✦
•
✦
Bimekizumab is the latest monoclonal antibody approved for the treatment of moderate to severe plaque psoriasis and, unlike other existing anti-interleukin (IL)-17 drugs, inhibits both IL-17A and IL-17F. But at the moment, there is limited data on its use in the real world. Therefore, this study evaluated the efficacy and safety of bimegizumab in the real world and compared its efficacy in biologic-naïve and biologic-laden patients.
1
Research Methods:
This is a short-term (16-week) single-center prospective study in patients with moderate to severe plaque psoriasis treated with bimejizumab. At baseline, demographic and clinical data were collected, including: (1) psoriasis course; (2) Psoriasis Area and Severity Index (PASI); (3) Dermatology Quality of Life Index (DLQI); (4) comorbidities; (5) previous psoriasis treatment; (6) Whether you have psoriatic arthritis. Psoriasis severity and adverse effects (AEs) were assessed at each follow-up visit (weeks 4-16).
The primary efficacy endpoints of the study were: PASI75, 90, 100, and DLQI, and the primary safety endpoints were: AEs. Statistical analysis was performed using GraphPadPrismv.8.0. All patients provided informed consent.
In this study, biologic-naïve patients were those who had not previously been treated with biologics, and biologic-experienced patients were those who had received prior biologics.
2
Findings:
A total of 56 patients (38 males [67.9%]; The mean age was 50.1±14.8 years; The mean duration of the disease was 13.6 ±10.2 years). At baseline, the mean values of PASI and DLQI were 16.9± 7.8 and 22.6±5.9, respectively, and decreased significantly at week 4 (PASI: 2.0±2.7; DLQI: 2.3±3.4; p<0.0001) and week 16 (PASI: 0.5±1.2; DLQI: 0.6±1.3; P<0.0001). The proportion of patients achieving PASI 75/90/100 was 76.8%/50.0%/42.9% at week 4 and 92.9%/82.1%/69.6% at week 16, respectively.
Twenty-nine (51.8%) were biologic-naïve patients and 27 (48.2%) were biologic-experienced patients. With the exception of the course of psoriasis, the two groups were comparable on all analytical criteria (biologics-naïve: 10.1± 7.5 years; Biological agent treatment: 17.5±11.4 years, p<0.05).
At baseline, the PASI and DLQI of the treatment-naïve group were significantly higher than those of the treatment-experienced group (PASI: 19.4± 7.7 vs. 14.2±7.0, p<0.05; DLQI: 25.3± 4.5 vs. 19.7±6.0, p<0.001）。 However, there was no statistically significant difference at weeks 4 and 16 (Figure 1A). Although there were no significant differences, the proportion of patients achieving PASI75 (79.3% vs. 63.0%, p=0.176), PASI90 (62.1% vs. 44.4%, p=0.186), and PASI100 (48.3% vs. 37.0%, p=0.396) at week 4 was higher in the biologic-naïve group compared with the biologic-experienced group. However, at week 16, the percentage of PASI75/90/100 responses was similar in both groups (Figure 1B).
Figure 1: (A) Psoriasis area and severity indices in the general population, biologic-naïve, and biologic-experienced patients at baseline, week 4, and week 16; (B) Percentage of patients in the general population, biologic-naïve, and biologic-experienced patients achieving PASI75, PASI90, and PASI100 response at weeks 4 and 16.
In terms of treatment-related adverse reactions, three patients developed candidiasis (5.4 percent) and one patient developed eczema (1.8 percent), with no difference between the two groups (biologics-naïve group: candidiasis [n=2], eczema [n=1]; Biologics-experienced group: candidiasis [n=1]). Two participants (3.6%) discontinued treatment due to ineffectiveness (biologic-naïve [n=1], 3.4%; biologics-experienced group [n=1], 3.7%); Three (5.4%) discontinued treatment due to AEs (biologics-naïve group: eczema [n=1], candidiasis [n=1]; Biologics-experienced group: candidiasis [n=1]).
3
Research Discussion
Real-world data is critical because patients in clinical trials are not representative of the population of everyday clinical practice, real-life individuals can vary, and the specific criteria used in clinical trials reduce clinical variability between individuals.
At present, most of the studies related to bimegizumab are related to case reports and limited clinical studies, and there are no studies in a broad population. Therefore, this study aims to evaluate the use of bimegizumab in the real world and to compare its efficacy in biologic-naïve and biologic-laden patients. A total of 56 patients were included in the study, and the results showed a significant reduction in PASI and DLQI since week 4. In the biologic-naïve group (n=29) versus the biologic-experienced group (n=27), the percentage of response to PASI75/90/100 was higher in the biologic-naïve group at week 4. However, at week 16, the percentage of PASI 75/90/100 responses was similar between the two groups.
In a recent multicenter study of 63 participants, 98.4% of patients treated with bimegizumab had a definite genital-psoriasis global assessment score at week 16. The proportion of patients achieving PASI 75/90/100 at weeks 4 and 16 was 70.5%/47.5%/41% and 93.4%/78.7%/68.9%, respectively, consistent with the data from this study. In addition, subgroup analyses showed that bimegizumab was not affected by prior biologics exposure or obesity.
4
Conclusions of the study
Studies have confirmed the efficacy and safety of bimejizumab, and failure of prior biologics does not appear to affect its efficacy.
参考文献：Megna M, Ruggiero A, Torta G, et al. Efficacy and Safety of bimekizumab in psoriasis management in real-life: bio-naïve vs bio-experienced. Clin Exp Dermatol. 2024 Apr 24:llae147. doi: 10.1093/ced/llae147.
Yimaitong is a professional online doctor platform, and the mission of the platform is to "sense the pulse of the world's medicine and help China's clinical decision-making". Yimaitong has a series of products such as "Clinical Guidelines", "Medication Reference", "Medical Literature King", "Yizhiyuan", "eYantong" and "ePulse", which fully meet the needs of medical workers in clinical decision-making, obtaining new knowledge and improving scientific research efficiency.