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Madox Valdivia
In plaque psoriasis and psoriatic arthritis, Stelara is injected under the skin. For adults the usual dose is 45 mg, whereas in children with plaque psoriasis the dose depends on their bodyweight. The dose in patients weighing over 100 kg is 90 mg for psoriasis, and this dose may also be considered for psoriatic arthritis. The first injection is followed by a further injection 4 weeks later, and then an injection every 12 weeks.
Patients or their caregivers may inject Stelara under the skin once they have been trained, if their doctor thinks that this is appropriate. For more information about using Stelara, see the package leaflet or contact your doctor or pharmacist.
In the treatment of moderate to severe plaque psoriasis, Stelara was more effective than placebo (a dummy treatment) in 2 main studies involving a total of 1,996 adult patients. In over half of these patients, other treatments for psoriasis had not worked, were not tolerated or could not be taken by the patients. The main measure of effectiveness was the number of patients whose symptom score improved by 75% or more after 12 weeks. Taking the results of the 2 main studies in adults together, symptoms improved in around 69% of the patients receiving Stelara after 12 weeks, compared with around 3% of the patients receiving placebo.
Longer-term results from these studies showed that with continuous treatment for 5 years, improvement of symptoms with Stelara is maintained. A study comparing Stelara with etanercept (another medicine used for psoriasis) found that Stelara is more effective than etanercept after 12 weeks of treatment.
Two studies were carried out in children with moderate to severe plaque psoriasis. The main measure of effectiveness for both studies was the number of patients whose symptom score improved after treatment for 12 weeks. The first study involved 110 children aged between 12 and 18 years. The children received placebo or Stelara. Around 69% of children who received Stelara achieved a score of cleared or minimal, compared with 5% of patients receiving placebo. The second study involved 44 children aged between 6 and 11 years. All children received Stelara and this was not compared to any other treatment. Around 77% of children achieved a score of cleared or minimal.
In the treatment of active psoriatic arthritis, Stelara was compared with placebo in 2 main studies involving a total of 927 adult patients whose condition was not controlled well enough with previous treatments. In both studies, the main measure of effectiveness was the number of patients whose symptom score improved after 24 weeks. In the first study, symptom score improved in around 42% of those given Stelara 45 mg and 50% of those given 90 mg, compared with around 23% of those given placebo. In the second study, symptom score improved in around 44% of those given either dose of Stelara, compared with around 20% of those given placebo.
In the treatment of ulcerative colitis, Stelara (given by infusion) was compared with placebo in 2 main studies. The first study involved 961 patients with moderately to severely active disease. The main measure of effectiveness was the number of patients whose symptoms were gone or almost gone 8 weeks after the infusion. Symptoms were gone or almost gone in 16% of patients who received Stelara compared with 5% of patients receiving placebo.
In the second study, a total of 523 patients from the first study whose symptoms had improved with Stelara went on to receive the medicine (injected under the skin) every 8 or 12 weeks, or placebo. After 44 weeks of starting treatment by injection under the skin, symptoms of ulcerative colitis were gone or almost gone in 44% of patients on Stelara every 8 weeks and 38% of patients on Stelara every 12 weeks, compared with 24% of patients on placebo.
The most common side effects with Stelara (seen in more than 1 in 20 during clinical trials) are headache and nasopharyngitis (inflammation of the nose and throat). The most serious side effect reported with Stelara is serious hypersensitivity (allergic reaction). For the full list of side effects of Stelara, see the package leaflet.
The Agency considered that studies had shown that Stelara was effective in the treatment of adults and children over 6 years of age with moderate to severe plaque psoriasis in whom other treatments had not worked or could not be used.
For adults with psoriatic arthritis whose condition had not improved enough with DMARDs, the Agency noted that limited treatments were available and considered that Stelara would be of benefit in these patients.
In ulcerative colitis, studies showed that Stelara was effective in treatment of patients in whom other treatments had not worked or could not be used. The side effects were as expected for this medicine.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stelara have been included in the summary of product characteristics and the package leaflet.
Ulcerative colitis
STELARA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.
Stelara 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 psoralen ultraviolet A.
Stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Stelara, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.
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