Quartier P - Patients with juvenile idiopathic arthritis (JIA) who withdraw from treatment with abatacept for periods of up to 6 months can have the drug safely reintroduced and can once again experience clinical efficacy. Methods
A randomized withdrawal design trial in which responders (n=122) are randomized to maintain active therapy or to receive placebo until they flare, at which time they can restart the active treatment
Pts age: 6–17 yrs; 73% female; 78% white; with active, polyarticular JIA despite previous treatment with one or more conventional DMARDs
Results
53% of pts on placebo experienced a flare
59 pts from this group went on to the long-term open-label extension phase of the study
Of the 60 who were randomized to abatacept, 20% experienced flares, and 11/12 entered the long-term extension phase
During the first 6 mos of the extension phase, when abatacept was again given a return toward prior levels of clinical response was seen
No discontinuations because of AEs thus far
Throughout the entire study, 1.2% of pts developed antibodies to the abatacept molecule
In 21% who developed antibodies to CTLA-4 during 85 d after withdrawal of abatacept, it was reversed on re-initiation of the treatment
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