Half-Dose Reduction of Targeted Therapies Maintains Disease Control in Rheumatoid Arthritis: Study
South Korea: Researchers have found in a randomized prospective trial that nearly 90% of patients with well-controlled rheumatoid arthritis maintained low disease activity for six months after reducing the doses of biologics and other targeted therapies by 50%. Outcomes were comparable to those with usual dosing, suggesting that dose tapering may be a feasible option for selected patients with well-controlled disease.
The study, published in Arthritis & Rheumatology, was conducted by Dong-Jin Park, Division of Rheumatology, Department of Internal Medicine, Chonnam National University Medical School and Hospital, Gwangju, Republic of Korea, and colleagues. The researchers assessed whether a structured reduction in biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) could preserve disease control without compromising patient safety.
Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease that can cause joint pain, swelling, and progressive damage. Although biologic and targeted synthetic DMARDs help control inflammation, sustained treatment can contribute to medication costs and potential adverse effects. Reducing doses may offer benefits to patients who maintain stable disease control, but evidence supporting this approach remains limited.
The 24-week, multicentre, randomized, open-label, non-inferiority trial enrolled 348 patients with RA who were receiving stable doses of b/tsDMARDs and had maintained low disease activity (LDA), assessed using the DAS28-ESR score, for at least six months.
Participants were randomly assigned to either a structured, stepwise dose-tapering strategy (171 patients) or continued treatment at their existing doses (177 patients). The primary outcome was the proportion of patients maintaining LDA at week 24. The researchers used a prespecified non-inferiority margin of −10 percentage points to determine whether tapering preserved disease control sufficiently compared with standard dosing.
The key findings were:
- Comparable disease control: In the per-protocol analysis, 88.2% of patients in the tapering group maintained LDA at week 24, compared with 89.6% in the continuation group.
- Non-inferiority achieved: The difference between the groups was −1.43 percentage points (95% CI, −8.09 to 5.23), meeting the trial's predefined criterion for non-inferiority. Similar results were observed in the full analysis set.
- Recovery after disease worsening: Most patients who experienced worsening disease activity regained LDA after treatment doses were increased again according to the study protocol.
- Secondary outcomes: Most measures were similar between groups, although some disease activity scores favoured continued treatment at specific time points.
- Safety: Adverse events were uncommon in both groups, with no major difference reported between the treatment strategies.
The findings suggest that structured dose reduction may help selected patients with sustained low disease activity maintain disease control over six months. However, some disease activity measures favoured continued treatment, indicating that tapering may not provide identical outcomes across all measures.
The researchers concluded that b/tsDMARD tapering was non-inferior to continuing treatment at existing doses over 24 weeks in patients with well-controlled RA. Longer-term studies are needed to assess the durability of disease control and the safety of sustained dose reduction.
Reference:
Reference:
Park, D. J., Choi, S. E., Kang, J. H., Choe, J. Y., Lee, H. S., Bang, S. Y., Cheon, Y. H., Lee, S. I., Kim, M., Sung, Y. K., Cho, S. K., Jung, J. H., Chang, S. H., Lee, S. W., Lee, Y. A., Lee, S. G., Kim, H. S., Kwok, S. K., Shim, S. C., . . . Lee, S. S. Outcomes of Tapering Biologic and Targeted Synthetic DMARDs in Rheumatoid Arthritis: A Multicenter Randomized Non-Inferiority Trial. Arthritis & Rheumatology. https://doi.org/10.1002/art.70363
Next Story