DESTIN, Fla. — In patients with giant cell arteritis, a regimen of tocilizumab given 162 mg weekly plus a 26-week prednisone taper demonstrated significant improvements in health-related quality of life and fatigue compared with patients treated with 26-week or 52-week prednisone taper alone, according to findings presented at the 2018 Congress of Clinical Rheumatology.
“Here we are demonstrating results from the GiACTA study, evaluating the use of tocilizumab in giant cell arteritis,” Nancy Richter, PhD, senior medical science liaison at Genentech, told Healio Rheumatology. “There are four different arms to the trial, two of which are basically placebo – a 6-month prednisone taper and 1-year prednisone taper – as well as two tocilizumab arms with weekly or every-other-week doses.”
The researchers conducted an exploratory analysis among patients treated with weekly or every-other-week tocilizumab to assess the rate of sustained glucocorticoid-free remission at 52 weeks in each tocilizumab group vs. the rates in the group that underwent the 26-week and 52-week prednisone taper. Additionally, the researchers evaluated patient-reported outcomes in the disparate trial arms.
According to the study results, patients who received weekly tocilizumab plus a 26-week prednisone taper demonstrated statistically greater improvements in SF-36 Physical Component Summary and Mental Component Summary scores, as well as Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue scores at 52 weeks than the groups that underwent either the 6-month prednisone taper and 1-year prednisone taper.
After 52 weeks, mean scores exceeded age and gender–matched normative scores with weekly tocilizumab plus a 26-week prednisone taper. Notably, higher proportions of patients reported scores age/gender norms in SF-36, Physical Component Summary and Mental Component Summary scores, and FACIT-Fatigue scores.
“At the end of 1 year with the placebo group, you only have 15-18% who were able to maintain that remission, but with the two different tocilizumab groups, approximately half the patients were able to be steroid-free and maintain their remission at the end of one year,” Richter said.
Additionally, researchers found that the median cumulative prednisone dose over 52 weeks was lower with weekly tocilizumab (1862.0 mg) than with 52-week prednisone taper (3817.5 mg) (P < 0.0001).
“The bottom line is that, as you would imagine, since the patients had better clinical response with more remission and less flare, the researchers saw better patient-reported outcomes.” Richter told Healio Rheumatology. – by Bob Stott
Strand V. Health-Related Quality of Life in Patients with Giant Cell Arteritis Treated with Tocilizumab in a Randomized Controlled Phase 3 Trial. Presented at: Congress of Clinical Rheumatology; May 17-20, 2018; Destin, Fla.
Strand reports the study was sponsored by F. Hoffman-La Roche.