Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS)

COVID-19 in persons with multiple sclerosis treated with ocrelizumab: pharmacovigilance update

Research Alert

Newswise — Background: Limited evidence-based data exist on potential risks of COVID-19 infection in persons with multiple sclerosis (pwMS) receiving immunotherapy. More than 160,000 pwMS have been treated with ocrelizumab (OCR), in clinical trial and real-world settings; data continue to show a consistent and favorable benefit/risk profile.

Objectives: To present a summary of postmarketing pharmacovigilance data (as of May 31, 2020) from pwMS treated with OCR, who have either confirmed or suspected COVID-19.

Methods: Pharmacovigilance-reported adverse event (AE) COVID-19 cases, identified in a search of the Roche Global Safety Database using MedDRA preferred terms and string searches, were defined as valid when at least an identifiable reporter, a single identifiable patient, a medicinal product and a suspected AE were provided. Cases were designated as serious if described by the reporter as serious according to their judgment or if adjudicated as serious by the company when regulatory definitions were met. Patient characteristics and details of OCR treatment were usually provided. All cases were conservatively considered as having confirmed COVID-19. Outcome was classified as recovered, recovering, not recovered, fatal, or not reported.

Results: Of 201 cases, 61% (n=122/201) were reported as non-serious, and 39% (n=79/201) were reported as serious, mostly due to hospitalization (n=51/79). Where known, reasons for hospitalization included, among others, treatment of pneumonia and treatment in ICU. Serious cases were reported as recovered/recovering in 32% (n=25/79) of patients, whilst the outcome was not reported in 33% (n=26/79) of serious cases. A fatal outcome was reported in 5.5% (n=11/201) of patients; risk factors included hypertension, diabetes mellitus, respiratory disease, and malignancy. Updated assessment of the pharmacovigilance cases will be presented.

Conclusions: Taking into account the known limitations of postmarketing safety data, this analysis appears to be in line with published larger case series of non-MS and MS COVID-19 patients. Risk factors in fatal cases were similar to known risk factors reported in the general population.

Presenter: Richard Hughes, F. Hoffmann-La Roche Ltd, , Grenzacherstrasse 124, N/A, Basel, CH




Filters close

Showing results

1120 of 4146
Newswise: COVID’s Collateral Damage: Germicidal Lamps May Damage Corneas
Released: 24-Nov-2020 5:15 PM EST
COVID’s Collateral Damage: Germicidal Lamps May Damage Corneas
University of Miami Health System, Miller School of Medicine

In a paper published in the journalOcular Immunology and Inflammation, physicians from the Bascom Palmer Eye Institute at the University of Miami Miller School of Medicine reported that several patients using germicidal lamps in an attempt to sanitize against the coronavirus, developed painful inflammation of the cornea, a condition called photokeratitis.

Released: 24-Nov-2020 4:35 PM EST
Cleveland Clinic Research Shows Bariatric Surgery May Reduce Severity of COVID-19 in Patients with Obesity
Cleveland Clinic

CLEVELAND: A Cleveland Clinic study shows that among patients who have obesity and who tested positive for COVID-19, a past history of bariatric surgery was significantly associated with a lower risk of hospital and intensive care unit admission. The results were published in the journal of Surgery for Obesity and Related Diseases.

Newswise: 249693_web.jpg
Released: 24-Nov-2020 3:40 PM EST
New therapy for flu may help in fight against COVID-19
Purdue University

A new therapy for influenza virus infections that may also prove effective against many other pathogenic virus infections, including HIV and COVID-19, has been developed by Purdue University scientists.

Released: 24-Nov-2020 3:30 PM EST
‘Crisis decision making at the speed of COVID-19’ – Bay Area public health officials share their experience with shelter-in-place order
Wolters Kluwer Health: Lippincott

In mid-March, public health officials across the San Francisco area issued the first U.S. regional shelter-in-place order in response to the emerging COVID-19 pandemic. A “field report” on the crisis decision-making approach followed in that effective early response is featured in a special COVID-19 supplement to the Journal of Public Health Management and Practice. The journal is published in the Lippincott portfolio by Wolters Kluwer.

Newswise: Research Helps Identify High-Risk Populations to aid
Health Officials Combating the Pandemic
Released: 24-Nov-2020 3:25 PM EST
Research Helps Identify High-Risk Populations to aid Health Officials Combating the Pandemic
UCLA Fielding School of Public Health

A team of UCLA Fielding School of Public Health researchers has developed a method to better guide public policy related to the control and prevention of COVID-19, based on identifying those most at risk in the pandemic

Released: 24-Nov-2020 3:15 PM EST
Workplace Expert: COVID-Safe Company Holiday Party Ideas and Why Celebrating is Significant
University of Maryland, Robert H. Smith School of Business

Maryland Smith workplace expert Vijaya Venkataramani says Zoom fatigue notwithstanding, a COVID-safe staff or company holiday celebration is ideal for leaders and managers to give thanks to team members for their resilience in 2020.

Newswise: Schooling Disrupted by the Pandemic in the United States Likely to Have Life-Long Impact, Study Says
Released: 24-Nov-2020 3:10 PM EST
Schooling Disrupted by the Pandemic in the United States Likely to Have Life-Long Impact, Study Says
UCLA Fielding School of Public Health

A team that includes UCLA Fielding School of Public Health researchers has found American children whose educations have been disrupted by the pandemic, even as little as 2-4 months, may face shortened life spans.

Newswise:Video Embedded hd-b-roll-of-cedars-sinai-vaccine-storage-freezers-now-available-for-download
VIDEO
Released: 24-Nov-2020 2:55 PM EST
HD B-roll of Cedars-Sinai Vaccine Storage Freezers Now Available for Download
Cedars-Sinai

B-roll available: Video shot today showing the freezers where Cedars-Sinai will store COVID-19 vaccines. Please note: There are NO vaccines in the video. The vaccines will not arrive until next month.


Showing results

1120 of 4146

close
2.0438