Psoriatic Arthritis

Psoriatic Arthritis

Clinical Toolkit

Risk factors. Several factors can increase your risk of psoriatic arthritis, including:
Psoriasis. Having psoriasis is the single greatest risk factor for developing psoriatic arthritis. People who have pitted, deformed nails are especially likely to develop psoriatic arthritis.
Your family history. Many people with psoriatic arthritis have a parent or a sibling with the disease.
Your age. Although anyone can develop psoriatic arthritis, it occurs most often in adults between the ages of 30 and 50.

Introduction

Psoriatic arthritis (PsA) is a complex and heterogeneous disease that leads to joint damage and deformities that significantly impact patients’ quality of life. Delays in diagnosis are common in PsA and are associated with disease progression and poorer physical functioning. Early initiation of therapy and the development of new treatments that target the underlying pathophysiology of the disease have the potential to shift goals of treatment for PsA from pain and stiffness reduction to disease remission.

However, the ongoing COVID-19 pandemic has complicated the management of patients with PsA. Although current evidence suggests that patients with PsA are not at increased risk of developing severe COVID-19, they are more likely to have comorbidities that increase the risk for COVID-19-related complications. Additionally, it is unknown if treatments for PsA impact the course of COVID-19.

Click on the links below to explore resources on the diagnosis and management of PsA during the COVID-19 pandemic.

Clinical Toolkit

PsA and COVID-19

Diagnosis

Treatment Considerations

Resources

Updates in the Treatment and Prevention of COVID-19

EUA of Bamlanivimab Plus Etesevimab Expanded to Include Younger Pediatric Patients

The emergency use authorization (EUA) for bamlanivimab plus etesevimab now includes an indication for treatment and post-exposure prophylaxis for children and newborn babies who are at high risk for severe disease. The expansion of the EUA is supported by a trial of 125 pediatric patients with at least one risk factor for severe illness; the study had safety and efficacy data similar to findings for adolescents and adults.

For more information visit www.fda.gov/news-events/press-announcements/fda-expands-authorization-two-monoclonal-antibodies-treatment-and-post-exposure-prevention-covid-19

Oral Antiviral Therapies With Emergency Use Authorization (EUA) for COVID-19

Two new oral antiviral therapies received emergency use authorization (EUA) for COVID-19: Paxlovid™ (nirmatrelvir tablets and ritonavir tablets, co-packaged) and molnupiravir. Both therapies are authorized for the treatment of mild-to-moderate COVID-19 in certain people who are at high risk of progressing to severe illness.

In the EPIC-HR clinical trial, nirmatrelvir/ritonavir significantly reduced the risk of hospitalization or death from any cause by 88% compared with placebo. This treatment is indicated for adults and pediatric patients, 12 years of age and older who weigh at least 40 kilograms. Side effects include an impaired sense of taste, diarrhea, high blood pressure, and muscle aches. The safety and effectiveness of this combination therapy continue to be evaluated.

The main outcome measure of the MOVe-OUT trial of molnupiravir was the percentage of people who were hospitalized or died due to any cause during 29 days of follow-up. Compared with 9.7% of people who received placebo, 6.8% of those in the molnupiravir group were hospitalized or died. One person who received molnupiravir died versus nine people in the placebo group. Molnupiravir is not recommended for pregnant women or for those people younger than 18 years of age because of its effect on bone and cartilage growth.

For more information regarding the EUA for these oral antivirals, visit the following FDA URLs:

www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19

www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-oral-antiviral-treatment-covid-19-certain

FDA Authorized Emergency Use Authorization (EUA) for Long-Acting Monoclonal Antibodies as Pre-Exposure Prophylaxis of COVID-19

Evusheld™ (tixagevimab co-packaged with cilgavimab and administered together) has been granted EUA for the prevention of COVID-19 in certain people with compromised immune systems or with a history of severe adverse reactions to a COVID-19 vaccine or any of its components. This combination is not meant to be a substitute for vaccination for those who have no contraindications to a COVID-19 vaccine.

The PROVENT clinical trial demonstrated a 77% reduction in the risk of developing COVID-19 compared with placebo, and protection appears to have been maintained through six months. Safety and efficacy of the tixagevimab/cilgavimab combination continues to be investigated.

For more information, visit www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-long-acting-monoclonal-antibodies-pre-exposure