Navigation Links
Belimumab for lupus erythematosus: Added benefit not proven
Date:8/29/2012

Belimumab (trade name Benlysta ) has been approved since July 2011 as an add-on therapy for adult patients with the autoimmune disease systemic lupus erythematosus (SLE). This monoclonal antibody is only considered as treatment when the disease is still active in spite of standard therapy. The German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined the added benefit of this drug pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG).

According to the findings, there is no proof that belimumab provides added benefit as the manufacturer's dossier does not contain any relevant studies for the assessment of added benefit.

Belimumab in comparison to optimized standard therapy

The Federal Joint Committee (G-BA) specified that the appropriate comparator therapy should be an optimized standard therapy with various drugs that have been approved in Germany. A (standard) therapy is said to be "optimized" when the treatment has been adapted to the individual patient with respect to tolerability, effect and clinical course. The dossier - or its assessment by IQWiG - was supposed to answer the question as to whether the additional administration of belimumab offers advantages in comparison with the optimization of standard therapy alone.

Adaptation of standard therapy was only possible in the studies to a limited extent

The manufacturer uses two approval studies in the dossier (BLISS52 and BLISS76). However, these are not suited to prove added benefit, as the study protocols inappropriately restricted the possibilities for adapting the standard therapy. In particular, the administration of glucocorticoids was explicitly restricted.

This restriction is a consequence of the intended purpose of these studies. In drug approval the main focus is on proving efficacy. If the adaptation of the standard therapy had not been restricted, the differences in the e
'/>"/>

Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

Page: 1 2

Related medicine news :

1. Chronic exposure to staph bacteria may be risk factor for lupus, Mayo study finds
2. New Guidelines Issued for Severe Lupus
3. Added benefit of fampridine is not proven
4. Added benefit of eribulin in breast cancer is not proven
5. Added benefit of linagliptin is not proven
6. Collagenase for Dupuytrens contracture: Added benefit not proven
7. Abiraterone: Indication of considerable added benefit in certain patients
8. Nurse Alert Provides Added Level of Senior Alert Care With New Nurse Triage Feature
9. Tafamidis: Approval denotes proven added benefit
10. No Added Cancer Risk From Hip Replacement Materials: Study
11. Exploring exercise benefits for breast cancer patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/21/2014)... To accommodate the ever-growing customer base, Angeldress.co.uk ... trendy items. Recently, the company has unveiled its 2014 ... and elegant wedding gowns, Angeldress.co.uk wants to make sure ... an easy way. Its high quality vintage wedding outfits ... off to 62% off. , Online shopping is becoming ...
(Date:9/21/2014)... More than 60 new GranuFlo ... the past month to a federal multidistrict litigation ... caused by the dialysis concentrate, Bernstein Liebhard LLP ... 15th shows 2,089 cases filed in a federal ... of Massachusetts. These claims were filed on behalf ...
(Date:9/21/2014)... “Cluster headaches are sometimes called ‘Suicide Headaches’ ... resolve,” said Steve Young of Ew Publishing; “I’ve had ... that is more intense.” , “It should be a ... migraines, that medical research is pointing to some relief ... , Serotonin (5-HT, 5-hydroxytryptamine) is a ubiquitous biochemical found ...
(Date:9/21/2014)... Developers and plugin specialist of Final ... transition plugin entitled Transpack Vol. 3 from Pixel Film ... that will add a level of professionalism to any ... Film Studios. “Blurring the line between professional and armature, ... Transpack Vol. 3 returns with over 85 all new ...
(Date:9/21/2014)... OH (PRWEB) September 21, 2014 C8 ... District of Ohio as the list of 20 possible ... been narrowed down to six, reports Wright & Schulte ... chosen from the almost 2500 C8 lawsuits filed that ... or testicular cancer as a result of being exposed ...
Breaking Medicine News(10 mins):Health News:Angeldress.co.uk Launches New Range Of 2014 Vintage Wedding Dresses In Its Online Store 2Health News:Federal GranuFlo Litigation Adds Dozens of Cases Alleging Serious Cardiovascular Injuries, Bernstein Liebhard LLP Reports 2Health News:Federal GranuFlo Litigation Adds Dozens of Cases Alleging Serious Cardiovascular Injuries, Bernstein Liebhard LLP Reports 3Health News:Federal GranuFlo Litigation Adds Dozens of Cases Alleging Serious Cardiovascular Injuries, Bernstein Liebhard LLP Reports 4Health News:Homeostasis: Equinox Serotonin (5HT) Headache Stories ~ New on the Bryan William Brickner Blog 2Health News:Pixel Film Studios Released Transpack Vol. 3 Plugin Exclusively for Final Cut Pro X 2Health News:C8 Lawsuit Claims Move Forward as Six Possible Cases for Bellwether Trials Selected in DuPont Water Contamination Lawsuits, Reports Wright & Schulte LLC 2Health News:C8 Lawsuit Claims Move Forward as Six Possible Cases for Bellwether Trials Selected in DuPont Water Contamination Lawsuits, Reports Wright & Schulte LLC 3Health News:C8 Lawsuit Claims Move Forward as Six Possible Cases for Bellwether Trials Selected in DuPont Water Contamination Lawsuits, Reports Wright & Schulte LLC 4
... to a report published in the October issue of ... , a grant-funded program tailored to provide advanced minimally ... helping address shortages of minority faculty members at US ... Diverse Surgeons Initiative (DSI) has helped 86 percent of ...
... Consortium (BCSC) facilities performing breast magnetic resonance imaging (MRI) ... Radiology Imaging Network (ACRIN) and European Society of Breast ... study in the November issue of the Journal of ... BCSC is a collaborative effort to improve breast cancer ...
... Oct. 30 (HealthDay News) -- Hepatitis C patients who receive ... recurrent hepatitis than those who receive a liver from a ... for black patients who receive a liver from a white ... Hospital in Detroit looked at 165 hepatitis C patients who ...
... Kan. A little self-awareness can help people struggling ... professor of communication studies at the University of Kansas. ... flirting among dating adults, surveying more than 5,100 people ... "Knowing something about the way you communicate attraction says ...
... , SUNDAY, Oct. 31 (HealthDay News) -- Heat ... cool environments, a new study has found. University ... underwent a 10-day heat acclimation program achieved increases of ... and cool conditions. In terms of competitive cycling, this ...
... Reporter , FRIDAY, Oct. 29 -- A good marriage ... life and experience less pain, a new study suggests. ... that seems to buffer a patient,s emotional health," said ... the Johns Hopkins University School of Medicine in Baltimore. ...
Cached Medicine News:Health News:Diverse surgeons initiative effectively increases underrepresented minorities in academic surgery 2Health News:Majority of community facilities performing breast MRI exams meet ACRIN and EUSOBI technical requirements 2Health News:Self awareness can help people navigate rocky seas of relationships 2Health News:Good Marriages May Help Rheumatoid Arthritis Patients 2Health News:Good Marriages May Help Rheumatoid Arthritis Patients 3
(Date:9/19/2014)... Five MinuteClinic walk-in medical clinics are opening inside select CVS/pharmacy stores ... opened in Memphis and Cordova ... in Springfield on September 24 and a ... open October 22.  MinuteClinic is the largest and fastest growing provider ... . The Memphis -area clinics join ...
(Date:9/19/2014)... 19, 2014  Lpath, Inc. (NASDAQ: ... therapeutics, announced today that it has entered into ... common stock and 3,605,042 unregistered warrants in a ... one registered share of common stock and one ... common stock will be $3.475.  The warrants have ...
(Date:9/19/2014)... -- Intarcia Therapeutics, Inc. today announced the ... candidate ITCA 650 (continuous subcutaneous delivery of exenatide) in ... at the 50 th Annual Meeting of the ... from the open-label, phase 3 FREEDOM-HBL (high baseline) trial ... with poorly controlled type 2 diabetes. The results were ...
Breaking Medicine Technology:MinuteClinic Walk-in Medical Clinics Opening in Memphis 2MinuteClinic Walk-in Medical Clinics Opening in Memphis 3Lpath, Inc. Announces $12.5 Million Registered Direct Offering 2Lpath, Inc. Announces $12.5 Million Registered Direct Offering 3Intarcia Announces Presentation of Phase 3 Data at EASD Showing ITCA 650 Markedly Reduces Blood Sugar In Patients With Poorly Controlled Type 2 Diabetes 2Intarcia Announces Presentation of Phase 3 Data at EASD Showing ITCA 650 Markedly Reduces Blood Sugar In Patients With Poorly Controlled Type 2 Diabetes 3Intarcia Announces Presentation of Phase 3 Data at EASD Showing ITCA 650 Markedly Reduces Blood Sugar In Patients With Poorly Controlled Type 2 Diabetes 4
... 23 Reportlinker.com announces that a new market research ... Eli Lilly & Co.: PharmaVitae Profile ... analysis examines the historical and forecast performance for Eli ... global company strategy, portfolio and pipeline analysis and assessment ...
... Sept. 23 As technologies for fat removal become ... not only reshaping the body but also recycling the ... to the most recent statistics from the American Society ... are among the two most popular invasive and non-invasive ...
Cached Medicine Technology:Reportlinker Adds Eli Lilly & Co.: PharmaVitae Profile 2Reportlinker Adds Eli Lilly & Co.: PharmaVitae Profile 3Reportlinker Adds Eli Lilly & Co.: PharmaVitae Profile 4Reportlinker Adds Eli Lilly & Co.: PharmaVitae Profile 5Reportlinker Adds Eli Lilly & Co.: PharmaVitae Profile 6Reportlinker Adds Eli Lilly & Co.: PharmaVitae Profile 7The New Face of Body Contouring 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: