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Canakinumab got approval from FDA for the treatment of systemic juvenile idiopathic arthritis(SJIA) by Clinnovo Research Labs

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Canakinumab got approval from FDA for the treatment of systemic juvenile idiopathic arthritis(SJIA) by
Article Posted: 06/16/2013
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Canakinumab got approval from FDA for the treatment of systemic juvenile idiopathic arthritis(SJIA)

Education,Health,Science & Technology
US Food and Drug Administration (FDA) has approved Ilaris (Canakinumab) drug on 10th May 2013 for the treatment of active systemic juvenile idiopathic arthritis (SJIA) for the patients aged 2 years and older.Ilaris is the first interleukin-1 beta (IL-1 beta) inhibitor approved for SJIA and the only treatment approved specifically for SJIA.

The drug Canakinumab is available with a trade name of Ilaris, which is a human monoclonal antibody targeted at interleukin-1 beta. It has no cross-reactivity with other members of the interleukin-1 family, including interleukin-1 alpha. The Interleukin 1 family (IL-1 family) is a group of 11 cytokines, which plays a central role in the regulation of immune and inflammatory responses to infections or sterile insults. The drug has to be administered once-monthly as a subcutaneous injection.

SJIA is a rare form of childhood arthritis which leads to disability. The symptom of the disease includes fever, rash and arthritis which can affect children as young as 2 years old and can continue into adulthood.SJIA affects 5-15 per 100,000 childrenin the United States. It is the most severe subtype of juvenile idiopathic arthritis.The disease can be life-threatening and the treatment options are limited. SJIA is a subset of arthritis seen in childhood, which may be transient and self-limited or chronic. This type of childhood arthritis differs significantly from arthritis in adults which are osteoarthritis, rheumatoid arthritis and other types of arthritis. It is an autoimmune disorder. The disease commonly occurs in children from the ages of 7 to 12, but it may occur in adolescents as old as 15 years of age, as well as in infants. SJIA affects approximately 1 in 1,000 children in any given year, with about 1 in 10,000 having a more severe form.

Symptoms of SJIA are often non-specific in the preliminary stage, and characterized by lethargy, reduced physical activity, and poor appetite. In children, limping could be taken as first manifestation of the disease. Children could also feel quite ill, including flu-like symptoms that persist. The major symptom is persistent swelling of the affected joint(s), which commonly include the knee, ankle, wrist and small joints of the hands and feet. Swelling may be difficult to detect clinically, especially for joints such for those of the spine, sacroiliac joints, shoulder, hip and jaw, where imaging techniques such as ultrasound or MRI are very useful. Pain is an important symptom, morning stiffness which gradually improves later in the day is a common feature.Late effects of arthritis include joint contracture (stiff, bent joint) and joint damage. Children with JIA may indicate the symptoms in different degrees in which they are affected and they may also have swollen joints.

The approval of this drug was based on the results of two Phase III trials with patients suffering from SJIA. Canakinumab manifested significant improvement in majority of the treated patients with age group between 2-19 years.Result of one study showed that 84% of patients treated with one subcutaneous dose of Ilaris achieved the primary endpoint of the adapted paediatric American College of Rheumatology 30 (ACR30), compared to 10% patient’s achievement of ACR30 for placebo at Day 15. In the open-label part (where the investigator and subjects knows about what intervention given to the subjects),of the second study, 92 of 128 patients attempted "corticosteroid tapering". Out of those 92 patients, 62% were able to substantially reduce their use of corticosteroids, and 46% completely discontinued corticosteroids.

The side effects of this drug is that it can interfere with the immune responses to infections, thus increasing the risk for serious infections and malignancies. Physicians has to be cautious when administering Canakinumab to patients with infections, a history of recurring infections or underlying conditions that may predispose to infection. The most common adverse events are cold symptoms (including runny nose and sore throat), upper respiratory tract infection, pneumonia, urinary tract infection, gastroenteritis, stomach pain etc.

The efficacy of this drug along with its less dosing in patients(like monthly subcutaneous dosing)make it one of the most promising and exciting new option for children suffering fromthis debilitating disease. The drug also has the potential to reduce corticosteroid usage, which is a major important aspect as use of this drug could eliminate the side effects associated with long-term use of corticosteroids in children. Thus Canakinumab opens a new dimension for the treatment of SJIA.

Clinnovo is a clinical innovation company. It is pioneer CRO industry in India. Clinnovo offers professional Clinical Research Course, clinical data management course , SAS and imaging training. Clinnovo has been serving different bio-pharma industries across the world with excellence and high quality. For more information contact at +91 9912868928, 040 64635501

Related Articles - FDA, active, systemic, juvenile, idiopathic, arthritis, drug, Canakinumab, Ilaris, human monoclonal, antibody, subcutaneous, injection, childhood,

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