|
Data from one of the few head-to-head trials in rheumatoid arthritis (RA) presented at EULAR 2012, the Annual Congress of the EuropeanLeague Against Rheumatism, demonstrates that at one year, 64.8% ofpatients receiving abatacept ( Orencia ) and 63.4% of patients receiving adalimumab ( Humira ) achieved ACR20*. The Phase IIIb AMPLE study (Abatacept Versus Adalimumab Comparisonin Biologic-Naive RA Subjects with Background Methotrexate) wascarried out in 646 biologic-na ve patients with active RA andinadequate response to methotrexate. At four weeks, 42.5% ofpatients in the abatacept group achieved ACR20 response versus47.6% in the adalimumab group. This remained comparable until theend of year one. At 12 months, ACR50* response was similar betweenthe two groups (46.2% in the abatacept group and 46% in theadalimumab group). ACR70* response was 29.2% versus 26.2% in theabatacept group and adalimumab groups respectively. These data showthe similar time course of response. Inhibition of radiographicprogression was also similar in both arms. "There have been very few head-to-head trials in rheumatoidarthritis and, to date, there have been no randomised, controlledstudies directly comparing the safety and efficacy of differentbiologic disease-modifying anti-rheumatic drugs (DMARDs) using thecombination of a biologic medication and methotrexate which is themost commonly prescribed treatment approach in moderate to severeRA," said Dr. Michael Schiff, University of Colorado, USA and leadauthor of the study. "This study is a great leap forward for us andour patients as it shows there is another treatment option that isas effective and as safe as adalimumab." The AMPLE study is a randomised, investigator-blinded study of 24months, with a 12 month efficacy primary endpoint. Patients werestratified by disease activity and randomised to either 125mgsubcutaneous abatacept (without an IV load) weekly or 40mgsubcutaneous adalimumab bi-weekly, in combination with a stabledose of methotrexate. The primary endpoint of the trial wasnon-inferiority by ACR20 response at 12 months with anon-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 adverseevents (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 infewer abatacept patients (3.8% versus 9.1%, 95% confidenceinterval: -5.37 (-9.13, -1.62) p=0.006). Abatacept (Orencia), which is produced by Bristol-Myers Squibb, isa first-in-class biologic which works to reduce co-stimulation ofT-cells, which in turn reduces activation of other cells in the RAinflammatory process, thereby blocking the pain, inflammation andjoint progression pathways in RA. Adalimumab (Humira) is produced by Abbott and is a biologicTNF-blocker, or anti-TNF. Adalimumab works by binding to TNF-alphareceptors, thereby blocking the pain, inflammation and jointprogression pathways in RA. We are high quality suppliers, our products such as Xenpak Transceivers , China PON Transceiver for oversee buyer. To know more, please visits BIDI SFP Transceiver.
Related Articles -
Xenpak Transceivers, China PON Transceiver,
|
