Late-Breaking Abstract Session Spans the Realm of Drug-Related Research

ACR CONVERGENCE 2020—The late-breaking abstract session at ACR Convergence covered a range of clinical trial results, from the use of tocilizumab for COVID-19 to mavrilimumab for remission of giant cell arteritis. Here’s a summary of various study findings shared during the session.

Tocilizumab for COVID-19
The use of tocilizumab, an interleukin-6 receptor blockade, did not prevent mechanical ventilation or death in patients who were moderately ill with COVID-19, reported John H. Stone, MD, MPH, professor of medicine, Harvard Medical School and the Edward A. Fox Chair in Medicine at Massachusetts General Hospital, Boston.

In a randomized, double-blind, placebo-controlled trial, 243 hospitalized patients with confirmed SARS-CoV2 infection were randomized 2:1 to standard care plus intravenous tocilizumab 8 mg/kg or placebo.¹ The primary outcome was the time to mechanical ventilation or death within 28 days. The study took place from April to June 2020.

For progression to intubation or death, the hazard ratio was 0.83 in the treatment group; for disease worsening, the hazard ratio was 1.11. At 14 days, disease worsening had occurred in 18% of the tocilizumab patients vs. 14.9% of the placebo patients. Also at 14 days, 24.6% of tocilizumab patients still needed oxygen vs. 21.2% in the placebo group. Those treated with tocilizumab experienced fewer serious infections.

Twelve percent of patients in the study were intubated or died, Dr. Stone said.

One-third of patients in the trial had received remdesivir, and fewer than 10% received glucocorticoids.

Results from the trial were published in the Oct. 21 issue of the New England Journal of Medicine.²

Mavrilimumab Reduces Time to Flare
Mavrilimumab worked better than placebo for controlled time to flare and sustained remission at week 26 in a phase 2 trial with giant cell arteritis (GCA) patients, reported Maria C. Cid, MD, of the Department of Internal Medicine, Hospital Clinic, Barcelona.

The randomized, double-blind, placebo-controlled trial included 70 patients with active new onset or relapsing refractory GCA.³ Patients were randomized 3:2 to receive mavrilimumab 150 mg (n=42) or placebo (n=28) subcutaneously every two weeks, as well as a protocol-defined 26-week prednisone taper that started at 20 to 60 mg/day.

By week 26, disease flare occurred in 19% and 46.4% of patients receiving mavrilimumab and placebo, respectively. Researchers could not estimate the median time to flare by week 26 in the treatment group because too few events occurred. Sustained remission occurred in 83.2% of patients in the treatment group and 49.9% in the placebo group by week 26. The drug was well tolerated.