Departments of Dermatology, Venereology, Allergology and Immunology, Staedtisches Klinikum Dessau, Brandenburg Medical School Theodor Fontane and Faculty of Health Sciences Brandenburg, Dessau, Germany.
Department of Dermatology, CHU Nice.
Br J Dermatol. 2024 May 17;190(6):836-845. doi: 10.1093/bjd/ljae098.
Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease associated with a substantial disease burden. Secukinumab has previously been reported to have sustained efficacy with a favourable safety profile in patients with moderate-to-severe HS. It is unknown whether prior biologic exposure affects the efficacy and safety of secukinumab.
To investigate the efficacy and safety of secukinumab in patients with moderate-to-severe HS based on prior exposure to -biologics.
This was an analysis of the SUNSHINE and SUNRISE phase III trials of secukinumab in patients with moderate-to-severe HS. Patients were randomized at baseline to receive secukinumab every 2 (SECQ2W) or 4 weeks (SECQ4W), or placebo for 16 weeks. After week 16, patients on the SECQ2W and SECQ4W schedules remained on the same treatment regimen, while patients randomized to placebo were switched to either SECQ2W or SECQ4W up to week 52. Assessments based on prior exposure to biologics included Hidradenitis Suppurativa Clinical Response (HiSCR), abscess and inflammatory nodule (AN) count, flare rates, HS-related pain [numerical rating scale 30 (NRS30)], 55% reduction in the International Hidradenitis Suppurativa Severity Score System (IHS4-55), Dermatology Life Quality Index, EuroQol-5D and safety.
Overall, 1084 patients were randomized in the SUNSHINE and SUNRISE trials and included in this analysis; 255 (23.5%) were biologic-experienced [SECQ2W (n = 80); SECQ4W (n = 81); placebo (n = 94)] and 829 (76.5%) were biologic-naïve [SECQ2W (n = 281); SECQ4W (n = 279); placebo (n = 269)]. At week 16, responses were more efficacious for secukinumab than for placebo with regard to HiSCR in patients who were biologic-experienced {SECQ2W 37.0% [odds ratio (OR) 1.60, 95% confidence interval (CI) 0.83-3.08]; SECQ4W 38.8% [OR 1.67, 95% CI 0.86-3.22]; placebo 27.3%} and biologic-naïve [SECQ2W 45.6% (OR 1.64, 95% CI 1.15-2.33); SECQ4W 45.4% (OR 1.61, 95% CI 1.13-2.29); placebo 34.2%]. Similar results were observed for AN count, NRS30 and IHS4-55. The higher response seen at week 16 with secukinumab was sustained, with a trend toward improvement over time, through to week 52 in both subgroups. Additional efficacy was observed for quality-of-life assessments, and no differences in safety between subgroups were observed.
Regardless of prior biologic exposure, secukinumab was efficacious in improving the signs and symptoms of HS. This finding positions secukinumab as the first option in patients who are biologic-naïve, as well as in patients who have previously been treated with other biologic therapy, based on individual patient needs.
化脓性汗腺炎（HS）是一种慢性炎症性皮肤病，与相当大的疾病负担有关。先前的研究表明，司库奇尤单抗在中重度 HS 患者中具有持续的疗效和良好的安全性。目前尚不清楚先前的生物制剂暴露是否会影响司库奇尤单抗的疗效和安全性。
根据先前的生物制剂暴露情况，研究司库奇尤单抗治疗中重度 HS 的疗效和安全性。
这是一项对司库奇尤单抗治疗中重度 HS 的 SUNSHINE 和 SUNRISE 三期临床试验的分析。患者在基线时随机接受司库奇尤单抗每 2 周（SECQ2W）或每 4 周（SECQ4W）一次或安慰剂治疗 16 周。在第 16 周后，接受 SECQ2W 和 SECQ4W 方案的患者继续接受相同的治疗方案，而接受安慰剂的患者在第 52 周前转换为 SECQ2W 或 SECQ4W。基于先前的生物制剂暴露情况，评估包括化脓性汗腺炎临床应答（HiSCR）、脓肿和炎性结节（AN）计数、发作率、HS 相关疼痛（数字评分量表 30 分[NRS30]）、国际化脓性汗腺炎严重程度评分系统（IHS4-55）降低 55%、皮肤病生活质量指数、EuroQol-5D 和安全性。
SUNSHINE 和 SUNRISE 试验共有 1084 名患者被随机分组，并纳入了这项分析；其中 255 名（23.5%）为生物制剂经验患者[SECQ2W（n = 80）；SECQ4W（n = 81）；安慰剂（n = 94）]，829 名（76.5%）为生物制剂初治患者[SECQ2W（n = 281）；SECQ4W（n = 279）；安慰剂（n = 269）]。在第 16 周，与安慰剂相比，司库奇尤单抗在生物制剂经验患者中对 HiSCR 的疗效更有效{SECQ2W 37.0%[优势比（OR）1.60，95%置信区间（CI）0.83-3.08]；SECQ4W 38.8%[OR 1.67，95% CI 0.86-3.22]；安慰剂 27.3%}和生物制剂初治患者[SECQ2W 45.6%（OR 1.64，95% CI 1.15-2.33）；SECQ4W 45.4%（OR 1.61，95% CI 1.13-2.29）；安慰剂 34.2%]。在 AN 计数、NRS30 和 IHS4-55 方面也观察到类似的结果。在第 16 周观察到的较高反应随着时间的推移持续存在，并在第 52 周时在两个亚组中都有改善的趋势。在生活质量评估方面观察到了额外的疗效，并且在两个亚组之间未观察到安全性的差异。
无论先前是否使用生物制剂，司库奇尤单抗都能有效改善 HS 的体征和症状。这一发现表明，根据患者的个体需求，司库奇尤单抗是生物制剂初治患者以及先前接受过其他生物制剂治疗的患者的首选药物。
