Abbott Receives Positive Opinion for HUMIRA(R) (Adalimumab) As First-Line Treatment of Moderate to Severe Early Rheumatoid Arthritis
Posted on: Monday, 27 June 2005, 09:00 CDT
ABBOTT PARK, Ill., June 27 /PRNewswire-FirstCall/ -- Abbott today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has issued a positive opinion recommending approval of HUMIRA(R) (adalimumab) for the first-line treatment of moderate to severe early rheumatoid arthritis (RA).
The positive opinion is based on results of the two-year, Phase III PREMIER study that found that methotrexate-naive patients with early RA, defined as RA for less than three years, experienced significant improvement in signs and symptoms while taking HUMIRA in combination with methotrexate.
The PREMIER study also found that approximately one in two patients receiving combination therapy achieved clinical remission by year two as defined by DAS28<2.6. The Disease Activity Score (DAS) measures disease activity responses in RA by assessing tender and swollen joint count, general health status and an inflammatory marker.
The PREMIER study showed that 62 percent of patients receiving combination therapy achieved ACR 50 at one year compared to only 46 percent in the group receiving only methotrexate. At two years, 59 percent of patients on combination therapy reached ACR 50 compared to 43 percent on methotrexate alone. ACR 50 is a measure developed by the American College of Rheumatology indicating a 50 percent or greater improvement in tender and swollen joint count and other clinical measures. PREMIER was the first trial of a tumor necrosis factor (TNF) antagonist (a treatment that targets TNF, a protein implicated in RA) to use ACR 50 as a primary endpoint and achieve it.
The positive opinion follows Abbott's simultaneous submission in December 2004 of a Type II Variation to the EMEA and a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval to market HUMIRA as a first-line treatment of moderately to severely active early RA.
"The committee recommendation signals that HUMIRA will provide patients and physicians with another first-line treatment option to combat this potentially debilitating disease," said Alejandro Aruffo, Ph.D., vice president, Global Pharmaceutical Research and Development, and president, Abbott Bioresearch Center, Abbott.
HUMIRA is currently indicated for the treatment of moderate to severe active RA in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate. Abbott was granted European Union approval to market HUMIRA in September 2003. The European Commission is expected to make an authorization decision regarding the marketing of HUMIRA for early RA in European Union countries in approximately 90 days.
More About PREMIER
The second primary endpoint, inhibition of radiographic progression, was measured by the change in Total Sharp Score (TSS), which assesses the change in bone erosion and joint-space narrowing on X-rays. The HUMIRA-methotrexate combination achieved significantly more favorable results than methotrexate alone in inhibiting radiographic disease progression. After one year, the mean change from baseline in TSS score for the combination arm was 1.3 as compared to 5.7 in the methotrexate alone arm. After two years, patients in the methotrexate-only group experienced five times the radiographic progression of patients in the combination therapy group, with mean change from baseline in TSS scores of 10.4 and 1.9, respectively. Also, 76 percent of patients treated with combination therapy showed no signs of radiographic progression at six months as measured by the change in TSS. Of these patients, 74 percent continued to show no progression after two years.
PREMIER data also showed that nearly half (49 percent) of early RA patients receiving combination therapy achieved clinical remission at two years, as defined by DAS28<2.6. Only 25 percent of patients taking methotrexate alone achieved a DAS28<2.6 at two years. At one year, DAS28<2.6 was achieved by 43 percent of patients in the combination group compared to 21 percent on methotrexate alone.
"Biologics like HUMIRA are helping to change the way we treat RA by allowing rheumatologists to measure for evidence of clinical remission in addition to clinical response," said Ferdinand Breedveld, M.D., professor, Department of Rheumatology, University of Leiden, Leiden, Netherlands and PREMIER study investigator.
PREMIER, a two-year, double-blind, controlled study compared the effectiveness of HUMIRA, methotrexate and the combination of the two drugs in adult patients with RA of less than three years duration who had not previously used methotrexate. A total of 799 methotrexate-naive patients were separated into three groups with each group receiving either the combination therapy of 40 mg HUMIRA every other week with methotrexate, HUMIRA alone or methotrexate alone.
About RA
More than five million people worldwide suffer from RA, a chronic autoimmune disease that causes pain, swelling and stiffness in the joints of the hands, feet and wrists, and often leads to the destruction of joints. Unlike osteoarthritis, the most common form of arthritis, RA is an autoimmune disease where joints are inflamed, resulting in eventual destruction of the joints' interior and the surrounding bone.
More information on RA and current treatment options can be found at http://www.ra.com/ .
Important Safety Information
Common adverse events (>1/100 and less than or equal to 1/10) at least possibly causally related to HUMIRA include headache, dizziness, respiratory tract and urinary tract infection, nausea, diarrhea, sore throat, herpes simplex, abdominal pain, rash, pruritis and anemia. Injection site pain was reported by >1/10 patients.
Patients must be monitored closely for infections, including tuberculosis (TB), before, during and after treatment with HUMIRA. Treatment should not be initiated in patients with active infections until infections are controlled. Patients who develop new infections while using HUMIRA should be monitored closely. HUMIRA should not be used by patients with active TB or other severe infections such as sepsis and opportunistic infections. HUMIRA should be discontinued if a patient develops a new serious infection until infections are controlled. Physicians should exercise caution when considering use of HUMIRA in patients with a history of recurring infection or with underlying conditions that may predispose patients to infections.
TNF antagonists, including HUMIRA, have been associated in rare cases with exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease. Prescribers should exercise caution in considering the use of HUMIRA in patients with pre-existing or recent-onset central nervous system demyelinating disorders.
Physicians should exercise caution when using HUMIRA in patients who have heart failure and monitor them carefully. In clinical studies with another TNF antagonist, a higher rate of serious congestive heart failure (CHF) related adverse events including worsening CHF and new onset CHF have been reported. Cases of worsening CHF have also been reported in patients receiving HUMIRA.
About HUMIRA
HUMIRA is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to disease-modifying antirheumatic drugs including methotrexate has been inadequate. In this population, 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.
To ensure maximum efficacy, HUMIRA is given in combination with methotrexate. HUMIRA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment of methotrexate is inappropriate. HUMIRA offers convenient every-other-week dosing by subcutaneous injection (shot beneath the skin) via a specially designed, pre-filled syringe.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 60,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/ .
Abbott
CONTACT: International Media, Rand Walton, +1-847-938-8848, or U.S.Media, Kelly Morrison, +1-847-772-1074, or Financial Community, Larry Peepo,+1-847-935-6722, all of Abbott
Web site: http://www.abbott.com/http://www.ra.com/
Company News On-Call: http://www.prnewswire.com/comp/110328.html
Source: PRNewswire-FirstCall
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