Source: DGNews | Posted 1 year ago
Doppler Ultrasound Can Reveal Presence of Subclinical Musculoskeletal Disease in Patients With Psoriasis
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NEW YORK -- July 7, 2010 -- The European Commission approved a new indication for abatacept (Orencia), in combination with methotrexate (MTX), for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to previous therapy with >=1 disease-modifying anti-rheumatic drugs (DMARDs).
The approval of abatacept as a first line biologic after DMARD inadequate response was supported by data from a 2-year open-label study from a trial in MTX-naïve patients with RA (AGREE), as well as by long-term open-label data from the core RA clinical trial programme in MTX inadequate responders (AIM, ATTEST, and a phase 2b study) and in anti-TNF- inadequate responders (ATTAIN and ARRIVE).
These data indicate that abatacept may provide improved outcomes in short-term efficacy as well as durable and sustained long-term efficacy (up to 7 years as demonstrated in the phase 2b study) when used with MTX earlier in the RA treatment paradigm.
In addition, a sustained reduction in the rate of progression of structural damage up to 5 years was demonstrated in the AIM trial.
· In the AGREE trial in MTX-naïve patients, 53% of patients with RA who had not previously received treatment with a DMARD and were subsequently treated with abatacept plus MTX (n = 256) achieved ACR50 at 6 months, compared with 38% of patients who were treated with placebo plus MTX (n = 253; P < .001).
· In the AIM trial, 40% of patients with RA who had an inadequate response to MTX alone and were subsequently treated with abatacept plus MTX (n = 424) achieved ACR50 at 6 months, compared with 17% of patients who were treated with placebo plus MTX (n = 214; P < .001).
· In the ATTAIN trial, 20% of patients with RA who had an inadequate response to tumour necrosis factor inhibitors and were subsequently treated with abatacept plus DMARDs (n = 256) achieved ACR50 at 6 months compared with 4% of patients who were treated with placebo plus DMARDs (n = 133; P < .001).
SOURCE: Bristol-Myers Squibb
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