From the update of the guidelines, look at the therapeutic status of biologics in systemic lupus.

According to the guidelines for diagnosis and treatment of SLE (2020 Edition), it is suggested that biological agents should be used for SLE patients with poor response, intolerance or recurrence after hormone and / or immunosuppressive therapy.systemic lupus erythematosus (SLE) is an autoimmune disease with multiple system damage, and its diagnosis and treatment are complicated.recently, the 2020 Chinese guideline for the diagnosis and treatment of systemic lupus erythematosus [1] has been updated. Compared with the 2010 edition, the new guideline gives corresponding evidence-based recommendations on 12 clinical issues of concern to rheumatologists in China. The grade classification system and the international practice guideline reporting standard (right) are adopted for the classification of recommendations.it is worth mentioning that in terms of drug treatment, the new guideline specifically mentions the application of biological agents in SLE, which we will further introduce in this issue.this guideline update has the following highlights: 1. Treatment principles and objectives for SLE patients. The 2020 guideline points out that the treatment of SLE should follow the principle of early and individualized treatment, so as to delay disease progression, reduce organ damage and improve prognosis. The short-term goal of SLE treatment is to control disease activity, improve clinical symptoms, achieve clinical remission or the lowest possible disease activity; the long-term goal is to prevent and reduce recurrence, reduce adverse drug reactions, prevent and control organ damage caused by disease, achieve long-term continuous remission, reduce mortality and improve the quality of life of patients.according to the systematic evaluation, early diagnosis and treatment can control disease activity and improve the prognosis of patients. The disease activity assessment tool used SLE disease activity index (SLEDAI ‐ 2000) and British island Lupus Assessment Group Index (BILAG ‐ 2004) to evaluate disease activity, and combined with physician's overall judgment (PGA), to improve the evaluation accuracy.in addition, as the only internationally recognized and validated SLE organ damage assessment standard, the SLE international cooperation group injury index (SDI) can be used to evaluate SLE organ damage. Prevention and control of infection in SLE patients is the first cause of death of SLE patients. During the whole treatment period of SLE, the possible infection risk of patients should be evaluated in time, and the infection should be identified, prevented and controlled through various ways. For hormone therapy, the dosage should be individualized and the dosage should be reduced or even stopped as soon as possible when the condition is stable.according to relevant studies, SLE patients who received prednisone > 7.5mg/d were more likely to suffer from hormone related cardiovascular (including myocardial infarction, heart failure and cerebrovascular disease), kidney, musculoskeletal damage, etc., while the cumulative damage of SLE patients was not related to hormone treatment ≤ 7.5mg/d.this guideline emphasizes the individualization of dosage and the early reduction or even withdrawal of glucocorticoids when the condition is stable. That is to say, without the successful reduction of glucocorticoids to a relatively safe dose range (≤ 7.5mg/d or ≤ 5mg / D), there will be no real remission / low disease activity of SLE, nor standard treatment of SLE. The use of biological agents is recommended according to the guidelines for the diagnosis and treatment of SLE (2020 Edition): Patients with SLE who are not effective, intolerant or relapsed after hormone and / or immunosuppressive therapy can be considered to use biological agents.currently, only baileyumab has been approved by the food and Drug Administration (FDA) and the State Food and Drug Administration (CFDA) for the treatment of SLE.as the first and only biological agent approved for SLE treatment in the world, baileyumab can significantly control disease activity, reduce hormone dosage, reduce organ damage, reduce the risk of serious recurrence, and has good safety.first, the phase III clinical trials of belizumab include bliss-52 [2], bliss-76 [3] and Northeast Asia Study [4].the results of bliss-52 / 76 study showed that the response rate of systemic lupus erythematosus response index-4 (sri4) in baileyumab group was significantly higher than that in control group, the expression level of biomarkers was significantly improved in the early stage, the complement level was significantly improved at the earliest 4 weeks, and the level of anti dsDNA was significantly decreased from week 8 to the end of the study.according to the main endpoint of the Northeast Asia Study [4], the proportion of patients who achieved sri4 response in the baileyumab treatment group was significantly higher than that in the control group from the 12th week, and lasted until the end of the study. The sri4 response rate reached 53.8% at the 52nd week, which was higher than that in the control group (40.1%).（P=0.0001）。main endpoint of Northeast Asia Study: the response rate of sri4 in baileyumab group was significantly higher than that in control group after 52 weeks of treatment. It showed that baileyumab could significantly reduce the risk of serious recurrence.compared with the control group, the risk of severe recurrence was reduced by 50% (P = 0.0004).the secondary end point of Northeast Asia Study: the risk of serious relapse was reduced by 50% in baileyumab group. 2. Baileyumab effectively reduced the hormone dosage. According to the results of real world study [5], 76.9% of patients achieved hormone reduction after 6 months of treatment, 9.1% of patients stopped hormonal withdrawal, and the proportion of patients with hormone > 7.5mg/d decreased from 67.5% to 18.4% from 67.5% at baseline 。the results of real-world studies show that baileyumab can reduce the hormone dosage to < 7.5mg/day. 3. Baileyumab can effectively reduce organ damage. According to the results of a 5-year propensity score matching comparative study [6], compared with conventional treatment, baileyumab treatment group has a 61% lower possibility of increasing organ damage index (SDI) score in any year.the results of a 5-year propensity score matching comparative study showed that baileyumab reduced the risk of organ damage progression by 61% in any year. 4. The overall safety of baileyumab was equivalent to that of placebo, and the incidence of serious infection was low. According to the results of Northeast Asia Study [4], the incidence of adverse events (AE) was similar to that of placebo in 52 weeks, and the vast majority of adverse events were adverse There was no new HBV infection.the results of Northeast Asia study showed that the overall safety of baileyumab was equivalent to that of placebo after 52 weeks of treatment. According to the results of 7-year follow-up study [7], the serious infection rate was low and showed a downward trend.7-year follow-up study showed that the incidence of severe infection was low and showed a downward trend in the 7-year follow-up study. Conclusion SLE has strong heterogeneity, and the clinical diagnosis and treatment has certain complexity.the new guidelines suggest that the treatment of SLE should follow the principles of early and individualized treatment, which can delay disease progression, reduce organ damage and improve prognosis.biological agents can be considered for SLE patients with poor response, intolerance or recurrence of hormone and / or immunosuppressive therapy.baileyumab is the only biological agent approved by FDA and CFDA for the treatment of SLE, which provides a new treatment option for SLE patients in China.References: [1] China systemic lupus erythematosus research cooperation group, national clinical medical research center of Dermatology and immune diseases, Chinese society of rheumatology. 2020 guidelines for diagnosis and treatment of systemic lupus erythematosus [J]. Chinese Journal of Internal Medicine, 2020,59 (3): 172-185. [2] Navarra SV, Guzman RM, gallacher AE, et al al.Eficacyand safety of belimumab in patients with activesystemic lupus eryt hematosus:A randomised ,placebo-controlled,phase 3trial.Lancet ,2011,377:721-731.[3]Furie R,Petri M,Zamani O,et al.A phaseⅢ,randomized,placebo-controlled study of belimumab,a monoclonal antibody that inhibits B lymphocyte stimulator,in patients with systemic lupuserythematosus.ArthritisRheum,2011,63:3918-3930.[4]Zhang F, et al.A pivotal phaseⅢ,randomised,placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China,Japan and SouthKorea.AnnRheum Dis,2018,77:355-363.[5]Collins CE,et al.Lupus Sci Med,2016,3(1):e000118[6]Urowitz MB,et al.Ann Rheum Dis,2019,78:372–379.[7]Ginzler EM,et al.J Rheumatol,2014, 41 (2): 300-309. [answer to this issue] Based on the key medical contents of this issue, which of the following statements do you think is correct? (multiple choice) A. the treatment principle of systemic lupus erythematosus (SLE) is early and individualized treatment, which can delay disease progression, reduce organ damage and improve prognosis. B. the long-term goal of SLE treatment is to prevent and reduce recurrence, reduce adverse drug reactions, prevent and control organ damage caused by disease, achieve long-term continuous remission, reduce mortality and improve patient's life Quality of life c.2020 guidelines for the diagnosis and treatment of SLE recommends that biological agents should be considered for SLE patients with poor efficacy, intolerance or recurrence of hormone and / or immunosuppressants. D. baileyumab is the only biological agent approved by FDA and CFDA to treat SLE. For details, please refer to the comment area~