We conducted a randomized clinical trial in adults with a new diagnosis of
ITP and a platelet count <30000/muL to test the hypothesis that initial intermittent treatment with
anti-D may avoid or defer the need for
splenectomy when compared to current routine care (
glucocorticoid treatment, followed by
splenectomy).
Splenectomy was to be performed in the
anti-D group if patients failed to respond to three consecutive
anti-D treatments given within 10 days. The incidences of
splenectomy were 14 of 37 (38%) in the routine care group and 14 of 33 (42%) in the
anti-D group (absolute risk reduction = 4.6% in favor of the routine care group, 95% CI, -18.4 to 27.6%). However,
splenectomy was performed prematurely, not according to the protocol, in 11 of 14 patients in the
anti-D group. The median time to
splenectomy was 36 days (range, 9-78) in the routine care group and 112 days (range, 19-558) in the
anti-D group (P = 0.045 at 100 days after randomization, P = 0.840 at 1 year after randomization, using log-rank analysis). Patients in the
anti-D group were treated with
prednisone for fewer days (70 days) compared to the routine care group (112 days, P = 0.01). No major
bleeding events occurred. In this study, initial treatment of patients with intermittent
anti-D initially deferred
splenectomy. Whether our aggressive regimen of
anti-D could have prevented
splenectomy if it had been adhered to in all patients remains uncertain. However, compliance with this
anti-D regimen was not feasible for many patients and/or their physicians.