NICE removes budesonide from recommended COVID-19 treatments

In updated guidance, the National Institute for Health and Care Excellence said there was “no statistically significant difference” between patients treated with inhaled budesonide for COVID-19 and those who received usual care.

While NICE acknowledged that there were some benefits from inhaled budesonide in COVID-19, it added that “corticosteroids can potentially affect wellbeing without affecting the COVID-19 disease process”

The inhaled corticosteroid budesonide should no longer be offered to patients with COVID-19 unless they are part of a clinical trial, the National Institute for Health and Care Excellence (NICE) has said.

In updated guidance, published on 14 December 2021, NICE said there was “no statistically significant difference” in the likelihood of hospitalisation, need for mechanical ventilation, admission to intensive care or death, between patients [with COVID-19] who used inhaled budesonide alongside usual care, compared with those who had usual care alone.

Inhaled budesonide did significantly reduce the need for oxygen administration, as well as shortening recovery time, the guidance said. However, it added that “corticosteroids can potentially affect wellbeing without affecting the COVID-19 disease process”.

Budesonide is a corticosteroid used for conditions including asthma and Crohn’s disease. It was the basis of the Steroids in COVID-19 (STOIC) study, which began recruiting participants in July 2020 and was added to the Platform Randomised Trial of Interventions against COVID-19 in Older People (PRINCIPLE) in November 2020.

In July 2021, data from the STOIC trial were published that showed the drug shortened recovery time and reduced the chances of needing urgent care. Data from the PRINCIPLE trial, published in August 2021, suggested that inhaled budesonide could improve recovery time and reduce hospital admissions or death from COVID-19.

However, the updated NICE guidance said that while trial evidence had suggested the inhaled drug could shorten recovery times, both major trials to date — PRINCIPLE and STOIC — were conducted with “mainly older people, which limits its generalisability to other age groups”, and that the STOIC trial was “very small and stopped early”.

NICE concluded that more research on inhaled budesonide in COVID-19 was needed and that, in the meantime, only people involved in clinical trials should be offered the drug. It added that people who take budesonide for other reasons should still continue to take it, even if they test positive for COVID-19.