Kingo Kulli, Papanastasiou Philemon, Beissert Stefan, Lazareva Svetlana, Villa Asunción Vicente, Bartonova Jirina, Ballona Rosalia, Bansal Amita, Martin Ruvie, Fan Heng, O'Doherty Charles, Ravichandran Shoba, Magnolo Nina
Tartu University Hospital and University of Tartu, Tartu, Estonia.
Novartis Pharma AG, Basel, Switzerland.
Paediatr Drugs. 2025 Aug 28. doi: 10.1007/s40272-025-00715-4.
The efficacy and safety of secukinumab up to week 52 in children and adolescents with moderate-to-severe chronic plaque psoriasis have been demonstrated previously (NCT03668613). Herein, we report the long-term efficacy, safety, and tolerability of secukinumab over a period of up to 208 weeks.
In this randomized open-label trial, patients (6 to < 18 years) were randomized 1:1 to receive low-dose (LD; N = 42) or high-dose (HD; N = 42) secukinumab stratified by weight (< 25 kg, 25 to < 50 kg, or ≥ 50 kg) and disease severity (moderate or severe). Patients weighing < 25 kg received 75 mg secukinumab (both LD and HD); 25 to < 50 kg received 75 mg (LD) or 150 mg (HD) secukinumab; and ≥ 50 kg received 150 mg (LD) or 300 mg (HD) secukinumab. The study assessed Psoriasis Area and Severity Index (PASI) 75/90/100 response, Investigator's Global Assessment modified 2011 (IGA mod 2011) 0/1 response, Children's Dermatology Life Quality (CDLQI) 0/1 response, and safety. The impact of secukinumab treatment on physical development was also assessed.
Overall, 79.8% (67 of 84) enrolled patients completed 4 years of treatment (secukinumab LD [N = 31] and secukinumab HD [N = 36]). Both treatment groups showed sustained PASI and IGA mod 0/1 responses throughout the treatment period (at week 208, PASI 75/90/100 [secukinumab LD: 96.3%/88.9%/51.9%; secukinumab HD: 87.9%/81.8%/72.7%] and IGA mod 2011 0/1 [secukinumab LD: 85.2%; secukinumab HD: 84.8%]). Mean PASI score remained low in both treatment groups, from week 12 through week 208; at week 208, mean percentage change in PASI scores from baseline was - 95.7% (mean absolute score: 18.46 [baseline]; 0.76 [week 208]) with secukinumab LD and - 94.5% (mean absolute score: 19.25 [baseline]; 1.07 [week 208]) with secukinumab HD. CDLQI 0/1 response remained high in both treatment groups from week 12 through week 208 (secukinumab LD: 75.0%; secukinumab HD: 88.2%). Safety profile of secukinumab with long-term (~313.9 patient-years) treatment was favorable and in line with the known safety profile reported previously for 52-week treatment. No dose-dependent safety observations were noted. There were no deaths recorded throughout the entire duration of the treatment. Nonfatal serious adverse events (SAEs) were reported in four (9.5%) patients in the LD group (coronavirus disease 2019 [COVID-19], Crohn's disease, infectious mononucleosis, intentional self-injury, tibia fracture) and two (4.8%) patients in the HD group (appendicitis, tonsillitis). The incidence of treatment-emergent adverse events was similar in both secukinumab dose groups (LD [78.6%] and HD [83.3%]). No impact on the growth and development, or sexual maturation of pediatric patients, was noted with long-term treatment.
Secukinumab demonstrated sustained long-term efficacy and improved quality of life through week 208 in pediatric patients with moderate-to-severe chronic plaque psoriasis. The treatment was well tolerated, and safety data were consistent with the known favorable safety profile of secukinumab.
NCT03668613.
司库奇尤单抗在中度至重度慢性斑块状银屑病儿童和青少年患者中长达52周的疗效和安全性已得到证实（NCT03668613）。在此，我们报告了司库奇尤单抗长达208周的长期疗效、安全性和耐受性。
在这项随机开放标签试验中，患者（6至<18岁）按1:1随机分组，根据体重（<25 kg、25至<50 kg或≥50 kg）和疾病严重程度（中度或重度）分层接受低剂量（LD；N = 42）或高剂量（HD；N = 42）司库奇尤单抗治疗。体重<25 kg的患者接受75 mg司库奇尤单抗（LD和HD组均如此）；体重25至<50 kg的患者接受75 mg（LD）或150 mg（HD）司库奇尤单抗；体重≥50 kg的患者接受150 mg（LD）或300 mg（HD）司库奇尤单抗。该研究评估了银屑病面积和严重程度指数（PASI）75/90/100应答、2011年改良版研究者整体评估（IGA mod 2011）0/1应答、儿童皮肤病生活质量（CDLQI）0/1应答以及安全性。还评估了司库奇尤单抗治疗对身体发育的影响。
总体而言，84名入组患者中的79.8%（67名）完成了4年治疗（司库奇尤单抗LD组[N = 31]和司库奇尤单抗HD组[N = 36]）。两个治疗组在整个治疗期间均显示出持续的PASI和IGA mod 0/1应答（在第208周时，PASI 75/90/100[司库奇尤单抗LD组：96.3%/88.9%/51.9%；司库奇尤单抗HD组：87.9%/81.8%/72.7%]以及IGA mod 2011 0/1[司库奇尤单抗LD组：85.2%；司库奇尤单抗HD组：84.8%]）。从第12周直至第208周，两个治疗组的平均PASI评分均维持在较低水平；在第208周时，司库奇尤单抗LD组PASI评分相对于基线的平均百分比变化为 - 95.7%（平均绝对评分：18.46[基线]；0.76[第208周]），司库奇尤单抗HD组为 - 94.5%（平均绝对评分：19.25[基线]；1.07[第208周]）。从第12周直至第208周，两个治疗组的CDLQI 0/1应答均维持在较高水平（司库奇尤单抗LD组：75.0%；司库奇尤单抗HD组：88.2%）。司库奇尤单抗长期（约313.9患者年）治疗的安全性良好，与先前报道的52周治疗的已知安全性特征相符。未观察到剂量依赖性安全性问题。在整个治疗期间均未记录到死亡病例。LD组有4名（9.5%）患者报告了非致命严重不良事件（SAEs）（2019冠状病毒病[COVID - 19]、克罗恩病、传染性单核细胞增多症、故意自伤、胫骨骨折），HD组有2名（4.8%）患者报告了非致命严重不良事件（阑尾炎、扁桃体炎）。司库奇尤单抗两个剂量组的治疗中出现的不良事件发生率相似（LD组[78.6%]和HD组[83.3%]）。长期治疗未观察到对儿科患者生长发育或性成熟的影响。
在中度至重度慢性斑块状银屑病儿科患者中，司库奇尤单抗在第208周时均显示出持续的长期疗效并改善了生活质量。该治疗耐受性良好，安全性数据与司库奇尤单抗已知的良好安全性特征一致。
NCT03668613。
