Long-term efficacy and safety of ixekizumab: A 5-year analysis of the UNCOVER-3 randomized controlled trial - 06/02/21
, Mark G. Lebwohl, MD, FAAD b, Tomotaka Mabuchi, MD, PhD c, Ann Leung, MS d, Alyssa Garrelts, PhD e, Heidi Crane, MS e, Hany ElMaraghy, MD e, Himanshu Patel, MD e, Terri Ridenour, MBA e, Kyoungah See, PhD e, Gaia Gallo, MD e, Carle Paul, MD, PhD fCet article a été publié dans un numéro de la revue, cliquez ici pour y accéder
Abstract |
Objective |
To report the efficacy and safety of the approved ixekizumab (IXE) dose over 5 years from UNCOVER-3 (NCT01646177).
Methods |
Patients (N = 1346) were randomized 1:2:2:2 to receive subcutaneous injections of placebo, etanercept 50 mg twice weekly, or IXE 80 mg every 2 weeks or every 4 weeks after an initial dose of IXE 160 mg, respectively. At week 12, patients entered the long-term extension period with dosing of IXE every 4 weeks and could escalate to every 2 weeks after week 60. Efficacy was reported for the IXE every 2 weeks/every 4 weeks group of the intent-to-treat population. Safety was reported for patients who received at least 1 dose of IXE every 2 or every 4 weeks.
Results |
Using modified nonresponder imputation, 78.8%/67.1%/46.2% of patients receiving the approved dose of IXE every 2 weeks/every 4 weeks (n = 385) achieved ≥75%, ≥90%, or 100% improvement from baseline in the Psoriasis Area and Severity Index, respectively, at week 264; static Physician's Global Assessment score of 0/1 and 0 responses were 69.2% and 45.3%, respectively. Infections were the most observed treatment-emergent adverse event (72.7% of patients).
Limitations |
Lack of comparison treatment group after week 12.
Conclusion |
IXE demonstrates sustained efficacy and consistent safety through 264 weeks in patients using the approved dose.
Le texte complet de cet article est disponible en PDF.Graphical abstract |
Key words : efficacy, ixekizumab, long-term, psoriasis, safety, UNCOVER-3
Abbreviations used : AE, ITT, IR, IXE, LTE, MI, mNRI, NRS, PASI, SAE, sPGA, TEAE
Plan
| Funding sources: Supported by Eli Lilly and Company. |
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| Portions of this work were previously presented in the form of an abstract at San Diego Dermatology Symposium (SDDS)—A Live Virtual Experience, September 11-13, 2020. |
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| IRB approval status: The protocol was approved by the IRB or ethics committee at each participating site. |
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| Reprints not available from the authors. |
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