Etanercept withdrawal and retreatment in nonradiographic axial spondyloarthritis: results of RE-EMBARK, an open-label phase IV trial

Clinical trial[Abstract] Objective: RE-EMBARK investigated etanercept (ETN) withdrawal and retreatment in patients with nonradiographic axial spondyloarthritis (nr-axSpA) achieving inactive disease. Methods: Patients received ETN and a background nonsteroidal antiinflammatory drug for 24 weeks in period 1 (P1); those achieving inactive disease (Ankylosing Spondylitis Disease Activity Score [ASDAS] with C-reactive protein [CRP] < 1.3) discontinued ETN for 40 weeks or less (period 2 [P2]). Patients who flared (ASDAS with erythrocyte sedimentation rate [ESR] ≥ 2.1) were retreated for 12 weeks in period 3 (P3). The primary endpoint was the proportion of patients with inactive disease who flared within 40 weeks of ETN withdrawal. Baseline characteristics were analyzed post hoc as predictors of maintenance and regaining of inactive disease, respectively, using univariate logistic and stepwise multivariable logistic regression models. Results: The proportion of patients experiencing flare following ETN withdrawal (P2) increased from 22.3% (25/112) after 4 weeks to 67% (77/115) after 40 weeks; 74.8% (86/115) experienced flare at any time during P2. Median time to flare was 16.1 weeks. Most patients (54/87, 62.1%) who were retreated with ETN in P3 reachieved inactive disease. Absence of both sacroiliitis detected on magnetic resonance imaging (MRI) and high-sensitivity CRP (hs-CRP) > 3 mg/L at baseline predicted inactive disease maintenance in P2 following ETN withdrawal in multivariable analysis; male sex and age younger than 40 years predicted regaining of inactive disease in P3 after flare/retreatment. There were no unexpected safety signals. Conclusion: Approximately 25% of patients maintained inactive disease for 40 weeks after discontinuing ETN. Absence of both MRI sacroiliitis and high hs-CRP at baseline predicted response maintenance after ETN withdrawal

Cost Effectiveness of Antibacterial Restriction Strategies in a Tertiary Care University Teaching Hospital

Objective: To compare various strategies for antibacterial administration in terms of patient outcomes, overall costs and quality of care provided. Design: Prospective, nonblind, randomized, clinical study. Setting: Tertiary care hospital in Greece from November 1995 to June 1996. Patients and participants: 458 patients admitted to the internal medicine department who received antibacterial therapy for infectious diseases. Methods: Patients were randomized into 4 different antibacterial administration policies defined by various levels of restriction control. Efficacy and resource use data were obtained from clinical study case report forms, the hospital financial database and physician expert opinion. Outcomes included complete infection control, disease improvement, unchanged patient condition, infection needing surgical treatment, and death. Direct medical costs were estimated. The perspective adopted was that of the healthcare system (hospital budget; third-party payor). Cost-minimisation analysis was based on cost per patient treated. Results: 382 eligible patient records examined showed no significant difference in clinical outcomes among patient groups. Baseline analysis showed the strict antibacterial control policy to produce statistically significant differences (pAntibacterials, Bacterial infections, Cost analysis, Pharmacoeconomics

Plain language summary for the manuscript: Etanercept Withdrawal and Re-Treatment in Non-Radiographic Axial Spondyloarthritis: Results of RE-EMBARK, an Open-Label, Phase IV Trial

This is a plain language summary (PLS) of an article published in a peer-reviewed scientific journal. This PLS is not peer-reviewed. The publisher of the orignial manuscript was not involved in the preparation of this PLS and has neither reviewed not approved its content.</p