Forty-Eight-Month Monitoring of Disease Activity in Patients with Long-Standing Rheumatoid Arthritis Treated with TNF-α Inhibitors: Time for Clinical Outcome Prediction and Biosimilar vs Biologic Originator Performance

Clin Drug Investig. 2024 Mar;44(3):141-148. doi: 10.1007/s40261-024-01341-7. Epub 2024 Jan 31.

Abstract

Background and objectives: Long-term treatment of patients with rheumatoid arthritis with tumor necrosis factor-α inhibitors leads to initial changes in disease activity that can predict a late treatment response. This observational and retrospective study aimed to determine when it is possible to foresee the response to therapy in the case of long-standing rheumatoid arthritis comparing also the efficacy of the original biologics with their biosimilars.

Methods: A total of 1598 patients were recruited and treated with the original biologics, adalimumab and etanercept, or with biosimilars. Patients were monitored over a period of 48 months and disease activity scores (28-Joint Disease Activity Score, Simplified Disease Activity Index, and Clinical Disease Activity Index) were measured every 6 months.

Results: No differences in disease activity levels were observed in etanercept versus biosimilars (GP2015/SB4) and adalimumab versus biosimilar (GP2017) patient groups. All scores significantly decreased in all treatments during the first 18 months of therapy, and after 24 months reached a minimum that lasted up to 48 months.

Conclusions: We conclude that biosimilars of adalimumab and etanercept have equivalent effectiveness over a long period of time compared to their originator drugs, and also that the levels of disease activity after 6 months of tumor necrosis factor-α inhibitors (originator drugs and biosimilars) might predict the response to therapy at 4 years in patients with long-standing rheumatoid arthritis.

Publication types

  • Observational Study

MeSH terms

  • Adalimumab / therapeutic use
  • Antirheumatic Agents*
  • Arthritis, Rheumatoid* / diagnosis
  • Arthritis, Rheumatoid* / drug therapy
  • Biosimilar Pharmaceuticals*
  • Etanercept / therapeutic use
  • Humans
  • Infliximab
  • Retrospective Studies
  • Treatment Outcome
  • Tumor Necrosis Factor Inhibitors / therapeutic use
  • Tumor Necrosis Factor-alpha

Substances

  • Etanercept
  • Tumor Necrosis Factor-alpha
  • Adalimumab
  • Antirheumatic Agents
  • Biosimilar Pharmaceuticals
  • Tumor Necrosis Factor Inhibitors
  • Infliximab