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Topic: Humira

In the News (Sun 27 Dec 09)

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	Psoriatic Arthritis Drug Humira® Submitted for US & European Approval
		The safety profile of HUMIRA in the psoriatic arthritis population was similar to that observed with HUMIRA in the rheumatoid arthritis population.
		HUMIRA is the only fully human monoclonal antibody approved by the FDA and the EMEA for reducing the signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis (RA) who have had insufficient response to one or more disease-modifying antirheumatic drugs (DMARDs).
		HUMIRA is the first fully human monoclonal antibody approved in Europe for RA, and the first tumor necrosis factor-alpha (TNF-α;) antagonist approved with an indication for use with methotrexate or as monotherapy.
	www.pharma-lexicon.com /medicalnews.php?newsid=17981 (1256 words)

	Abbott's HUMIRA® (adalimumab) Approved in the European Union for Treatment of Severe Ankylosing Spondylitis
		HUMIRA also is approved in the European Union for the treatment of severe, active and progressive rheumatoid arthritis and psoriatic arthritis.
		Rheumatoid Arthritis: 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 as well as 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.
	www.abbott.com /global/url/pressRelease/en_US/60.5:5/Press_Release_0322.htm (1240 words)

	Humira Information from Drugs.com
		Humira is used in the treatment of rheumatoid arthritis and psoriatic arthritis.
		Humira is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby.
		Humira is administered as a subcutaneous (under the skin) injection.
	www.drugs.com /humira.html (1513 words)

	Humira Online, Description, Chemistry, Ingredients - Adalimumab - RxList Monographs
		HUMIRA (adalimumab) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF).
		HUMIRA was created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions.
		HUMIRA is produced by recombinant DNA technology in a mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps.
	www.rxlist.com /cgi/generic3/humira.htm (335 words)

	Humira (Adalimumab) Approved in Europe for Treatment of Psoriatic Arthritis and as First-Line Treatment of Severe ... (Site not responding. Last check: 2007-10-12)
		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.
		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.
		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.
	www.pslgroup.com /dg/25200e.htm (1844 words)

	Abbott Receives FDA Approval for New HUMIRA® Delivery Device (Site not responding. Last check: 2007-10-12)
		HUMIRA is currently indicated for moderate to severe rheumatoid arthritis and for active arthritis in patients with psoriatic arthritis and is being studied as a possible treatment for other autoimmune diseases.
		HUMIRA is the only fully human monoclonal antibody approved by the FDA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
		HUMIRA is indicated for reducing the signs and symptoms of active arthritis in patients with psoriatic arthritis.
	www.abbott.com /global/url/pressRelease/en_US/60.5:5/Press_Release_0328.htm (1167 words)

	Humira 40 mg Solution for Injection in Pre-filled Syringe , SPC from the eMC (Site not responding. Last check: 2007-10-12)
		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 is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
		Humira treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis.
	emc.medicines.org.uk /emc/assets/c/html/displaydoc.asp?DocumentID=13111 (5091 words)

	Psoriasis patients receiving HUMIRA® (adalimumab) achieved significant improvement in disease activity (Site not responding. Last check: 2007-10-12)
		Results showed that 63 percent of patients receiving HUMIRA 40 mg eow were "clear" or "almost clear" of their psoriasis, as were 79 percent of patients taking HUMIRA 40 mg weekly after 60 weeks of therapy.
		HUMIRA is the only fully human monoclonal antibody approved by the FDA and the EMEA for reducing the signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).
		HUMIRA is the first fully human monoclonal antibody approved in Europe for RA, and the first tumor necrosis factor alpha (TNF-á) antagonist approved with an indication for use with methotrexate or as monotherapy.
	www.medicalnewstoday.com /medicalnews.php?newsid=20213 (1455 words)

	Rheumatoid Arthritis Treatment to help relieve pain and slow progression - HUMIRA (Site not responding. Last check: 2007-10-12)
		HUMIRA is approved for reducing the signs and symptoms, inducing major clinical response, slowing the progression of joint damage, and improving physical function in adult patients with moderate to severe rheumatoid arthritis.
		HUMIRA is also approved for reducing the signs and symptoms of active arthritis in patients with psoriatic arthritis.
		HUMIRA can be used alone or with methotrexate or other DMARDs (disease modifying anti-rheumatic drugs).
	www.humira.com /hu/huStore/cgi-bin/indexnewc.htm (600 words)

	Humira (Adalimumab) Receives Positive Opinion for Treatment of Psoriatic Arthritis from the European Medicines Agency (Site not responding. Last check: 2007-10-12)
		The positive opinion for Humira as a treatment for psoriatic arthritis is based upon two placebo-controlled studies, including data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT), a Phase III clinical trial showing patients on Humira achieved significant improvement in both arthritic and psoriatic signs and symptoms.
		Humira is currently approved by the EMEA for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (Dads), including methotrexate, has been inadequate.
		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.
	www.pslgroup.com /dg/24e9c2.htm (1419 words)

	Humira, Drug for Rheumatoid Arthritis - Health and Medical Information produced by doctors - MedicineNet.com
		Humira is a human antibody that blocks a protein known as tumor necrosis factor (TNF), which plays a key role in inflammation.
		HUMIRA can be used alone or in combination with methotrexate or other DMARDs.
		HUMIRA was found to reduce signs and symptoms of rheumatoid arthritis in over half the patients.
	www.medicinenet.com /script/main/art.asp?articlekey=22058&rd=1 (638 words)

	FDA Approves Humira for Rheumatoid Arthritis
		HUMIRA, developed by Abbot Laboratories, is designed to target the damaging protein cells and block them.
		HUMIRA is currently approved by the FDA for those patients with moderate or severe rheumatoid arthritis, whose use of disease-modifying anti-rheumatic drugs has had an inadequate response.
		Warnings about the use of HUMIRA include the possibility of serious infections including tuberculosis and sepsis, as is the case with other TNF-blocking agents.
	www.allaboutarthritis.com /AllAboutArthritis/layoutTemplates/html/en/contentdisplay/document/condition/arthritis/clinicalNews/humira_FDA_approved.htm (408 words)

	HUMIRA (adalimumab) (Site not responding. Last check: 2007-10-12)
		HUMIRA is indicated for reducing signs and symptoms and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
		HUMIRA is a human-derived antibody that binds to human tumor necrosis factor alpha (TNF alpha).
		The efficacy and safety of HUMIRA were assessed in four randomized, double-blind studies in adult patients.
	www.sparks.org /Library/FDADrugApprovals/HUMIRA.htm (250 words)

	News - Humira (Adalimumab) Improves Rheumatoid Arthritis Disease Activity
		The efficacy of Humira was assessed using the American College of Rheumatology ACR 20 response, which represents a 20 percent improvement in clinical measures such as the number of tender and swollen joints.
		Humira is available in a pre-filled syringe that was specially designed for use by patients who may have limited use of their hands as a result of the destructive progression of RA.
		Humira was isolated and optimized by Abbott and CAT as part of this collaboration.
	www.docguide.com /news/content.nsf/news/8525697700573E1885256CBE005CF231 (1620 words)

	Treatment Of Psoriatic Arthritis - Humira® (Adalimumab) Approved In Europe (Site not responding. Last check: 2007-10-12)
		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.
		HUMIRA, which is a fully human monoclonal antibody that resembles antibodies normally found in the body, works by specifically blocking TNF-.
		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.
	www.medicalnewstoday.com /medicalnews.php?newsid=29453&nfid=crss (1636 words)

	New Warnings on Humira Drug Label
		Humira was approved by the FDA in 2002.
		The new warning says Humira should be "discontinued immediately" if anaphylactic or other serious reactions occur, noting that overall, about 1% of patients taking Humira in clinical trials had allergic reactions.
		Humira isn't the only rheumatoid arthritis drug in its class with warnings on its label.
	www.webmd.com /content/article/96/103938.htm (364 words)

	News - Humira (Adalimumab) Receives FDA Approval for Treatment of Psoriatic Arthritis Patients on Humira Showed ...
		The safety profile of Humira in the ADEPT clinical trial was similar to that observed in the Humira RA clinical trials.
		Humira, which is a fully human monoclonal antibody that resembles antibodies normally found in the body, works by specifically blocking TNF-alpha.
		Humira is the only fully human monoclonal antibody approved by the FDA for reducing the signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis (RA).
	www.docguide.com /news/content.nsf/news/8525697700573E188525709000523812 (1406 words)

	Humira® (Adalimumab) receives FDA approval for psoriatic arthritis - The Doctors Lounge(TM)
		Psoriatic arthritis is the first new disease indication for HUMIRA beyond rheumatoid arthritis (RA) and is one of the five autoimmune diseases Abbott is studying for HUMIRA therapy.
		The HUMIRA approval is based on results of the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT), which is the largest biologic trial in PsA.
		The recommended dose of HUMIRA for psoriatic arthritis is 40 mg every-other-week by subcutaneous injection (a shot beneath the skin), the usual dose used for HUMIRA in the treatment of moderate to severe RA.
	www.thedoctorslounge.net /rheumatology/articles/psoriasis/adalimumab_fda (781 words)

	FDA approves Humira® (adalimumab) to improve physical function in rheumatoid arthritis patients (Site not responding. Last check: 2007-10-12)
		HUMIRA is the only fully human monoclonal antibody approved by the FDA for reducing the signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adults with moderately to severely active RA who have had insufficient response to one or more disease modifying antirheumatic drugs (DMARDs).
		HUMIRA was approved by the FDA on December 31, 2002.
		HUMIRA is the first fully human monoclonal antibody approved in Europe for RA, and the first tumor necrosis factor alpha (TNF—á) antagonist approved with an indication for use with methotrexate or as monotherapy.
	www.pharma-lexicon.com /medicalnews.php?newsid=11921 (1097 words)

	EndoNurse - Newly Published Study Evaluates Abbott's HUMIRA® in Crohn's Disease
		Five of the 11 patients taking concomitant corticosteroid therapy were able to discontinue their use (by week 14 of treatment with Humira) and three were able to decrease the dose (at last follow-up).
		Humira is the only fully human monoclonal antibody approved by the FDA for reducing the signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).
		Humira is the first fully human monoclonal antibody approved in Europe for RA, and the first tumor necrosis factor alpha (TNF-a) antagonist approved with an indication for use with methotrexate or as monotherapy.
	www.endonurse.com /hotnews/51h3111134.html (1398 words)

	AAD: Long-Term Gains in Psoriasis Treatment with Humira (adalimumab) - CME Teaching Brief® - MedPage Today
		Advise patients who have taken Humira (adalimumab) to clear psoriatic lesions or who are considering this treatment that the gains in therapy can last for over a year.
		Humira is approved for reducing the signs and symptoms and improving physical function in people with rheumatoid arthritis and is being investigated for treatment of psoriasis.
		After 60 weeks, 67% of patients receiving Humira 40 mg by injection every other week and 73% of patients receiving Humira 40 mg by injection every week had achieved a Psoriatic Area and Severity Index (PASI) of 75 -- a measure of improvement of the signs and symptoms of psoriasis.
	www.medpagetoday.com /Dermatology/Psoriasis/tb/575 (592 words)

	HUMIRA(R) (adalimumab) Receives FDA Approval for First-Line Treatment of Moderate to Severe Rheumatoid Arthritis
		The approval offers RA patients an important therapeutic option early in the course of their disease, when there is a critical window of opportunity to intervene before the potential crippling effects of joint destruction and long-term disability set in.
		In 2002, HUMIRA was approved to treat patients with moderately to severely active RA, who have had insufficient response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
		HUMIRA Offers Proven Benefit in Early RA The approval for the expanded indication is based on clinical and radiographic data from the two-year PREMIER study of 799 methotrexate (MTX)-naive patients with active recent onset moderate to severe RA (defined as disease of less than three years duration).
	www.prnewswire.com /cgi-bin/stories.pl?ACCT=104&STORY=/www/story/10-04-2005/0004159177&EDATE= (249 words)

	ots.at: Abbott\'s HUMIRA(R) (Adalimumab) Shown to Improve Quality of Life for Psoriatic Arthritis Patients (Site not responding. Last check: 2007-10-12)
		Patients treated with HUMIRA had significantly less change in mTSS than patients treated with placebo at week 24 and new data from the open-label extension showed that the inhibition of disease progression at week 24 achieved in patients taking HUMIRA was maintained through week 48.
		About HUMIRA HUMIRA is the only fully human monoclonal antibody approved by the EMEA and the FDA for the treatment of moderate to severe, active RA in adult patients when the response to DMARDs including methotrexate (MTX) has been inadequate.
		HUMIRA can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.
	www.ots.at /presseaussendung.php?schluessel=AGTHIST_20050610_OTE0001&woher= (1813 words)

	New Type of Rheumatoid Arthritis Drug
		Humira is given as a single injection underneath the skin every other week.
		Humira is for patients with moderately to severely active rheumatoid arthritis who don't respond well to one or more disease-modifying anti-rheumatic drugs (DMARDs).
		The manfacturer, Abbott Laboratories, is making Humira available free to Medicare-eligible seniors who don't have prescription drug benefits until such a Medicare benefit is adopted by Congress.
	www.webmd.com /content/article/57/66161.htm (247 words)

	Humira
		HUMIRA is intended for use under the guidance and supervision of a physician.
		HUMIRA is dispensed in a carton containing two alcohol preps and two dose trays.
		HUMIRA is dispensed in a carton containing four alcohol preps and two trays.
	www.musc.edu /pharmacyservices/Drugs/H/Humira.htm (5869 words)

	Clinical Trials to Explore Use of Humiraâ¢ in Psoriasis and Psoriatic Arthritis
		Humira is an FDA approved human monoclonal antibody that resembles antibodies normally found in the body that works by specifically blocking TNF-Ã¡.
		Humira reduces the signs and symptoms and inhibits the progression of structural damage in adults with moderately to severely active rheumatoid arthritis (RA) who have had insufficient response to one or more traditional disease modifying antirheumatic drugs (DMARDs) and can be used alone or in combination with methotrexate (MTX) or other DMARDs.
		Humira will be studied in a randomized, multicenter, Phase II clinical trial that will assess safety and efficacy in adult patients with moderate to severe chronic-plaque psoriasis.
	www.arthritissupport.com /library/showarticle.cfm/ID/682/e/1/T/Arthritis (713 words)

	Report on New Patented Drugs - Humira
		The introductory price of Humira was found to be within the Guidelines because the cost of therapy did not exceed the cost of therapy of existing drugs in the therapeutic class comparison and the price did not exceed the prices in the other comparator countries where Humira was sold.
		Humira is a new active substance and the PMPRB's Human Drug Advisory Panel (HDAP) recommended that Humira be reviewed as a category 3 new medicine (provides moderate, little or no therapeutic advantage over comparable medicines).
		In 2004, Humira was being sold in all of the seven countries listed in the Patented Medicines Regulations, that is France, Germany, Italy, Sweden, Switzerland, United Kingdom and the United States.
	www.pmprb-cepmb.gc.ca /english/view.asp?x=478 (1147 words)

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