primarily localized allergic hypersensitivity reactions and allergic rash.
Isolated mild to moderate elevations of liver aminotransferases (ALT more common than AST) were observed in children with JIA exposed to Humira alone; liver enzyme test elevations were more frequent among those treated with the combination of Humira and MTX than those treated with Humira alone. In general, these elevations did not lead to discontinuation of Humira treatment.
In the JIA trial, 10% of patients treated with Humira who had negative baseline anti-dsDNA antibodies developed positive titers after 48 weeks of treatment. No patient developed clinical signs of autoimmunity during the clinical trial.
Approximately 15% of children treated with Humira developed mild-to-moderate elevations of creatine phosphokinase (CPK). Elevations exceeding 5 times the upper limit of normal were observed in several patients. CPK levels decreased or returned to normal in all patients. Most patients were able to continue Humira without interruption.
Psoriatic Arthritis and Ankylosing Spondylitis Clinical Studies
Humira has been studied in 395 patients with psoriatic arthritis (PsA) in two placebo-controlled trials and in an open label study and in 393 patients with ankylosing spondylitis (AS) in two placebo-controlled studies. The safety profile for patients with PsA and AS treated with Humira 40 mg every other week was similar to the safety profile seen in patients with RA, Humira Studies RA-I through IV.
Crohn’s Disease Clinical Studies
Humira has been studied in 1478 patients with Crohn’s disease (CD) in four placebo-controlled and two open-label extension studies. The safety profile for patients with CD treated with Humira was similar to the safety profile seen in patients with RA.
Ulcerative Colitis Clinical Studies
Humira has been studied in 1010 patients with ulcerative colitis (UC) in two placebo-controlled studies and one open-label extension study. The safety profile for patients with UC treated with Humira was similar to the safety profile seen in patients with RA.
Plaque Psoriasis Clinical Studies
Humira has been studied in 1696 patients with plaque psoriasis (Ps) in placebo-controlled and open-label extension studies. The safety profile for patients with Ps treated with Humira was similar to the safety profile seen in patients with RA with the following exceptions. In the placebo-controlled portions of the clinical trials in Ps patients, Humira-treated patients had a higher incidence of arthralgia when compared to controls (3% vs. 1%).
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Humira. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Humira exposure.
Gastrointestinal disorders: Diverticulitis, large bowel perforations including perforations associated with diverticulitis and appendiceal perforations associated with appendicitis, pancreatitis
General disorders and administration site conditions: Pyrexia
Hepato-biliary disorders: Liver failure
Immune system disorders: Sarcoidosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps): Merkel Cell Carcinoma (neuroendocrine carcinoma of the skin)
Nervous system disorders: Demyelinating disorders (e.g., optic neuritis, Guilla |
