*Only for reference by medical professionals
Under the new normal of epidemic prevention and control, IL-12/IL-23 inhibitors are the "safe choice" for the treatment of psoriasis patients.
With the implementation of the "New Ten Measures" in various places, the prevention and control of the domestic COVID-19 epidemic has entered a new stage. Although the pathogenicity and virulence of Omicron have been significantly reduced, its transmissibility has increased. After the adjustment of epidemic prevention and control measures, the number of new coronavirus infections has increased dramatically, and many experts predict that there may be a peak of population infections in the next two to three months.
Psoriasis is a chronic, relapsing, inflammatory disease caused by the interaction of genetic, immune and environmental factors. Under the new situation of epidemic prevention and control, as a high-risk group, psoriasis patients are undoubtedly the key group of clinical response to the peak of infection. Facing the uncertainty of the epidemic, the needs and challenges of long-term management of psoriasis patients are also changing.
In this special period, psoriasis patients’ demand for medication safety has escalated!
Since psoriasis is a chronic and relapsing disease, long-term management of patients is required to stabilize the condition in clinical practice. Medication safety is an important prerequisite for long-term management of psoriasis and is also the basic need for treatment by patients.
Among the systemic treatments for psoriasis, biological agents are a relatively safe class of drugs. By specifically targeting key causative factors in the disease process, biological agents can exert precise therapeutic effects, thereby reducing interference with normal immune function and having fewer side effects than traditional systemic therapeutic drugs. However, different biologics have different safety profiles due to differences in their mechanisms of action. In treatment selection, possible safety risks should be avoided.
In addition to considering the safety of the drug itself during long-term treatment, during the current special period of epidemic prevention and control, psoriasis patients have more demands for the use of biological agents. At the same time, they also face greater challenges: Will the use of different biological agents affect the body's immunity to the new coronavirus and increase the risk of infection? Does the use of biological agents affect the vaccination of the new coronavirus vaccine? How to reduce the occurrence of adverse reactions and reduce the risk of infection due to frequent hospitalization for testing and treatment?
Under the new situation of epidemic prevention and control, how can we better meet the multiple needs of psoriasis patients for the safety of biologic drugs?
Both safe medication and epidemic prevention are ensured. IL-12/IL-23 inhibitors make psoriasis patients more secure in their treatment.
Among the different types of biological agents currently available for the treatment of psoriasis, the safety performance of IL-12/23 inhibitors is very outstanding. Regarding the risk of infection that everyone is generally worried about during the use of biological agents, real-world studies have shown that compared to TNF-α inhibitors and IL-17 inhibitors, IL-12/23 inhibitors have a lower risk of serious infection[1].
Ustekinumab, a "dual-targeted" biological agent that targets IL-12 and IL-23, is the world's first biological agent that targets the interleukin pathway to treat psoriasis. It was first approved by the U.S. Food and Drug Administration (FDA) in 2009 for the treatment of moderate to severe plaque psoriasis in adults. It has been used globally for more than 10 years, during which time it has accumulated rich safety data.
In 2017, ustekinumab was officially approved for the indication of moderate to severe plaque psoriasis in my country, opening a grand road to benefit Chinese psoriasis patients. Its safety among Chinese patients has also been confirmed by relevant research data. China's phase 3 study showed that the incidence of serious adverse events after 36 weeks of ustekinumab treatment was low (serious adverse events were only 0.6%, comparable to the placebo group), and the incidence rates of serious infections, malignant tumors, and major adverse cardiovascular events were all 0 (Figure 1) [2].
Figure 1: Safety data of ustekinumab in China’s Phase 3 study
The safety results of a summary of four clinical studies with a follow-up period of up to 5 years showed that during the placebo-controlled period, the risk of overall adverse events, common adverse events and infections in the ustekinumab treatment group was equivalent to that of the placebo group. During 5 years of continuous treatment, ustekinumab not only demonstrated stable clinical efficacy, but also had a relatively low incidence of serious adverse events, which was comparable to the placebo group. In addition, an Italian real-world study with a follow-up period of up to 8 years showed that ustekinumab was well tolerated in the long term, and the reported adverse reactions were generally mild.7[4]
The above domestic and foreign safety data fully demonstrate that the IL-12/IL-23 inhibitor ustekinumab has unique advantages in meeting the needs of psoriasis patients for long-term treatment safety.
So, under the new normal of epidemic prevention and control, how does ustekinumab perform for psoriasis patients who have further demands for medication safety? Will its use increase the risk of COVID-19 infection, and will it affect the safety and efficacy of the COVID-19 vaccine?
First of all, from the current understanding of the new coronavirus defense immune mechanism, IL-12 and IL-23 do not participate in the new coronavirus defense immune response (Figure 2) [5]. As a regulator of the IL-23/Th17 immune axis, IL-23 induces the secretion of pathological IL-17 in the pathogenesis of psoriasis. Theoretically, it has less impact on gamma interferon and mucosal immunity, which play an important role in antiviral immunity. It is reasonable to speculate that inhibiting IL-12/23 will not interfere with the body's defense against the new coronavirus. Moreover, research evidence has shown that the use of IL-23 inhibitors will not increase the infection rate of new coronavirus [6], further supporting this speculation.
Figure 2: New coronavirus defense immune mechanism
In addition, in order to determine the impact of using different immunotherapy regimens on the effectiveness of the new coronavirus vaccine, a study conducted a prospective evaluation and analyzed the antibody production levels of patients with chronic inflammatory diseases treated with different treatment methods after vaccination with the mRNA new crown vaccine [7]. The results of the study suggest that after the patients using IL-12/23 inhibitors were vaccinated with the COVID-19 vaccine, the antibody titer and the intensity of the antibody neutralization reaction were not significantly different from those in the normal control group (Figure 3), indicating that IL-12/23 inhibitors have no impact on the immunity of the COVID-19 vaccine and do not affect its effectiveness. Psoriasis patients who receive ustekinumab treatment can be vaccinated with inactivated or inactivated vaccines [8] at the same time. It is also suggested that when patients are treated with ustekinumab, simultaneous vaccination with inactivated vaccines or recombinant vaccines does not increase the safety risk.
Figure 3: The impact of different treatment options on the immune function of the new coronavirus vaccine
What should I do if I accidentally become "positive"? IL-12/IL-23 inhibitors can be used as the preferred drug for biological treatment of psoriasis patients.
After the epidemic prevention and control was gradually relaxed, the number of "yang" groups around us spread rapidly. Many psoriasis patients are panicking about this. If they accidentally get infected, can they still continue to use biological agents for treatment?
In this regard, experts writing for the American Journal of Clinical Dermatology in 2021 suggested that based on previous good clinical safety data, the IL-12/IL23 inhibitor ustekinumab and IL-23 inhibitors can be used as first-line biological treatments for psoriasis patients with new coronavirus pneumonia infection[9]; Unique Occasionally, in a review published in the journal Biomedicines in 2022, the following recommendations were made for the selection of biological agents for psoriasis patients during COVID-19 infection: IL-23 inhibitors and IL-12/23 inhibitors are preferred drugs (++). The use of IL-17 inhibitors is still controversial and is not among the preferred drugs, but it can be used (- +)[10].
The above recommendations have also been confirmed in clinical practice.There is evidence that psoriasis patients who are infected with COVID-19 during treatment with IL-23 inhibitors can still fully recover and remain asymptomatic or mildly symptomatic.[6], suggesting that the use of IL-23 inhibitors does not affect the treatment or health of COVID-19. Complex; other case reports show that after being infected with COVID-19, psoriasis patients treated with ustekinumab, without interrupting biologic treatment and not receiving any other drug treatment, the symptoms of COVID-19 resolved spontaneously, and the psoriasis condition continued to be stable, with a good outcome.[11]. These cases all remind us that continued use of IL-12/23 inhibitors or IL-23 inhibitors does not affect COVID-19 infection and post-infection recovery, and may have a certain protective effect.
However, it should be noted that because the novel coronavirus continues to evolve, our understanding and understanding of it are also constantly evolving. Research evidence is still quite limited on the impact of biologic treatments on psoriasis patients with novel coronavirus infection [9] . Various research reports unanimously point out that it is not recommended to use biological agents during the active stage of novel coronavirus infection. As for the specific medication decisions under different infection conditions in clinical practice, it is recommended that clinicians and patients make joint decisions and make careful choices to guide psoriasis patients on safe medication use during the COVID-19 pandemic.
Summary
Under the new normal of epidemic prevention and control, psoriasis patients will face more unknowns and uncertainties. How to ensure the long-term diagnosis and treatment of psoriasis amid numerous risks? Medication safety should be the primary consideration when selecting treatments for patients in the clinic. The IL-12/IL-23 inhibitor ustekinumab is not only safe and helpful in helping patients maintain long-term treatment, but research evidence also shows that its use will not increase the risk of COVID-19 infection and has no significant impact on the immunity of the COVID-19 vaccine. With both safe medication and epidemic prevention in mind, ustekinumab is the “safe choice” for psoriasis patients during the epidemic.
References :
[1]Li X, Andersen KM,Chang H-Y, et al.Ann Rheum Dis. Epub ahead of print
[2]Zhu 2013, 168(4): 844-54.
[4]Galluzzo M, et al. Expert Opin Biol Ther. 2020, 20(1): 95-104.
[5]Upreti S, et al. Pharm Res. 2022, 39(9):2119-2134.
[6]Huanhuan Zeng, et al. Front Med (Lausanne). 2021 Dec 6;8:759568
[7]Deepak P, et al. medRxiv [Preprint]. 2021. doi: 10.1101/2021.04.05.21254656.
[8] Ustekinumab instructions
[9]Thatiparthi A, et al. Am J Clin Dermatol. 2021, 22(4):425-442.
[10]Motolese A, et al. Biomedicines. 2022, 10(2):228.
[11]Conti A, et al. J Eur Acad Dermatol Venereol. 2020, 34(8):e360-e361.
This article is only used to provide scientific information to medical and health professionals and does not represent the position of the platform.
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