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Prolonged efficacy of etanercept in refractory enthesitis-related arthritis
Michael Henrickson1, Andreas Reiff
1Division of Rheumatology, Children's Hospital Central California, Madera, California 93638-8762, USA. mhenrickson@childrenscentralcal.org
Insights
Etanercept, a TNF-alpha inhibitor, shows sustained efficacy in treating children with enthesitis-related arthritis (ERA) refractory to traditional therapies. This 2-year study found significant improvements in joint counts and inflammatory markers with no reported side effects.
Area of Science:
- Pediatric Rheumatology
- Immunology
- Pharmacology
Background:
- Enthesitis-related arthritis (ERA) in children often presents with significant morbidity and limited response to conventional disease-modifying antirheumatic drug (DMARD) treatments.
- Tumor necrosis factor-alpha (TNF-alpha) is a key mediator in spondyloarthropathies, suggesting targeted therapy may be beneficial.
Purpose of the Study:
- To evaluate the long-term efficacy and safety of etanercept, a TNF-alpha inhibitor, in pediatric patients with ERA resistant to DMARD therapy.
Main Methods:
- An open-label pilot trial involving 8 children with active, inflammatory ERA treated with subcutaneous etanercept (25-37.5 mg twice weekly) for 2 years.
- Assessed outcomes included morning stiffness, active joint count, hemoglobin, and erythrocyte sedimentation rate (ESR). Concomitant NSAID and DMARD use at stable doses was permitted.
Main Results:
- All 8 patients demonstrated rapid and significant improvements in active joint count, hemoglobin, and ESR within 2 months.
- Seven patients maintained statistically significant efficacy throughout the 2-year trial, reporting increased mobility and well-being.
- No side effects were observed in any patients, indicating good tolerability.
Conclusions:
- Etanercept offers a rapid and sustained clinical response in children with refractory ERA.
- These findings suggest etanercept is a promising therapeutic option for managing severe pediatric ERA, despite the study's limited sample size.
Objective:
For many children enthesitis-related arthritis (ERA) causes substantial morbidity, and conventional treatments frequently offer limited efficacy. Tumor necrosis factor-alpha (TNF-alpha) has been found to play a central role in the spondyloarthritides. We investigated the longterm efficacy of the TNF fusion protein etanercept in the treatment of patients with ERA refractory to disease modifying antirheumatic drug (DMARD) therapy.
Methods:
Eight patients with active, inflammatory ERA were treated in an open-label pilot trial of twice weekly subcutaneous injections (dosing range of 25 to 37.5 mg twice weekly, 0.2-0.8 mg/kg/dose) of etanercept for 2 years. Outcome measures included duration of morning stiffness, active joint count, hemoglobin, and erythrocyte sedimentation rate (ESR). Patients were permitted concomitant nonsteroidal antiinflammatory drugs (NSAID) and DMARD at stable doses.
Results:
Treatment with etanercept resulted in significant improvement in active joint count, hemoglobin, and ESR in all 8 patients within 2 months. Additionally, all patients noted increased mobility and overall well being. Improvement in morning stiffness did not achieve statistical significance. One patient was lost to followup after completing one year of the study. The remaining 7 patients had sustained statistically significant efficacy for active joint count, hemoglobin, and ESR throughout the entire 2-year trial. All patients tolerated etanercept with no side effects.
Conclusion:
Despite limited power, these results indicate that etanercept provided a rapid clinical response in our cohort of patients with refractory ERA, who achieved sustained efficacy over a 2-year period.