Maintenance of skin clearance with ixekizumab treatment of psoriasis: Three-year results from the UNCOVER-3 study - 15/10/18
, Catherine Maari, MD b, c, Sandra Philipp, MD d, Orin Goldblum, MD e, Lu Zhang, MS e, Nicole Burkhardt, PhD e, Susan Ball, PhD e, Lotus Mallbris, MD, PhD e, Pablo Gonzalez, MD f, Pablo Fernández-Peñas, MD, PhD g, Luis Puig, MD, PhD hAbstract |
Background |
Psoriasis is a chronic disease that may require long-term treatment. Ixekizumab (IXE), which is a high-affinity monoclonal antibody that selectively targets interleukin 17A, is an approved therapy for patients with moderate-to-severe plaque psoriasis.
Objective |
To evaluate the efficacy and safety of IXE through 156 weeks from the UNCOVER-3 study in patients who were treated with the recommended dose regimen (160 mg of IXE at week 0, 80 mg every 2 weeks up to week 12, and 80 mg every 4 weeks thereafter).
Methods |
Patients randomized to IXE every 2 weeks, IXE every 4 weeks, etanercept twice weekly, or placebo were switched to IXE every 4 weeks during the long-term extension period. Efficacy data were summarized by using the as-observed, multiple imputation, and modified nonresponder imputation methods.
Results |
At week 156, 80.5% of patients had achieved at least a 75% improvement from baseline in their Psoriasis Area Severity Index (PASI) score, 66.0% had achived at least a 90% improvement from baseline in their PASI score, and 45.1% had achieved a 100% improvement from baseline in their PASI score with use of the modified nonresponder imputation method, and 97.2% and 86.2% of patients had achived at least a 75% improvement from baseline in their PASI score with use of the as-observed and multiple imputation methods, respectively. Similar response rates were observed in patients with baseline scalp, nail, or palmoplantar involvement. No new safety signals were identified through year 3.
Limitations |
No placebo or active comparison after week 12.
Conclusion |
IXE sustained high responses with clearance of skin and nail lesions, with no new safety concerns through 3 years.
Le texte complet de cet article est disponible en PDF.Key words : efficacy, interleukin 17, ixekizumab, long-term, psoriasis, safety, UNCOVER-3
Abbreviations used : AE, IXE, LTE, MI, mNRI, PASI, sPGA, TEAE
Plan
| Funding sources: Supported by Eli Lilly and Company. |
|
| Disclosure: Dr Leonardi is in the speakers bureaus of AbbVie, Celgene, Eli Lilly, and Novartis; he is a consultant or in the advisory board of Abbvie, Amgen, Boehringer Ingelheim, Eli Lilly, Janssen, Dermira, Pfizer, Ortho Dermatologics, Sandoz, and UCB; and he is a principal investigator for Actavis, Amgen, Boehringer Ingelheim, Celgene, Cellceutix, Coherus, Corrona, Dermira, Eli Lilly, Gelnmark, Janssen, Loe Pharma, Novartis, Novella, Pfizer, and Sandoz. Dr Maari has been an advisory board member, investigator, and/or speaker for AbbVie, Amgen, Celgene, Eli Lilly and Company, Galderma, Pfizer, Leo Pharma, Merck, Novartis, Janssen, and Tribute. Dr Philipp has received honoraria for speaker services from AbbVie, Almirall, Amgen, Biogen, BMS GmbH, Celgene, Janssen Cilag, MSD, mundipharma, Novartis, and UCB Pharma; for advisory board services from AbbVie, Biogen, Eli Lilly, Janssen Cilag, Leo Pharma, Pfizer, MSD, and Novartis; and for investigator services from AbbVie, Almirall, Amgen, Biogen, Boehringer-Ingelheim, Celgene, Dermira, Eli Lilly, GSK, Janssen Cilag, Leo Pharma, Pfizer, Maruho, MSD, Novartis, UCB Pharma, and VBL Therapeutics. Dr Gonzalez has received honoraria as speaker and/or consultant and/or investigator from AbbVie, Celgene, Eli Lilly and Company, Janssen, and Novartis. Dr Fernández-Peñas has been an advisory board member, investigator, and/or speaker for Sanofi, Merck, Sun Pharma, Novartis, Merck-Serono, Roche, Leo, Abbvie, Lilly, Celgene, UCB, Janssen, Kyowa Hakko Kirin, Arena, Galderma, Amgen, and MSD. Dr Puig has been an advisory board member, investigator, and/or speaker for Abbvie, Almirall, Amgen, Baxalta, Biogen, Boehringer Ingelheim, Celgene, Gebro, Janssen, Leo-Pharma, Lilly, Merck-Serono, MSD, Novartis, Pfizer, Regeneron, Roche, Sanofi, Sandoz, and UCB. Dr Goldblum, Ms Zhang, Dr Burkhardt, Dr Ball, and Dr Mallbris own stock in and are employees of Eli Lilly and Company. |
Vol 79 - N° 5
P. 824 - novembre 2018 Retour au numéro
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