Guidance on the Use of Biologic during COVID-19 Outbreak

Guidance on the use of biologic agents during the COVID-19 outbreak.  From the American Academy of Dermatology Accociation.

Due to the recent pandemic, there is concern about the immunomodulatory effects of biologic therapy in the context of coronavirus (COVID-19).  Currently, the Centers for Disease Control and Prevention (CDC) and the world Health Organization (WHO) have no guidelines on the use of biologics during the pandemic.  In addition, there is no data on the specific risk of COVID-19 infection with biologic therapy.  Specifically, we do not have direct evidence to support any preferred biologic class or mechanism-of-action with regards to COVID-19 infection risk at this moment: althought we will continue to monitor the situation as more data becomes available. A main priority for dermatologists, at this point, is to keep our patients out of emergency rooms and urgent care so as to not tax the healthcare system unnecessarily.  Dermatologist must deliciately balance the risk of immunosuppression with the risk of disease flare reguiring urgent intervention.  Therefore, the Academy strongly recommends that patients should not stop biologic therapy without consulting their physicians.   To better serve patients and their physicians, the Academy is putting forthe the following interim recommendations.

Patients already on biologic therapy

1.  Patients on biologic therapy who have not tested positive or exhibited signs/symptoms of COVID-19.  There is insufficient evidence to recommend discontinuation of biologics at this time.  Physicians should continue to weigh the risk vs. benefits of the use of biologic medication on a case-by-case basis.  the discussion, at the level of the individual patient, should include the original indication for the biologic, the severity of the original indication, the patient's age (whether they are 60>years old) and comorbidities.  Comorbidities that may put patients at higher risk for serious illness from COVID-19 include serious chronic medical conditions such as cardiovascular disease, diabetes, severe hypertension, liver disease, kidney disease, respiratory system compromise, internal malignancies or tobacco use, among others. 1-3.

2.  Patients on biologic therapy who have tested positive for COVID-19:  We recommend physicians discontinue or postpone the biologic therapy wintil the patient recovers from COVID-19, consistent with guidelines on the management of patients with active infections on biologics therapy. (AAD Biologic Guideline) .

Patients not on biologic therapy

3.  Patients being considered for biologic therapy initiation:  We recommend physicians assess the risk vs. benefits in low-risk patients before initiating biologics therapy on a case-by-case basis.  In a high-risk population (e.g.: individuals 60 years and older, or patients with recognizes comorbidities such as cardiovascular disease, diabetes, severe hypertension, liver disease, kidney disease, respiratory system compromise, internal malignancies or tabacco use, among others),1-3 we recommend that physicians consider deferring initiation of biologic therapy.  alternative therapeutic approaches can be considered to treat high risk patients. 

This document was prepared on March 18, 2020, and will be updated as new data evolves in this area.  For the latest information on the COVID-19 outbreak, refer to the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) website. Also refer to the International Psoriasis Council  (IPC) recommendations and the American College of Rheumatology (ACR) recommendations for additional insights on the use of biologics.

References

1.  Wang T, Du Z, Zhu F, et al. Comorbidities and multi-organ injuries in the treatment of COVID-19. Lancet,2020.

2.  Yang J, Zheng Y, Gou X, et al.  Prevalence of comorbidities in the novel Wuhan coronavirus (COVID-19) infection: a systematic review and meta-analysis. Int J infect Dis. 2020.

3. Fang L, Karakiulakis G, Roth M. are patients with hypertension and diabetic mellitus at increased risk for COVID-19 infection? Lancet Respir Med. 2020.