Treatment with tocilizumab (Actemra) reduced the need for high-dose steroid treatment and increased the chance of remission for patients with giant cell arteritis, a randomised phase 3 trial shows.
Results from the multicentre GiACTA trial were the basis for the Food and Drug Administration’s approval of tocilizumab to treat giant cell arteritis back in May.
Published in this week’s New England Journal of Medicine the double blind phase 3 trial randomised 251 patients with giant-cell arteritis (GCA) in a 2:1:1:1 ratio to tocilizumab (162mg) weekly or every other week, combined with a 26-week prednisolone taper, or placebo with a 26 week or 52 week prednisolone taper.
Sustained remission at week 52, the primary outcome of the study, occurred in 53% and 56% of the patients treated with tocilizumab, compared to 14% and 18% of the patients in the placebo groups.
Over the study period patients receiving tocilizumab also had higher quality of life scores, and were on lower doses of prednisolone compared to those in the placebo group.
Adverse events were similar between the tocilizumab groups but serious events occurred more often in the patients who received placebo.
Lead author John Stone, MD, MPH, of the Massachusetts General Hospital (MGH) Rheumatology Unit, said the trial was the first to demonstrate “beyond any doubt” that an alternative to chronic, unending steroid treatment exists.
“One of the most surprising findings was just how poorly the traditional, steroid-only regimens worked. These results are likely to have an immediate, sustained impact on the lives of hundreds of thousands of patients across the world,” he said.
Writing in an accompanying editorial Dr David B Hellman from the John Hopkins University School of Medicine in Baltimore said he believed the trial was likely “to herald the coming of more ecstasy and less agony for patients with giant-cell arteritis”.
However he stressed that additional studies were needed before the interleukin-6 inhibitor could be recommended for all patients with GCA.
Until then, Dr Hellman says he will reserve tocilizumab for patients who are at risk for serious side effects from prednisolone and for patients with repeated flares that are not manageable with steroids.
The trial was supported by F. Hoffmnann-La Roche.