An indirect comparison of long-term efficacy of every-2-week dosing vs. recommended dosing of ixekizumab in patients who had static Physician's Global Assessment > 1 at week 12

被引:2
|
作者
Papp, K. [1 ]
Maari, C. [2 ]
Cauthen, A. [3 ]
Gooderham, M. [4 ,5 ]
Spelman, L. [6 ]
Yamanaka, K. [7 ]
Polzer, P. [8 ]
Zhang, L. [8 ]
Osuntokun, O. [8 ]
Augustin, M. [9 ]
机构
[1] K Papp Clin Res & Prob Med Res, Waterloo, ON, Canada
[2] Innovaderm Res, Montreal, PQ, Canada
[3] MidState Skin Inst, Ocala, FL USA
[4] SkiN Ctr Dermatol & Prob Med Res, Peterborough, ON, Canada
[5] Queens Univ, Kingston, ON, Canada
[6] Verac Clin Res, Brisbane, Qld, Australia
[7] Mie Univ, Grad Sch Med, Dept Dermatol, Tsu, Mie, Japan
[8] Eli Lilly & Co, Indianapolis, IN 46285 USA
[9] Univ Med Ctr, Inst Hlth Serv Res Dermatol & Nursing, Hamburg, Germany
关键词
CONTROLLED-TRIAL; DOUBLE-BLIND; PSORIASIS; ETANERCEPT; MODERATE; SAFETY;
D O I
10.1111/bjd.18550
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Background Long-term efficacy and safety of ixekizumab [160 mg at week 0, then 80 mg every 2 weeks (Q2W) for 12 weeks, followed by every 4 weeks (Q4W) thereafter (i.e. Q2W/Q4W), which is the labelled psoriasis dosing where approved, except in Japan] have been established for the treatment of adults with moderate-to-severe plaque psoriasis. However, some patients may benefit from remaining on Q2W dosing beyond 12 weeks. Methods Among patients who had static Physician's Global Assessment (sPGA) > 1 at week 12, efficacy through week 52 of continuous Q2W dosing in the IXORA-P study was compared indirectly with Q2W/Q4W in the integrated data from the UNCOVER-1, UNCOVER-2 and UNCOVER-3 studies. The continuous Q4W dose group, which had comparable results across studies, was used as the common comparator. Results In the IXORA-P study, among patients with sPGA > 1 at week 12, 64% of patients in the continuous Q2W group achieved sPGA <= 1 at week 52, which was statistically significantly higher than the 36% of patients with sPGA > 1 in the Q2W/Q4W group based on the integrated data from the UNCOVER studies (P = 0 center dot 0007). There were no clinically meaningful differences in frequencies of safety events between patients with sPGA <= 1 and patients with sPGA > 1 at week 12 in the IXORA-P study. Conclusions Among patients who did not have clear or almost clear skin at week 12, nearly 30% more patients who were treated continuously with ixekizumab Q2W in IXORA-P had clear or almost clear skin at week 52 when compared indirectly with those who were treated using the labelled psoriasis dosing in integrated UNCOVER studies. What's already known about this topic? Most patients with moderate-to-severe psoriasis who were given the labelled psoriasis dosing of ixekizumab [160-mg loading dose at week 0, 80 mg every 2 weeks (Q2W) through week 12, and 80 mg every 4 weeks (QW4) thereafter] respond quickly with a high percentage of skin clearance. Additionally, patients who achieve static Physician's Global Assessment (sPGA) <= 1 by week 12 tend to maintain this response, even after switching to Q4W. What does this study add? Here, we assessed whether patients with sPGA > 1 at week 12 benefited from receiving more frequent dosing beyond the first 12 weeks. The results showed that Q2W dosing beyond 12 weeks resulted in more patients achieving sPGA <= 1 by week 52 than the labelled psoriasis dosing among patients with sPGA > 1 at week 12.
引用
收藏
页码:52 / 59
页数:8
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