作者 Al-Abdouli, Khuloud Asad
書名 An open-label, randomized, prospective study to evaluate the effectiveness and safety of continuous long-term versus intermittent etanercept in the treatment of psoriasis
國際標準書號 9780542078927
book jacket
說明 129 p
附註 Source: Dissertation Abstracts International, Volume: 66-04, Section: B, page: 1966
Major Professor: Tania Phillips
Thesis (Sc.D.)--Boston University, 2005
Background. Psoriasis is recognized as the most prevalent T cell-mediated immune disease in which CD4+ and CD8 + memory effector T cells stimulate the hyperproliferation of keratinocytes. TNF is a pro-inflammatory cytokine known to play an important role in the pathogenesis of psoriasis. Etanercept acts as a competitive inhibitor of tumor necrosis factor (TNF) and blocks its interaction with cell surface TNF receptors
Aim. To evaluate the effectiveness and safety of continuous long-term versus intermittent etanercept in the treatment of psoriasis
Method. All patients (n = 9) received etanercept 50 mg twice weekly SC for the first 12 weeks. At week 12 patients were randomized equally (1:1) to one of two treatment groups, the continuous therapy and intermittent therapy. The continuous therapy group received etanercept 50 mg once weekly SC for weeks 13 through 24. The intermittent therapy group was assessed for response. Those who achieved a responder status (PGA score ≤ 2 and improved from baseline) at week 12 discontinued therapy. Upon relapse of PGA responder status at week 16 or 20, etanercept will resumed at a dose of 50 mg once weekly SC through week 24. Patients who had not achieved a responder status on PGA at week 12 continued etanercept without interruption, as in the continuous therapy group
Results. In the first 12 weeks, all patients (n = 9) improved in all three parameters, BSA% (P = 0.048), PGA (p = 0.013), and Scalp score (p = 0.0083). These results demonstrated statistically significant improvement compared to baseline. In the second half of the study, (from week 12 to 24) there was statistically significant difference in BSA% in the continuous therapy group compared to the intermittent therapy group (p = 0.012). However there was no difference in PGA (p = 0.12) and Scalp score (p = 0.34)
Conclusion. Our study shows that continuous therapy appears to be more effective than intermittent therapy with improvement in BSA%. Relapse (defined as PGA > 2) only occurred in the intermittent group. Two patients relapsed at week 16 (40%), one relapsed at week 20 (20%), and two did not relapse by 24 weeks. Etanercept was safe and well tolerated in both groups. No serious events occurred during the study. Three patients (3/9) had the most common drug related adverse events, injection site reactions (33%). Four patients (4/9) did not have drug related adverse events. Other adverse events were considered unrelated to the study drug
School code: 0017
DDC
Host Item Dissertation Abstracts International 66-04B
主題 Health Sciences, Pharmacology
Health Sciences, Immunology
0419
0982
Alt Author Boston University