Fingolimod

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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 woman developed lymphopenia and COVID-19 infection complicated by pneumonia during immunosuppressive treatment with fingolimod for relapsing remitting multiple sclerosis (MS) [times to reactions onsets not stated; not all outcomes stated].

The obese woman, who had relapsing remitting MS since 1996, had been previously treated with interferon-β-1a [IFN-beta 1a], mitoxantrone, glatiramer acetate and teriflunomide. From 2017, she had been receiving fingolimod 0.5 mg/day [route not stated]. During the fingolimod therapy, lymphocytes varied between 0.5−0.9×10³ /μL. On 3 March 2020, she developed asthenia and fever (>38°C). Respiratory rate and oxygen saturation were 18 breaths/min and 97%, while she breathed ambient air.

Fingolimod was discontinued on 3 March 2020, and she was admitted to hospital in Italy on the following day. A chest radiography revealed streaky opacities in both the lung lower lobes, which was consistent with atypical pneumonia. CRP, neutrophils and lymphocytes were noted to be 108 mg/mL, 3.21×10³ /μL and 0.37×10³ /μL. On 5 March 2020, real-time RT-PCR was positive for SARS-CoV-2; however, she was unaware of the source of COVID-19 exposure. She developed COVID-19 infection complicated by pneumonia secondary to the immunosuppressive therapy with fingolimod. After 5 days, she was subjected to continuous positive airway pressure because oxygen saturation dropped to 86%. Also, haemoglobin reduced from 14.7 g/dL to 11.7 g/dL, and neutrophils were noted to be 4.85×10³ /μL. Lymphocytes had decreased from 0.77×103 /μL (1 month before hospitalisation) to 0.26×103 /μL, which indicated lymphopenia secondary to fingolimod. She received off-label treatment with hydroxychloroquine and lopinavir/ritonavir for COVID-19 infection. Also, she was treated with paracetamol, when needed (symptomatic treatment). After 15 days, she was asymptomatic, without cough, fever and breathing difficulties, and she recovered well. During hospitalisation, she remained without any MS therapy for about 1 month. She was discharged, after which she re-started interferon-β-1a therapy for the MS.