Tocilizumab, Alone or With Methotrexate, Potent in Active RA
Subcutaneous tocilizumab, either as monotherapy or in combination with methotrexate, demonstrated greater efficacy than methotrexate alone and was well tolerated in patients with active rheumatoid arthritis (RA) who had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).
METHODOLOGY:
Researchers conducted a phase 3 trial at 19 sites in China between July 2017 and August 2022 to evaluate the efficacy of subcutaneous tocilizumab, administered either as monotherapy or in combination with methotrexate, in 340 patients with moderate to severe active RA (mean age, 47.5 years; 86.5% women).
The patients had a diagnosis of RA for ≥ 6 months, had received methotrexate for ≥ 12 weeks, experienced treatment failure with at least one csDMARD (including methotrexate), had at least six swollen joints and at least eight tender joints, and had either a high-sensitivity C-reactive protein level ≥ 4 mg/L or an erythrocyte sedimentation rate ≥ 28 mm/h.
Patients were randomly assigned to receive tocilizumab-methotrexate combination therapy (n = 136), tocilizumab monotherapy with placebo (n = 136), or methotrexate monotherapy with placebo (n = 68) for 24 weeks. Tocilizumab (162 mg) was administered subcutaneously once every 2 weeks, and methotrexate (10-25 mg) was administered orally once every week.
Patients achieving a Disease Activity Score in 28 joints of ≤ 3.2 after 24 weeks continued their randomly assigned treatment, whereas those with a score > 3.2 switched to unblinded tocilizumab-methotrexate treatment.
The primary efficacy endpoint was the proportion of patients who achieved a ≥ 20% improvement in the American College of Rheumatology (ACR20) response criteria at 24 weeks, with long-term efficacy analyzed at 48 weeks and safety monitored for 56 weeks.
TAKEAWAY:
The ACR20 response rate at 24 weeks was higher in the tocilizumab-methotrexate combination therapy (52.9%) and tocilizumab monotherapy (50.0%) groups than in the methotrexate monotherapy group (25.0%), with significant differences of 27.9 and 25.0 percentage points, respectively ( P < .001 for both).
< .001 for both). Long-term efficacy analysis at 48 weeks showed maintained or improved efficacy in patients continuing tocilizumab monotherapy or tocilizumab-methotrexate combination therapy, with an improved disease status in those who switched to unblinded tocilizumab-methotrexate treatment at 24 weeks.
Tocilizumab was well tolerated as both monotherapy and in combination with methotrexate, with no new safety signals.
IN PRACTICE:
'Subcutaneous tocilizumab, both as monotherapy and in combination with methotrexate, had clinically significant efficacy compared with methotrexate monotherapy in Chinese patients with moderate to severe active RA,' the authors wrote.
SOURCE:
This study was led by Tian Liu, MD, Peking University People's Hospital in Beijing, China. It was published online on May 19, 2025, in JAMA Network Open .
LIMITATIONS:
Only Chinese patients were included, thus limiting the generalizability of the findings. Researchers did not include imaging analysis. The recruitment was extended over a period of 4 years owing to the COVID-19 pandemic, which resulted in missing the efficacy assessments and tocilizumab administration in some patients.
DISCLOSURES:
This study received funding from and was conducted in collaboration with F. Hoffmann-La Roche Ltd. Three authors reported receiving grants from various pharmaceutical companies, including Roche. Two authors reported being employed by Roche (China) Holding.
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