CHICAGO — Tocilizumab (TCZ) appears to be more effective than methotrexate (MTX) for giant cell arteritis (GCA) in maintaining remission and preventing relapse at 52 weeks, according to new data from a randomized, controlled trial.

Maxime Samson, MD, professor of internal medicine at the Centre Hospitalier Universitaire Dijon Bourgogne, Dijon, France, presented week 78 results of the noninferiority, multicenter, prospective trial METOGiA, at American College of Rheumatology (ACR) 2025 Annual Meeting.

Glucocorticoid-Sparing Strategies Needed

The researchers conducted the trial because glucocorticoid (GC)-sparing strategies are needed to improve treatment for GCA. While GCs are effective and relatively inexpensive, most patients develop GC-related complications that lead to morbidity and disability.

In this trial, patients were randomly assigned to receive either TCZ 162 mg/wk subcutaneously (SC) or MTX 0.3 mg/kg/wk SC (without exceeding 20 mg/wk) during 52 weeks in combination with a GC taper regimen.

Patients in the trial were at least 50 years old and had been diagnosed with new-onset or relapsing GCA and had active GCA within 6 weeks before the start of the study. The primary endpoint was the percentage of patients alive, without any relapse after initial remission or deviation from the GC taper regimen from inclusion to week 78.

Secondary endpoints included the percentage of patients alive, without any relapse after initial remission or deviation from the GC taper regimen by week 52.

The researchers defined remission as the absence of symptoms attributable to GCA and C-reactive protein (CRP) ≤ 10 mg/L. Relapse was defined as the recurrence of symptoms attributable to active GCA regardless of the value of CRP.

A total of 218 patients (TCZ, n = 110; MTX, n = 108) were analyzed in the intention-to-treat (ITT) population. Average age was about 72 years in both groups.

At week 78, the primary endpoint was reached in 37% of patients receiving MTX vs 46% of patients receiving TCZ, which did not meet the predefined noninferiority margin of 20%. Thus, in the ITT population, MTX was not noninferior to TCZ (P = .054) at 78 weeks.

Joseph E. Huffstutter, MD, a community-based rheumatologist in Hixson, Tennessee, who was not involved in the study, said the presentation supports what he has already been doing in his practice.

“It looks like there’s no question that tocilizumab works better than methotrexate,” he said. TCZ “is more efficacious in getting a response and preventing a relapse. [Sampon] is spot on with that, and I totally agree with that. I would immediately start tocilizumab in these patients and hold methotrexate back if they weren’t responding,” he told Medscape Medical News.

TCZ Significantly More Effective at Week 52

However, at week 52, secondary endpoint results suggest that TCZ is significantly more effective than MTX in maintaining remission and preventing relapse. Remission without prednisone at week 52 was achieved by 81% in the TCZ group vs 60% in the MTX group (P = .0007).

“At 1 year, results are exploratory but strongly suggest that TCZ is more effective than MTX in maintaining remission and preventing relapse,” Samson said.

Huffstutter called the results of this week 52 secondary endpoint striking. “The 20% difference for noninferiority [at week 78] is frankly arbitrary,” he said. “You have to look at what [disease] you’re treating. With RA [ rheumatoid arthritis], for example, if you flare, you inject the joint or you change the medicine and you’re back to baseline. If you don’t control the flare in GCA, that could lead to stroke or death. You have less of a margin of error for letting these people get sick and having permanent devastating problems.”

By week 78, 15 MTX-related serious adverse events (SAEs) occurred in 14 patients (eight infections, including five pneumocystis infections, one of which was fatal) and 13 TCZ-related SAEs occurred in 11 patients (six neutropenia, three infections). Overall, at week 78, seven deaths were reported (one in the TCZ group and six in the MTX group).

Samson pointed to the increased risk for pneumocystis pneumonia infections with MTX and said prophylaxis should be considered.

Samson reported financial relationships with AbbVie/Abbott, AstraZeneca, Boehringer Ingelheim, Chugai, Fresenius Kabi, GSK, Novartis, and Vifor Pharma.

Huffstutter reported having no relevant financial relationships.

Marcia Frellick is an independent, Chicago-based healthcare journalist and a regular contributor to Medscape.