Global Development Franchise Head Immunology & Dermatology
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Psoriasis is a chronic immune-mediated inflammatory disease that negatively impacts patients’ quality of life (QOL); therefore QOL outcomes are increasingly recognized as an important measure of efficacy in psoriasis, complementing traditional measures of severity such as the Psoriasis Area and Severity Index (PASI).
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.
Biologic therapies for psoriasis have previously been associated with a fall-off in efficacy over time; accordingly, extended follow-up is required to adequately evaluate novel therapeutic strategies like IL-17A inhibition. Recently, results from the extension of the SCULPTURE secukinumab trial showed that high responses initially achieved with secukinumab at year 1 in the SCULPTURE study were sustained over time up to 3 years with no new or unexpected safety concerns. In this analysis, we examined whether the sustained efficacy observed in SCULPTURE up to 3 years was translated into sustained effect of secukinumab on patient’s QOL measured by the Dermatology Life Quality Index (DLQI) questionnaire.
SCULPTURE, a multi-center extension study, was conducted with subjects who completed 52 weeks of treatment. Subjects were randomized into two maintenance dosing regimens; a fixed-interval schedule of secukinumab 300 mg every 4 weeks (Fixed interval dosing regimen (FI) cohort), and secukinumab retreatment-as-needed (Retreatment as needed (RAN) cohort), in which subjects received placebo until start of relapse, at which time secukinumab 300 mg every 4 weeks was re-initiated.
The analysis using as-observed data showed that at Year 3, improvements in the total score on DLQI was well sustained in both FI and RAN cohorts. Approximately two-thirds of the subjects in the FI cohort reported no impact of skin disease on QOL (corresponding to a score of 0 or 1 on DLQI). The proportion of patients in the RAN cohort reporting no impact of the disease on their QOL was well sustained through 3 years but remained consistently lower than those observed in the FI cohort. The results for each subscale of the DLQI questionnaire were consistent with those with DLQI total score i.e. showing high and sustained proportions of patients reporting no impact of the disease on different domains of health-related QOL in the two secukinumab cohorts with greater effect in the FI cohort compared to the RAN cohort.
MedicalResearch.com: What should readers take away from your report?
Response: The extension study with follow-up data up to 3 years confirms that secukinumab 300mg FI treatment delivered sustained improvement in subject-reported health-related QOL, consistent with sustained efficacy results. These data are very pertinent to treatment selection for a condition that typically requires long-term management such as psoriasis.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Additional extension data are required to further characterize the therapeutic profile of secukinumab over the long-term. These findings are expected to be confirmed in a real-world setting when data become available.
MedicalResearch.com: Is there anything else you would like to add? Any disclosures?
Response: The study was sponsored by Novartis Pharma AG. Basel, Switzerland.
Disclosures: The authors of the study report the following disclosures:
- Bissonnette, M.D., President of Innovaderm Research Inc, Montréal, QC, Canada, serves as an advisory board member and has received honoraria from AbbVie, Amgen, BMS, Janssen, and Merck. He is a consultant for and receives honoraria from AbbVie, Amgen, Celgene, Eli Lilly and Company, Galderma, Incyte, Janssen, Leo Pharma, Merck, and Novartis. He is a speaker for and receives honoraria from AbbVie, Amgen, Galderma, Janssen, Leo Pharma and Merck. He is an investigator for and his institution receives grant support from AbbVie, Amgen, Boehringer Ingelheim Celgene, Eli Lilly and Company, Galderma, GSK-Stiefel, Merck, Novartis, Pfizer, Kineta, Incyte, Janssen, and Leo Pharma.
- Luger, M.D., Director and Chairman at Department of Dermatology, University of Münster, Münster, Germany has been an investigator and consultant for AbbVie, Almirall, Bayer, Biogen, Boehringer Ingelheim, Celgene, CERIES, Delenex, Galderma, Janssen, La Roche Posay, Leo Pharma, Eli Lilly, Maruho, Meda, MSD, Novartis, Pfizer, Sanofi-Aventis, Symrise, and Wolff.
- Thaçi, M.D., of Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lübeck, Germany, has been working as an advisor and/or presenter and/or recipient of research support and/or participant at clinical studies for the following companies: Abbott/AbbVie, Almirall-Hermal, Amgen, Biogen Idec, Celgene, Centocor, Eli Lilly, Forward Pharma, Galderma, Janssen, Leo Pharma, Maruho, Meda, Medac, Mitsubishi Pharma, MSD, Novartis, Pfizer, and VBI.
D.Toth, M.D., currently affiliated with XLR8 Medical Research, Windsor, ON, Canada, has been a principal investigator for Abbott, Amgen, Celgene, Eli Lilly, Merck, Janssen, Novartis, Pfizer, Regeneron, Genentech, LEO Pharma, and Galderma, and has served on advisory boards for Abbott, Celgene, Amgen, Eli Lilly, Janssen, Novartis, Regeneron, Genentech, LEO Pharma, and Galderma.
Messina, V. Bhosekar, T. Fox, I.Gilloteau and C. Papavassilis are employees of Novartis.
Secukinumab Provides Sustained Improvements in Dermatology-Specific Quality of Life in Moderate to Severe Psoriasis Patients Through 3 Years of Treatment: Results from the SCULPTURE Extension Study
R Bissonnette, T Luger, D Thaçi, D Toth, I Messina, V Bhosekar, T Fox, I Gilloteau, C Papavassilis
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