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TOPLINE: 

Discontinuing concomitant methotrexate (MTX) was noninferior to continuing it for maintenance of low disease activity (LDA) in patients with rheumatoid arthritis (RA) who had already achieved the state with a combination therapy of MTX plus certolizumab pegol (CZP).

METHODOLOGY:

• Researchers in Japan conducted a clinical trial to compare the effects of stopping vs continuing MTX with CZP on maintaining LDA in 84 patients with RA who achieved a Clinical Disease Activity Index Score < 10 for 12 weeks or more on combination therapy.
• The mean age of the included participants was 59.2 years and most (83.3%) were women.
• Participants were randomly assigned to either continue MTX (n = 41) or discontinue it after a 12-week reduction period (n = 43). The mean dose of MTX at baseline was 8.3 mg/wk.
• The primary endpoint was the proportion of patients maintaining LDA without a flare at week 36, with flare defined as a Clinical Disease Activity Index Score > 10 or intervention with rescue treatments.
• Noninferiority was verified if the lower limit of the 90% CI for the between-group difference in LDA exceeded the noninferiority margin of −18%.

TAKEAWAY:

• The proportion of patients maintaining LDA at week 36 was 85.4% (90% CI, 76.3%-94.4%) in the MTX continuation group and 83.7% (90% CI, 74.5%-93.0%) in the MTX discontinuation group, demonstrating noninferiority of the MTX discontinuation treatment regimen.
• Adverse events were similar in the groups, with no serious adverse events reported and COVID-19 (two cases in each group) being the only reported infection.
• At week 36, the proportion of patients having gastrointestinal symptoms, determined by a Frequency Scale for Symptoms of Gastroesophageal Reflux Disease Score ≥ 8, was significantly lower in the MTX discontinuation group than in the MTX continuation group (2.4% vs 15.8%, P = .034).

IN PRACTICE:

“The results of the present study demonstrate that discontinuing MTX is noninferior to continuing MTX in terms of subsequent maintenance of LDA sustained with CZP + MTX therapy, and discontinuing concomitant MTX is clinically feasible for RA patients treated with CZP,” the authors wrote.

SOURCE:

This study was led by Shuji Asai, MD, PhD, Department of Orthopaedic Surgery and Rheumatology, Nagoya University Graduate School of Medicine in Nagoya, Japan. It was published online on April 5, 2025, in Arthritis Research & Therapy.

LIMITATIONS:

According to the authors, the open-label design where both patients and evaluators were aware of MTX reduction and discontinuation could potentially influence assessments. This study may have selection bias as it included patients who maintained LDA in clinical practice, possibly resulting in favorable outcomes. Additionally, the observation period was restricted despite the chronic nature of patient conditions requiring long-term treatment.

DISCLOSURES:

The clinical trial received funding from Astellas Pharma, with a portion of expenses covered by UCB through Astellas. The funders had no role in the study design, data collection, analysis and interpretation, or preparation of the study manuscript. Some authors disclosed receiving grant/research support, consulting fees, and/or speakers’ fees from several pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.