Background

Since the first report of coronavirus disease (COVID-19) in late 2019 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the disease quickly became a pandemic with a variety of clinical presentations, including death.

The risk of COVID-19 for patients with multiple sclerosis (MS) receiving interferon beta-1b (IFN β-1b) has been unclear.

In the absence of specific antiviral agents, IFN β has been suggested as a potential therapeutic option for COVID-19 based on its immunomodulatory and antiviral properties. In preclinical studies, IFN β has shown antiviral activities against coronavirus in Middle East Respiratory Syndrome and Severe Acute Respiratory Syndrome, but currently there is no clinical data supporting its therapeutic use in COVID-19 patients.

Objectives

The objective of our study is to review the current safety data on IFN β-1b in MS and non-MS patients impacted by COVID-19.

Methods

Retrospective data on IFN β-1b case reports with mention of COVID-19 were extracted from Bayer’s pharmacovigilance (PV) database through July 29, 2020.

Results

A total of 109 cases mentioned COVID-19, which included 75 MS patients (68.8%) and 34 non-MS patients (31.2%) who received IFN β-1b.

Of the 75 MS patients, 23 (30.7%) were diagnosed with COVID-19 (median 49 years; range 27-65 years). No relevant drug-related adverse events (AE) were reported. Two patients (2.7% of 75, 8.7% of 23; ages 42 and 49 years) died due to COVID-19. The 52 patients (69.3%) with no evidence of COVID-19 reported being negatively impacted with depression, anxiety, and difficulty accessing medical care for MS exacerbations and other health conditions.

Of the 34 non-MS patients who received IFN β-1b for experimental COVID-19 treatment, AEs were reported in 19 (55.8%). The most frequently reported AEs were associated with hepatic impairment such as hepatitis, mixed liver injury, hyperbilirubinemia, and increased hepatic enzyme. These events are appropriately reflected in the reference safety information. In almost all cases, IFN β-1b was concomitantly used with other antiviral drugs. Seven patients (20.6%) died due to COVID-19 (median 71 years; range 64-79 years) but IFN β-1b use was not implicated. Five patients (14.7%) reported non-approved route of administration (sublingual), however no AEs were associated with this method.

Conclusions

Our study revealed a small portion of MS patients using IFN β-1b who became infected with SARS-CoV-2 or developed COVID-19.

Although underreporting is a known limitation of PV data, our findings are in accordance with the published low incidence of COVID-19 in IFN β-treated MS population. Future serum anti-SARS-CoV-2 antibody tests may determine the number of asymptomatic COVID-19 IFN-b-1b-treated MS patients.

AEs reported in IFN β-1b-treated COVID-19 patients are consistent with the established safety profile. No new safety concerns were observed in MS or non-MS COVID-19 patients treated with IFN β-1b.