Humira(adalimumab)

Humira (adalimumab) is indicated for various inflammatory conditions. It was approved on June 30, 2016, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA). It is also indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients 2 years of age and older, and for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PsA). Additionally, Humira is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS).

For Crohn's disease, Humira is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy, or who have lost response to or are intolerant to infliximab. On September 23, 2014, it was approved for the treatment of pediatric Crohn’s Disease in patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to corticosteroids or immunomodulators. In a study, the 15 mg/kg anti-TNF group showed a 76% reduction in total EAU group mean scores (both eyes combined) compared to a control group mean score of 3.4 (moderate/severe). The 15 mg/kg anti-TNF group achieved a total EAU group mean score of 0.8 (minimal).

Safety data indicates a malignancy rate (excluding non-melanoma skin cancer, NMSC) of 0.7 per 100 patient-years in HUMIRA-treated adults, compared to 0.7 per 100 patient-years in control-treated adults. The NMSC rate in HUMIRA-treated adults was 0.8 per 100 patient-years, versus 0.2 per 100 patient-years in control-treated adults. Injection site reactions occurred in 20% of HUMIRA-treated patients compared to 14% in placebo-treated patients. Discontinuation due to adverse reactions in HUMIRA-treated RA patients was 7%.