A62: GO‐KIDS Imaging Substudy: MRI Treatment Response to 30 mg/m2 Q4W Subcutaneous (SC) Injections of Golimumab (GLM) and Placebo in Children With Polyarticular JIA (pJIA)—Preliminary Results of the Placebo Controlled Portion (Week 48)
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A62: GO‐KIDS Imaging Substudy: MRI Treatment Response to 30 mg/m2 Q4W Subcutaneous (SC) Injections of Golimumab (GLM) and Placebo in Children With Polyarticular JIA (pJIA)—Preliminary Results of the Placebo Controlled Portion (Week 48)
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Background/Purpose:The GO‐KIDS trial is a double blind placebo controlled Phase III trial, where patients 2–17 yrs of age with pJIA received open label SC GLM 30 mg/m2 every 4 weeks until W16, followed by 1:1 randomization to placebo or GLM from W16 to W48 for children achieving ACR Pedi 30 response at W16 with resumption of GLM in PBO randomized subjects upon flare. Primary endpoint is % of children who did not experience flares of JIA between W16 and 48. 173 patients were enrolled globally.Methods:Patients participating in the GO‐KIDS trial at a single center could voluntarily participate in the GO‐KIDS Imaging substudy after obtaining separate informed consent. Gadolinium enhanced MRI examinations of a reference peripheral joint region were obtained at Weeks 0, 16, 28, 48 (primary endpoint). MRI was scored (grade 0–3) for synovitis (S) and synovial hypertrophy (SH). Statistical analysis used Shapiro‐Wilk‐W‐test, non‐parametric Wilcoxon rank‐sum test.Results:From the 17 children with complete data sets at W16 (10 female) with a median age of 9 (7–17) years at study inclusion in the Imaging substudy, 14 of the 17 children reached W48 in the substudy (8 GLM, 6 PBO). Discontinuations through W48 were due to 2 clinical non‐responders at W16 and 1 possible allergic reaction to GLM before W48. At W16 and W48 the MRI was significantly improved compared to W0 both for S and SH (p < 0.001 for W16, p < 0.0001 for W48) for the peripheral joints.After unblinding, 6 patients were on placebo (PBO) where 4 demonstrated through W48 both inactive disease on MRI and clinical improvement above ACR Ped 30 compared to baseline. One of the 4 patients flared after W48, while the remaining 3 do not show residual disease activity on MRI beyond W72. The remaining 2 patients, who were randomized to PBO at W16, flared and resumed GLM treatment. MRI at W28 predicted clinical flare in both patients with evidence of recurrent synovitis. One of the 2 patients responded to reintroduction of GLM showing inactive disease on MRI at W48. The other patient did not respond clinically or by MRI to GLM reintroduction.Changes in synovitis (S) on Gd enhanced MRI were a significant. Data presented as mean, mininal and maximal values.imageConclusion:At the primary endpoint of the GO‐KIDS trial, overall, children with pJIA demonstrated significant improvement on MRI measurements of synovitis and synovial hypertrophy between W0 and W48 during the GO‐KIDS Imaging substudy, particularly children randomized to continued GLM between W16 and W48. In 4/6 patients randomized to placebo at W16, GLM treatment from W0 to W12 alone induced inactivity on MRI through W48. MRI predicted clinical flare in 2 patients randomized to PBO.