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TOPLINE: 

Tetrandrine, a plant-derived alkaloid compound used for centuries in traditional Chinese medicine, has demonstrated modest efficacy in the treatment of moderate to severe rheumatoid arthritis that is inadequately responding to methotrexate in a randomized controlled trial.

METHODOLOGY:

• The efficacy and safety of tetrandrine were tested in a 24-week randomized trial conducted across 26 hospitals in China between 2022 and 2024.
• Adults with rheumatoid arthritis who had been receiving methotrexate for at least 12 weeks and were on a stable dose (7.5-20 mg/week) for at least 4 weeks but had inadequately controlled disease were recruited and continued the drug throughout the trial.
• Participants taking prednisone at a dose ≤ 10 mg/day or equivalent corticosteroid therapy were also allowed to continue their medication, provided no dose adjustments were made.
• There was an initial double-blind, placebo-controlled phase during which participants were randomly allocated to receive tetrandrine 40 mg three times per day or matching placebo three times a day for 12 weeks. A 12-week blinded extension phase followed, during which all participants received tetrandrine.

TAKEAWAY: 

• The primary endpoint of 20% improvement in American College of Rheumatology response criteria (ACR20) at 12 weeks was met by 56.1% of the 107 participants treated with tetrandrine and 40.7% of the 113 participants given placebo (P = .011).
• Secondary endpoints of ACR50 and ACR70 at 12 weeks were a respective 25.5% and 10.8% in the tetrandrine group and 17.3% and 6.4% in the placebo group. And, at 24 weeks, ACR20, ACR50, and ACR70 were a respective 76.5%, 53.9%, 29.4% in the group that had continued to receive tetrandrine vs 63.2%, 38.7%, and 22.6% in those treated with tetrandrine after placebo.
• Change in pain from baseline was assessed using a visual analog scale and was significantly reduced for tetrandrine vs placebo, but only at 12 weeks.
• Declines in Disease Activity Score in 28 joints (DAS28) using erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) from baseline to week 12 were 1.09 and 0.93 for tetrandrine and 0.80 and 0.78 for placebo, and from baseline to week 24 the declines were 1.07 and 0.88 vs 1.11 and 1.04.
• Similar rates of adverse events occurred in the tetrandrine and placebo groups in both the double-blind (58.0% vs 53.4%) and blinded extension (26.2% vs 26.4%) phases.

IN PRACTICE:

“In China, there are about 5 million patients with rheumatoid arthritis, and some of them are refractory and have limited use of DMARDs [disease-modifying antirheumatic drugs]” or other targeted agents, said study investigator Miao Shao, MD, from Peking University People’s Hospital in Beijing, China. Tetrandrine could offer another approach to treating these patients, she said. 

John Isaacs, MBBS, PhD, professor of clinical rheumatology at Newcastle University, Newcastle upon Tyne, UK, told Medscape Medical News: “There’s a high placebo response, considering the nature of the treated population. [Also] there’s a difference in ACR50 and ACR70 that is not mirrored in DAS28-CRP differences, which is unusual.”

SOURCE:

The study findings were presented at the European Alliance of Associations for Rheumatology (EULAR) 2026 Annual Meeting (abstract OP0355).

LIMITATIONS:

These are preliminary findings presented in abstract form at a conference. They will require further scrutinization following their official publication.

DISCLOSURES:

Shao and Isaacs have disclosed no relevant financial relationships.