Immunosuppressants

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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

In a case series, a middle-aged woman and an elderly woman [exact ages not stated] were described, who developed SARS-CoV-2 pneumonia or SARS-CoV-2 infection following immunosuppression therapy with antithymocyte-globulin, mycophenolate, prednisone or tacrolimus [routes and durations of treatments to reactions onsets not stated; not all dosages stated].

Patient 1: A middle-aged woman developed SARS-CoV-2 pneumonia following immunosuppression therapy with antithymocyte-globulin, mycophenolate, prednisone and tacrolimus. The woman, who had undergone kidney transplant, presented to the clinic with loss of appetite, fatigue and temperature of 37.3°C since one week. Her laboratory test showed new-onset leukopenia. She had a medical history of end-stage renal disease secondary to chronic pyelonephritis, sleeve gastrectomy, haemodialysis and type 2 diabetes. Her post-transplant immunosuppression therapy comprised of anti-thymocyte globulin 5 mg/kg as induction and then maintenance therapy with mycophenolate, tacrolimus and prednisone. She experienced delayed graft function. She received prophylactic therapy with valganciclovir and cotrimoxazole [trimethoprim-sulfamethoxazole]. Upon presentation to the clinic, she underwent test for SARS-CoV-2 infection and remained self-isolated at home due to pending results. On the following morning, her test for SARS-CoV-2 infection returned positive. Thus, mycophenolate was stopped. But, she developed cough, dyspnoea and rhinorrhea on the following day. Thereafter, she presented to the emergency department and was found hypoxic with an oxygen saturation of 85% on room air. Her chest x-ray showed diffused bilateral patchy opacification. Hence, she underwent further evaluation and diagnosed with SARS-CoV-2 pneumonia that required oxygen supplementation. The dose of tacrolimus was adjusted to a lower target level of 4-7 ng/mL and the dose of prednisone was maintained at 5 mg/day. On hospital day 3, her fever worsened and dyspnoea progressed. Her CT scan of the chest revealed extensive bronchovascular crazy paving with consolidations and areas of lobular sparing. Therefore, she started receiving off-label treatment with hydroxychloroquine for SARS-CoV-2 pneumonia. Eventually, her supplemental oxygen was stopped and she was discharged on day 11. On the day of discharge, her IgM and IgG antibodies to the SARS-CoV-2 spike receptor-binding test showed positive result and repeated RT-PCR of nasopharyngeal swab remained positive for SARS-CoV-2. She was discharged on immunosuppression therapy with prednisone and tacrolimus. After 26 of diagnosis, her RT-PCR showed negative results for SARS-CoV-2 and mycophenolate was resumed.

Patient 2: An elderly woman developed SARS-CoV-2 infection during immunosuppression therapy with mycophenolate, prednisone and tacrolimus. The woman, who had undergone kidney transplant, presented to emergency department with dry cough and fevers since a week. She had a medical history of end-stage renal disease due to diabetic nephropathy, hypertension, type 2 diabetes and obesity. She had been receiving immunosuppression therapy with mycophenolate, prednisone and tacrolimus with well kidney allograft function. She was also receiving losartan. Upon presentation, she was found hypoxic and required oxygen supplementation. Her chest x-ray showed bilateral interstitial infiltration and RT-PCR for SARS-CoV-2 showed positive results. Thus, she was diagnosed with SARS-CoV-2 infection on day 7 after onset of the symptoms. Therefore, she started receiving off-label treatment with ceftriaxone, hydroxychloroquine and azithromycin for SARS-CoV-2 infection. By day 7 after the diagnosis, she had improvement and was discharged. Mycophenolate was stopped on day 8 and remaining immunosuppression regimen were continued throughout the hospitalisation. Her RT-PCR test showed negative result for SARS-CoV-2 on day 23 after the diagnosis and mycophenolate was resumed. IgM and IgG antibodies to the SARS-CoV-2 spike receptor-binding test showed positive result on day 29 after the diagnosis.