Switching from Adalimumab Originator to Biosimilar in Patients with Hidradenitis Suppurativa Results in Losses of Response-Data from the German HS Registry HSBest

被引:12
|
作者
Kirsten, Natalia [1 ,2 ]
Ohm, Frenz [1 ]
Gehrdau, Kathrin [1 ]
Girbig, Gefion [1 ]
Stephan, Brigitte [1 ]
Ben-Anaya, Nesrine [1 ]
Pinter, Andreas [2 ,3 ]
Bechara, Falk G. [2 ,4 ]
Presser, Dagmar [2 ,5 ]
Zouboulis, Christos C. [2 ,6 ,7 ,8 ,9 ]
Augustin, Matthias [1 ,2 ]
机构
[1] Univ Med Ctr Hamburg Eppendorf UKE, Inst Hlth Serv Res Dermatol & Nursing IVDP, D-20251 Hamburg, Germany
[2] European Hidradenitis Suppurat Fdn eV, D-06847 Dessau, Germany
[3] Univ Hosp Frankfurt, Dept Dermatol Venereol & Allergol, D-60590 Frankfurt, Germany
[4] Ruhr Univ Bochum, Dept Dermatol Venereol & Allergol, D-44791 Bochum, Germany
[5] Univ Hosp Wurzburg UKW, Dept Dermatol Venerol & Allergol, D-97080 Wurzburg, Germany
[6] Brandenburg Med Sch Theodor Fontane, Dessau Med Ctr, Dept Dermatol, D-06847 Dessau, Germany
[7] Brandenburg Med Sch Theodor Fontane, Dessau Med Ctr, Dept Venereol, D-06847 Dessau, Germany
[8] Brandenburg Med Sch Theodor Fontane, Dessau Med Ctr, Dept Allergol, D-06847 Dessau, Germany
[9] Brandenburg Med Sch Theodor Fontane, Dessau Med Ctr, Dept Immunol, D-06847 Dessau, Germany
来源
LIFE-BASEL | 2022年 / 12卷 / 10期
关键词
hidradenitis suppurativa; biologics; TNF alpha; adverse drug reaction; biosimilar; drug effectiveness; switching; adalimumab; registry; SEVERITY;
D O I
10.3390/life12101518
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
Since 2021, adalimumab biosimilar ABP 501 can be used alternatively to adalimumab originator (ADAO) in the treatment of hidradenitis suppurativa (HS). Effectiveness and safety data remain scarce. We investigated the impact of switching from ADAO to ABP 501 on disease severity and the occurrence of adverse events (AEs) in patients with HS. We analyzed clinical data on patients enrolled in the German HSBest registry. Evaluation outcomes were assessed at three time points (baseline of originator (t0), prior to switching to biosimilar (t1) and 12 to 14 weeks after switching (t2)) and included patient-reported AEs and disease severity using the International Hidradenitis Suppurativa Severity Score System (IHS4) score. In total, 94 patients were switched from ADAO to ABP 501. Overall, 33.3% (n = 31/94) of the patients developed AEs and/or loss of response (LoR) within 12 to 14 weeks after switching. Of these, 61.3% (n = 19/31) experienced LoR but no AEs, 22.6% (n = 7/31) LoR combined with AEs and 16.1% (n = 5/31) AEs only. Our study showed that switching HS patients from ADAO to ABP 501 does significantly affect treatment effectiveness. Switching patients who are on remission maintenance therapy should be viewed critically.
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页数:8
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