Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials

被引:3
作者
Merola, Joseph F. [1 ,2 ]
Gottlieb, Alice B. [3 ]
Pinter, Andreas [4 ]
Elewski, Boni [5 ]
Gooderham, Melinda [6 ,7 ]
Warren, Richard B. [8 ,9 ]
Piaserico, Stefano [10 ]
Wixted, Krista [11 ]
Cross, Nancy [11 ]
Tilt, Nicola [12 ]
Wiegratz, Susanne [13 ]
Mrowietz, Ulrich [14 ]
机构
[1] UT Southwestern Med Ctr, Div Rheumatol, Dept Dermatol, 5323 Harry Hines Blvd, Dallas, TX 75390 USA
[2] UT Southwestern Med Ctr, Div Rheumatol, Dept Med, 5323 Harry Hines Blvd, Dallas, TX 75390 USA
[3] Icahn Sch Med Mt Sinai, Dept Dermatol, New York, NY 10029 USA
[4] Univ Hosp Frankfurt, Frankfurt, Germany
[5] Case Western Reserve Univ, Univ Hosp Cleveland, Dept Dermatol, Cleveland, OH 44106 USA
[6] Prob Med Res, SKiN Ctr Dermatol, Peterborough, ON, Canada
[7] Queens Univ, Dept Med, Kingston, ON, Canada
[8] Northern Care Alliance NHS Fdn Trust, Dermatol Ctr, Manchester, Lancs, England
[9] Manchester Univ NHS Fdn Trust, Manchester Acad Hlth Sci Ctr, NIHR Manchester Biomed Res Ctr, Manchester, Lancs, England
[10] Univ Padua, Dept Med, Dermatol Unit, Padua, Italy
[11] UCB, Morrisville, NC USA
[12] UCB, Slough, Berks, England
[13] UCB, Monheim, Germany
[14] Univ Med Ctr Schleswig Holstein, Dept Dermatol, Psoriasis Ctr, Campus Kiel, Kiel, Germany
关键词
Bimekizumab; Clinical trial; Efficacy; High-impact areas; Nail; Palmoplantar; Palms; Soles; Psoriasis; Scalp; SEVERE PLAQUE PSORIASIS; DOUBLE-BLIND; MULTICENTER; MODERATE; SAFETY;
D O I
10.1007/s13555-024-01295-w
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Introduction: Psoriasis in high-impact areas, including the scalp, nails, palms, and soles, can disproportionately impair patient quality of life. Here, we evaluate the 2-year efficacy of bimekizumab treatment in patients with moderate to severe plaque psoriasis in post hoc analyses of five phase 3/3b trials. Methods: High-impact area efficacy data were pooled through 2 years across five phase 3/3b trials: BE VIVID, BE READY, BE SURE, their ongoing open-label extension (OLE) BE BRIGHT, and BE RADIANT (including its double-blinded treatment period and the first year of its OLE). Complete clearance of psoriasis in high-impact areas is reported over 2 years using the scalp Investigator's Global Assessment (IGA), palmoplantar IGA, and modified Nail Psoriasis Severity Index (mNAPSI). Patients included in these analyses had baseline moderate to severe scalp or palmoplantar involvement (scalp or palmoplantar IGA score >= 3) or mNAPSI score > 10. Results: A total of 1107 patients were randomized to bimekizumab and entered the OLEs. Subsets of 821 patients had scalp IGA >= 3 at baseline, 377 had mNAPSI > 10, and 193 had palmoplantar IGA >= 3. Complete scalp clearance in patients with baseline scalp IGA >= 3 randomized to bimekizumab was achieved rapidly, with high responses sustained from first (86.4%) to second year (85.9%). Nail clearance responses in patients with baseline mNAPSI > 10 increased from 63.4% to 68.5% from first to second year. Palmoplantar clearance in patients with baseline palmoplantar IGA >= 3 was sustained from first (88.3%) to second year (89.8%). Similar trends were seen in the 374 patients who received bimekizumab 320 mg every 4 weeks (Q4W)/every 8 weeks (Q8W) initial/maintenance dosing. Conclusion: In these analyses pooled across 2 years, bimekizumab showed sustained efficacy in psoriasis in high-impact areas.
引用
收藏
页码:3291 / 3306
页数:16
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