Greater Efficacy with Secukinumab Treatment is Associated with Greater Psoriasis Symptom Relief: Results from Secukinumab Clinical Trial Data

Background Psoriasis negatively affects patients’ quality of life. Secukinumab is a human interleukin-17A antagonist indicated for the treatment of moderate-to-severe plaque psoriasis. Objectives The current analysis evaluated the benefits of secukinumab by assessing relationships between disease severity and patient-reported symptoms. Methods Correlations between psoriasis-related itching, pain, and scaling and disease severity scores (Psoriasis Area and Severity Index [PASI] and Investigator's Global Assessment [IGA]) were evaluated at baseline, Week 12, and change from baseline to Week 12 using secukinumab clinical data from ERASURE and FIXTURE. Symptom responder status and PASI/IGA change were evaluated using logistic modeling. Results Correlation coefficients ranged 0.11-0.49 for PASI and 0.19-0.52 for IGA. Greater PASI response was related to greater symptom response/complete relief. Conclusions Results further demonstrate the relationship between traditional clinical measures of disease severity and patient-reported, psoriasis-related itching, pain, and scaling –- hence the need to consider both outcomes together to evaluate treatment effects in this disease fully.

[1]  B. Strober,et al.  Secukinumab Provides Clearer Skin and Better Control on Patient-Reported Psoriasis Symptoms of Itching, Pain, and Scaling than Placebo and Etanercept , 2016 .

[2]  G. Girolomoni,et al.  Effects of Apremilast on Pruritus and Skin Discomfort/Pain Correlate With Improvements in Quality of Life in Patients With Moderate to Severe Plaque Psoriasis. , 2016, Acta dermato-venereologica.

[3]  B. Strober,et al.  Secukinumab improves patient‐reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo‐controlled clinical trials , 2016, International journal of dermatology.

[4]  B. Strober,et al.  Psychometric validation of the Psoriasis Symptom Diary using Phase III study data from patients with chronic plaque psoriasis , 2016, International journal of dermatology.

[5]  S. Feldman,et al.  The 5-point Investigator’s Global Assessment (IGA) Scale: A modified tool for evaluating plaque psoriasis severity in clinical trials , 2015, The Journal of dermatological treatment.

[6]  B. Elewski,et al.  Secukinumab in plaque psoriasis--results of two phase 3 trials. , 2014, The New England journal of medicine.

[7]  M. Lebwohl,et al.  Patient perspectives in the management of psoriasis: results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis Survey. , 2014, Journal of the American Academy of Dermatology.

[8]  Y. Poulin,et al.  Health-Related Quality of Life Worsens Disproportionately to Objective Signs of Psoriasis After Withdrawal of Adalimumab Therapy , 2014, Dermatology and Therapy.

[9]  L. Miot,et al.  Psoriasis: correlation between severity index (PASI) and systemic treatment , 2013 .

[10]  B. Strober,et al.  Item-level psychometric properties for a new patient-reported psoriasis symptom diary. , 2013, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[11]  L. Miot,et al.  Psoriasis: correlation between severity index (PASI) and quality of life index (DLQI) in patients assessed before and after systemic treatment* , 2013, Anais brasileiros de dermatologia.

[12]  Rosa Parisi,et al.  Global epidemiology of psoriasis: a systematic review of incidence and prevalence. , 2013, The Journal of investigative dermatology.

[13]  H. Nakagawa,et al.  Dramatic impact of a Psoriasis Area and Severity Index 90 response on the quality of life in patients with psoriasis: An analysis of Japanese clinical trials of infliximab , 2012, The Journal of dermatology.

[14]  P. Deshpande,et al.  Patient-reported outcomes: A new era in clinical research , 2011, Perspectives in clinical research.

[15]  C. Griffiths,et al.  Definition of treatment goals for moderate to severe psoriasis: a European consensus , 2010, Archives of Dermatological Research.

[16]  J. Saurat,et al.  Relationship between Clinical Response to Therapy and Health-Related Quality of Life Outcomes in Patients with Moderate to Severe Plaque Psoriasis , 2008, Dermatology.

[17]  A. Finlay,et al.  The Dermatology Life Quality Index: assessing the efficacy of biological therapies for psoriasis , 2007, The British journal of dermatology.

[18]  J. Gudjonsson,et al.  Immunopathogenic mechanisms in psoriasis , 2004, Clinical and experimental immunology.

[19]  A. Gottlieb,et al.  A randomized trial of etanercept as monotherapy for psoriasis. , 2003, Archives of dermatology.

[20]  S. Weisman,et al.  Psoriasis disease severity measures: comparing efficacy of treatments for severe psoriasis , 2003, The Journal of dermatological treatment.

[21]  D M Reboussin,et al.  Psoriasis causes as much disability as other major medical diseases. , 1999, Journal of the American Academy of Dermatology.

[22]  A. Finlay,et al.  Dermatology Life Quality Index (DLQI)—a simple practical measure for routine clinical use , 1994, Clinical and experimental dermatology.

[23]  P. Lachenbruch Statistical Power Analysis for the Behavioral Sciences (2nd ed.) , 1989 .