Abbott Launches Humira (Adalimumab) For Crohn's Disease

Main Category: Crohn's
Also Included In: GastroIntestinal / Gastroenterology
Article Date: 14 Jun 2007 - 1:00 PDT

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Abbott launches HUMIRA® (adalimumab) as a treatment for severe, active Crohn's disease. Adalimumab is the first fully-human tumour necrosis factor antagonist (anti-TNF) to receive a licence for Crohn's disease, a chronic inflammatory disease of the gastrointestinal tract that impairs the lives of up to 60,000 people in the UK1 and causes 70-80% of patients to require major surgery within their lifetime.2

"Currently, there is no cure for Crohn's disease, which reinforces the need for effective treatment options that will help maintain control of the disease. Adalimumab represents an important advance in managing this serious and debilitating condition," said Professor Ghosh, Gastroenterologist from Hammersmith Hospital, London.

Clinical trials of adalimumab showed that:

-- Adalimumab demonstrated response from as early as week one3
-- Three times as many patients who continued on adalimumab maintained clinical remission*at one year compared with placebo4
-- 29% of patients on adalimumab in clinical remission at one year were able to discontinue use of corticosteroids compared with only 6% on placebo.4

Adalimumab is the second anti-TNF licenced for Crohn's disease but the first to offer adult patients the convenience of self-injection at home.

"The unpredictability of Crohn's disease makes it difficult to lead a normal life as the disease can flare-up at any time. We welcome the approval of adalimumab as a new treatment option which will assist patient independence and improve quality of life for Crohn's disease patients" said Richard Driscoll, Director of the National Association for Colitis and Crohn's Disease (NACC).

How adalimumab works

Adalimumab is a fully human monoclonal antibody that works by specifically blocking the activity of TNF, which is a key component of the inflammatory process associated with Crohn's disease. Fully human monoclonal antibodies are essentially indistinguishable from antibodies found in the body and represent the latest advance in the evolution of monoclonal antibodies.

Clinical trials

The EMEA's decision is based on the results of three-randomised, double-blind, placebo-controlled, multi-centre trials of adalimumab. In each trial, clinical remission was measured by a Crohn's Disease Activity Index (CDAI) score of less than 150. CDAI is a weighted composite score of eight clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, levels of general wellness and other measures.

CLASSIC I (Clinical assessment of Adalimumab Safety and efficacy Studied as an Induction therapy in Crohn's disease)3 was a study of 299 patients with moderate to severe Crohn's disease who were new to anti-TNF therapy. Results showed that adalimumab demonstrated response from week 1 and resulted in a greater percentage of patients achieving clinical remission at four weeks compared to placebo.

CHARM (Crohn′s trial of the fully Human antibody Adalimumab for Remission Maintenance) 4 was a 56-week trial that enrolled 854 patients with moderate to severely active Crohn's disease. The 499 patients who demonstrated clinical response (CDAI decrease of greater than or equal to 70 points from baseline) to adalimumab during a four-week, open-label induction phase were randomized to receive either adalimumab or placebo. Three times as many patients who continued on adalimumab maintained clinical remission at one year compared to placebo.

GAIN (Gauging Adalimumab effectiveness in Infliximab Non-Responders)5 evaluated the efficacy of adalimumab in 325 patients with moderate to severely active Crohn's disease who had previously lost response or were unable to tolerate infliximab. Adalimumab induced significantly higher rates of clinical remission compared to placebo.

More about Crohn's disease

Typically diagnosed before the age of 40, 6 Crohn's disease can have a devastating impact on the day-to-day life of patients, many of whom are young and active. Five years after developing Crohn's, 15-20% of people are disabled to some degree by their disease.7 Common symptoms include diarrhoea, abdominal pain, weight loss, fever, and in some cases, rectal bleeding. Many patients develop complications such as intestinal obstruction, fistulas (ulcers that form tunnels to surrounding tissues), and malnutrition.

Adalimumab licensed indications8

Crohn's disease

Adalimumab 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, adalimumab should be given in combination with cortiocosteroids. Adalimumab can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate.

The recommended adalimumab induction dose regimen for adult patients with severe Crohn's disease is usually 80 mg at week 0 followed by 40 mg at week 2.

In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80 mg at week 2, can be used with the awareness that the risk for adverse events is higher during induction. After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection.

Rheumatoid arthritis

Adalimumab in combination with methotrexate, is indicated for:

-- the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.

-- the treatment of severe, active and progressive RA in adults not previously treated with methotrexate.

Psoriatic arthritis

Article Type Normal Article Headline Article Article Type 2 Normal What Is? Insert for Today 14 June 1Adalimumab is indicated for the treatment of active and progressive psoriatic arthritis (PsA) in adults when the response to previous disease-modifying anti?rheumatic drug therapy has been inadequate.

Ankylosing spondylitis

Adalimumab is indicated for the treatment of adults with severe active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy.

For RA, PsA and AS, adalimumab is usually administered as 40mg every other week as a single dose via subcutaneous injection.

Please refer to the Summary of Product Characteristics for full information on adalimumab including contraindications, special warnings and precautions and side effect information.8

To date, adalimumab has been approved across indications in 67 countries, and more than 180,000 people worldwide are currently being treated with adalimumab. Clinical trials are currently under way evaluating the potential of adalimumab in other immune-mediated diseases.

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, device and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.

http://www.abbott.com

References

1 The National Association for Colitis and Crohn's Disease (UK) IBD Basics Accessed 04 April 2007 http://www.nacc.org.uk/content/ibd.asp
2 Carter M et al. Guidelines for the management of inflammatory bowel disease in adults. Gut. 2004; 53: 1-16
3 Hanauer SB, et al. Human anti-tumour necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC 1 trial. Gastroenterology 2006; 130:323-333
4 Colombel JF, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology 2007;132:52-65
5 Sandborn, Rutgeerts et al. Adalimumab Induction Therapy for Crohn Disease Previously Treated with Infliximab: A Randomized Trial. nnals of internal Medicine 2007;146 (12)
6 Crohn's disease NHS Direct Online Health Encyclopedia Accessed 22 May 2006 http://www.nhsdirect.nhs.uk
7 Binder V, et al. Prognosis in Crohn's disease--based on results from a regional patient group from the county of Copenhagen. Gut 1985 Feb;26(2):146-50
8 Electronics Medicines Compendium Humira (adalimumab) Summary of Product characteristics http://www.emc.medicines.org.ukbr>