作者
Miao Zhang,Seokgyeong Hong,Qingyun Wang,Xiaoying Sun,Yaqiong Zhou,Ying Luo,Liu Liu,Jiao Wang,Chunxiao Wang,Naixuan Lin,Juntang Yan,Xin Li
摘要
Importance Patients with psoriasis may require a switch to another therapy due to high treatment costs, primary effectiveness failure, biologic fatigue, or adverse effects associated with the initial biologic treatment; however, the availability of evidence for the effectiveness and safety of interclass biologic switching for the treatment of psoriasis is unknown. Objective To investigate the effectiveness and safety of psoriasis treatment after the failure of initial biologic therapy, particularly when patients switch to a second biologic. Data Sources PubMed, Embase, and the Cochrane Library were searched from inception through January 25, 2025. Study Selection The study included randomized clinical trials (RCTs) of patients with plaque psoriasis aged 18 years or older involving crossover or switching from 1 biologic agent to another initial biologic within the same or different drug class. Data Extraction and Synthesis Two researchers independently screened the records and abstracted data using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guideline. Data were pooled using random-effects models. Main Outcomes and Measures The prespecified primary end point was psoriasis area and severity index (PASI) 90. Secondary end points included clinician- and patient-reported outcomes (PROMs) and safety. Clinical effectiveness was evaluated based on the PASI responses (PASI 75, 90, and 100) and the Investigator’s and Physician’s Global Assessments scores of 0 or 1 and body surface area of 1% or less. PROMs included the dermatology life quality index and psoriasis symptoms and signs diary. Safety concerns included adverse events (AEs), serious AEs, severe AEs, treatment-related AEs, and specific AEs. Results Twenty-four RCTs involving 12 661 patients with psoriasis and 8 switching categories were analyzed. Significant differences observed in PASI 90 between week 4 and week 0 (odds ratio [OR], 6.53; 95% CI, 2.58-16.51). Substantial disparities were noted across various PASI response metrics, specifically PASI 90 (OR, 28.61; 95% CI, 12.89-63.47), PASI 75 (OR, 11.11; 95% CI, 5.95-20.75), and PASI 100 (OR, 18.76; 95% CI, 8.37-42.01). No difference exists in safety outcomes between the end point and week 0, including in serious AEs (OR, 1.63; 95% CI, 0.72-3.69), severe AEs (OR, 1.40; 95% CI, 0.61-3.26), and treatment-related AEs (OR, 1.79; 95% CI, 0.41-7.88). The highest risk of infection was associated with switching from anti−TNF-α agents to anti−interleukin (IL)-23p19, anti−IL-17A, or anti−IL-12/23p40 agents, with infection rates of 0.62%, 0.54% and 0.39%, respectively. Conclusions and Relevance This systematic review and meta-analysis found that interclass biologic switching was effective in a significant number of patients. With the introduction of biologics with diverse mechanisms of action, these options may become viable and potentially superior. However, further confirmatory data from larger patient cohorts and longer follow-up periods are required to obtain more conclusive results. Our results highlight the importance of vigilance for infections when switching biologics.