SUMMARY  

• No randomized clinical trials evaluating the use of OPSUMIT with COVID-19 have been published.
• In a retrospective chart review of 11 patients with pulmonary arterial hypertension (PAH) who were diagnosed with coronavirus disease 2019 (COVID-19), 6 patients were on OPSUMIT therapy at baseline.¹
  • Of these 6 patients, 4 recovered from COVID-19.
• The most common adverse reactions of OPSUMIT (more frequent than placebo by >3%) that were observed in the pivotal, phase 3 SERAPHIN trial were anemia (13% vs 3%), bronchitis (12% vs 6%), headache (14% vs 9%), and nasopharyngitis (14% vs 10%). Some of these adverse reactions may be similar to symptoms experienced by patients with COVID-19.²
• For patients currently taking OPSUMIT who have been diagnosed with COVID-19, clinicians should use clinical judgment to decide whether to delay treatment until the patient is recovered or continue treatment as scheduled. It will be important to evaluate the risk-benefit of continued treatment based on the patient’s clinical status in terms of PAH symptoms vs the severity of symptoms from COVID-19.
• If a decision is made to continue treatment, appropriate precautions should be taken to minimize the potential spread of infection and to protect clinical staff. Please see the CDC website for the latest infection prevention information and control recommendations for patients with suspected or confirmed COVID-19 in healthcare settings.³

CLINICAL DATA

Sulica et al. (2021)¹ conducted a retrospective chart review of 11 patients with PAH who had either confirmed (n=10) or suspected (n=1) COVID-19 during March-May, 2020.

• Overall, mean age was 59.54 years (male, n=4; female, n=7), and mean duration of PAH was 4.54 years.
• A total of 6 patients were on OPSUMIT therapy at baseline, of which 4 patients had PAH associated with connective tissue disease, 1 patient had PAH associated with portopulmonary hypertension, and 1 patient had idiopathic PAH. None of these patients required oxygen supplementation at baseline.
• Overall hospitalization and intensive care unit (ICU) admission rate were 81.8% and 63.6%, respectively.
• Among the 6 patients who were on OPSUMIT therapy at baseline, 2 patients died, and 4 patients recovered. Hospitalization and clinical outcomes in these 6 patients are presented in Table: Hospitalization and Clinical Outcomes in OPSUMIT-Treated Patients With PAH and COVID-19.

ADDITIONAL INFORMATION and RESOURCES

Please note, this is not a complete list of publicly available resources available pertaining to this topic.

Publicly Available Websites: U.S. Government and World Health Organization

• For information from the U.S. Centers for Disease Control and Prevention (CDC), visit: Coronavirus Disease 2019 (COVID-19).
• For information from the U.S. Food and Drug Administration (FDA), visit: Coronavirus Disease 2019 (COVID-19).
• For information from the World Health Organization (WHO), visit: Coronavirus disease (COVID-19) pandemic.

Publicly Available Websites: Patient-Related Foundations Within the Johnson & Johnson Pulmonary Hypertension Therapeutic Area

• American Lung Association (ALA): Stay Safe and Informed about Coronavirus Disease (COVID-19).
• Pulmonary Hypertension Association (PHA): COVID-19 and Pulmonary Hypertension.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, Derwent^® (and/or other resources, including internal databases) was conducted on 27 December 2024.