Cyclophosphamide/rituximab

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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 26-year-old woman developed COVID-19 infection during treatment with rituximab and cyclophosphamide for granulomatosis with polyangiitis (GPA) [dosages and routes not stated].

The woman, who had obstructive sleep apnoea and fibromyalgia was diagnosed with ENT-limited GPA in 2017. Her treatment began with azathioprine followed by methotrexate and in 2018 switched to rituximab. Thereafter, she experienced organ-threatening manifestations with bilateral hearing loss. She was stable on periodic infusions of rituximab at 6 to 9 monthly intervals and did not develop other organ-threatening features. She received one dose of rituximab for a flare of her GPA. In between rituximab doses, she was admitted with acute COVID-19 infection with COVID-19 related pneumonia and received treatment with unspecified antibacterials [antibiotics], fluids and oxygen. After discharge, she was readmitted with worsening symptoms of non-resolving COVID-19 pneumonia which was observed on chest X-ray. Subsequently, levofloxacin was initiated. Later, improvement in her condition was noted and was discharged, thereafter. She took 2 ^nd dose of rituximab after it had been delayed by approximately 2 weeks. She was afebrile after the acute COVID-19 infection and her persistent positive results were explained as related viral shedding over a period of 8 weeks. After 1 week, she presented with fever, cough and shortness of breath and her blood tests revealed that a remarkable rise in inflammatory markers which included a CRP of 242. She was receiving treatment for non resolving COVID-19 pneumonitis with worsening chest X-ray features. Following discharge, her GPA continued to flare with persistent epistaxis with nasal crusting. She also developed worsening inflammatory arthritis with purpuric rash on her legs. Examination revealed nasal septum perforation, without renal involvement. Later, additional cyclophosphamide was given via the day-case unit. Before cyclophosphamide, her SARS-CoV-2 serology was negative. After 2 doses of cyclophosphamide, she was SARS-CoV-2 positive. However, she was afebrile and stable.