EC approve label update for Humira

AbbVie (NYSE: ABBV) has announced the European Commission (EC) has approved an update to the label for HUMIRA® (adalimumab) for the treatment of adults with moderate to severe rheumatoid arthritis (RA). The update adds data demonstrating the long-term clinical benefit of HUMIRA, making it the first and only biologic medication available with data on label to support its use for up to 10 years.

“HUMIRA is one of the most comprehensively studied biologics available,” said John R. Medich, PhD, divisional vice president, Immunology Clinical Development, Global Pharmaceutical Research and Development, AbbVie. “This label update reinforces AbbVie’s solid commitment to research in rheumatoid arthritis. In addition, the overall clinical database for HUMIRA spans 15 years across multiple indications, including 71 clinical trials and over 23,000 patients.”

This label update was based on data from the open-label extension of AbbVie’s DE019 study that evaluated the use of HUMIRA treatment for up to 10 years in patients with long-standing moderate to severe RA and an inadequate response to methotrexate (MTX). Patients were assessed for improvements in signs and symptoms of the disease, such as joint pain, swelling and stiffness, as well as physical function. In this open-label extension, most patients who were ACR responders in the double blind portion of the trial, maintained response when followed for up to 10 years.

Improvement in physical function was measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI), which is a measure of a patient’s functional ability.  In the DE019 open-label extension study, most patients who achieved improvement in physical function and continued treatment with HUMIRA 40 mg every other week plus MTX, maintained improvement through 10 years of open-label treatment.

DE019 also assessed the ability of HUMIRA to inhibit radiographic progression. Data from the open-label extension phase of DE019 indicate that the reduction in rate of progression of structural damage was maintained for 8 and 10 years in a subset of patients. At 8 years, 81 of 207 patients originally treated with 40 mg of HUMIRA every other week plus methotrexate were evaluated radiographically.  Among those, 48 patients showed no progression of structural damage defined by a change from baseline in the modified total Sharp score (mTSS) of 0.5 or less. The mTSS is a score used to measure the degree of radiographic progression.  At 10 years, 79 of the 207 patients originally treated with 40 mg Humira every other week plus methotrexate were evaluated radiographically. Among those, 40 patients showed no progression of structural damage.

DE019 was a Phase 3, randomised, placebo-controlled trial in which patients with long-standing moderate to severe RA and an inadequate response to MTX were randomised to one year of HUMIRA or placebo injections; all received concomitant MTX. The primary endpoints were ACR 20 response rate at 6 months, change in HAQ-DI and change in mTSS at week 52.  Results of this trial demonstrated the clinical, functional and radiographic superiority of HUMIRA plus MTX over placebo plus MTX.

Humira in combination with methotrexate is indicated for:

• the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate
• the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Humira 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 methotrexate.