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| |  Adalimumab Effective in Patients With Rheumatic Disease Unresponsive to Other Anti-TNF Therapies PARIS -- June 13, 2008 -- Adalimumab therapy is effective and well-tolerated in ankylosing spondylitis (AS), rheumatoid arthritis (RA), and psoriatic arthritis (PsA) patients with a previously inadequate response to anti-tumour necrosis factor (anti-TNF) therapies etanercept and infliximab. Study results were presented today at EULAR 2008, the Annual Congress of the European League Against Rheumatism. This positive response to adalimumab was greatest for patients who had been intolerant of their anti-TNF therapies or who had lost their initial responses compared with those who experienced no response to prior anti-TNF therapies. Investigators examined patients with a disease duration of 9 to 12 years who were enrolled into 3 large, open-label studies. There were 1,250 AS patients in the RHAPSODY (Review of Safety and Effectiveness With Adalimumab in Patients With Active Ankylosing Spondylitis) trial; 6,610 RA patients in ReAct (Research in Active Rheumatoid Arthritis) trial; and 442 PsA patients in STEREO (Safety and Efficacy Study of Adalimumab in Patients With Active Psoriatic Arthritis) trial. All patients received adalimumab 40 mg subcutaneously every other week for 12 weeks in addition to their current antirheumatic treatment regimens. Patients with prior anti-TNF experience could only enrol into the RHAPSODY or STEREO studies if infliximab therapy had been discontinued 2 months or longer previously and/or etanercept therapy had been discontinued 3 or more weeks previously. Those who entered the ReAct trial had to have discontinued etanercept and infliximab therapies 2 months or more prior to the start of the study. After 12 weeks of treatment with adalimumab, AS patients were found to have a mean reduction in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of -2.4 following previous etanercept and/or infliximab treatment and a reduction of -2.9 in those who did not have prior anti-TNF therapy. RA patients had a mean reduction of -1.9 in the 28-joint Disease Activity Score (DAS28) following previous treatment with either etanercept or infliximab. Of the AS patients, 61% who had lost their initial responses to previous anti-TNFs reached 20% improvement in the Assessment in Ankylosing Spondylitis (ASAS20) after 12 weeks of adalimumab therapy and 42% of patients reached ASAS40. Of patients who had previously been intolerant of their medications, 54% reached ASAS20 and 37% reached ASAS40. Of those who had had no response to previous treatment, 41% reached ASAS20 and 27% achieved ASAS40. Sixty-six percent of RA patients who had lost response to their previous anti-TNF treatment reached American College of Rheumatology 20% symptom improvement criteria (ACR20) after 12 weeks and 36% reached ACR50. Of the previously anti-TNF-intolerant patients, 67% reached ACR20 and 39% attained ACR50. Fifty-one percent of patients who had had no response to an anti-TNF in the past reached ACR20 and 26% achieved ACR50. Forty-two percent of PsA patients who had previously undergone anti-TNF therapy achieved ACR50 and had a mean change in DAS28 of -2.1 after 12 weeks of adalimumab therapy. In these 3 studies, adalimumab appeared to be well tolerated in patients with prior anti-TNF treatment in all 3 disease groups. Lead researcher, GR Burmester, MD, Berlin University Hospital, Berlin, Germany, commented, "An increasing number of patients with rheumatic diseases, such as AS, RA, or PsA, are experiencing an inadequate response to, or are intolerant of, treatment with existing anti-TNFs, including etanercept or infliximab. The results of our study show that adalimumab offers new hope for those who have tried, but not responded well, to other treatment options for their diseases." SOURCE: European League Against Rheumatism
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