FDA has extended the indication for adalimumbab (Humira, AbbVie) to include the treatment of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) to reducing signs and symptoms in patients aged 2 years and older.
FDA has extended the indication for adalimumab (Humira, AbbVie) to include the treatment of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients aged 2 years and older.
Humira was approved in the United States in 2008 for polyarticular JIA in patients aged 4 and older.
“The approval of Humira for moderately to severely active polyarticular JIA in those that are 2 years of age or older serves to increase the availability of this agent to a larger number of patients,” according to Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala.
“The lowering of the initial starting age from 4 years old to 2 years old now allows younger patients to be treated and ultimately be able to enjoy improved quality of life," Dr Farinde said.
Humira will be available to patients aged 2 years and older with polyarticular JIA with the dose based on patient weight. Humira is available for this patient population in a 10-mg pre-filled syringe, 20-mg pre-filled syringe, 40-mg pre-filled syringe and 40-mg Humira auto-injector pen.
JIA is the most common form of childhood arthritis. Polyarticular JIA, which occurs in approximately 25% of all JIA patients, is 1 of 7 types of JIA, and involves 5 or more joints. Symptoms include painful, swollen and tender joints, limping, morning stiffness, decreased activity and the reluctance to use an arm or leg. Early diagnosis and appropriate management of JIA are important in managing this chronic disease.
In the European Union, Humira was approved in 2008 for the treatment of children and adolescents aged 4 to 17 years living with polyarticular juvenile idiopathic arthritis and in 2013 the age range was expanded to patients aged 2 to 17 years.