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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 45-year-old exhibited lack of efficacy of dapsone while being treated for immune-thrombocytopenia. Five years later, at the age of 50 years, she developed serum sickness following treatment with rituximab for the immune-thrombocytopenia.
The woman, who had a history of depressive syndrome and partial thyroidectomy for nodules was diagnosed with immune-thrombocytopenia in 2012. She received unspecified corticosteroid therapy in 2012, 2014, twice in 2015. Then, she started receiving dapsone. Due to lack of efficacy of dapsone, she started receiving rituximab 1 g/day infusion from day 01−day 15 [route not stated]. She had good clinical response. She remained stable. At the age of 50 years, in October 2020 she was again diagnosed with thrombocytopenia. She received unspecified corticosteroid, but she was resistant to the corticosteroid treatment. She received a second course of rituximab 1 g/day infusions from day 01−day15. On day 01, she also received unspecified anti-allergy drug as premedication and completed the treatment without complications. However, five days following the infusion, she had onset of progressively generalized rash with progressive pruritus, oedema of the hands, wrists and ankles with joint pain then breathing difficulties, temporomandibular pain and febrile syndrome up to 39°C. She presented at 48 hours after the onset of symptoms. By that time, the skin rash almost disappeared. However, she had persistence of oedema of the extremities with pain and fever of 37.6°C. Examinations revealed hyperleukocytosis at 18,700, predominantly neutrophils, eosinophils at 318, CRP was 178, haptoglobin was 2,05 g and platelets were 75,000. Renal function and liver function tests were normal. Blood cultures and COVID-19 PCR were negative. Her complement fraction C4 level was at the lower limit of normal. Based on the findings, she was diagnosed with rituximab related serum sickness.
The woman received unspecified corticosteroid therapy. Within a week she had rapid favourable progress.
Reference
- Garrigues P, et al. Maladie serique secondaire a une seconde cure de rituximab au cours de la prise en charge d'un PTI : a propos d'une observation. Revue de Medecine Interne 42 (Suppl. 2): A373-A374, Dec 2021. Available from: URL: 10.1016/j.revmed.2021.10.058 [French abstract; summarised from a translation] [DOI]