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News Release - September 18, 2008
Continuous Treatment With Abbott's HUMIRA(R) Achieves Superior Long-Term Efficacy for Psoriasis Patients Compared to Interrupting TreatmentAdditional Analysis Shows HUMIRA Effectively Treats Adult Patients with Moderate to Severe Psoriasis Regardless of Age, Duration of Disease, Diagnosis of Psoriatic Arthritis or Recent Systemic Therapy
PARIS, Sept. 18 (HSMN NewsFeed) -- More psoriasis patients achieve efficacy when they receive continuous treatment with HUMIRA® (adalimumab) compared to patients who interrupt their therapy, according to data presented at the European Academy of Dermatology and Venereology (EADV) Congress in Paris. The findings were from a sub-analysis of Abbott's pivotal, 52-week study, REVEAL (The Randomized Controlled EValuation of Adalimumab Every Other Week in Moderate to Severe Psoriasis Trial) and the period of open-label treatment that followed.
The sub-group analysis was designed to determine whether interrupting HUMIRA treatment would affect efficacy in psoriasis patients who had already achieved good response to HUMIRA. After 33 weeks, patients who had achieved adequate response to HUMIRA (as measured by PASI 75, or greater than 75 percent clearance) were randomized into two groups. One group continued to receive HUMIRA and the other was given placebo. Beginning at week 52, all patients received HUMIRA during the open-label extension period.
Patients who had maintained adequate response after HUMIRA was discontinued were more likely to achieve a PASI 75 response when they were restarted on treatment. Among those who discontinued and then re-started HUMIRA, 84 percent of the 161 patients who had maintained adequate response achieved PASI 75 after 24 weeks of re-treatment, compared to 55 percent of the 66 patients who had lost adequate response after stopping treatment. A loss of adequate response was defined as less than PASI 50 response relative to baseline and at least a 6-point increase in PASI score relative to week 33.
"The goal of treatment for dermatologists is to maintain disease remission, and these results are relevant to use of HUMIRA in psoriasis patents," said Kim Papp, M.D., of Probity Medical Research in Waterloo, Ontario Canada.
A separate analysis of REVEAL evaluated whether specific patient characteristics would affect the efficacy of HUMIRA therapy. This second sub-group analysis found that HUMIRA effectively treats adults with psoriasis regardless of a patient's age, disease duration, whether the patient has a diagnosis of psoriatic arthritis (PsA), or if he or she has a recent history of systemic therapy, including biologic treatments. At 16 weeks, 71 percent of patients treated with HUMIRA achieved a PASI 75 response, compared with 6.5 percent of patients treated with placebo, with similar results seen among the patient subgroups.
Percentages of HUMIRA patients in subgroups who achieved PASI 75 at 16 weeks:
* Age (mean age = 44.5 years)
o 74 percent of patients 18-39 years
o 70 percent ages 40-64 years
o 61 percent age 65 and older
* Psoriasis duration (mean duration = 18.2 years)
o 68 percent diagnosed between 0.5-9.7 years
o 67 percent 9.7 - 15.9 years
o 82 percent 15.9 - 24.8 years
o 73 percent 24.8 - 65 years
* PsA diagnosis
o 70 percent of patients with a medical history of PsA
* Prior systemic treatment
o 78 percent of patients with recent history of systemic biologic
o 68 percent of patients with recent history of non-biologic
"These results are very reassuring for dermatologists and are important because they demonstrate that HUMIRA is a treatment option that is effective in a variety of patients with moderate to severe psoriasis," said Alan Menter, M.D., Baylor University Medical Center.
"These studies pertain to the efficacy of HUMIRA and provide further evidence for physicians and patients regarding HUMIRA's ability to clear the frequently-painful skin lesions associated with psoriasis," said Rebecca Hoffman, M.D., divisional vice president, Immunology, Abbott. "Abbott is committed to continuing research into HUMIRA's optimal use in psoriasis and other therapeutic areas."
About the REVEAL Trial
The REVEAL study was a 52-week, double blind, randomized, placebo-controlled Phase III trial to evaluate the efficacy and safety of HUMIRA in 1,212 patients with moderate to severe chronic psoriasis in the United States and Canada.
Psoriasis affects an estimated 125 million people worldwide. The severity of the disease varies from person to person with approximately 25 percent of people with psoriasis experiencing moderate to severe disease.
Psoriasis can develop anywhere on the skin and most commonly appears on the scalp, knees, elbows, lower back, hands and feet. It may even occur in the fingernails and toenails. While psoriasis occurs in people of all ages, it typically first appears in people between the ages of 15 and 25.
Psoriasis can be a very isolating disease and people with psoriasis may suffer from poor self-image, depression and an increased risk of premature death.
Important Safety Information
Globally, prescribing information varies; refer to the individual country product label for complete information.
Serious infections, sepsis, rare cases of tuberculosis (TB), and opportunistic infections, including fatalities, have been reported with the use of TNF antagonists, including HUMIRA. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease could predispose them to infections. Patients must be monitored closely for infections, including tuberculosis, before, during and after treatment with HUMIRA. Treatment should not be initiated in patients with active infections until infections are controlled. HUMIRA should not be used by patients with active TB or other severe infections such as sepsis and opportunistic infections.
If latent tuberculosis is diagnosed, appropriate treatment for latent tuberculosis must be initiated with anti-tuberculosis prophylaxis therapy before starting treatment with HUMIRA, and in accordance with local recommendations. Patients who develop new infections while using HUMIRA should be monitored closely. 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-blocking agents have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of the virus. Some cases have been fatal. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating HUMIRA.
The combination of HUMIRA and anakinra and HUMIRA and abatacept is not recommended.
TNF antagonists, including HUMIRA, have been associated in rare cases with demyelinating disease including multiple sclerosis, Guillain-Barre syndrome and optic neuritis, and serious allergic reactions. Rare reports of pancytopenia including aplastic anemia have been reported with TNF-blocking agents. Adverse events of the haematologic system, including medically significant cytopenia have been infrequently reported with HUMIRA.
More cases of malignancies including lymphoma have been observed among patients receiving a TNF antagonist compared with control patients in clinical trials. The size of the control group and limited duration of the controlled portions of studies precludes the ability to draw firm conclusions.
Furthermore, there is an increased background lymphoma risk in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation. During the long-term open-label trials with HUMIRA, the overall rate of malignancies was similar to what would be expected for an age, gender and race matched general population. With the current knowledge, a possible risk for the development of lymphomas or other malignancies in patients treated with a TNF antagonist cannot be excluded.
All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment, should be examined for the presence of non-melanoma skin cancer prior to and during treatment with HUMIRA.
Rare postmarketing cases of hepatosplenic T-cell lymphoma have been identified in patients treated with adalimumab. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. Some of these hepatosplenic T-cell lymphomas with HUMIRA have occurred in young adult patients on concomitant treatment with azathioprine or 6-mercaptopurine used for Crohn's disease. A risk for the development of hepatosplenic T-cell lymphoma in patients treated with HUMIRA cannot be excluded.
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. Physicians should exercise caution when using HUMIRA in patients who have heart failure and monitor them carefully. HUMIRA should not be used in patients with moderate or severe heart failure.
The most frequently reported adverse event (>1/10 patients) at least possibly causally related to HUMIRA is injection site reaction (including pain, swelling, redness or pruritus). Other common adverse events (reported by >1/100 patients) at least possibly causally related to HUMIRA include lower respiratory infections (including pneumonia, bronchitis), viral infections (including influenza, herpes infections), candidiasis, bacterial infection (including urinary tract infections), upper respiratory infection, dizziness (including vertigo), headache, neurologic sensation disorders (including paraesthesias), cough, nasopharyngeal pain, diarrhea, abdominal pain, stomatitis and mouth ulceration, nausea, hepatic enzymes increased, rash, pruritus, musculoskeletal pain, pyrexia, fatigue (including asthenia and malaise). Adverse drug reactions reported post-marketing include intestinal perforation, interstitial lung disease including pulmonary fibrosis and cutaneous vasculitis.
HUMIRA is the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), psoriasis, ankylosing spondylitis (AS), Crohn's disease and juvenile idiopathic arthritis (JIA) in the United States and Europe. HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-alpha), a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases. To date, HUMIRA has been approved in 76 countries and more than 270,000 people worldwide are currently being treated with HUMIRA. Clinical trials are also under way evaluating the potential of HUMIRA in ulcerative colitis.
In Europe, HUMIRA, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active RA in adult patients when the response to disease-modifying anti-rheumatic 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. 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 MTX.
Also in Europe, HUMIRA is indicated for the treatment of active and progressive PsA in adults when the response to previous DMARD therapy has been inadequate and for the treatment of severe, active AS in adults who have had an inadequate response to conventional therapy. HUMIRA has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.
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 cortiocosteroids. HUMIRA can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate.
HUMIRA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA.
HUMIRA in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in adolescents aged 13 to 17 years who have had an inadequate response to one or more DMARDs. HUMIRA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Abbott's Commitment to Immunology
Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. The Abbott Bioresearch Center, founded in 1989 in Worcester, Mass., United States, is a world-class discovery and basic research facility committed to finding new treatments for autoimmune diseases.
Abbott (NYSE: ABT) 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 68,000 people and markets its products in more than 130 countries.
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