Latest covid 19 and ibd drugs

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Patients with inflammatory bowel disease (IBD) who develop COVID-19 should stop taking thiopurines, methotrexate, tofacitinib, and biological therapies during the viral illness, according to a clinical practice update from the American Gastroenterological Association (AGA).

"While the COVID-19 pandemic is a global health emergency, patients with IBD have particular concerns for their risk for infection and management of their medical therapies. This clinical practice update incorporates the emerging understanding of COVID-19 and summarizes available guidance for patients with IBD and the providers who take care of them," the authors write.

David T. Rubin, MD, University of Chicago Medicine Inflammatory Bowel Disease Center, and colleagues' recommendations were published online April 10 in an expert commentary in Gastroenterology.



Rubin and another author report a variety of financial relationships with pharmaceutical companies.

Patients with IBD are asking whether they are at increased risk for COVID-19, Rubin told Medscape Medical News. "Because they are often on immune-modifying therapy for their inflammatory bowel disease, they worry that they are in the population of folks who are immune compromised.

"In fact, immune suppression is not [the] goal of our management of IBD, it is the immune regulation of an overactive immune response. In some ways, the inflammatory reaction of COVD-19 that results in symptoms and respiratory failure are the same thing — an overactive immune response," he explained.

Clinical Picture May Vary for Patients With IBD and COVID-19


Drugs and biologics that are withheld during viral infection can be resumed once the patient's symptoms have resolved or when follow-up viral testing results are negative or serologic testing shows the patient is in the "convalescent stage of illness," the authors write.


For those hospitalized with severe COVID-19 and at risk of doing poorly, treatment of the IBD will "likely take a back seat" to COVID-19 treatment, but clinicians should consider the coexisting IBD when deciding on therapies for COVID-19 when possible. "It is of interest that clearance of [cytomegalovirus] is enhanced when IBD therapy is added to ganciclovirand that thiopurines and cyclosporine may have anti-coronavirus properties," the authors observe.

For patients who are hospitalized for IBD and who have "milder or incidentally identified COVID-19," the emphasis should be on the acute IBD and on giving standard IBD care.

Patients with IBD who are known to have SARS-CoV-2 infection but who are not ill with COVID-19 should stop taking thiopurines, methotrexate, and tofacitinib. Biological therapies should be withheld for 2 weeks, and the patient should be monitored for COVID-19 symptoms.

Patients With IBD Who Are Not Infected Should Continue IBD Treatment
Those with IBD who are not infected with SARS-CoV-2 should continue with their IBD therapies and with their infusion regimen at "appropriate infusion centers," the authors write.


The goal for these individuals is to sustain symptomatic or clinical remission and "objectively confirmed inflammation control," as evidenced by "endoscopic improvement and normalized laboratory values."


Although some patients may be reluctant to visit infusion centers for fear of exposure to infected individuals, the authors caution that it could be much riskier for a nurse to visit patients in their homes and possibly expose others in the household.


Patients with IBD are worried about having to stop their IBD medications if they get COVID-19, "because maintenance therapies are there to keep their IBD in remission," Rubin told Medscape Medical News.


"The longer a patient is off their therapy for a chronic condition like IBD, the more likely they are to suffer from a relapse of the disease. We reassure them that in most cases, COVID-19 lasts a few weeks and after they have improved, can restart their medications safely."


Role of Anticytokine-Based Treatments and Antivirals for COVID-19 Is Unclear
"It should be known that anti-cytokine-based treatments are being studied for COVID-19 therapy, and it is possible that we will learn that, for example, continuing anti-TNF [tumor necrosis factor] therapies might reduce progression to acute respiratory distress syndrome and multi-organ system failure," the authors explain. "However, in the absence of those data, guidance is currently based on deciding whether to hold or to continue specific IBD therapies.


"Of additional interest are the anti-viral therapies and other anti-cytokine therapies that are being studied for COVID-19. Choosing therapies that may have secondary benefit in IBD (or at least do not induce bowel inflammation) would be appropriate to consider."


When considering treatments for COVID-19 and whether to increase IBD treatment, clinicians and patients should weigh the risks against the benefits.


Social Distancing Works for Patients With IBD
Evidence from the Wuhan IBD center in China suggests that strict social distancing for patients with IBD works, Rubin said.


Gastroenterologists at Wuhan University instituted a number of measures to protect patients with IBD from COVID-19 nearly 3 weeks before the general shutdown in Wuhan. These included distributing educational information and instructions to patients, updating them as needed, and recording patient information, such as infection risks and actions taken. None of the 318 patients with IBD had been diagnosed with the infection at the end of February.


Individuals with IBD should observe strict social distancing, work from their home, practice careful hand hygiene, and stay away from individuals known to be infected, Rubin and colleagues recommend.


Patients With IBD Who Experience Relapse Need Careful Evaluation
Rubin urges clinicians to "carefully evaluate their IBD patients who have a relapse both because it may be digestive symptoms from COVID-19 instead, but also because much more likely it will be the usual causes — other infections, loss of response to therapy or due to patients who stopped their therapy on their own. A thoughtful clinical approach to these patients is critically important so that our patients can be kept safe and get the treatments that they need."


He added, "We are learning more every day about COVID-19 and about new options for testing, screening, and outcomes of our IBD patients who get infected. Patients should check with their doctors if they have concerns or questions, and both patients and clinicians should stay tuned as more information becomes available. The IBD community of experts and care providers are all working together."


A decision support tool and quick reference chart for social sharing are available for download on the AGA website, and clinicians are asked to submit cases involving patients who have both IBD and confirmed COVID-19 to the SECURE-IBD registry.

 

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NEW YORK (Reuters Health) - The disease course of COVID-19 appears to be milder in patients with inflammatory bowel disease (IBD), according to two new reports.

IBD patients often receive immunosuppressive treatments, which raises concerns about whether they are more susceptible to COVID-19. On the other hand, immunomodulatory therapies might also suppress the hyperinflammatory cytokine response associated with the most severe presentations of COVID-19.

Dr. Lorenzo Norsa from Papa Giovanni XXIII Hospital, in Bergamo, Italy, and colleagues describe the experience of their IBD center during the COVID-19 pandemic in an area with one of the highest rates of SARS-CoV-2 infection per 100,000 inhabitants worldwide.

The 522 patients with IBD in their center were advised not to modify their treatment regimens. There were no reported cases of COVID-19 in this group, and no patients were admitted to hospital with proven SARS-CoV-2 infection.


Based on their calculations using data from the Wuhan region, however, there should have been 21 cases among their IBD patients.

In contrast, during the same period, 479 patients without a history of IBD were admitted to their hospital because of severe COVID-19 after presenting to the emergency department with respiratory failure, the authors report in Gastroenterology.

In the previous SARS and MERS coronavirus outbreaks, they note, immunosuppression was not found to be a risk factor, and no patient with IBD as the only risk factor was reported to develop severe SARS or MERS-related disease.



"These findings warrant further investigation, to confirm our preliminary findings and allow implementing guidelines on the management of these patients during the SARS-CoV-2 global pandemic," Dr. Norsa and colleagues conclude.

In another report, published in the Journal of Pediatric Gastroenterology and Nutrition, Dr. Dan Turner of Shaare Zedek Medical Center at The Hebrew University of Jerusalem, in Israel, and colleagues from centers around the world provide provisional guidance for managing pediatric IBD in the face of COVID-19.

They identified eight children with pediatric IBD globally who developed COVID-19, all with mild infections not requiring hospitalization, despite treatment with immunomodulators and/or biologics.

None of these cases were from China or South Korea, but 17 (22%) of 79 children there had exacerbations of their IBD after biologic treatment was delayed.

Elsewhere, face-to-face appointments were often replaced by remote consultations but almost all maintained current IBD treatment.


Based on the available evidence and on consensus rates ranging from 92% to 100%, the group issued 10 guidance points for clinicians caring for pediatric IBD patients in pandemic areas.


They conclude that IBD per se does not seem to be a risk factor for acquiring SARS-CoV-2 or for a more severe infection, so they recommend using the same measures as the local population for decreasing the risk of contracting SARS-CoV-2 in these children.

Active IBD should be treated according to standard guidance, as before the pandemic, since the risk of IBD complications in active IBD outweigh the risk of COVID-19 complications, especially in children.


Along the same lines, there appears to be no clear indication to stop IBD treatment during COVID-19 infection, but the group recommends suspending immunosuppressive treatment during an acute febrile illness until fever subsides and the child returns to normal health, irrespective of the SARS-CoV-2 testing status.


Children should continue follow-up visits, preferably by remote telemedicine consultations, and elective surgeries and nonurgent endoscopies should be postponed during the pandemic, the authors say.

Dr. Giovanni Monteleone of the University of Rome Tor Vergata, who recently reviewed evidence suggesting that IBD patients are not at increased risk for COVID-19, told Reuters Health by email, "Cytokine blockers may actually have a beneficial effect. Indeed, early research suggests that interleukin-6 receptor blocker may be helpful for treating COVID-19 pneumonia."


"IBD patients should continue to take their drugs," said Dr. Monteleone, who was not connected to the new reports, "but it is important they must stop smoking, as this seems to be a factor increasing the risk of infection."


Dr. Silvio Danese of Humanitas University, in Milan, Italy, who recently reviewed the management of IBD during COVID-19, told Reuters Health by email that it remains unclear why IBD patients seem to be protected from COVID-19.

"We don't know if it is (the disease itself) or drugs protecting the patient, or if patients might be better with social isolation, as they know about their immunosuppressed status," said Dr. Danese, who also was not involved in the new studies.


While he admits that "we are still learning," he endorses following the current recommendations of the International Organization for the Study of Inflammatory Bowel Disease (IOIBD), which can be found at https://bit.ly/3e9b49m.


Dr. Norsa and Dr. Turner did not respond to a request for comments.