Humira now approved for Crohn’s disease in adolescents

The indications for AbbVie’s Humira (adalimumab subcutaneous [SC] injection) have been extended to include the management of Crohn’s disease in adolescents (13–17 years of age). Humira is the first subcutaneous biologic to be approved in Canada for the treatment of Crohn's disease in children.The drug is specifically indicated for reducing signs and symptoms, and inducing and maintaining clinical remission, in children 13–17 years of age weighing ≥ 40 kg with severely active Crohn’s disease—and/or those who have had an inadequate response or were intolerant to conventional therapy (a corticosteroid and/or aminosalicylate and/or an immunosuppressant) and/or a tumour necrosis factor alpha antagonist.For this new indication, the recommended induction dosage regimen is 160 mg at Week 0 (administered as four 40 mg SC injections in one day or as two 40 mg SC injections per day for two consecutive days), followed by 80 mg at Week 2 (given as two 40 mg SC injections in one day).The recommended maintenance dosage is 20 mg SC every other week beginning at Week 4. Increasing the maintenance dose to 40 mg SC every other week may be considered in adolescents who experience a disease flare or non-response.The use of adalimumab in adolescents with Crohn’s disease has been evaluated in clinical studies of up to one year in duration. If a patient has not responded by Week 12, continuing adalimumab therapy should be reconsidered.Humira is supplied in a 40 mg/0.8 mL single-use pen and a 40 mg/0.8 mL single-use prefilled syringe. A 40 mg/0.8 mL single-use vial is also available for children who do not require a full 40 mg dose (eg, for children who require the 20 mg every other week maintenance dose).Humira is also approved in Canada for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, and psoriasis in adults. In addition, it is indicated for use in children 4–17 years of age for the treatment of polyarticular juvenile idiopathic arthritis. ReferencesCanada Newswire. New treatment option available for Canadian children living with severely active pediatric Crohn's disease. Montreal, QC; August 27, 2013. www.newswire.ca/en/story/1215475/new-treatment-option-available-for-canadian-children-living-with-severely-active-pediatric-crohn-s-disease (accessed August 28, 2013).AbbVie Corporation. Humira (adalimumab subcutaneous injection) product monograph. St-Laurent, QC; August 21, 2013.

Humira now approved for Crohn’s disease in adolescents

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