Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study - 18/04/17
, Kristian Reich, MD b, Tsen-Fang Tsai, MD c, Stephen Tyring, MD, PhD d, Francisco Vanaclocha, MD e, Külli Kingo, MD, PhD f, Michael Ziv, MD, BSc g, Andreas Pinter, MD h, Ronald Vender, MD, FRCPC i, Sophie Hugot, MSc j, Ruquan You, MSc k, Marina Milutinovic, MD j, Diamant Thaçi, MD lAbstract |
Background |
Secukinumab demonstrated superior efficacy to ustekinumab at week 4 and week 16 of the CLEAR study, with comparable safety, in subjects with moderate-to-severe plaque psoriasis.
Objective |
To compare the efficacy and safety of secukinumab and ustekinumab use over 52 weeks.
Methods |
Analysis of 52-week data from CLEAR, a randomized, double-blind, phase 3b study.
Results |
Among 676 randomized subjects, secukinumab demonstrated superiority to ustekinumab at week 52 in the proportion of subjects with ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) (76% vs 61% [P < .0001]); PASI 100 responses were 46% versus 36% (P = .0103) and Investigator's Global Assessment responses of clear/almost clear skin were 80% versus 65% (P < .0001). Subjects on secukinumab reported greater reductions in psoriasis-related pain, itching, and scaling, and greater improvement across all quality-of-life measures evaluated (Dermatology Life Quality Index [DLQI], EuroQoL 5-Dimension Health Questionnaire, Work Productivity and Activity Impairment Questionnaire-Psoriasis, and Health Assessment Questionnaire-Disability Index). At week 52, 72% of subjects on secukinumab versus 59% on ustekinumab (P = .0008) reported no impact of skin disease on their lives (DLQI 0/1 response). Safety and tolerability was comparable.
Limitations |
There was no placebo arm.
Conclusion |
In this head-to-head, double-blind study, secukinumab demonstrated sustained superior efficacy in comparison with ustekinumab in clearing skin through week 52, greater improvement in quality of life, and a favorable and comparable safety profile.
Le texte complet de cet article est disponible en PDF.Key words : psoriasis, secukinumab, ustekinumab, clinical trial, Psoriasis Area and Severity Index (PASI), efficacy, safety
Abbreviations used : AE, DLQI, EQ-5D-3L, HAQ-DI, HRQOL, IGA mod 2011, IL, MI, NRI, PASI, PASI 75, PASI 90, PASI 100, PsA, WPAI-PSO
Plan
| Supported by Novartis Pharma AG, Basel, Switzerland. |
|
| Disclosure: Dr Blauvelt has served as a scientific consultant and clinical study investigator for AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Celgene, Dermira, Eli Lilly, Genentech, GSK, Janssen, MedImmune, Merck, Novartis, Pfizer, Regeneron, Sandoz, Sanofi, UCB, and Valeant and as a paid speaker for Eli Lilly. Dr Reich has served as a consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Amgen, Biogen-Idec, Celgene, Centocor, Covagen, Eli Lilly, Forward Pharma, GSK, Janssen-Cilag, Leo Pharma, Medac, MSD, Novartis, Pfizer, Vertex, Takeda, and Xenoport. Dr Tsai has served as a consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Celgene, Eli Lilly, Janssen-Cilag, Leo Pharma, Galderma, Novartis, and Pfizer. Dr Tyring has received grants from Novartis. Dr Vanaclocha has served as a principal investigator in clinical studies sponsored by Celgene, Janssen, Merck, and Novartis. Dr Kingo has served as a principal investigator in clinical studies sponsored by Celgene, Mitsubishi Pharma, Novartis, Merck, Regeneron, and Sandoz. Dr Ziv has served as a paid speaker/consultant/clinical trials investigator for AbbVie, Coherus Biosciences, Janssen-Cilag, Novartis, and Pfizer. Dr Pinter has served as a clinical study investigator, scientific consultant, and/or paid speaker for AbbVie, Amgen, Biogen-Idec, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen-Cilag, Leo Pharma, Merck, Novartis, Pfizer, and Regeneron. Dr Vender has been a speaker for AbbVie, Amgen, Celgene, Galderma, Janssen, Leo Pharma, Novartis, and Pfizer and an investigator for AbbVie, Amgen, Celgene, Galderma, Janssen, Leo Pharma, Lilly, Merck, Novartis, and Pfizer. Ms Hugot, Mr You, and Dr Milutinovic are employees of and/or own stock in Novartis. Dr Thaçi has received research support from AbbVie, Almirall, Amgen, Astellas, Biogen-Idec, Boehringer-Ingelheim, Celgene, Dignity, Eli-Lilly, Forward-Pharma, GSK, Leo, Janssen-Cilag, Maruho, Mitsubishi Pharma, MSD, Novartis, Pfizer, Roche, and Sandoz and honoraria from AbbVie, Biogen-Idec, Celgene, Janssen, Leo, Mundipharma, Novartis, Pfizer, and Roche-Possay. He has acted as a consultant for AbbVie, Biogen-Idec, Celgene, Dignity, Galapagos, Maruho, Mitsubishi, Novartis, Pfizer, and Xenoport and sat on scientific advisory boards for AbbVie, Amgen, Biogen-Idec, Celgene, GSK, Leo Pharma, Janssen, Lilly, Mundipharma, Novartis, Pfizer, and Sandoz. |
|
| Reprints not available from the authors. |
Vol 76 - N° 1
P. 60 - janvier 2017 Retour au numéro
Article précédent
- The effect of smoking and age on the response to first-line therapy of hidradenitis suppurativa: An institutional retrospective cohort study
- George Denny, Milan J. Anadkat
- Secukinumab shows significant efficacy in palmoplantar psoriasis: Results from GESTURE, a randomized controlled trial
- Alice Gottlieb, John Sullivan, Martijn van Doorn, Alexey Kubanov, Ruquan You, Anne Parneix, Sophie Hugot, Marina Milutinovic
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?