Adalimumab Therapy Effective in Ankylosing Spondylitis, Rheumatoid Arthritis and Psoriatic Arthritis Patients Refractory to Other Anti-tnf Therapies

PARIS, France, Thursday, 12 June 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, according to results of research presented today at EULAR 2008, the Annual European Congress of Rheumatology in Paris, France. This positive response to adalimumab was greatest for patients who had been intolerant of their anti-TNF therapies, or had lost their initial responses, compared with those who had had no response to prior anti-TNF therapies at all.

After 12 weeks of treatment with adalimumab, AS patients were found to have a mean reduction in BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) of -2.4 following previous etanercept and/or infliximab treatment, and a reduction of -2.9 in those who have not had prior anti-TNF therapy. RA patients had a mean reduction in DAS28 (Disease Activity Scale 28) of -1.9 following previous treatment with either etanercept or infliximab.

Lead researcher, Dr G R Burmester of Berlin University Hospital, 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." Ankylosing spondylitis 61% of AS patients who had lost their initial responses to previous anti-TNFs reached ASAS20 (a measure of 20% improvement in 4 domain commonly affected in AS including: pain, inflammation, function, and patient’s global assessment of disease activity) after twelve weeks of adalimumab therapy and 42% of patients reached ASAS40 (a 40% improvement across these domains). 54% of patients who had previously been intolerant of their medications reached ASAS20 and 37% reached ASAS40. Of those who had had no response to previous treatment, 41% reached ASAS20, and 27% achieved ASAS40. Rheumatoid arthritis 66% of RA patients who had lost response to their previous anti-TNF treatment reached ACR20 (American Collage of Rheumatology 20% symptom improvement) after twelve weeks, and 36% reached ACR50 (50% symptom improvement). 67% of previously anti-TNF intolerant patients reached ACR20, and 39% attained ACR50. 51% of patients who had had no response to an anti-TNF in the past reached ACR20, and 26% achieved ACR50. Psoriatic arthritis 42% 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. About the Trials Investigators examined patients with a disease duration of 9-12 years who were enrolled into three large, open-label studies: 1,250 AS patients in the RHAPSODY trial, 6,610 RA patients in ReAct, and 442 PsA patients in STEREO. All patients received 40mg adalimumab subcutaneously every other week for 12 weeks, in addition to their current antirheumatic treatment regimens. Patients with prior anti-TNF experience could only enroll into RHAPSODY or STEREO studies if infliximab therapy had been discontinued two months or longer previously and/or etanercept therapy had been discontinued three or more weeks previously. Those who entered the ReAct trial had to have discontinued etanercept and infliximab therapies two months or more prior to the start of the study. In these three studies, adalimumab appeared to be well-tolerated in patients with prior anti-TNF treatment in all three disease groups. For further information on this study, or to request an interview with the study lead, please do not Email: eularpressoffice@uk.cohnwolfe.com

Rory Berrie: Onsite tel: +44 (0) 7876 190 439

Camilla Dormer: Onsite tel: +44 (0) 7789 270 392

Abstract number: THU0130 EULAR PRESS RELEASE

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. The aims of EULAR are to reduce the burden of rheumatic diseases on the individual and society and to improve the treatment, prevention and rehabilitation of musculoskeletal diseases. To this end, EULAR fosters excellence in education and research in the field of rheumatology. It promotes the translation of research advances into daily care and fights for the recognition of the needs of people with musculoskeletal diseases by the governing bodies in Europe. Diseases of bones 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. As new treatments emerge and cellular mechanisms are discovered, EULAR 2008 brings together more than 12,000 experts - scientists, clinicians, healthcare workers, pharmaceutical companies and patients - to share their knowledge in a global endeavour to challenge the pain and disability caused by musculo-skeletal disorders. To find out more information about the activities of EULAR, visit: www.eular.org

Posted: June 2008

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