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Adalimumab Approved by European Commission As a Treatment for Psoriatic Arthritis and Early Rheumatoid Arthritis

ABBOTT PARK, Ill., Aug. 15 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT - News) announced that it has received approval from the European Commission to market HUMIRA® (adalimumab) as a treatment for psoriatic arthritis and early rheumatoid arthritis (RA) in Europe.

"Until today, the options for patients and physicians seeking an effective medication to treat both the joint and skin aspects of psoriatic arthritis were limited," said Serge Steinfeld, M.D., Ph.D., professor of medicine, Erasme University Hospital, Brussels, Belgium. "This approval brings a new option and new hope in treating the potentially devastating physical aspects of a disease that can be accompanied by significant emotional elements."

HUMIRA will be available immediately to patients with psoriatic arthritis in Germany, United Kingdom, Spain, Finland and Denmark. Availability in other European Union countries will occur in subsequent months as each country adopts pricing and reimbursement policies.

"In addition to HUMIRA being approved for psoriatic arthritis, the approval for first-line use in RA opens the door for patients with severe, active and progressive RA to have the opportunity to experience the benefits of HUMIRA earlier in the treatment phase," said Alejandro Aruffo, Ph.D., vice president, Global Pharmaceutical Development and Abbott Bioresearch Center, Abbott. "This is important because the earlier we can treat RA with HUMIRA, the better the chances for slowing the progression of the disease."

The approval for psoriatic arthritis marks the second indication for HUMIRA, while the early RA approval establishes HUMIRA as a first-line treatment for severe, active and progressive RA in adults not previously treated with methotrexate. HUMIRA was previously approved for the treatment of moderate to severe, active RA in adult patients when the response to disease-modifying antirheumatic drugs including methotrexate has been inadequate.

A decision regarding the FDA's approval of HUMIRA for these expanded indications in the United States is anticipated by the end of 2005.

HUMIRA in Psoriatic Arthritis
Psoriatic arthritis combines the symptoms of arthritis, including joint inflammation, which leads to pain and possible damage, with the symptoms of psoriasis, such as dry, scaly skin. Psoriasis affects nearly 3 percent of the world's population and it is estimated that as many as 10-30 percent of psoriasis sufferers may develop psoriatic arthritis.

Abbott previously released clinical trial data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT) showing HUMIRA's ability to treat both the joint and skin symptoms associated with psoriatic arthritis. Patients' arthritic symptoms exhibited a response to HUMIRA, with nearly 60 percent of patients achieving ACR 20 at week 12, one of the study's primary endpoints, and with a sustained response through week 24. American College of Rheumatology (ACR) scores measure the percentage of improvement in tender and swollen joint count and a minimum of three out of five other clinical measures.

The study's second primary endpoint examined the change in modified Total Sharp Score (mTSS), a measurement used to assess changes in bone erosion and joint-space narrowing in X-rays, at week 24. Patients treated with HUMIRA had significantly less change in mTSS than patients treated with placebo at week 24. Approximately three times as many patients receiving placebo had worsening in their scores (increase in mTSS >0.5 units) than patients treated with HUMIRA (28.9 percent vs. 9 percent, respectively) at week 24. Data from the open-label extension showed that the inhibition of disease progression in patients taking HUMIRA at week 24 was maintained through week 48; two-year data will be collected for a future submission to European Medicines Agency (EMEA).

In addition, in this clinical study, among the 69 patients in the trial who had greater than 3 percent body surface involvement who were treated with HUMIRA, 42 percent achieved a PASI 90 response at 24 weeks, which reflects at least 90 percent improvement in psoriasis symptoms assessed by the Psoriasis Area and Severity Index (PASI).

HUMIRA as a First-Line Treatment for Severe Early RA
The first-line treatment approval gives patients with severe, active and progressive RA the opportunity to begin HUMIRA treatment after diagnosis. The PREMIER clinical trial, on which the approval was based, also demonstrated that the combination therapy of HUMIRA and methotrexate successfully inhibited radiographic progression (joint damage) in patients with recently diagnosed, severe RA (less than three years disease duration).

One of the study's co-primary endpoints was ACR 50. This measure indicates 50 percent or greater improvement in tender and swollen joint count and a minimum of three out of five other relevant clinical measures. At 52 weeks, approximately 62 percent of the patients on combination therapy achieved ACR 50, compared to 46 percent in the group receiving only methotrexate. PREMIER is the first RA study to achieve ACR 50 as a primary endpoint.

PREMIER's second primary endpoint, inhibition of radiographic progression, was measured by the change in mTSS. 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 mTSS score for the combination arm was 1.3 as compared to 5.7 in the methotrexate alone arm. After two years, the mean change from baseline in mTSS score for patients in the combination arm was 1.9, while patients in the methotrexate-only group experienced five times the radiographic progression, with mean clinically significant change from baseline in mTSS scores of 10.4. In addition, approximately two times more patients in the combination therapy group were without radiographic disease progression versus methotrexate alone (61 percent vs. 34 percent) at the end of year two. No radiographic progression was defined as PREMIER data also showed that nearly one in two (49 percent) of the early RA patients receiving combination therapy achieved clinical remission at two years, as defined by DAS28 The recommended dose of HUMIRA for psoriatic arthritis and the usual dose in RA is 40 mg every-other-week by subcutaneous injection (a shot beneath the skin). HUMIRA is packaged in specially designed pre-filled syringes, which feature handles and plunger heads designed for use by patients whose hands have been affected by their disease.

About Psoriatic Arthritis
Psoriatic arthritis combines symptoms of psoriasis, such as dry, scaly skin and patches of red, raised skin known as plaques, with arthritis symptoms including joint pain and inflammation. Common symptoms of psoriatic arthritis include varying degrees of psoriasis activity along with stiffness, pain, swelling and tenderness of the joints that can lead to a reduced range of motion and potential severe joint destruction.

Left untreated, psoriatic arthritis can be a progressively disabling disease. The arthritic manifestations often include debilitating disease of the hands and feet, as seen in rheumatoid arthritis, as well as painful inflammation of the tendon insertions and arthritis of the spine. Psoriatic arthritis is often found in patients who suffer from psoriasis, a chronic skin disease that affects nearly 3 percent of the world's population. It is estimated that as many as 10-30 percent of people with psoriasis also develop psoriatic arthritis.

Like RA, psoriatic arthritis is an autoimmune disorder in which a human protein, tumor necrosis factor-alpha (TNF-a), has been suggested to play a role in disease development. HUMIRA, which is a fully human monoclonal antibody that resembles antibodies normally found in the body, works by specifically blocking TNF-a.

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 . Important Safety Information
Common adverse events (>1/100 and less than or equal to 1/10) from RA clinical trials 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.

HUMIRA has been studied in 395 patients with psoriatic arthritis. Elevations in certain liver enzymes (alanine aminotransferase, ALT) were more common in these patients compared with patients in RA clinical studies.

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 antirheumatic drugs including methotrexate has been inadequate. 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. HUMIRA is also indicated for 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 of methotrexate is inappropriate.

HUMIRA is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate.

To date, HUMIRA has been approved in 58 countries and prescribed to more than 110,000 patients suffering from RA worldwide. Clinical trials are currently underway evaluating the potential of HUMIRA in other autoimmune diseases.

Source: Abbott

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