Clinical trial of secukinumab combined with acitretin in the treatment of patients with moderate to severe plaque psoriasis
10.13699/j.cnki.1001-6821.2024.24.001
- VernacularTitle:司库奇尤单抗联合阿维A治疗中、重度斑块型银屑病患者的临床研究
- Author:
Min TIAN
1
;
Wei XIONG
1
;
Yun-hua TU
1
;
Yu-feng XIAO
1
;
Xi WANG
1
Author Information
1. 贵阳市第二人民医院皮肤科,贵州贵阳 550081
- Publication Type:Journal Article
- Keywords:
secukinumab injection;
acitretin capsule;
plaque psoriasis;
evaluation of safety
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(24):3523-3527
- CountryChina
- Language:Chinese
-
Abstract:
Objective To observe the clinical efficacy and safety of secukinumab injection combined with acitretin capsules in the treatment of patients with moderate to severe plaque psoriasis.Methods Patients with moderate to severe plaque psoriasis were randomized into control group and treatment group.The control group received acitretin capsules 30 mg per time,qd,orally,after 4 weeks of maintenance therapy,the dose was reduced to 10-20 mg·d-1 and continued for 12 weeks.On the basis treatment of control group,the treatment group received secukinumab injection 300 mg per time,subcutaneous injection,once a week,after 4 weeks of maintenance treatment,it was adjusted to once every 4 weeks and continued treatment for 12 weeks.The clinical efficacy,serum inflammatory factors,humoral immune indicators and safety were compared between the two groups.Results Fifty-three patients were enrolled in the treatment group,with one dropout,and 52 patients were finally included in the statistical analysis;fifty-two patients were enrolled in the control group,with two dropouts,and 50 patients were finally included in the statistical analysis.After treatment,the total effective rates of treatment and control groups were 80.77％(42 cases/52 cases)and 62.00％(31 cases/50 cases),and the difference was statistically significant(P＜0.05).After treatment,the interleukin(IL)-17 levels of treatment and control groups were(21.06±3.14)and(23.82±3.51)ng·L-1;the IL-23 levels were(97.15±20.21)and(121.17±21.63)ng·L-1;the tumor necrosis factor-α levels were(33.65±5.71)and(37.53±7.64)ng·mL-1;the ratios of neutrophil count to lymphocyte count were 2.04±0.25 and 2.16±0.29;the mmunoglobulin(Ig)A levels were(2.34±0.32)and(2.51±0.38)g·L-1;the IgG levels were(11.51±2.16)and(12.79±2.41)g·L-1;the IgM levels were(1.02±0.26)and(0.91±0.25)g·L-1;the neutrophil counts were(5.19±1.12)× 109 and(4.32±0.94)× 109·L-1;the lymphocyte counts were(2.33±0.34)× 109 and(2.29±0.31)× 109·L-1;the PASI scores were(7.51±2.03)and(11.29±2.65)points;the DLQI scores were(7.04±1.26)and(9.23±2.51)points,respectively.The differences of above indexes were statistically significant between the treatment group and control group(all P＜0.05).The adverse drug reactions of treatment group were dry eyes,elevated transaminase,rhinitis/bronchitis,pruritus and gastrointestinal reactions,while those in control group were dry eyes,elevated transaminases,gastrointestinal reaction and elevated triacylglycerol.The incidences of total drug adverse reactions in the treatment and control groups were 17.31％and 16.00％,without significant difference(P＞0.05).Conclusion The clinical efficacy of secukinumab injection combined with acitretin capsules in the treatment of patients with moderate to severe plaque psoriasis is better than acitretin capsules alone,which can inhibit inflammation,improve immune function,reduce PASI and DLQI scores,without increasing the incidence of adverse drug reactions.
