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Recent News and Articles on the Keywords: remicade + arthritis + approves  Related to the article below (Last Update: 8/5/2008)


ChattahBox
2nd UPDATE: FDA Panel Backs Roche Athritis Drug Actemra
CNNMoney.com - Jul 29, 2008
The drug is already approved to treat juvenile idiopathic arthritis and systemic- onset juvenile idiopathic arthritis in Japan . - By Jared A. Favole, ...
New athritis drug gets approval recommendation The Associated Press
FDA Advisory Panel Recommends Approval Of Roche's Arthritis Drug ... AHN
all 147 news articles »  OTC:RHHBY - SWF:RO - SWF:HUE
FDA: Roche's Actemra Appears Effective in Rheumatoid Arthritis
Wall Street Journal - Jul 25, 2008
Such therapies include Johnson & Johnson's blockbuster drug Remicade, Abbott Laboratories' Humira, and Enbrel, which is marketed by Wyeth Pharmaceuticals ...
Place Your Biotech Bets Motley Fool
all 26 news articles »  OTC:RHHBY - SWF:RO - SWF:HUE
Drug Makers: Trial Shows Combination Therapy Helps Arthritis
CNNMoney.com - Jul 15, 2008
The drug, approved to treat rheumatoid arthritis in adults and children and psoriasis in adults, had sales of $3.2 billion in 2007. ...AMGN
Chugai Shares Rise After FDA Says Actemra Drug Works (Update2)
Bloomberg - Jul 28, 2008
By Kanoko Matsuyama July 28 (Bloomberg) -- Chugai Pharmaceutical Co. rose the most in a month in Tokyo trading after US regulators said its arthritis ...TYO:4519
Tumor Necrosis Factor Inhibitors vs New Biologics for Joint Diseases
Medscape (subscription) - Jul 31, 2008
The clinical picture seen in rheumatoid arthritis (RA) is the result of a complex cascade involving antigen-presenting cells, the major histocompatibility ...
UCB: European submission for rheumatoid arthritis treatment
Pharmaceutical Business Review - Jul 7, 2008
... if it is approved for RA, will be its late market entry compared to similar TNF-alpha inhibitors already on the market: Enbrel, Remicade and Humira. ...
Charities criticise NICE rheumatoid arthritis ruling
Healthcare Republic - Jul 21, 2008
But the latest move, coupled with NICE?s earlier decision not to approve abatercept for RA, means that the drug options for RA patients has effectively ...

Dividend.com
Abbott Reports Stronger-than-Expected Sales and Earnings Growth in ...
MarketWatch - Jul 16, 2008
Seven-year data from open label extension studies show treatment with HUMIRA resulted in clinical remission among long-standing rheumatoid arthritis ...
Abbott tops forecast San Diego Union Tribune
all 76 news articles »  ABT

RTT News
Johnson & Johnson Reports 2008 Second-Quarter Results:
MarketWatch - Jul 15, 2008
... an antipsychotic medication; and REMICADE in the US, a biologic approved for the treatment of a number of immune mediated inflammatory diseases. ...
Johnson & Johnson Q2 2008 Earnings Call Transcript Seeking Alpha
all 25 news articles »  JNJ - OTC:CMTX
Making Genentech Disappear
Forbes, NY - Jul 22, 2008
Centocor, one of the pioneers of biotech with drugs like Reopro and Remicade, has continued to churn out important new medicines as part of Johnson ...DNA - OTC:RHHBY
Source: Google News

Infliximab: An Updated Review of its Use in Crohn's Disease and Rheumatoid Arthritis. -
GM Keating, CM Perry - BioDrugs, 2002 - biodrugs.adisonline.com
... n = 31 and 61 evaluable patients) showed that leflunomide may be an alternative
to methotrexate for use in combination with infliximab in rheumatoid arthritis. ...

[PDF] Infliximab for the treatment of extensive plaque psoriasis--regulation, cost and reimbursement. -
M Rabinovich, M Fainaru - Isr. Med. Assoc. J, 2003 - ima.org.il
... has the authority to approve the provision ... Infliximab (Remicade 1 , Schering Plough) ?
a chimeric mono ... third- line therapy for rheumatoid arthritis and Crohn's ...
-

[CITATION] FDA approves infliximab as first-line therapy for RA
PA Malvern, D Yocum

[CITATION] News and Trends: Can A Toothpaste Ingredient Protect The Skin?
FDAAE Foam, NDWL Cleared

US FDA Approves Drug to Treat Facial Wasting
MFVSP Benefit, FDAAHA Test - MMWR Morb Mortal Wkly Rep, 2004 - UChicago Press
... US FDA Approves Drug to Treat Facial ... conditions such as rheumatoid arthritis or Crohn's ...
TNF-a antagonists, such as Remicade (infliximab), Enbrel (etanercept ...

[CITATION] Possible link between rheumatoid arthritis and multiple sclerosis
A Gandey

Treatment of rheumatoid arthritis. -
A GAFFO, KG SAAG, JR CURTIS - American Journal of Health-System Pharmacy, 2006 - pt.wkhealth.com
... Table 1. Current Pharmacologic Therapies for the Treatment of Rheumatoid Arthritis. ...
mediators of tissue damage in RA, include infliximab, etanercept, adalimumab ...

[CITATION] FOR IMMEDIATE RELEASE CONTACT: Christopher Molineaux
I Centocor
-

[PDF] New Drug Approvals -
FDAGO Approval - reportdisability.com
... Approved NEW INDICATIONS ? FDA Approves Aranesp? For ... with methotrexate for the treatment
of rheumatoid arthritis. Remicade is also being studied for other ...
-

Regulatory Affairs -
IT TNF-a - Biotechnology Law Report, 2002 - liebertonline.com
... FDA Approves Monoclonal Antibody for Maintenance of ... Remicade is already approved
for the treatment ... moderate to severe rheumatoid arthritis, another autoimmune ...

Source: Google Scholar
 
 

FDA approves Remicade for psoriatic arthritis

 
 
FDA ( Food and Drug Administration ) has approved Remicade ( Infliximab ) to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis.

Psoriatic arthritis affects approximately one million men and women in the U.S. and is often characterized by the complex symptoms of joint inflammation and skin lesions.

Data from the Induction and Maintenance of Psoriatic Arthritis Clinical Trial 2 ( IMPACT 2 ) served as the primary basis for the approval.

Significant improvements in both ACR 20 and PASI 75 were observed in patients treated with Infliximab as early as week two, with further improvements through 24 weeks.
At week 14, 58 percent of patients treated with Infliximab experienced at least 20 percent improvement in arthritis symptoms, according to the American College of Rheumatology scoring criteria ( ACR 20 ) versus 11 percent of placebo-treated patients ( P < 0.001 ).
At week 24, 27 percent of patients treated with Infliximab experienced at least 70 percent improvement ( ACR 70 ) versus two percent of placebo-treated patients ( P < 0.001 ).
Additionally, at week 24, 60 percent of patients treated with Infliximab experienced at least 75 percent improvement from baseline in psoriasis, as assessed by Psoriasis Area Severity Index ( PASI 75 ), versus one percent of placebo-treated patients.
At week 24, more than one-third ( 39 percent ) of patients receiving Infliximab achieved PASI 90, a dramatic improvement in psoriasis symptoms. No patients receiving placebo achieved a PASI 90 response at week 24.

Patients in the Infliximab group also experienced decreased symptoms of dactylitis and enthesopathy, two common disease manifestations causing pain and swelling.

Dactylitis, swelling of digits in the hands or feet, and enthesopathy, inflammation of a tendon, or ligament insertion to the bone, are estimated to affect more than one-third of people with psoriatic arthritis.

In the study, 40 percent of Infliximab patients and 41 percent of patients in the placebo group had dactylitis in at least one digit at baseline.
After 24 weeks of treatment, only 15 percent of Infliximab patients continued to experience symptoms, compared to 33 percent of patients receiving placebo ( P greater than or equal to 0.05 ).

At baseline, enthesopathy was observed in 42 percent of patients in the Infliximab group and 35 percent of patients receiving placebo.
At week 24, only 22 percent of Infliximab patients still experienced enthesopathy, compared to 36 percent in the placebo group ( P = 0.004 ).

IMPACT 2 was a Phase III randomized, double-blind, placebo-controlled study of 200 patients with active psoriatic arthritis ( defined as affecting at least five joints ).
The study evaluated the safety and efficacy of Infliximab in patients who had an inadequate response to DMARDs or nonsteroidal anti- inflammatory drugs ( NSAIDs ). Patients received Infliximab ( 5mg/kg ) or placebo at weeks zero, two, six and every eight weeks until week 22.

Patients treated with Infliximab also experienced significant improvement in the physical component summary ( PCS ) and mental component summary ( MCS ) scores of the short form 36 ( SF-36 ).

The SF-36 is a 36-item questionnaire that assesses impact in eight areas, including physical functioning, pain, vitality, social functioning, psychological functioning, general health perceptions and role limitations due to physical and emotional problems. SF- 36 scores range from zero to 100, and lower scores indicate poorer functioning and well-being.

At week 14, Infliximab patients experienced an average increase in PCS score of 9.1 units, compared to an average 1.1-unit increase in patients receiving placebo ( P < 0.001 ).
Additionally, patients in the Inflixiamb group experienced an average 3.8-unit increase in MCS score, while patients receiving placebo averaged a decrease of 1.2 units ( P = 0.001 ).

Through 24 weeks, a similar number of patients experienced adverse events in each treatment group. No deaths, cases of tuberculosis or other opportunistic infections, or serious infusion reactions were reported and serious infections were uncommon. Also, with the exception of one case of basal cell carcinoma in the placebo group, no malignancies were reported.
Significant laboratory abnormalities were unusual, with an elevation in liver function tests being the most common abnormality.
There were more patients with serious adverse events in the Infliximab group ( 8.7 percent ) than in the placebo group ( 6.2 percent ).

Source: Centocor, 2005
 
 
 
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