Efficacy and safety of open‐label ixekizumab treatment in Japanese patients with moderate‐to‐severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis. (30th October 2014)

• Record Type: Journal Article
• Authors: Saeki, H.; Nakagawa, H.; Ishii, T.; Morisaki, Y.; Aoki, T.; Berclaz, P.‐Y.; Heffernan, M.
• Is Part Of: Journal of the European Academy of Dermatology and Venereology. Volume 29:Number 6(2015:Jun.)
• Page Start: 1148
• Page End: 1155
• Publication Date: 2014-10-30
• Subjects: Dermatology -- Periodicals; Sexually transmitted diseases -- Periodicals; 616.5
• DOI: 10.1111/jdv.12773
• Languages: English
• ISSNs: 0926-9959

Abstract

<abstract abstract-type="main" id="jdv12773-abs-0001"> <title>Abstract</title> <sec id="jdv12773-sec-0001" sec-type="section"> <title>Background</title> <p>Ixekizumab, an anti‐IL‐17A monoclonal antibody, demonstrated a high level of efficacy in moderate‐to‐severe plaque psoriasis (PP) patients.</p> </sec> <sec id="jdv12773-sec-0002" sec-type="section"> <title>Objective</title> <p>To evaluate the efficacy and safety of open‐label ixekizumab in Japanese patients with moderate‐to‐severe PP, erythrodermic psoriasis (EP) and generalized pustular psoriasis (GPP).</p> </sec> <sec id="jdv12773-sec-0003" sec-type="section"> <title>Methods</title> <p>Patients received 160‐mg subcutaneous ixekizumab injection at Week 0, 80‐mg every 2 weeks through Week 12 and 80‐mg every 4 weeks through Week 24. Efficacy and safety are reported through 24 weeks; additional safety data are available for some patients.</p> </sec> <sec id="jdv12773-sec-0004" sec-type="section"> <title>Results</title> <p>A total of 78 patients with PP, 8 with EP and 5 with GPP enrolled. In PP patients, PASI75 and PASI90 response rates were 98.7% (77/78) and 83.3% (65/78) at Week 12 respectively. In EP patients, PASI75 and PASI90 were 100.0% (8/8) and 62.5% (5/8) and in GPP patients were 80.0% (4/5) and 60.0% (3/5). Overall, 84.0% (76/91) had a treatment‐emergent AE through ≥24 weeks. There were no serious AEs, deaths, cases of tuberculosis or invasive fungal infections.</p> </sec> <sec id="jdv12773-sec-0005" sec-type="section"> <title>Limitations</title> <p>No control group and small sample sizes, especially for EP and GPP.</p> </sec> <sec id="jdv12773-sec-0006" sec-type="section"> <title>Conclusion</title> <p>By Week 12, nearly all patients with PP, EP and GPP achieved PASI75. The safety profile was consistent with reported results and no unexpected safety signals were observed.</p> </sec> </abstract>