MedicalResearch.com Interview with:
Eric Hughes, Global Head of Development, Immunology & Dermatology
Novartis Pharma AG
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: It is well established that psoriasis negatively affects quality of life and work productivity. However, how the treatments affect psoriasis severity (based on skin clearance, itch, pain and scaling symptoms), health-related quality of life (HRQOL), work productivity, and daily activity directly or indirectly (via other factors) are still largely unknown.
Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin-17A (IL-17A), exhibits significant efficacy in the treatment of moderate-to-severe psoriasis, ankylosing spondylitis, and psoriatic arthritis, demonstrating a rapid onset of action and a favorable safety profile.
In CLEAR, a Phase 3b head-to-head study versus ustekinumab, secukinumab demonstrated sustained superior efficacy in clearing skin through Week 52, greater improvement in symptoms and HRQOL, greater relief of work and activity limitations, and a comparable safety profile. In this sub-analysis of the CLEAR study, Novartis was interested in examining the relationships among multiple variables that are thought to be important to patients with psoriasis. The direct and indirect (i.e. mediated) effects of treatment (secukinumab or ustekinumab) on psoriasis severity and patients’ HRQOL, work productivity, and daily activity were examined. The evaluation was conducted using structural equation modeling (or path analysis) and compared these relationships for secukinumab versus ustekinumab at 16 and 52 weeks. Structural equation modeling or path analysis is a statistical method that models the direct and indirect relationship between multiple patient-relevant outcomes simultaneously.
Goodness-of-fit statistics for all models were excellent confirming the robustness of the results. Results at Week 16 and at Week 52 for different Psoriasis Area and Severity Index (PASI) response categories (e.g. PASI 75, PASI 90, PASI 100) indicated that psoriasis treatment indirectly affected HRQOL and work productivity and daily activity, measured with the Dermatology Life Quality Index (DLQI) and the Work Productivity and Activity Impairment (WPAI) questionnaires, respectively.
Actually, greater effect of secukinumab over ustekinumab on DLQI was mediated by greater improvement of secukinumab in PASI response as well as by greater improvement in psoriasis-related symptoms (itch, pain and scaling). Greater effect of secukinumab over ustekinumab on work productivity and daily activity was mediated by greater improvement of secukinumab in psoriasis-related symptoms.
MedicalResearch.com: What should readers take away from your report?
Response: The results from these statistical analyses demonstrate that treatment, psoriasis severity, HRQOL, work productivity, and daily activity are connected via direct and indirect relationships.
It is well known that PASI and HRQOL are correlated but this analysis demonstrated the critical role of psoriasis-related symptoms in improving HRQOL and work productivity and daily activity which was not shown before. These findings underscore how important it is to consider the patients’ perception of their psoriasis symptoms and not just clinical severity in understanding how psoriasis and treatment affect patients’ lives.
These results also contribute to our understanding of the implications of greater effects of secukinumab in improving skin clearance and relief of symptoms compared to ustekinumab from a patient perspective.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Several potential avenues for future exploration include whether these relationships vary by age, gender, presence of psoriatic arthritis, and the influence of psoriasis and its treatment on other dimensions of patients’ lives that were not captured in clinical trials or by the patient-reported measures. In addition, examining these relationships in real-world settings will be valuable for confirming the robustness of these results.
The study was sponsored by Novartis Pharma AG. Basel, Switzerland.
Disclosures: L. Puig has participated in research/educational grants through Hospital de la Santa Creu I Sant Pau for AbbVie, Amgen, Janssen, Lilly, Novartis, Pfizer, Regeneron, Roche and a consultant for AbbVie, Almirall, Amgen, Baxalta, Biogen, Boehringer Ingelheim, Celgene, Gebro, Janssen, Leo-Pharma, Lilly, Merck-Serono, MSD, Novartis, Pfizer, Regeneron, Roche, Sandoz; C.E.M. Griffiths is a paid advisor and/or in receipt of research grants from AbbVie, Actelion, BMS, GSK, Galderma, Janssen, Leo Pharma, MSD, Pfizer, Novartis, Sandoz, Eli Lilly, Regeneron, Roche, L’Oreal, DSM, Clarins, Walgreens Boots Alliance and UCB Pharma; I. Gilloteau, Novartis Pharma AG; Y. Zhao, Novartis Pharmaceuticals Corporation; A. Guana, Novartis Pharmaceuticals Corporation; A. Finlay has served as a consultant for Sanofi, Novartis, Napp and Galderma and a joint copyright owner of the DLQI: Cardiff University; B. Sherif, RTI Health Solutions; K. Houghton, RTI Health Solutions; D. Stull, RTI Health Solutions.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
AAD 2017 Poster
Secukinumab Provides Greater Improvement in Quality of Life, Work Productivity, and Daily Activity Than Ustekinumab in Patients With Moderate-to-Severe Psoriasis: A Structural Equation Modeling Approach Using the CLEAR Study
Luis Puig, Christopher E.M. Griffiths, Isabelle Gilloteau, Yang Zhao, Adriana Guana, Andrew Y. Finlay, Bintu Sherif, Katherine Houghton, Donald E. Stull
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
More Medical Research Interviews on MedicalResearch.com