Abbott (ABBOTT PARK, Illinois), announced it has received marketing authorization from the European Commission for the use of the TNF antagonist HumiraR (adalimumab) as a treatment for moderate-to-severe plaque psoriasis. Humira is the first fully human, self-injectable biologic for the treatment of psoriasis. In one clinical trial, >80% of patients taking the drug achieved skin clearance of >e;75% and in another trial, ~75% of patients achieved 75% clearance. In both trials, ~50% of the patients taking Humira achieved 90% clearance as early as 16 weeks into treatment. Psoriasis is the fifth approved indication for Humira in the EU. A regulatory application for the drug to treat psoriasis is also under review with the US FDA.

In the EU, the treatment is now indicated for the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to, who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate (MTX), or PUVA. The recommended dosing for adult patients with moderate-to-severe psoriasis is 80 mg at week 0, followed by 40 mg eow starting at week 1. Humira is administered subcutaneously.

The approval in the EU is primarily based on the results of two randomized, controlled, multicenter clinical trials in adult patients: CHAMPION and REVEAL. In both trials, the signs and symptoms of psoriasis were measured and evaluated using the Psoriasis Area and Severity Index among other measures. CHAMPION was the first head-to-head study comparing a biologic medication with MTX. The most commonly reported adverse events were nasopharyngitis, upper respiratory tract infection and headache.

Humira is the only fully human monoclonal antibody approved in the US and Europe for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and Crohn's disease. To date, the drug has been approved in 73 countries and >190,000 people worldwide are currently use the treatment.

In Europe, Humira plus MTX is indicated for the treatment of moderate-to-severe, active RA in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including MTX has been inadequate, and for the treatment of severe, active and progressive RA in adults not previously treated with MTX. Humira can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. The drug has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.

Also in Europe, Humira is indicated for the treatment of active and progressive PsA in adults whose response to previous DMARD therapy has been inadequate and for the treatment of severe, active AS also in adults who response to conventional therapy has been inadequate. Humira is indicated for treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant, or who are intolerant to or have medical contraindications for such therapies. For induction treatment, Humira should be given in combination with corticosteroids. The drug can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate.

In May 2007, Abbott announced it had submitted EU and US regulatory applications for Humira to treat juvenile RA, also known as juvenile idiopathic arthritis. Clinical trials are underway evaluating the drug's potential in ulcerative colitis.