Abatacept Induces Zero Joint Tenderness & Inflammation in RA Patients w/Inadequate Response to MTX or ANTI-TNF Therapy

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ABATACEPT INDUCES ZERO JOINT TENDERNESS AND INFLAMMATION IN RHEUMATOID

ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO METHOTREXATE OR ANTI-TUMOR

NECROSIS FACTOR THERAPY

http://www.jrheum.com/subscribers/06/02/81-100.html

Objective:The proportion of rheumatoid arthritis (RA) patients with zero

swollen and tender joints was assessed in two Phase III trials of the

selective co-stimulation modulator abatacept in patients with active RA and

an inadequate response to methotrexate (MTX) or anti-TNF therapy.

Methods:AIM (Abatacept in Inadequate responders to MTX) and ATTAIN

(Abatacept Trial in Treatment of Anti-TNF INadequate responders) were

randomized, double-blind, placebo-controlled, multicenter, Phase III trials

assessing the efficacy and safety of a fixed dose of abatacept approximating

10 mg/kg or placebo for 6 and 12 months, respectively. In AIM, patients had

active RA despite MTX treatment. In ATTAIN, all patients had active RA and

inadequate efficacy responses to ≥3 months of anti-TNF therapy (etanercept,

infliximab or both). All patients washed out anti-TNF therapy prior to the

trial start. A total of 68 joints were assessed for tenderness and 66 for

swelling at randomization and prior to monthly study drug administration.

Patients were required to have ≥10 swollen joints and ≥ 12 tender joints for

inclusion.

Results Obtained and Conclusion: A total of 433 and 219 patients in AIM and

258 and 133 patients in ATTAIN were randomized and treated with abatacept

and placebo, respectively. Of these, 424 and 214 patients in AIM, and 256

and 133 patients in ATTAIN, respectively were available for efficacy

assessments as a few patients were excluded from one site due to compliance

issues. Baseline characteristics including average tender and swollen joint

counts were similar between groups (>30 tender joints and >20 swollen joints

for all). In both trials, abatacept increased the number of patients with

zero joint inflammation vs. placebo at 6 months (AIM, 4.0 vs. 0.5%; ATTAIN,

3.5 vs. 0.0%). This significant proportion continued to increase through 1

year in the AIM trial (8.5 vs. 0.5%).

Brief Conclusion: The selective co-stimulation modulator abatacept induced

zero joint tenderness and swelling in two populations of RA patients: those

with inadequate responses to MTX and/or to anti-TNF therapy. These results

demonstrate that abatacept treatment translates into real-life benefits for

RA patients.

Proton Rahman , Schiff, Abud-Mendoza, Aranda,

Jean-Claude Becker, Oksana Mokliatchouk , Covucci, Piet van Riel,

Fedra Irazoque, Teng (Memorial University, Newfoundland, Canada,

Denver Arthritis Clinic, Denver CO, USA, Hospital Central Dr Ignacio Morones

Prieto, San Potosi, Mexico, Bristol-Myers Squibb, Princeton NJ, USA,

University Hospital Nijimegen, Nijimegen, The Netherlands, Hospital Angeles

Mocel, San Chapultepec, Mexico)