JULY 2000 VOL 59 SUPPLEMENT [
`
`nnals of the
`Rheumatic
`'Diseases
`
`eular
`
`81
`?L•
`
`1r
`
`Annual European Congress of
`RHEUMATOLOGY
`R 20
`Abstracts
`Nice, 21-24 June 2000
`
`4The EULAR Journal
`
`Ex. 1107 - Page 1
`
`

`

`EULAR 2000
`
`•
`;0E0561 SIX MONTH EFFICACY OF THE FULLY HUMAN ANTI-TNF ANTIBODY D2E7 IN RHEUMATOID
`ARTHRITIS
`n de Pawl, 11,,Rau2 C. Breed*, r ift Kalcfpn', M.G. mapise5 M, SOFfienkirchne", R Emery!, G.A Burniesrerg, H. Zeldkr
`11' Moinsopolilos D Compagnone R Dressler , pompon! , kiippee
`'
`
`P (cid:9)J UnieersiOe Leiden, The Netherfandh Ithemakflalk Raangen; 'Universe Erlangen; Universirdt Altinehen; g
`UPtiverJOy Wiimegeork
`Meetpnisehe Hochschule Hannover: Knoll AG Ludwigshafen, Germany, Unlversky Liege. Belgium, Leeds
`Univerantil (cid:9)
`General Infirmeny; UK. thriversrly Athens, Greece
`Objeelire: Dose-finding phase it seedy comparing 3 dose levels or D2E7, a Mal iy human anti-TNE antibody, and placebo over 3 months in
`patients with long standing Naive rheumatoid erthriliS. followed by 3 months blinded D2E7 lireetliellt. • (cid:9)
`.
`Methods: A 061 of 283 patients were included in this randomised double-blind, placebo-controlled study. Overall patient characteristics at
`baseline (median): age 53 years, duration (IRA 8 yours. TX 30, 51C II, ESR 45 mnvb, CRP 5.1 insfa 4 previous DMARDI. DMARDn
`were discontinued at least 4 weeks before study treatment. Patients welt randomised equally into four arms to receive weekly doses of either
`D2E7 at 20, 40, 80 mg or placebo by subcutaneous (s.e.) self injection for 3 months. After month 3 placebo treated patients were given still
`blinded 40 mg D2E7 weekly, wh ite all other doses were continued as modernised.
`Results: Clinical 14$13433305 after 3 and 6 months of treatment are summarised below based on ITT analysis:
`I Response er Improvement
`Plea/40 mg 20 mg 40 mg 00 stg
`Tree anent
`Trearnens period [rrontbs] 316
`316
`316
` 13/59
`49156 53/64 56/63
`ACR 23
`57169 61/63 55/63
`'NC Enedianl
`41/54 59/60 61/42
`00c I/14.411Rn]
`54159 67/54 64/66
`CRP (Median)
`
`5/55
`16/56
`1/67
`
`3/6
`
`The typo and incidence of adverse picots was similar between the three dale groups of 0217 end placebo.
`For ail efficacy parameters studied, all doses of D2E7 were gal iS iitally significantly superior so placebo (p e 0.001). 20, 40 and
`80 rnp/week were statistically equally efficacious when given s.e. in patients with active RA. The treatment benefit was stable for 611
`parieleterS over
`
`Concurrent Session OS: Rheum:, Oki Arthritis - Treatment
`
`Supported by 86 0nrolricla educational gram from Wyeth AyerSi.
`Page i
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`Ex. 1107 - Page 2
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