Objective:

To analyze the outcomes of rheumatoid arthritis patients who would have been excluded from phase 3 randomized controlled trials when treated with biologic or targeted synthetic disease-modifying antirheumatic drugs in routine care.

Approach:

Key Findings:

• 40% of patients met at least one exclusion criterion, with anemia and lymphopenia being the most common.
• Patients meeting exclusion criteria had higher baseline disease activity and greater functional disability.
• After propensity score adjustment, remission rates were similar between groups: 24% for patients with no exclusion criteria and 23% for those with at least one criterion.
• Janus kinase inhibitors showed higher remission rates compared to tumor necrosis factor inhibitors among patients who met no exclusion criteria.

Interpretation:

Limitations:

• The observational design limits causal inference and residual confounding could not be excluded.
• The definition of trial ineligibility was restricted to variables captured in the registry, omitting some exclusions like psychiatric disorders and pregnancy intention.
• Findings may not be generalizable outside Japan due to differing methotrexate practices and patient characteristics.

Conclusion:

Sources:

• RMD Open
Source

Based on findings from:

Trial Exclusions May Skew RA Drug Comparisons

Andrea Surnit. MDSpire News, 2026.

https://news.mdspire.com/rheumatology/articles/trial-exclusions-may-skew-ra-drug-comparisons/

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