The Tocilizumab vs. Prednisone in Established Rheumatoid Arthritis Patients (TOPIRA) trial examines the differences between 2 widely utilized treatment approaches for the management of chronic rheumatoid arthritis (RA). RA is characterized by persistent synovial inflammation, joint discomfort, and gradual structural deterioration.
The long-term use of prednisone, a glucocorticoid, has been restricted due to its metabolic and cardiovascular adverse effects. Through cytokine inhibition, the interleukin-6 receptor inhibitor tocilizumab provides a tailored strategy to reduce inflammation and stop the course of the illness.
In patients with established RA who frequently exhibit refractory symptoms and cumulative joint degeneration, the TOPIRA trial looks at their relative efficacy, safety profiles, and effects on functional outcomes. The study intends to assist doctors in choosing the best long-term treatment plans and offer a balance between effectiveness and tolerability in the management of chronic RA by directly comparing different treatments.
In a 12-month treat-to-target approach, this investigator-initiated, open-label, randomized study compared weekly subcutaneous tocilizumab (TCZ, 162 mg) and 10 mg daily prednisone added to stable conventional synthetic DMARDs (csDMARDs) treatment. Patients moved to the other arm if, after 3 months, the treatment response was insufficient. The Clinical Disease Activity Index (CDAI), averaged across months 6–12, was the main outcome. The Glucocorticoid Toxicity Index (GTI), adverse events associated with TCZ, and radiographic advancement were secondary objectives.
The intention-to-treat population consisted of 65 individuals with developed RA. Over months 6–12, TCZ was better at lowering CDAI (mean difference on square root scale: −0.64; 95% CI: −1.18 to −0.09). Prednisone was used in 52% of cases, whereas TCZ was used in 28%.
Toxicity (GTI: P = 0.922; TCZ-related adverse events: P = 1.00) and radiographic advancement (P = 0.376) did not differ significantly. Analyses conducted throughout therapy produced comparable findings. Overall, TCZ improved disease activity more when compared to prednisone. Both the course of joint deterioration over a 12-month period and adverse events did not differ significantly.
Reference:
Fadaei, S., van der Leeuw, M. S., Linn-Rasker, S. P., de Klerk, B., Peeters, J. J. W., den Uyl, D., Maas-de Kok, A., Bos, R., Tekstra, J., Nap, F., Marijnissen, A. C. A., Welsing, P. M. J., & van Laar, J. M. (2025). Tocilizumab vs prednisone in established rheumatoid arthritis patients (TOPIRA): an investigator-initiated randomised clinical trial. Rheumatology (Oxford, England), keaf591. https://doi.org/10.1093/rheumatology/keaf591
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