With the growing prevalence of Covid-19 globally it is very important that the health of patient groups suffering from other diseases, such as inflammatory bowel disease (IBD), is not compromised. Information from China and Italy suggests that the hospital admission of non-Covid-19 patients can help to exacerbate the spread of infection. According to GlobalData’s internal models, under a low transmission risk, epidemiologists have forecasted that if confirmed new daily coronavirus cases does not start to decrease, cases could reach over 300,000 in the next two weeks in the UK. In order to protect active IBD patients who are more prone to infection, the British Society of Gastroenterology (BSG) published a consensus for the management of IBD patients during the coronavirus pandemic.
The BSG consensus advice for the management of IBD during the Covid-19 pandemic suggests patients with severe symptoms will continue to be assessed in a location away from Covid-19 assessment areas. However, in order to reduce traffic in outpatient clinics, mild IBD patients will be deferred to a telemedicine system, which will be adopted to conduct appointments and review new IBD patients. Furthermore, biomarker and endoscopy testing will be limited due to the presence of the virus in the stool. On behalf of the BSG, a UK-wide Covid-19 group has defined IBD patient risk for Covid-19 into three subsets, which are the highest risk, moderate risk, and lowest risk. Shielding is recommended for patients who could be classified as the highest risk of Covid-19; this means those who are extremely vulnerable should minimise contact with other members of their household and should not leave their homes. Most patients who suffer from IBD will usually be classified into the moderate or lowest risk groups, which suggests self-isolation (staying at home and only leaving for essential purposes) and social distancing (maintaining a two-meter distance from other people), respectively. However, patients who are above 70 years old and/or have at least one comorbidity such as respiratory conditions, cardiac conditions, hypertension, or diabetes mellitus are classified as the highest risk group.
IBD patients who either are currently administering steroids or immunomodulators, have recently begun anti-TNF therapy, or patients with moderate to severe active inflammation, are also classified into the highest risk group. However, physicians have maintained that patients should continue their medications and will maintain access to intravenous treatment in order to prevent flares and the formation of anti-drug antibodies, because of poor compliance. In a review from the World Health Organization (WHO), corticosteroids are not recommended for use in viral conditions as they could possibly promote pro-inflammatory responses, which could worsen the viral disease. Prominent biological therapies such as Remicade, Humira, and Stelara in IBD could enhance the risk of bacterial and viral infections, as these drugs inhibit the function of cytokines, which could help the immune system against Covid-19; however, there is no concrete evidence of these therapies increasing the risk of infection. With uncertainty surrounding the use of biologics, this could reduce patient adherence and potentially reduce the uptake of these therapies, as physicians may be hesitant in starting new patients, especially those in the mild-to-moderate category.
Clinical development of new therapies will be affected by the outbreak of Covid-19. Sponsors will now have to rely on telemedicine systems for trial visits and hospital attendance will need to be postponed unless clinically unavoidable. Lastly, many healthcare teams will be stretched as doctors are being redeployed to deal with the coronavirus outbreak. Eli Lilly has paused the enrollment of ongoing studies and delayed new studies for the first-in-class IL-23 therapy, mirikizumab, while Boehringer Ingelheim has suspended the development of spesolimab for fistulising Crohn’s disease. Currently, trial enrollment for IBD trials has been very competitive because of the increasing number of drugs in development and therapeutic alternatives to investigational drugs. Depending on whether Covid-19 will be a continued threat in the years to come, sponsors may need to conduct research on whether potential pipeline therapies could increase the risk of patients contacting Covid-19. Thereby, the SARS-CoV-2 outbreak will cause even more delays in trial enrollment and will likely delay the entrance of new products into the IBD market.