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AIM: To assess the efficacy of Quyin Koufuye in different types of psoriasis vulgaris and analyzes the relationship between efficacy and various disease-related factors, as well as its complementary role in biologic therapy. METHODS: This study included a total of 396 patients with psoriasis. Based on the patient history, participants were categorized into the biologics group (n=98), Quyin Koufuye-assisted biologics group (n=62), and Quyin Koufuye monotherapy group (n=236). Patient history data were collected, including gender, duration of illness, disease type, initial site of onset, degree of itching, recurrence status and time, smoking habits, joint pain, family history of psoriasis, nail damage, treatment plan, and PASI/BSA scores. A retrospective analysis was conducted to identify factors influencing the efficacy of Quyin Koufuye and to analyze its combined effects with biologics. RESULTS: Combining Quyin Koufuye with biologics significantly boosted the PASI90 response rate to 72.6% (P=0.014). Responders to PASI50 with Quyin Koufuye experienced longer recurrence intervals (> 6 months) than non-responders (50% vs. 33.6%, P= 0.045). Influencing factors included psoriasis-affected body surface area (OR=0.960, P=0.000), prolonged smoking history (OR=2.10, P=0.046), and psoriasis type (OR=2.47, P=0.015). CONCLUSION: This study underscores the synergy of Quyin Koufuye and biologics in treating psoriasis, particularly for longer recurrence intervals-factors like smoking history, psoriasis type, and affected body surface area impact Quyin Koufuye's efficacy.
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OBJECTIVE To provide reference for safe drug use in the clinic by mining the adverse drug event (ADE) signals of 4 kinds of biological agents for the treatment of inflammatory bowel disease (IBD). METHODS ADE data of infliximab, adalimumab, ustekinumab and vedolizumab were collected from the FDA adverse event reporting system between the first quarter in 2004 and the fourth quarter in 2022, and were mined by using reporting odds ratio (ROR) method and proportional reporting ratio (PRR) method. The system organ class (SOC) was used for the classification and statistics of drug ADE terminology. RESULTS & CONCLUSIONS A total of 65 173, 247 894, 37 596 and 6 134 ADE reports were retrieved for the above 4 biologic agents, involving 1 664, 1 731, 588, 303 ADE signals and 27, 27, 24, 26 SOC, respectively. The largest number of ADE reported of infliximab were various musculoskeletal and connective tissue diseases, and the signal intensity of disseminated tuberculosis was stronger. The largest number of ADE reported of adalimumab were systemic disease and various reactions at the administration site, and the signal intensity of papular at the injection site was stronger. The largest number of ADE reported of ustekinumab were various injuries, poisoning and operation complications, and the signal intensity of latent tuberculosis was slightly stronger. The largest number of ADE reported of vedolizumab were systemic diseases and various reactions at the administration site, and the signal intensity of shorter treatment response time was stronger. When clinically administering the four drugs, it is crucial to pay close attention to common ADEs and other ADE not mentioned in the drug label. For infliximab, clinicians should exercise caution due to the potential risk of synovitis and basal cell carcinoma; when prescribing adalimumab, caution should be exercised due to ADEs related to synovitis and hernia; for ustekinumab, the ADE associated with hepatobiliary diseases should be vigilant; for vedolizumab, clinicians should be vigilant for blood in the stool, increasing frequency of defecation. Except for ustekinumab, the other 3 biological agents also require attention for ADE associated with pregnancy.
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Thyroid-associated ophthalmopathy(TAO)is a rare organ-specific autoimmune disease with an unclear pathogenesis. At present, the treatment still relies mainly on glucocorticoids and traditional immunosuppressants. However, some patients respond poorly to these drugs and experience treatment-related adverse reactions, highlighting the urgent need for novel drugs for TAO treatment. In recent years, with the deepening of research on the pathogenesis of TAO, a multitude of biologics targeting specific targets have emerged. Among them, teprotumumab, which targets the insulin-like growth factor-I receptor(IGF-IR), has been approved by the Food and Drug Administration for the treatment of TAO, and several other biologics are currently in clinical trials. This review provides the latest reference for the clinical prevention, treatment, and research of TAO by summarizing the current clinical research status of biologics targeting IGF-IR, neonatal Fc receptor(FcRn), thyroid-stimulating hormone receptor(TSHR), B cells, cytokines, and other biological agents in TAO and analyzing their impact on clinical treatment and future research trends.
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Objective:To evaluate clinical efficacy and safety of immunotherapy by retrospectively analyzing clinical medica-tion of patients with recurrent pregnancy loss(RPL)complicated with abnormal immune factors.Methods:A retrospective cohort study was conducted on RPL cases in outpatient department of Hebei Reproductive Health Hospital from January 2021 to April 2022.Efficacy and safety of immunotherapy were evaluated from pregnancy outcome,adverse reactions and birth defects of offspring.Results:According to guidelines,192 cases with abnormal autoimmunity and/or immune indicators were included.Early abortion rate was 4.16%in group of two lost pregnancies,which was lower than that in group of three lost pregnancies(16.66%).Twelve week sus-tained pregnancy rate was 89.58%in the former group,and 28 week sustained pregnancy rate was 86.45%,which were significantly higher than those in the latter group(75.00%,71.87%).RPL patients were divided into groups according to their exposure to immuno-modulatory drugs before 12 weeks of pregnancy.There was no significant difference in pregnancy outcome,adverse reaction rate and birth defect rate of their offspring(P>0.05).Conclusion:Immunotherapy can effectively reduce risk of recurrent abortion and increase rate of persistent pregnancy in patients with immune RPL.Personalized immunotherapy can make RPL patients with immune factors achieve expected effect of fetal protection.
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ABSTRACT Background: Monocyte to high-density lipoprotein cholesterol ratio (MHR) is a novel inflammatory biomarker which has been associated with cardiovascular diseases. Objective: To study MHR in patients with psoriasis treated with biological agents. Methods: Between April 2019 and August 2022, MHR was retrospectively evaluated in patients with psoriasis before and 3 months after treatment with infliximab, adalimumab, etanercept, ixekizumab, secukinumab, and ustekinumab in a university hospital in Ankara, Turkey. Results: This study included 128 patients, 53 females and 75 males. 39 (30.5%) patients were treated with infliximab, 26 (20.3%) with adalimumab, 8 (6.3%) with etanercept, 18 (14.1%) with ixekizumab, 12 (9.4%) with secukinumab, and 25 (19.5%) with ustekinumab. The median MHR was 0.0127 (0.0086-0.0165) in females and 0.0146 (0.0119-0.0200) in males (p = 0.011). The median MHR decreased after treatment with adalimumab, ixekizumab, secukinumab, and ustekinumab, whereas it increased after treatment with infliximab and etanercept (p = 0.790, p = 0.015, p = 0.754, p = 0.221, p = 0.276, p = 0.889, respectively). Conclusion: MHR significantly decreased in patients with psoriasis after treatment with ixekizumab. Since high MHR levels have been associated with poor clinical outcomes in patients with cardiovascular diseases, ixekizumab might have a positive impact in the treatment of psoriasis patients who had cardiovascular diseases. We suggest that MHR may be useful both in establishing appropriate biological agent treatment and in the follow-up of patients with psoriasis treated with biological agents.
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The pathogenesis of atopic dermatitis is complex, and mainly related to genetic background, environmental stimuli, epidermal barrier defects, immune disorders, and other factors. Using Th2-type inflammatory cytokines and the JAK-STAT pathway as therapeutic targets has become a hotspot in drug development for atopic dermatitis. By now, multiple monoclonal antibodies and small-molecule drugs have been successfully used in the treatment of atopic dermatitis, marking that the treatment of atopic dermatitis has entered the era of precision therapy and targeted therapy.
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Objective:To evaluate the disease burden (number of patients and characteristics of disease) and unmet medical needs (current status and inadequacy of medical treatment) in Chinese patients with moderate-to-severe psoriasis (msPsO) .Methods:High-quality real-world evidence on Chinese msPsO patients was sorted and reviewed in the MEDLINE, EMBASE, Web of Science, Wanfang, VIP, and CNKI databases from January 1st, 2012 to August 31st, 2022. The disease burden as well as challenges and shortcomings of systemic therapeutic drugs were analyzed in Chinese msPsO patients.Results:In China, msPsO patients made up a high proportion (67.0%) of psoriasis patients, and the number was estimated to be about 5 million. They were characterized by high severity of disease (the mean psoriasis area and severity index score of 16.3 points), large affected body surface area (22.1%), a high proportion of scalp psoriasis (63.1%), and high prevalence of comorbid metabolic syndrome (21.2%). Current evidence suggested that traditional oral therapeutic drugs were still challenged by limited efficacy and a high risk of adverse reactions, whereas patients showed relatively high rates (58.7% - 91.2%) of 75% improvement in psoriasis area and severity index (PASI75) response after 12-week treatment with biological agents; however, discontinuation of biological therapies was common after 52 weeks (15.0% - 54.2%), and the main reason was the lack of efficacy (8.3% - 31.4%), followed by economic pressures (5.6% - 19.0%) and adverse reactions (2.3% - 4.8%) .Conclusion:The number of Chinese msPsO patients is relatively large, and there is an urgent need for new effective, durable, safe, and easily usable drugs to meet the demand for long-term therapeutic management of msPsO.
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Interleukin-17 (IL-17) has been proved to be closely associated with the pathogenesis of various inflammatory skin diseases. Its main source is Th17 cells, whose differentiation is evoked by interleukin-23 (IL-23). Therefore, the IL-23/Th17 axis is an emerging target for the treatment of inflammatory skin diseases. IL-17 antagonists, IL-23 antagonists and IL-12/23 antagonists have shown satisfactory efficacy and safety in the treatment of psoriasis, atopic dermatitis, hidradenitis suppurativa, pityriasis rubra pilaris and SAPHO syndrome in latest clinical trials. Accordingly, this review mainly summarizes progress in molecular signaling pathways in and pathophysiological basis of the IL-23/Th17 axis in the occurrence of inflammatory skin diseases, as well as clinical application of different biological agents targeting this axis.
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Objective:To investigate the effects of biologics on psychological status and quality of life in patients with inflammatory bowel disease (IBD).Methods:A cross-sectional survey was conducted in 42 hospitals in 22 provinces (autonomous regions and municipalities directly under the central government) from September 2021 to May 2022. General clinical information and the use of biologics were obtained from adult patients diagnosed with IBD who voluntarily participated in the study. Psychological status was evaluated using the Generalized Anxiety Disorder (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Pittsburgh Sleep Quality Index (PSQI), and Inflammatory Bowel Disease Questionnaire (IBDQ) assessment tools. Counts were analyzed via the Chi-square test, and datasets that were not normally distributed were analyzed via nonparametric tests. P<0.05 was considered statistically significant. Results:A total of 2 478 valid questionnaires were collected. The GAD-7 score of the biologics group was significantly lower than that of the non-use group [6 (2, 9) vs. 7 (3, 10), Z=-3.49, P<0.001]. IBDQ scores [183 (158, 204) vs. 178 (152, 198), Z=-4.11, P<0.001], intestinal symptom scores [61 (52, 67) vs. 58 (49, 65), Z=-5.41, P<0.001], systemic symptom scores [28 (24, 32) vs. 27 (23, 31), Z=-2.37, P=0.018], emotional ability scores [69 (58, 77) vs. 67 (56, 75), Z=-3.58, P<0.001] and social ability scores [26 (22, 29) vs. 25 (22, 29), Z=-2.52, P=0.012] in the biologics group were significantly higher than in the non-use group. GAD-7 scores [5 (2, 9) vs. 6 (3, 10), Z=-3.50, P<0.001] and PSQI scores [6 (4, 9) vs. 6 (4, 9), Z=-2.55, P=0.011] were significantly lower in the group using infliximab than in the group not using it. IBDQ scores were significantly higher in patients using vedolizumab than in those not using it [186 (159, 205) vs. 181 (155, 201), Z=-2.32, P=0.021] and were also significantly higher in the group treated with adalimumab than in the group not treated with adalimumab [187 (159, 209) vs. 181 (155, 201), Z=-2.16, P=0.030]. However, ustekinumab had no significant effect on any of the scores. Conclusion:The use of biologics is strongly associated with improvements in anxiety status and quality of life in IBD patients.
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Objective:To investigate COVID-19 vaccination status and relevant adverse reactions in patients with psoriasis treated with biological agents, and to explore the effect of COVID-19 vaccination on psoriatic lesions.Methods:Clinical data were collected from 572 psoriasis patients aged 18 - 60 years, who were registered in the management system of psoriasis patients treated with biological agents in the University of Hong Kong-Shenzhen Hospital from May 2019 to June 2021. The COVID-19 vaccination status was investigated by telephone interviews, and the vaccination-related information was obtained by fixed healthcare workers during a fixed time period according to a predesigned questionnaire. Measurement data were compared between two groups by using t test, and enumeration data were compared by using chi-square test or Fisher′s exact test. Results:The COVID-19 vaccination coverage rate was 43.13% (226 cases) among the 524 patients who completed the telephone interview, and was significantly lower in the biological agent treatment group (30.79%, 105/341) than in the traditional drug treatment group (66.12%, 121/183; χ2 = 60.60, P < 0.001) . The main reason for not being vaccinated was patients′ fear of vaccine safety (49.66%, 148/298) , followed by doctors′ not recommending (26.51%, 79/298) . In the biological agent treatment group after vaccination, the exacerbation of psoriatic lesions was more common in patients receiving prolonged-interval treatment (42.86%, 6/14) compared with those receiving regular treatment (4.40%, 4/91; Fisher′s exact test, P < 0.001) . Skin lesions were severely aggravated in two patients after COVID-19 vaccination, who ever experienced allergic reactions and whose skin lesions did not completely subside after the treatment with biological agents. Conclusions:The COVID-19 vaccination coverage rate was relatively low in the psoriasis patients treated with biological agents, and no serious adverse reaction was observed after vaccination. Prolonged-interval treatment due to COVID-19 vaccination ran the risk of exacerbation of skin lesions.
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Psoriasis is prone to be accompanied by cardiovascular diseases. Psoriasis and atherosclerosis have similar pathogenesis, involving the activation of innate immunity and autoreactive T cells. In recent years, more and more biological agents have been applied to systemic treatment of psoriasis, including tumor necrosis factor-α, interleukin-12/23 inhibitors and interleukin-17A inhibitors. The efficacy and safety of different biological agents, as well as their impact on cardiovascular diseases, have also attracted the attention of dermatologists. This review summarizes the common immunological pathogenesis of psoriasis and atherosclerosis, as well as the effects of different biological agents on cardiovascular diseases and related metabolic changes.
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Objective:To compare the efficacy and safety of biologics versus methotrexate in the treatment of severe pediatric plaque psoriasis.Methods:A retrospective matched case-control study was carried out. Twenty children with severe plaque psoriasis from Beijing Children′s Hospital, Capital Medical University from June 2016 to November 2021 were included in this study, and the patients treated with biologics (adalimumab or secukinumab) were matched with those treated with methotrexate at a ratio of 1∶1 according to the psoriasis area and severity index (PASI) score and age. PASI, physician′s global assessment (PGA) , and body surface area (BSA) scores were assessed at weeks 4, 8 and 12 after the start of treatment, and adverse drug reactions were recorded. Statistical analysis was mainly carried out by using Mann-Whitney U test, Fisher′s exact test and generalized estimating equations. Results:At weeks 4 and 8, the proportions of patients achieving PASI75 and PASI90 were significantly higher in the biologics group (PASI75: 7/10, 10/10, PASI90: 5/10, 9/10, respectively) than in the methotrexate group (PASI75: 1/10, 5/10, PASI90: 0, 1/10, respectively; all P < 0.05) , while there was no significant difference between the biologics group and methotrexate group at week 12 (PASI75: 10/10 vs. 8/10, PASI90: 9/10 vs. 4/10, both P > 0.05) . There were no significant differences in the PASI, BSA or PGA scores between the two groups at baseline (all P > 0.05) , while the biologics group showed significantly decreased PASI and BSA scores at weeks 4, 8 and 12, and significantly decreased PGA score at week 8 compared with the methotrexate group (PASI: Z = 2.50, 3.56, 2.63, respectively; BSA: Z = 2.87, 3.57, 2.40, respectively; PGA: Z = 2.81; all P<0.05) . Analysis of changes over time showed that the PASI, PGA and BSA scores in the biologics group significantly decreased at weeks 4, 8 and 12 compared with those at baseline (all P<0.01) ; the PASI and PGA scores significantly decreased at weeks 8 and 12 compared with the corresponding scores at week 4 (all P<0.05) ; however, there were no significant differences in the PASI, PGA or BSA scores between week 12 and 8 (all P>0.05) . In the methotrexate group, the PASI, PGA and BSA scores at weeks 4, 8 and 12 were all significantly lower than the corresponding scores at the previous adjacent time points (all P<0.05) . There was no significant difference in the incidence of adverse reactions between the two groups ( P = 0.650) , and no serious adverse reactions occurred in either group. The main adverse reaction was infection in the biologics group, while infection and elevation of transaminase levels were common in the methotrexate group. Conclusion:Biologics and methotrexate were both effective and safe for the treatment of severe pediatricplaque psoriasis, and biologics facilitated rapider achievement of PASI75 and PASI90 compared with methotrexate.
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Objective:To evaluate clinical efficacy and safety of dupilumab in the treatment of moderate and severe atopic dermatitis (AD) in the elderly.Methods:An observational study was conducted, and a total of 42 elderly patients with moderate to severe AD were collected from Department of Dermatology, the First Affiliated Hospital of Soochow University from September 2021 to June 2022. These patients all received subcutaneous injection of dupilumab at an initial dose of 600 mg, followed by every-2-week injections at a dose of 300 mg, and the total course of treatment was 16 weeks. Clinical indicators, including eczema area and severity index (EASI) , numerical rating scale (NRS) , dermatology life quality index (DLQI) and investigator′s global assessment (IGA) , were recorded at weeks 0, 4, 8, 12 and 16, and the proportion of patients achieving more than 50% (EASI-50) and 75% (EASI-75) improvement in EASI scores were calculated; related laboratory indicators, including total serum immunoglobulin E (IgE) levels and eosinophil counts, were recorded at weeks 0, 4 and 16. During the treatment, adverse events were recorded. Statistical analysis was carried out by using chi-square test, one-way analysis of variance and t test with SPSS27 and GraphPad Prism 9.0 software. Results:Among the 42 patients, there were 25 males (59.5%) and 17 females (40.5%) , and their age was 71.82 ± 16.81 years. Among them, 17 patients (40.5%) presented with generalized eczema phenotype, 15 (35.7%) with flexor eczema phenotype, and 10 (23.8%) with prurigo nodularis phenotype. At weeks 4 and 16 after start of the treatment, the mean EASI score significantly decreased by 38.4% and 73.3% respectively, the mean NRS score significantly decreased by 53.0% and 77.4% respectively, and the mean DLQI score significantly decreased by 58.2% and 93.8% respectively compared with the corresponding scores before the treatment ( P < 0.05 or 0.001) . At weeks 4 and 16, the proportions of patients achieving an IGA score of 0 or 1 were 11.9% and 61.9% respectively, the proportions of patients achieving EASI-50 were 11.9% and 76.2% respectively, and the proportions of patients achieving EASI-75 were 2.4% and 57.1% respectively. Compared with the baseline levels, the mean total serum IgE level decreased by 23.1% and 38.2% at weeks 4 and 16 respectively ( P = 0.274, 0.395, respectively) , and the mean eosinophil count decreased by 24.4% and 37.5% at weeks 4 and 16 respectively ( P = 0.059, 0.735, respectively) . During the treatment, mild adverse events occurred in 6 (14.3%) patients, including conjunctivitis (3 cases) , fungal infection of the head and face (2 cases) , and psoriasiform dermatitis (1 case) , which subsided after symptomatic treatment. Conclusion:Dupilumab exhibited a rapid onset and marked efficacy in the treatment of moderate and severe AD in the elderly, with few and mild adverse events; however, some patients had not achieved EASI-50 or EASI-75 after 16-week treatment, and maintenance treatment was required.
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With the increasing understanding of inflammatory pathogenesis of acne inversa, as well as with the development and application of biological agents in the treatment of autoimmune inflammatory diseases, some biological agents have shown good efficacy and potential for the treatment of acne inversa in clinical research and practice. This review mainly summarizes the research progress in biotherapy of acne inversa in recent years.
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Objective:To evaluate the real-world short-term effectiveness of ixekizumab in the treatment of psoriasis, and to investigate factors influencing the effectiveness.Methods:Baseline data and short-term effectiveness evaluation results were retrospectively collected from patients with psoriasis, who received ixekizumab treatment in Department of Dermatology, Xiangya Hospital from November 2019 to September 2021. A descriptive analysis was performed on the baseline characteristics of patients, continuous data were described as median (lower quartile, upper quartile), and categorical data were described as percentages. Comparisons of disease severity scores before and after the treatment with ixekizumab were performed using Wilcoxon signed-rank test or paired McNemar test. Multivariable logistic regression analysis was conducted to explore factors influencing the effectiveness of 4-week ixekizumab treatment.Results:A total of 118 patients with psoriasis were included, including 94 males and 24 females, and their age [ M ( Q1, Q3) ] was 43.4 (32.5, 53.0) years; plaque psoriasis (99 cases, 83.9%) and severe psoriasis (72 cases, 68.6%) predominated among the 118 patients, and skin lesions were mainly located on the scalp (59/116, 50.9%). Among the 49 patients who had received 2-week ixekizumab treatment, 27 (55.1%) achieved a 50% improvement in the psoriasis area and severity index (PASI) score (PASI50) ; after 4-week treatment, 44 (89.8%), 30 (61.2%), 13 (26.5%) and 10 (20.4%) patients achieved PASI50/75/90/100 respectively, and their PASI scores (2.1 [1.1, 7.1]), involved body surface area (3.9% [0.5%, 14.5%]), dermatology life quality index scores (1.0 [0.0, 2.0]) and physician global assessment (PGA) scores (1.0 [1.0, 3.0]) were significantly lower than the corresponding scores at baseline (12.4 [8.8, 23.2], 22.0% [11.3%, 43.4%], 6.0 [3.0, 11.0], 4.0 [3.0, 5.0], respectively; all P < 0.001]. Multivariable logistic regression analysis showed that the baseline body mass index was significantly associated with the PASI75 response rate ( OR = 0.814, 95% CI: 0.659 - 0.958, P = 0.029) and the proportion of patients with PGA0/1 ( OR = 0.743, 95% CI: 0.562 - 0.917, P = 0.017) after 4-week ixekizumab treatment, and the baseline BSA score was significantly associated with the proportion of patients with PGA0/1 after 4-week ixekizumab treatment ( OR = 0.924, 95% CI: 0.870 - 0.968, P = 0.003) . Conclusion:The 4-week ixekizumab treatment significantly decreased the severity of psoriasis, and may be more effective in patients with lower disease severity and lower body mass index at baseline.
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Objective:To evaluate clinical efficacy and safety of secukinumab in the treatment of patients with localized pustular psoriasis irresponsive or intolerant to conventional treatment.Methods:Clinical data were collected from 13 patients with refractory localized pustular psoriasis, who received secukinumab treatment in Department of Dermatology, Xijing Hospital from December 2019 to April 2022. Efficacy was evaluated by comparing palmoplantar pustulosis (PPP) area and severity index (PPPASI) score and physician global assessment (PGA) score in PPP patients before and after the treatment, and by comparing clinical global impression (CGI) score in patients with acrodermatitis continua of Hallopeau (ACH). Adverse events were recorded during the treatment.Results:Among the 13 patients with refractory localized pustular psoriasis, 6 were diagnosed with PPP, 3 with ACH, and 4 with PPP complicated by ACH. There were 3 males and 10 females, and their age was 33.2 ± 14.6 years. After 12-week treatment, the PPPASI score decreased from 13.88 ± 3.62 points at baseline to 6.81 ± 2.31 points in 10 patients presenting with PPP lesions, 4 achieved 75% improvement in the PPPASI score (PPPASI75), and 5 achieved PGA0/1; at the same time, 6 of the 7 patients presenting with ACH lesions achieved moderate or marked improvement in the CGI score, and 4 of the 6 patients achieved marked improvement. Two patients with PPP discontinued the treatment after 3- and 5-week treatment respectively due to poor response, and 1 patient with ACH achieved mild improvement in the CGI score after 12-week treatment. No severe adverse events were reported during the treatment. However, inflammatory follicular papules occurred in 1 patient, and eczematoid lesions occurred in another 1 patient, which both regressed after symptomatic treatment.Conclusion:Secukinumab was effective and safe in the treatment of refractory localized pustular psoriasis, and may serve as a new treatment option for refractory PPP and ACH.
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Systemic lupus erythematosus has always been a research hotspot in the field of autoimmune diseases in China and other countries. In 2022, Chinese and international researchers have made a lot of new progress in epidemiology, pathogenesis, diagnosis and evaluation, and treatment of systemic lupus erythematosus. This review mainly summarizes major representative advances.
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Objective:To investigate the efficacy and safety of omalizumab in the treatment of chronic urticaria (CU) patients with poor response to H1 antihistamines.Methods:CU patients, who showed poor response to H1 antihistamines and received omalizumab treatment, were collected from the Department of Dermatology, Xiangya Hospital, Central South University from June 2020 to June 2021. The efficacy of omalizumab was evaluated by using the 7-day urticaria activity score (UAS7) and urticaria control test (UCT) score at weeks 4, 12 and 24 after the start of treatment. The t-test, chi-square test, and Pearson correlation analysis were used to analyze the relationship between the clinical characteristics and efficacy. Results:A total of 121 CU patients who met the inclusion criteria and had relatively complete medical records were included in this study, including 54 males (44.63%) and 67 females (55.37%) , and their ages ranged from 13 to 70 years (39.88 ± 14.36 years) ; 88 patients were diagnosed with chronic spontaneous urticaria (72.73%) , 10 with chronic inducible urticaria (8.26%) , and 23 with chronic spontaneous urticaria accompanied by chronic inducible urticaria (19.01%) . At week 4 after the start of omalizumab treatment, the response rate was 50.86% (59/116) , and the complete response rate was 25.86% (30/116) ; at week 12, the response rate was 78.26% (54/69) , and the complete response rate was 34.78% (24/69) ; at week 24, the response rate was 64.71% (22/34) , and the complete response rate was 23.53% (8/34) . At week 4, CU patients with baseline serum total IgE levels of < 40 IU/ml had a lower response rate (26 cases, 30.77%) than those with baseline serum total IgE levels of ≥ 40 IU/ml (61 cases, 65.57%; χ2 = 8.93, P = 0.004) . Correlation analysis showed that the age at treatment, age at onset, allergic diseases, concomitant symptoms, baseline erythrocyte sedimentation rates, and baseline C-reactive protein levels were significantly correlated with the UCT scores (all P < 0.05) , while the course of disease, clinical types, serum total IgE levels, peripheral blood counts, dermatology life quality index scores, and UAS7 scores were not significantly correlated with the UCT scores. Among the 121 CU patients, 8 (6.61%) reported mild to moderate adverse reactions. Conclusion:Omalizumab could effectively improve clinical symptoms and signs of CU patients with poor response to H1 antihistamines, and was well tolerated;omalizumab treatment may be more beneficial to patients without allergic comorbidities such as allergic rhinitis, without concomitant symptoms such as angioedema, and with lower erythrocyte sedimentation rates and C-reactive protein levels.
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Objective:To retrospectively analyze clinical efficacy and safety of omalizumab in the treatment of chronic urticaria (CU) in southern Zhejiang, China.Methods:A retrospective observational study was conducted on CU patients who received omalizumab treatment at the First Affiliated Hospital of Wenzhou Medical University from January 1st, 2018 to August 1st, 2021. Through the outpatient follow-up visits, the disease activity, condition control, and quality of life were evaluated using the 7-day urticaria activity score (UAS7) , urticaria control test (UCT) , and dermatology life quality index (DLQI) . In addition, changes in disease condition, recurrence after withdrawal, and adverse events were assessed. Independent-sample t test was used for intergroup comparisons of normally distributed measurement data, Wilcoxon signed-rank sum test or Kruskal-Wallis H test was used for comparisons of non-normally distributed measurement data, and chi-square test or Fisher′s exact test was used for comparisons of enumeration data. Results:A total of 252 CU patients with poor response to antihistamines were included, with a baseline UCT score of 5.0 ± 2.4 points, a UAS7 score of 25.6 ± 6.2 points, and a DLQI score of 17.5 ± 4.7 points; among them, 204 (81.0%) were treated with omalizumab at an initial dose of 300 mg, and 48 (19.0%) with omalizumab at an initial dose of 150 mg. At the end points (12.0 ± 1.4 months after the start of treatment) , an overall control rate of 90.3% (224/248) was achieved after the omalizumab treatment; concretely, 137 (55.2%) patients achieved complete control (UCT = 16 points) , 87 (35.1%) achieved partial control (12 points ≤ UCT < 16 points) , and 24 (9.7%) showed no response (UCT < 12 points) , while 10 with partial response shifted to complete control after dose increase. During the treatment period, recurrence occurred in 50 patients (36.5%) , of whom 32 patients opted for retreatment with omalizumab, and then 30 (93.8%) achieved partial or complete control. Adverse events were reported in 8 patients (3.2%) , and all were mild or moderate.Conclusion:Omalizumab was effective in the real-world treatment of CU, and could improve patients′ quality of life, with a favorable safety profile.
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Perianal fistula is a predictor of long⁃term poor prognosis in patients with Crohn’s disease, and perianal fistulizing Crohn’s disease (pfCD) seriously affects the quality of life of patients. The treatment of pfCD advocates a combination of surgery and drug therapy. The advent of biologic agents, especially TNF⁃α agents, has greatly changed the prognosis of patients with pfCD. In recent years, some new biological agents and mesenchymal stem cells have also been shown to contribute to the remission of the disease. For complex perianal fistula, preservation of sphincter has greatly reduced postoperative complications such as urinary incontinence, bringing new hope to pfCD patients. This article reviewed the progress in research on the diagnosis and treatment of pfCD.