Abbott Announces Patient Enrollment in Two Phase 3 Studies of HUMIRA® (adalimumab) for Moderate to Severe Hidradenitis Suppurativa - (Europe)
- Key Clinical Trials will Assess Drug’s Efficacy and Safety; No EMA-Approved Treatment Exists Today for Patients with Moderate to Severe Cases
Date: March 15, 2012
Abbott Park, Illinois (NYSE: ABT) — Abbott today announced the initiation of two Phase 3 clinical trials designed to evaluate the safety and efficacy of an investigational use of HUMIRA® (adalimumab) in adult patients with moderate to severe hidradenitis suppurativa (HS).
Hidradenitis suppurativa is a difficult-to-treat, chronic, inflammatory skin disease characterized by painful, recurrent abscesses, and nodules that primarily appear in the groin or under the armpits or breasts and start out as tender, swollen bumps. Over time, these lesions can fill with fluid, burst, and result in scars. This can lead to pain and discomfort.
“Treating hidradenitis suppurativa has remained a challenge for specialists and patients, since there is no
EMA-approved therapy available,” said Gregor Jemec, M.D., professor and chairman, Department of Dermatology, University of Copenhagen, Roskilde Hospital. “This investigation of adalimumab in HS patients is potentially a significant step for this underserved patient population.”
The Phase 3 trials (M11-313 and M11-810) are 36-week, multinational, randomized, double-blind, placebo-controlled studies designed to evaluate clinical outcomes and safety of adalimumab in approximately 600 patients with moderate to severe HS. They will be conducted at approximately 50 sites worldwide, including sites in Australia, Canada, Europe and the United States.
Selected inclusion criteria include: participants who have been diagnosed with moderate to severe HS for at least one year prior to enrollment with stable disease for the last two months, lesions in two distinct areas, and have had an inadequate response to at least a three-month trial of an oral antibiotic for treatment of moderate to severe HS. At baseline, subjects must have a total abscess and inflammatory nodule count of greater than or equal to three.
"Ten years ago, HUMIRA was approved for moderate to severe rheumatoid arthritis and since then has achieved five additional indications to treat millions of patients across a range of immune diseases," said John Medich, Ph.D., divisional vice president, Clinical Development, Immunology, Abbott. "Abbott is committed to investigating adalimumab as a treatment option for patients with hidradenitis suppurativa, and these studies represent another important step in continuing this exploration."
Results of these Phase 3 trials are expected in 2013. More information on the trials is available at www.clinicaltrials.gov (NCT01468207 and NCT01468233).
About HUMIRA® (adalimumab)
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. HUMIRA in combination with methotrexate, is 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 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.
HUMIRA in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in children and adolescents aged 4 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs. HUMIRA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. HUMIRA has not been studied in children aged less than 4 years.
HUMIRA is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. 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 the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
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.
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.
Important Safety Information for approved indications
Globally, prescribing information varies; refer to the individual country product label for complete information.
HUMIRA is contraindicated in people with hypersensitivity to the active substance or to any of the excipients; active tuberculosis or other severe infections such as sepsis and opportunistic infections; and moderate to severe heart failure (NYHA class III/IV).
Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, or viral pathogens, cases of tuberculosis (TB), and other opportunistic infections such as listeriosis and pneumocystis have been reported with the use of HUMIRA. Hospitalization or fatalities have been reported.
TNF-antagonists have been associated with reactivation of hepatitis B in patients who are chronic carriers of the virus. Some cases have been fatal. The frequency of serious infection among HUMIRA treated subjects over 65 years of age was higher than for those under 65 years of age.
TNF-antagonists, including HUMIRA, have been associated in rare cases of central nervous system demyelinating disease including multiple sclerosis and peripheral demyelinating disease including Guillain-Barré syndrome. Serious allergic reactions have been reported rarely following HUMIRA administration.
More cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients in clinical trials. Furthermore, there is an increased background lymphoma and leukemia risk in rheumatoid arthritis patients with longstanding, highly active, inflammatory disease, which complicates the risk estimation. With the current knowledge, a possible risk for the development of lymphomas, leukemia, or other malignancies in patients treated with a TNF-antagonist cannot be excluded.
Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-antagonists including HUMIRA in the post marketing setting.
Rare post marketing cases of hepatosplenic T-cell lymphoma, a disease with a very aggressive and usually fatal outcome, have been identified in patients treated with HUMIRA. Some of these cases 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.
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 reports of pancytopenia including aplastic anaemia have been reported with TNF-antagonists. Adverse events of the haematologic system, including medically significant cytopenia have been reported with HUMIRA.
Patients on HUMIRA may receive concurrent vaccinations, except for live vaccines. In clinical studies with another TNF-antagonist, worsening congestive heart failure (CHF) and mortality due to CHF have been reported. Cases of worsening CHF have also been reported in patients receiving HUMIRA.
The combination of HUMIRA and anakinra or HUMIRA and abatacept is not recommended.
The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling), headache and musculoskeletal pain.
The benefits and risks of HUMIRA should be carefully considered before starting therapy.
This is not a complete list of the Important Safety Information for HUMIRA.
For additional important safety information, please click for the Full Prescribing Information and Medication Guide.
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 approximately 91,000 people and markets its products in more than 130 countries.