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. 2013 Sep 11;40(5):319–325. doi: 10.1159/000355006

Table 1.

Randomized clinical trials with TRA in ITP

Author / study Patients Control New therapy Na Response rateb (HR, OR) Durable responsec
Bussel, 2007 chronic ITP, placebo Elt 50d 59 11 vs. 70e
TRA 100773A [37] 2nd or 3rd line p < 0.001
Bussel, 2007 chronic ITP, placebo Elt 75 57 11 vs. 81
TRA 100773A [37] 2nd or 3rd line p < 0.001
Bussel, 2009 chronic ITP, placebo Elt 50 114 16 vs. 59
TRA 100773B [38] 2nd or 3rd line p < 0.0001
Cheng, 2011 chronic ITP, placebo Elt 50 197 28 vs. 79 10 vs. 60
RAISE [39] 2nd or 3rd line OR 8,20f
p < 0.0001 p < 0.0001
Kuter, 2008 [40] chronic ITP
after splenectomy placebo Rom 63 0 vs. 79 p < 0.0001 0 vs. 38 p = 0.0013
Kuter, 2008 [40] chronic ITP no splenectomy placebo Rom 62 14 vs. 88
p < 0.0001 5 vs. 56
p < 0.0001
Kuter, 2010 [41] chronic ITP, no splenectomy placebo Rom 234 26 vs. 81 OR 2.3f p < 0.001

HR = Hazard ratio; OR = odds ratio; Elt = eltromboag; Rom = romiplostim.

a

Number of patients.

b

% of patients with ≥50,000/µl at the prespecified endpoint.

c

% of patients with ≥50,000/µl for at least 6 weeks.

d

Number indicates the dose in mg.

e

Results for controls vs. results for new therapy.

f

HR or OR for new therapy.