Navigation Links
Head-to-head study in RA shows that abatacept has comparable efficacy to adalimumab
Date:6/7/2012

Berlin, Germany, June 7 2012: Data from one of the few head-to-head trials in rheumatoid arthritis (RA) presented today at EULAR 2012, the Annual Congress of the European League Against Rheumatism, demonstrates that at one year, 64.8% of patients receiving abatacept (Orencia) and 63.4% of patients receiving adalimumab (Humira) achieved ACR20*.

The Phase IIIb AMPLE study (Abatacept Versus Adalimumab Comparison in Biologic-Naive RA Subjects with Background Methotrexate) was carried out in 646 biologic-nave patients with active RA and inadequate response to methotrexate. At four weeks, 42.5% of patients in the abatacept group achieved ACR20 response versus 47.6% in the adalimumab group. This remained comparable until the end of year one. At 12 months, ACR50* response was similar between the two groups (46.2% in the abatacept group and 46% in the adalimumab group). ACR70* response was 29.2% versus 26.2% in the abatacept group and adalimumab groups respectively. These data show the similar time course of response. Inhibition of radiographic progression was also similar in both arms.

"There have been very few head-to-head trials in rheumatoid arthritis and, to date, there have been no randomised, controlled studies directly comparing the safety and efficacy of different biologic disease-modifying anti-rheumatic drugs (DMARDs) using the combination of a biologic medication and methotrexate which is the most commonly prescribed treatment approach in moderate to severe RA," said Dr. Michael Schiff, University of Colorado, USA and lead author of the study. "This study is a great leap forward for us and our patients as it shows there is another treatment option that is as effective and as safe as adalimumab."

The AMPLE study is a randomised, investigator-blinded study of 24 months, with a 12 month efficacy primary endpoint. Patients were stratified by disease activity and randomised to either 125mg subcutaneous abatacept (without an IV load) weekly or 40mg subcutaneous adalimumab bi-weekly, in combination with a stable dose of methotrexate. The primary endpoint of the trial was non-inferiority by ACR20 response at 12 months with a non-inferiority margin of 12%.

There was a similar rate of adverse events, serious adverse events, serious infections and malignancies in both groups.

More patients in the abatacept arm experienced autoimmune adverse events (3.1% versus 1.2%), but none were considered to be serious. There were also fewer discontinuations due to adverse events (2.5% versus 6.1%) and serious infections (0 versus 5 discontinuations) in the abatacept arm. Injection site reactions also occurred in fewer abatacept patients (3.8% versus 9.1%, 95% confidence interval: -5.37 (-9.13, -1.62) p=0.006).

Abatacept (Orencia), which is produced by Bristol-Myers Squibb, is a first-in-class biologic which works to reduce co-stimulation of T-cells, which in turn reduces activation of other cells in the RA inflammatory process, thereby blocking the pain, inflammation and joint progression pathways in RA.

Adalimumab (Humira) is produced by Abbott and is a biologic TNF-blocker, or anti-TNF. Adalimumab works by binding to TNF-alpha receptors, thereby blocking the pain, inflammation and joint progression pathways in RA.


'/>"/>

Contact: Candice Debleu
eularpressoffice@cohnwolfe.com
44-789-438-6425
European League Against Rheumatism
Source:Eurekalert

Related medicine news :

1. For Lung Disorder, Spiriva Beat Serevent in Head-to-Head Trial
2. Newer Drugs Beat Gleevec in Head-to-Head Trials
3. UT Southwestern investigators perform head-to-head comparison of incontinence treatments
4. Exercise Appears to Ease Nerve-Damage Pain in Rat Study
5. New Medicine Might Fight Drug-Resistant TB, Study Says
6. Exercise Controls Weight in White Girls Better Than in Black Girls: Study
7. Gout Flare-ups Rise Sharply With Certain Foods: Study
8. Dana-Farber: Study reports first success of targeted therapy in type of non-small cell lung cancer
9. Humans Can Sniff Out Old Age in Others, Study Shows
10. Infant Smarts Similar With Different Types of Formula: Study
11. Pre-op Treatments Boost Survival for Esophageal Cancer Patients: Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... Viejo, California (PRWEB) , ... June 25, 2016 , ... ... to fit their specific project," said Christina Austin - CEO of Pixel Film Studios. ... fully customizable and all within Final Cut Pro X . Simply select a ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Conventional wisdom preaches ... success. In terms of the latter, setting the bar too high can result in ... than just slow progress toward their goal. , Research from PsychTests.com ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association (PHA) ... will receive two significant new grants to support its work to advance research ... anniversary by recognizing patients, medical professionals and scientists for their work in fighting ...
(Date:6/24/2016)... ... 2016 , ... People across the U.S. are sharpening their pencils and honing ... contest in which patients and their families pay tribute to a genetic counselor by ... Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In ...
(Date:6/24/2016)... ... June 24, 2016 , ... National recruitment firm Slone Partners ... with extensive sequencing and genomics experience, as Vice President of North American Capital Sales ... be responsible for leading the sales team in the commercialization of the HTG EdgeSeq ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Any dentist who has ... of the current process. Many of them do not even ... technical difficulties and high laboratory costs involved. And those who ... it at such a high cost that the majority of ... Dr. Parsa Zadeh , founder of Dental Evolutions ...
(Date:6/23/2016)... , June 23, 2016  In a startling report released today, ... their residents by lacking a comprehensive, proven plan to eliminate prescription ... definitive ranking of how states are tackling the worst drug crisis ... four states – Kentucky , New ... Vermont . Of the 28 failing states, three – ...
(Date:6/23/2016)... -- Research and Markets has announced the addition ... - Forecast to 2022" report to their offering. ... to date financial data derived from varied research sources to ... potential impact on the market during the next five years, ... of sub markets, regional and country level analysis. The report ...
Breaking Medicine Technology: