Health Boards
Sat-10-10-2015, 10:59 AM
Here is some info about IXEKIZUMAB -
Our study is taking place internationally and there will be about 300 other patients all around the world who will be taking part including approximately 15 patients in the UK. It will take about two years to complete the whole study but your participation in the study is expected to last up to one year and three months.
The main reason for you to take part in this study is not to treat you for your condition, we hope that the results of this study will help to answer the following research question:
• Can ixekizumab help patients with moderate-to-severe plaque psoriasis when compared to ustekinumab?
Ustekinumab is recommended by the National Institute for Health and Care
Excellence for the treatment of severe plaque psoriasis which has failed to respond to other
recommended standard treatments. The study compares the recommended treatment,
Ustekinumab, with the investigational medication, Ixekizumab.
. As of 15 September 2014, ixekizumab (LY2439821) has been given to at least 4204 people with psoriasis (Ps), 532 people with rheumatoid arthritis (RA), and approximately 208 people with psoriatic arthritis (PsA).
Ixekizumab is an antibody that has been created to block a protein called interleukin-17 (IL-17) in the body. IL-17 is involved in defence against certain types of infections, but uncontrolled IL-17 production may be involved in certain diseases including RA, Ps, PsA, and axial spondyloarthritis (AS).
Ixekizumab has been given as a subcutaneous (SC) injections under the skin or as an intravenous (IV) infusion into a vein in 12 studies, either as a single dose or as many doses repeated at various time points. In some studies, ixekizumab was given as often as every 2 weeks for at least 12 weeks.
Adverse events that occurred in ≥3% (3 out of 100) of ixekizumab treated patients are listed below, in order from most to least frequent:
Psoriasis Patients
Runny nose and sore throat; cold symptoms
Injection site reaction
Upper respiratory infection
Headache
Joint pain
Sinus irritation
Back pain
Diarrhea
Urinary tract infection
Bronchitis
Injection site redness
High blood pressure
Common side effects (may affect up to 1 in 10 people):
• Diarrhea
• Nausea
• Feeling tired
• Feeling dizzy
• Headache
• Itching (‘pruritus’)
• Back, muscle or joint pain
• Sore throat
• Tooth infections
• Redness and pain where the injection is given.
Uncommon side effects (may affect up to 1 in 100 people):
• Depression
• Blocked or stuffy nose
• Bleeding, bruising, hardness, swelling and itching where the injection is given
• Drooping eyelid and sagging muscles on one side of the face (‘facial palsy’ or ‘Bell’s palsy’), which is usually temporary
• A change in psoriasis with redness and new tiny, yellow or white skin blisters, sometimes accompanied by fever (pustular psoriasis).
• Peeling of the skin (skin exfoliation)
Rare side effects (may affect up to 1 in 1000 people)
• Redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural change in the type of psoriasis symptoms (erythrodermic psoriasis).
Our study is taking place internationally and there will be about 300 other patients all around the world who will be taking part including approximately 15 patients in the UK. It will take about two years to complete the whole study but your participation in the study is expected to last up to one year and three months.
The main reason for you to take part in this study is not to treat you for your condition, we hope that the results of this study will help to answer the following research question:
• Can ixekizumab help patients with moderate-to-severe plaque psoriasis when compared to ustekinumab?
Ustekinumab is recommended by the National Institute for Health and Care
Excellence for the treatment of severe plaque psoriasis which has failed to respond to other
recommended standard treatments. The study compares the recommended treatment,
Ustekinumab, with the investigational medication, Ixekizumab.
. As of 15 September 2014, ixekizumab (LY2439821) has been given to at least 4204 people with psoriasis (Ps), 532 people with rheumatoid arthritis (RA), and approximately 208 people with psoriatic arthritis (PsA).
Ixekizumab is an antibody that has been created to block a protein called interleukin-17 (IL-17) in the body. IL-17 is involved in defence against certain types of infections, but uncontrolled IL-17 production may be involved in certain diseases including RA, Ps, PsA, and axial spondyloarthritis (AS).
Ixekizumab has been given as a subcutaneous (SC) injections under the skin or as an intravenous (IV) infusion into a vein in 12 studies, either as a single dose or as many doses repeated at various time points. In some studies, ixekizumab was given as often as every 2 weeks for at least 12 weeks.
Adverse events that occurred in ≥3% (3 out of 100) of ixekizumab treated patients are listed below, in order from most to least frequent:
Psoriasis Patients
Runny nose and sore throat; cold symptoms
Injection site reaction
Upper respiratory infection
Headache
Joint pain
Sinus irritation
Back pain
Diarrhea
Urinary tract infection
Bronchitis
Injection site redness
High blood pressure
Common side effects (may affect up to 1 in 10 people):
• Diarrhea
• Nausea
• Feeling tired
• Feeling dizzy
• Headache
• Itching (‘pruritus’)
• Back, muscle or joint pain
• Sore throat
• Tooth infections
• Redness and pain where the injection is given.
Uncommon side effects (may affect up to 1 in 100 people):
• Depression
• Blocked or stuffy nose
• Bleeding, bruising, hardness, swelling and itching where the injection is given
• Drooping eyelid and sagging muscles on one side of the face (‘facial palsy’ or ‘Bell’s palsy’), which is usually temporary
• A change in psoriasis with redness and new tiny, yellow or white skin blisters, sometimes accompanied by fever (pustular psoriasis).
• Peeling of the skin (skin exfoliation)
Rare side effects (may affect up to 1 in 1000 people)
• Redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural change in the type of psoriasis symptoms (erythrodermic psoriasis).