The 5-point Investigator’s Global Assessment (IGA) Scale: A modified tool for evaluating plaque psoriasis severity in clinical trials

<div><p></p><p><i>Background</i>: To evaluate new psoriasis treatments, clinicians, regulators and pharmaceutical developers require well-accepted, clinically meaningful measures of disease severity. The Psoriasis Area and Severity Index (PASI) score is most widely used as a primary endpoint in clinical trials, although it is not routinely used in clinical practice. <i>Objective</i>: Characterize a 5-point Investigator’s Global Assessment (IGA) tool and evaluate whether it meets the needs for a valid, clinically meaningful measure. <i>Methods</i>: A 5-point IGA tool was developed with input from regulatory authorities and clinical trial investigators involved with psoriasis drug development and evaluation. Associations between IGA 0/1 responder rates and PASI scores were evaluated using data from two phase 2 studies with the anti-interleukin (IL)-17A monoclonal antibody secukinumab (AIN457) that utilized a similar 6-point IGA. <i>Results</i>: The 5-point IGA has a more stringent definition for a score of 1 (“almost clear”) compared with 6-point IGA/Physician’s Global Assessment (PGA) tools used in previous trials of other biologics in moderate-to-severe psoriasis. Whereas IGA/PGA 0/1 responder rates for earlier scales are strongly associated with PASI 75, the IGA 0/1 rate for the secukinumab 6-point scale was more robust, demonstrating a strong association with PASI 90, and the results for the 5-point IGA are expected to show the same association. <i>Discussion</i>: The 5-point IGA is a valid measure of disease severity and meets the need for a clinically meaningful measure of success for psoriasis treatment studies.</p></div

Improvements in psoriasis within different body regions vary over time following treatment with ixekizumab

<p><b>Background:</b> Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin-17 A.</p> <p><b>Objective:</b> Examine the efficacy of ixekizumab in clearing psoriasis within different body regions.</p> <p><b>Methods:</b> Data from 3 placebo- (PBO) or PBO- and etanercept (ETN)-controlled trials were integrated. Patients with moderate-to-severe psoriasis were randomized to 12 weeks of PBO (UNCOVER-1, -2, -3, <i>N</i> = 792; UNCOVER-2, -3, <i>N</i> = 361), 50 mg ETN twice weekly (<i>N</i> = 740), or 80 mg ixekizumab every 2 (IXE Q2W; <i>N</i> = 1169; <i>N</i> = 736) or 4 weeks (IXE Q4W; <i>N</i> = 1165; <i>N</i> = 733) after a 160-mg starting dose.</p> <p><b>Results:</b> Mean percent improvements in regional Psoriasis Area and Severity Index (PASI) were noted at Week 1 and increased through Week 12 in the IXE Q2W (approved dosing regimen) group for each body region. Week 12 improvements were 91.4% (head/neck); 92.8% (trunk); 89.9% (arms); and 88.7% (legs) (all regions <i>p</i> < .001 vs. PBO). Mean regional PASI improvements at Week 12 were ≥84.2% for ixekizumab versus ≤70.9% for ETN in all regions (<i>p <</i> .001). Scaling and thickness reduced faster than erythema.</p> <p><b>Conclusions:</b> Within 12 weeks of ixekizumab treatment, all signs of psoriasis across all body regions reached clinically meaningful improvements, with the head/neck and trunk responding quicker than psoriasis of the arms and legs, especially with reduced scaling and thickness.</p

Building Bridges in Dermatology: Proceedings of the 9th Skin Academy Symposium

<p><b>Article full text</b></p> <p><br> </p> <p>The full text of this article can be found here<b>. </b><a href="https://link.springer.com/journal/13555/7/1/suppl/page/1">https://link.springer.com/journal/13555/7/1/suppl/page/1</a></p><p></p> <p><br></p> <p><b>Provide enhanced content for this article</b></p> <p><br></p> <p>If you are an author of this publication and would like to provide additional enhanced content for your article then please contact <a href="http://www.medengine.com/Redeem/”mailto:[email protected]”"><b>[email protected]</b></a>.</p> <p><br></p> <p>The journal offers a range of additional features designed to increase visibility and readership. All features will be thoroughly peer reviewed to ensure the content is of the highest scientific standard and all features are marked as ‘peer reviewed’ to ensure readers are aware that the content has been reviewed to the same level as the articles they are being presented alongside. Moreover, all sponsorship and disclosure information is included to provide complete transparency and adherence to good publication practices. This ensures that however the content is reached the reader has a full understanding of its origin. No fees are charged for hosting additional open access content.</p> <p><br></p> <p>Other enhanced features include, but are not limited to:</p> <p><br></p> <p>• Slide decks</p> <p>• Videos and animations</p> <p>• Audio abstracts</p> <p>• Audio slides</p