IBD, biologics not linked to severe COVID-19 outcomes

Last Updated: 2020-06-09

By Marilynn Larkin

NEW YORK (Reuters Health) - Inflammatory bowel disease (IBD) and its treatment were not associated with severe COVID-19 outcomes in a matched cohort study in New York City.

"Our results support the notion that biologic therapies do not lead to increased risk of severe outcomes," Dr. Dana Lukin of New YorkPresbyterian Hospital-Weill Cornell Medicine in New York City told Reuters Health by email. "Clinicians should make efforts to ensure that patients understand the results from our study and others... have shown a consistent and reassuring message that IBD and steroid-sparing therapies are not associated with risk, and delaying such treatments might actually increase risk for adverse outcomes."

Dr. Lukin and colleagues compared outcomes of COVID-19 patients with and without IBD at two New York City hospitals. Separately, they studied a cohort of active IBD patients to estimate the prevalence of COVID-19 among them.

As reported in Gastroenterology, 80 COVID-19 cases with IBD were matched with 160 COVID-19-only controls. Patients' mean age was 48 and 56% were men. Comorbidities were similar between the groups, except IBD cases had significantly lower BMI, chronic obstructive pulmonary disease, and asthma, but a higher prevalence of malignancy and immunosuppressive medication use.

Vital signs, hypoxemia, and inflammatory markers were similar between the groups at presentation; however, IBD cases more frequently presented with diarrhea (45% versus 19%) and abdominal pain (20% versus 5%).

The primary outcome - a composite of death, ICU admission, or intubation - was similar, but numerically lower in IBD cases compared with controls (24% versus 35%).

Among IBD patients, after adjustment for age, fever and gastrointestinal symptoms, ulcerative colitis was associated with an emergency visit or hospital admission (adjusted odds ratio, 12.7). In addition, the proportion of patients on vedolizumab or on no biologic therapy was numerically higher among IBD cases requiring an emergency visit/hospitalization (no biologic, 29%; vedolizumab, 30%; ustekinumab, 8%; TNF-antagonist, 6%).

In the separate longitudinal cohort of active 119 IBD patients (median age 44; 55% women; 55% Crohn's disease), 24.4% met criteria for COVID-19, consistent with rates estimated in the general NYC population. The distribution of age, sex, race/ethnicity, smoking, IBD type, disease location, or extraintestinal manifestations was similar between IBD patients with or without COVID-19.

New-onset diarrhea (19.3% vs. 11.1%) and abdominal pain (12.6% vs. 8.9%) were significantly more frequent in IBD patients with COVID-19 compared to those without.

Further, a higher proportion of IBD patients with COVID-19 had active ulcerative colitis (92.9% vs. 62.5%,); endoscopically active Crohn's disease (92.3% vs. 45.7%) or ulcerative colitis (85.7% vs. 48.4%); and elevated baseline biomarker levels, including C-reactive protein (>0.9 mg/dL) and fecal calprotectin > 50 ug/mg).

Whereas proportional baseline corticosteroid use was higher among COVID-19 patients, no overall differences were observed based on biologic, immunomodulator, or aminosalicylate use.

Of 83 patients receiving biologic therapy, COVID-19 infection was similar across therapeutic classes, with fewer overall cases among patients on ustekinumab (13.8%) compared with vedolizumab (30.4%), TNF antagonists (25.0%), or tofacitinib (42.9%).

Dr. Lukin said, "The findings from our and other retrospective cohorts should be interpreted with some caution as the overall number of adverse outcomes is limited and these are uncontrolled observations. While the number of severe outcomes, such as need for mechanical intubation, ICU stay, or death has been reassuringly low, larger numbers of patients and longer follow-up periods are needed to further validate our findings."

"Furthermore," he continued, "many patients held their medication upon getting diagnosed with COVID-19 based on their own decision or the managing physician for the COVID. However, based on guidelines from organizations such as the IOIBD, when the gastroenterologist is aware of patients with COVID-19, the recommendation is to hold the medication during the acute period and until the patient is symptom-free." (https://bit.ly/2zjKqer)

He added, "There is limited data pertaining to patients who had their medication administered during the symptomatic period, which requires further study."

Internist and gastroenterologist Dr. Niket Sonpal, Adjunct Professor at Touro College in New York City, commented in an email to Reuters Health, "The study is important as it does help give a small sense of assurance that those on steroids or immunosuppressants did not have worse symptoms, as previously postulated. My practice has not seen similar findings, but the number of positive patients was dramatically less than in this study."

"I think we need larger data sets to truly see the impact of COVID on IBD patients with severe disease," he said. "This study is a good starting point."

Meanwhile, he added, "patients should be managed globally taking into account IBD and other infections."

SOURCE: https://bit.ly/3e0Lovj Gastroenterology, online May 28, 2020.