Early clinical response as a predictor of subsequent response to ixekizumab treatment: results from a phase II study of patients with moderate‐to‐severe plaque psoriasis. (December 2013)

• Record Type: Journal Article
• Authors: Zhu, B.; Edson‐Heredia, E.; Cameron, G.S.; Shen, W.; Erickson, J.; Shrom, D.; Wang, P.; Banerjee, S.; Gordon, K.B.
• Is Part Of: British journal of dermatology. Volume 169:Number 6(2013:Dec.)
• Page Start: 1337
• Page End: 1341
• Publication Date: 2013-12
• Subjects: Dermatology -- Periodicals; Skin -- Diseases -- Periodicals; 616.5
• DOI: 10.1111/bjd.12610
• Languages: English
• ISSNs: 0007-0963

Abstract

<abstract abstract-type="main" id="bjd12610-abs-0001"> <title>Summary</title> <sec id="bjd12610-sec-0001" sec-type="section"> <title>Background</title> <p>Early identification of responsiveness to biologic treatments in psoriasis has significant clinical and economic implications.</p> </sec> <sec id="bjd12610-sec-0002" sec-type="section"> <title>Objectives</title> <p>To evaluate whether early clinical improvements in Psoriasis Area and Severity Index (PASI) scores could predict subsequent clinical responses in patients treated with ixekizumab, an anti‐interleukin‐17 monoclonal antibody.</p> </sec> <sec id="bjd12610-sec-0003" sec-type="section"> <title>Methods</title> <p>This <italic>post hoc</italic> analysis was derived from a phase II study in patients with moderate‐to‐severe plaque psoriasis (<italic>n </italic>=<italic> </italic>114) who received multiple doses of ixekizumab 10, 25, 75 or 150 mg subcutaneously over 20 weeks. PASI score improvements from baseline to weeks 2, 4 and 6 were evaluated to determine the optimal threshold for predicting subsequent PASI responses at week 12.</p> </sec> <sec id="bjd12610-sec-0004" sec-type="section"> <title>Results</title> <p>Early clinical improvement in disease symptoms at weeks 4 and 6 was predictive of ≥ 75% improvement in PASI score (PASI 75) at week 12 with ≥ 90% predictability. A 40–50% improvement in PASI (PASI 40 to PASI 50) from baseline to weeks 4 and 6 was the optimum range for predicting PASI 75 response at week 12. For all doses combined, achieving PASI 40 at week 4 or week 6 was associated with high negative predictive values (NPVs) (80% and 95%, respectively) and positive predictive values (PPVs) (89% and 84%, respectively). For all doses combined, achieving PASI 50 at week 4 or week 6 was associated with NPVs of 71% and 89% and PPVs of 94% and 89%, respectively. Sensitivity analysis with the high‐dose group (75 and 150 mg) results confirmed these findings.</p> </sec> <sec id="bjd12610-sec-0005" sec-type="section"> <title>Conclusions</title> <p>Early clinical responses (and nonresponse) may help predict later clinical responses in patients treated with ixekizumab.</p> </sec> </abstract>