will help improve your skin condition.

Your Diet

 There is more to skin care than applying topical lotions and creams. Good skin care begins from within so you need to supply your body with the rights nutrients which will give your body a chance to be able to beat eczema. If you know that you’re not eating a proper balanced diet then you need to make a change for your better health.

Researchers have found that foods high on acidity are connected to increased eczema outbreak. It seems that the high acid content makes the skin susceptible to irritation which will bring on the eczema outbreak. A good dietician can be helpful steering clear of high acid food is more difficult than you think. Kelp which is alkali will neutralize acid in your system which will be helpful to beat eczema.

Moisturize Often

Moisturizing needs to become a regular practice at least once or twice a day. Olive oil is good to use along with aloe vera make for a good moisturizer also coconut oil is believed to have special properties that add added moisture to your skin which is very important in the battle to defeat eczema. The absolute best time is after you shower so that you can lock in all the moisture you can. Pat yourself down lightly and apply to damp skin. This will make your skin more pliable and less likely to crack or get dry which is an important step needed to beat eczema.

Protect Yourself

Be aware of things that irritate or increase your eczema symptoms and avoid these. Wear a all cotton clothing all bedding should be cotton as much as possible cotton should be the only fabric to come in contact with your skin because just about everything else will irritate your skin and cause a eczema outbreak avoid shampoos, soaps and deodorant that are scented including the detergent your do your laundry with.

The steps I have mentioned in this article aren’t all that complicated involves some common sense and a small commitment to hopefully beat eczema but for a more complete plan to beat eczema read on.

 

Curing eczema can prove to be a challenge. However, new research has shown that an all natural cure commonly referred to as Beat Eczema has proven very successful in eliminating eczema. You can read about the beat eczema system by visiting child eczema.info

Eczema Natural Treatment – Treat Your Eczema Naturally For Improved Results

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Those who have eczema, usually also have very sensitive skin. This means that the treatment used to help the eczema should be mild but effective in the form of eczema natural treatment. Now, anyone with or without eczema should be careful about what comes into contact with their skin, however eczema sufferers need to be that bit more vigilant, due to the fragile high irritation levels.

So, what comes under the bracket of eczema natural treatment? Well, anything that is organic and does not contain chemicals, it really is as simple as that.

Most eczema sufferers will have gone down the route of steroid treatment which is effective in clearing severe eczema for a very short period of time but cannot be used long-term, due to it’s dangerous side-effects and the fact that it becomes ineffectual after prolonged use.

Eczema skin is usually very dry and cracked, so it requires consistent moisturization to keep the skin from cracking and letting in allergenic substances which facilitates an out-break of eczema. The best eczema cream is organic cream which uses only natural plant oils and extracts. Just make sure to read the ingredients in case there are any fruit, vegetable or nut extracts included in the ingredients that you have an allergy to!

Your next move in the eczema natural treatment plan is to eat a healthy and well-balanced diet. Your skin requires certain nutrients to remain healthy and eczema sufferers require additional nutrients such as zinc for healing and lots of vitamin C to help the skin regenerate healthy skin cells. Foods containing zinc include seafood, beef, chicken, nuts and seeds. Foods containing vitamin C are fruits, vegetables, pulses and tubers.

Eczema also tends to break out when foods containing preservatives are eaten. Watch out for MSG (mono-sodium glutamate) and E numbers. Those are eczema sufferers’ greatest enemies and should be avoided at all times.

Finally, high levels of stress can also put a great deal of strain on the skin, especially for those with eczema. Although it may be difficult, try to stay calm and relaxed. Taking part in activities such as yoga and tai chi are excellent as they do not induce sweating (which can in turn lead to itchy skin), are great for keeping fitness levels high as well as toning muscles and are instrumental in keeping stress levels very low.

These types of fitness activities are ideal for those with eczema on many levels and have already vastly improved the quality of life for many.

These are just a few methods in making the all important start to clearing your eczema. Already, many people have eradicated their eczema permanently using a ground-breaking new, all natural guide to healing and preventing eczema. To access the guide, continue to Eczema Natural Treatment.

Having suffered from eczema for 15 years and finally found a way to prevent eczema and maintain my skin, I feel qualified to pass on my advice. Remember to consult your doctor when embarking on a new treatment.

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