关键词: 银屑病, 司库奇尤单抗, 临床疗效, 安全性评价

Abstract:

Objective To evaluate the clinical efficacy and safety of secukinumab in the treatment of moderate to severe the adults with plaque psoriasis. Methods The clinical data from 183 adult patients with moderate to severe plaque psoriasis treated with secukinumab were collected. The patients received subcutaneous injections of secukinumab once a week at weeks 0， 1， 2， 3， and 4， followed by an injection every 4 weeks， with each dose of 300 mg. The follow-up period was 52 weeks. The psoriasis area and severity index（PASI）， body surface area （BSA）， investigator global assessment （IGA）， and dermatology life quality index （DLQI） scores of the patients with psoriasis were caculated. The clinical efficacy and safety of secukinumab in the treatment of moderate to severe plaque psoriasis were evaluated， and the influencing factors were analyzed. Results Compared with week 0， the PASI、 BSA、 IGA and DLQI scores of the patients were significantly decreased at weeks 4， 12， 24， and 52 of secukinumab treatment （P<0.05）. After treated with secukinumab， the percentages of the patients achieving PASI 75， PASI 90， and PASI 100 at week 4 were 95.6%， 84.2%， and 47.5%， respectively； at week 12， they were 97.3%， 95.6%， and 78.7%， respectively； at week 24， they were 97.8%， 96.7%， and 84.2%， respectively； and at week 52， they were 98.4%， 97.8%， and 83.6%， respectively. The percentages of the patients with BSA≤1% at weeks 4， 12， 24， and 52 were 80.9%， 94.5%， 95.6%， and 94.0%， respectively. The percentages of the patients with IGA score of 0/1 at week 4， 12， 24， and 52 were 86.3%， 97.3%， 96.7%， and 95.6%， respectively. The percentages of the patients with DLQI score of 0/1 at weeks 4， 12， 24， and 52 were 76.6%， 89.1%， 92.9%， and 91.8%， respectively. At week 4 of secukinumab treatment， there were significant differences in age， body mass index （BMI）， disease duration， baseline PASI score， and history of previous biologic treatment between the patients in two groups （P<0.05）. At week 24 of secukinumab treatment， there were significant differences in age and BMI between the patients in two groups （P<0.05）. At week 4， BMI≥25 kg·m^-2， disease duration≥10 years， baseline PASI score≥10， and a history of previous biologic treatment were risk factors affecting the recovery of the patient （P<0.05）. At week 24， age≥40 years was a risk factor affecting the recovery of the patient （P<0.05）. During the treatment period， 44 out of 183 psoriasis patients reported 49 adverse reactions， and the adverse reaction rate was 24.0%. No serious adverse events or fatal adverse reactions occurred. The adverse reactions included upper respiratory tract infections in 23 cases， eczema-like skin lesions in 10 cases， skin fungal infections in 6 cases， urticaria in 3 cases， mild liver function abnormalities in 2 cases， folliculitis in 2 cases， conjunctivitis in 2 cases， and otitis media in 1 case. Conclusion Secukinumab treatment for the adult patients with moderate to severe plaque psoriasis is rapid-acting and has lasting efficacy. The BMI， disease duration， baseline PASI score， history of previous biologic treatment， and age are the factors influencing the clinical efficacy of secukinumab. The overall safety is good， and secukinumab may be used as a first-line treatment option for moderate to severe plaque psoriasis.

Key words: Psoriasis, Secukinumab, Clinical efficacy, Safety evaluation