abatacept effective for anti-TNF inadequate responders

[Mary Z]

Title: Efficacy of Abatacept following Wash-Out of Anti-TNF Therapy in
Rheumatoid Arthritis Patients in the ATTAIN (Abatacept Trial in
Treatment of Anti-TNF INadequate Responders) Trial: Current versus
Prior Discontinuation
Category: 18. RA treatment — biologics and gene therapy
Author(s): M. Genovese1, M. Schiff2, M. Luggen3, R. Aranda4, J-C
Becker4, A. White4, M. Dougados5. 1Stanford University Medical Center,
Stanford, CA; 2Denver Arthritis Clinic, Denver, CO; 3University of
Cincinnati Medical Sciences Center, Cincinnati, OH; 4Bristol-Myers
Squibb, Princeton, NJ; 5Rene Descartes University, Service de
Rhumatologie B, Paris, France
Presentation Number: 1490
Poster Board Number: 266
Purpose: To examine the efficacy of the selective co-stimulation
modulator abatacept in rheumatoid arthritis (RA) patients with
inadequate responses to anti-TNF therapy who discontinued anti-TNF
therapy either prior to, or at entry into the ATTAIN trial.
Methods: ATTAIN was a 6-month, randomized, double-blind,
placebo-controlled, multicenter, Phase III trial of a fixed dose of
abatacept approximating 10 mg/kg vs placebo in patients with active RA
(=10 swollen joints and =12 tender joints). Two groups of patients
were enrolled: those with a previous inadequate response (‘prior’) and
those who were currently not responding adequately (‘washout’) to =3
months of anti-TNF therapy. Patients washed out etanercept or
infliximab for =30 or 60 days, respectively, prior to randomization. A
sub-analysis of ACR and Health Assessment Questionnaire (HAQ)
responses (improvement of =0.3 units from baseline) is presented for
the prior and washout groups.
Results: A total of 391 patients were randomized 2:1 and treated with
abatacept or placebo. For abatacept vs placebo, baseline
characteristics were similar overall and for washout and prior groups;
patients had long-standing disease (~12 years). Overall ACR 20
responses were higher with abatacept vs placebo at 6 months (50.4 vs
19.5%; p<0.001). Significantly more abatacept-treated patients
achieved an ACR 20 or HAQ response vs placebo (Figure) in both the
washout and prior groups. Washout of anti-TNF therapy did not induce
disease flare between enrollment and randomization; similary, there
was no disease flare in the placebo group throughout the 6-month
study, as evidenced by minimal changes in CRP levels and tender and
swollen joint counts.

Conclusions: Abatacept significantly improved RA signs and symptoms
and physical function in these patients, regardless of time since
discontinuation of anti-TNF therapy. Lack of artificially induced
disease flare following washout of anti-TNF therapy confirms that
patients were true anti-TNF therapy inadequate responders, suggesting
these clinical benefits were due to abatacept treatment. These data
support the use of a therapy with a novel mode of action, such as
abatacept, in patients who have previously tried and discontinued
anti-TNF therapy, as well as those who have continued anti-TNF therapy
despite inadequate responses.

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