Efficacy of Abatacept in Juvenile Idiopathic Arthritis (JIA)

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Presentation Number:679

Presentation Time:11/8/2007 3:00:00 PM

Title:Efficacy of Abatacept in Different Sub-Populations of Juvenile

Idiopathic Arthritis (JIA): Results of a Randomized Withdrawal Study

Category:11. Pediatric rheumatology clinical and therapeutic disease

Author(s):E. H. Giannini1, N. Ruperto2, A. M. Prieur2, E. Paz2, N. E.

Rubio-2, C. A. Silva2, C. Abud2, R. Burgos-Vargas2, V. Gerloni2, J.

Melo-Gomes2, C. Saad Magalhaes2, F. Sztajnbok2, C. Goldenstein-Schainberg2,

M. Scheinberg2, P. Hashkes1, C. Hom1, L. H. Sigal3, A. J. Block3, A.

Covucci3, D. J. Lovell1, A. i2. 1Cincinnati Children's Hospital

Medical Center, PRCSG, Cincinnati, OH; 2IRCCS Istituto G Gaslini-PRINTO,

University of Genoa, Genoa, Italy; 3Global Clinical Research - Immunology,

Bristol-Myers Squibb, Princeton, NJ

PURPOSE: Abatacept (ABA), a selective co-stimulation modulator, has been

shown to be effective and generally safe and well tolerated in JIA1. A

sub-analysis of efficacy data from the open-label (OL) lead-in period of

this randomized withdrawal study was conducted to determine efficacy in each

of the JIA categories enrolled in the trial as well as in the cohort

previously treated with other biologic therapies.

METHODS: Patients (pts) received ABA 10 mg/kg (IV infusion) on Days 1, 15

and every 28 days thereafter in the 4-month OL lead-in period, and were

permitted (but not required) to receive MTX (10-30 mg/m2/week). No other

DMARDs were permitted. At the end of the OL lead-in period (Day 113)

response (by ACR Pediatric [Pedi] 30, 50, 70 and 90) was assessed in pts

completing the lead-in period. ACR Pedi 30 responders who elected to enter

the double-blind (DB) withdrawal period were randomized (1:1) to receive ABA

10 mg/kg or placebo. ACR Pedi response data are presented for the OL lead-in

period.

RESULTS: 190 pts were enrolled. Pts were representative of those with JIA in

clinical practice, predominantly Caucasian (77.4%), female (72.1%), with a

mean age of 12.4 years. The majority of pts were of the JIA polyarthritis

category (64.2%; 20.0% rheumatoid factor [RF] positive); 19.5% Systemic JIA;

14.2% extended oligoarticular JIA and 1.6% persistent oligoarticular JIA.

170 pts completed the lead-in period; 123 achieved an ACR Pedi 30 response

at Day 113. ACR Pedi 30 responder rates were similar across categories:

polyarthritis-RF positive, 26/38 (68.4%); polyarthritis-RF negative, 54/84

(64.3%); Systemic, 24/37 (64.9%); oligoarticular extended, 16/27 (59.3%);

and persistent oligoarticular 2/2 (100%).

30% of pts entering the lead-in period had previously received

TNF-antagonists (56 pts) or anakinra (1 pt). In the 70% who had not

previously received biologic therapy, ACR Pedi 30, 50, 70, and 90 response

rates were 75.9%, 60.2%, 36.1% and 17.3%, respectively.

For pts who received previous biologic therapy, response rates were 38.6%,

24.6%, 10.5% and 1.8%, respectively.

For pts receiving MTX (73.7% [140/190]), ACR Pedi 30, 50, 70 and 90 response

rates were 68.8%, 50.7%, 27.5% and 12.3%, respectively; for pts not taking

MTX, rates were 53.8%, 46.2%, 30.8% and 13.5%, respectively.

CONCLUSIONS: Abatacept was effective in treating all JIA categories enrolled

in the study. Abatacept is the first agent to show efficacy in JIA pts who

previously had received biologic therapy.

Disclosures: E.H. Giannini, Bristol-Myers Squibb, 2; N. Ruperto,

Bristol-Myers Squibb, 2; A.M. Prieur, None; E. Paz, None; N.E. Rubio-,

None; C.A. Silva, None; C. Abud, None; R. Burgos-Vargas, None; V. Gerloni,

None; J. Melo-Gomes, None; C. Saad Magalhaes, None; F. Sztajnbok,

Investigator at a clinical site in the Bristol-Myers Squibb sponsored JIA

trial, 9; The Rheumatology unit receives a grant corresponding to the

patients' monthly infusions and medical visits from Bristol-Myers Squibb, 9;

C. Goldenstein-Schainberg, None; M. Scheinberg, None; P. Hashkes, None; C.

Hom, Investigator at a clinical site in the Bristol-Myers Squibb sponsored

JIA trial, 9; L.H. Sigal, Bristol-Myers Squibb, 3; A.J. Block, Bristol-Myers

Squibb, 1; Bristol-Myers Squibb, 3; A. Covucci, Bristol-Myers Squibb, 3;

D.J. Lovell, Abbott, 5; Amgen, 5; Bristol-Myers Squibb, 5; Centocor, 5;

Hoffmann-La Roche, 5; Novartis, 5; Pfizer, 5; Regeneron, 5; Xoma, 5;

Editorial Board, Clinical and Experimental Rheumatology; Associate Editor,

Arthritis Care and Research, 9; A. i, Bristol-Myers Squibb, 2.