Head-to-head study in RA shows that abatacept has comparable efficacy to adalimumab

(Press-News.org) 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-naïve 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.

### Abstract Number: OP0022

*ACR (American College of Rheumatology) criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate), patient assessment, physician assessment, pain scale and disability/functional questionnaire. ACR20 refers to a 20% improvement in tender/swollen joint counts, as well as three of the five other criteria. ACR50 refers to a 50% improvement and ACR70 refers to a 70% improvement.

NOTES TO EDITORS: For further information on this study, or to request an interview with the study lead, please do not hesitate to contact the EULAR congress Press Office in Hall 6 on the 3rd floor of the Congress Centre during EULAR 2012 or on:

Email: eularpressoffice@cohnwolfe.com

Candice Debleu:
Onsite tel: +44 7894 386 425

About EULAR The European League Against Rheumatism (EULAR) is the organisation which represents the patient, health professional and scientific societies of rheumatology of all the European nations In line with The European Union of Medical Specialists (UEMS), EULAR defines rheumatology as including rheumatic diseases of the connective tissue, locomotor and musculoskeletal systems EULAR aims to promote, stimulate and support the research, prevention, treatment and rehabilitation of rheumatic diseases. With 45 scientific member societies, 36 PARE organisations and 10 health professionals associations, EULAR underscores the importance of combating rheumatic diseases not only by medical means, but also through a wider context of care for rheumatic patients and a thorough understanding of their social and other needs Diseases of the bone and joints such as rheumatoid arthritis and osteoarthritis cause disability in 4-5% of the adult population and are predicted to rise as people live longer EULAR 2012 is set to be the biggest rheumatology event in Europe with over 15,000 scientists, physicians, allied health professionals, and related audiences in attendance from over 115 countries. Over the course of the congress, more than 275 oral and 1400 poster abstract presentations will be featured, with 1,010 invited speaker lectures taking place in 190 sessions To find out more about the activities of EULAR, visit: www.eular.org