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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
A 51-year-old woman experienced lack of efficacy following treatment with prednisone and immune globulin for thrombocytopenia.
The woman was diagnosed with systemic lupus erythematosus at the age of 33 years. Shortly thereafter, she developed acute deep-vein thrombosis which was diagnosed with antiphospholipid syndrome. Eight years later (i.e. at the age of 41 years), she developed acute occlusion of the right posterior tibial artery, resulting in a left below-knee amputation complicated by a perioperative cerebrovascular accident. Over the following 10 years, her disease was successfully managed with hydroxychloroquine, azathioprine, belimumab and warfarin. She had chronic mild thrombocytopenia. At the age of 51 years, she presented with haemoptysis in the setting of COVID-19 infection. Her blood tests revealed isolated thrombocytopenia. A peripheral blood smear showed thrombocytopenia without evidence of platelet clumping. Red blood cells and white blood cells counts were normal in both numbers and morphology. A CT scan of the chest demonstrated ground glass opacities in the left lower lobe. Immune thrombocytopenic purpura was suspected, and she received one unit of platelets on admission; however, no effect on her platelet count was noted. Azathioprine, belimumab and warfarin were held, and hydroxychloroquine (off-label therapy to treat COVID-19) was continued at 300mg daily. On hospital day 1, she started receiving IV immune-globulin and received two doses over days 1 and 2 (total of 2 g/kg body weight), with no effect on the platelet count. On day 2, oral prednisone 60mg daily was initiated. On day 3, she received another unit of platelets, but her platelet count remained unchanged. However, she had felt well since admission, did not have haemoptysis and did not require supplemental oxygen. On day 7, she received IV immune-globulin at 1 g/kg body weight, with no improvement in the platelet count.
In view of the severe thrombocytopenia refractory to prednisone and immune-globulin, the woman received treatment with eltrombopag on hospital day 8. The following morning, her platelet count improved. Her platelet count further improved after 4 days of eltrombopag therapy. She was discharged on prednisone 60mg daily and eltrombopag.