Efficacy and Safety of Risankizumab in Patients with Psoriatic Arthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

INTRODUCTION: Currently, the cause of psoriatic arthritis (PsA) is unknown, and the effectiveness of current drug treatments is unsatisfactory. In March 2019, the US Food and Drug Administration (FDA) approved risankizumab, a humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting the p19 subunit of interleukin (IL)-23, for the treatment of PsA in adults. This study aimed to conduct a meta-analysis of double-blind, randomized, placebo-controlled trials to evaluate the effectiveness and safety of risankizumab in moderate-to-severe PsA. METHODS: We conducted a thorough search of relevant databases from the establishment of the databases to October 1, 2023. We conducted a meta-analysis using Stata 12.0 and utilized I2 and Egger tests to assess heterogeneity and publication bias among the studies. Bias assessment was performed using the risk bias map and bias risk summary diagram generated by Revman5.4 software. The review protocols were registered on PROSPERO (CRD42023451894) and adhered to the preferred reporting item of system evaluation (PRISMA) guideline. RESULTS: Six randomized controlled trials (RCTs) involving 5038 patients with PsA treated with either risankizumab or placebo were included in the analysis. At 24 weeks, the risankizumab group demonstrated a significantly higher American College of Rheumatology-20 (ACR20) response rate compared to the placebo group (RR 1.760, 95% CI 1.568-1.977, P < 0.001). Additionally, the risankizumab group showed a significantly higher Minimal Disease Activity (MDA) response rate compared to the placebo group (RR 1.827, 95% CI 1.048-3.184, P < 0.05). The risankizumab group also exhibited improvement in Short Form 36 Questionnaire (SF-36) score (SMD 0.51, 95% CI 0.33-0.69, P < 0.001), with significantly lower Health Assessment Questionnaire Disability Index (HAQ-DI) score (SMD - 0.27, 95% CI - 0.37 to - 0.17, P < 0.001) and higher Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score (SMD 0.27, 95% CI 0.20-0.35, P < 0.001) compared to the placebo group. Moreover, the risankizumab group had a significantly lower Psoriasis Area and Severity Index (PASI) score (SMD - 6.12, 95% CI - 10.02 to 2.23, P < 0.001). A study by Mease et al. indicated that patients receiving risankizumab generally demonstrated numerical improvements in the Leeds Enthesitis Index (LEI), although the small sample size limits the evidence. Further research is necessary to provide evidence-based guidelines. There were no significant differences in the incidence of serious adverse events (SAE) and serious treatment-emergent adverse events (STEAE) between the risankizumab and placebo groups (RR 0.76, 95% CI 0.45-1.28, P = 0.31; RR 0.99, 95% CI 0.49-1.99, P = 0.97, respectively), and the overall incidence of adverse events (AE) was not comparable (RR 1.10, 95% CI 0.63-1.94, P = 0.73). CONCLUSION: Risankizumab showed superior efficacy across multiple outcome measures compared to placebo, with no significant increase in adverse events. Our findings endorse risankizumab as an excellent treatment option for PsA, offering valuable insights for clinicians and patients when choosing appropriate therapeutic interventions. TRIAL REGISTRATION: Retrospectively registered (CRD42023451894, 16 August 2023).

Establishment of a multi-parameter prediction model for the functional cure of HBeAg-negative chronic hepatitis B patients treated with pegylated interferonα and decision process based on response-guided therapy strategy.

BACKGROUND & AIMS: This study aimed to establish multivariate prediction models according to a response-guided therapy (RGT) based strategy at baseline and week 12 and 24 of follow-up to predict the functional cure for HBeAg-negative patients with chronic hepatitis B (CHB) treated with pegylated interferonα (PEG-IFNα). METHODS: A total of 242 HBeAg-negative patients with CHB were treated with PEG-IFNα for 52 weeks and followed up for 24 weeks. Responses at the end of follow-up (EOF) were defined as hepatitis B surface antigen (HBsAg) loss, and patients were defined as either responders or non-responders. RESULTS: The three most meaningful predictors were an age ≤ 40 years, alanine aminotransferase (ALT) levels ≤ 40 U/L, and HBsAg levels ≤ 100 IU/mL at baseline; ALT levels ≥ 80 U/L, anti-HBc levels ≤ 8.42 S/CO, and HBsAg levels ≤ 50 IU/mL at week 12; and ALT levels ≥ 40 U/L, anti-HBc levels ≤ 8.46 S/CO, and HBsAg levels ≤ 0.2 IU/mL at week 24. The response rates of patients with a score of 0-1 and 4-5 at baseline, week 12, and 24 were 13.5%, 7.8%, and 11.7%; and 63.6%, 68.1%, and 98.1%, respectively. At week 12, the cumulative scores were 0-2, 3-4, 5-7, and 8-10 (response rates 5.0%, 18.9%, 41.3%, and 71.4%, respectively). At week 24, the cumulative scores were 0-3, 4-6, 7-10, and 11-15 (response rates: 1.3%, 12.3%, 37.0%, and 92.5%, respectively). At baseline, patients with scores of 0-1 were slightly recommended; at week 12, patients with 0-1 or 0-2 cumulative scores were recommended to stop treatment. At week 24, patients with a score of 0-1 or a cumulative score of 0-6 were recommended to stop treatment. CONCLUSION: We established a multi-parameter prediction model for the functional cure of HBeAg-negative patients with CHB treated with PEG-IFNα.

A new model for predicting the outcome and effectiveness of drug therapy in patients with severe fever with thrombocytopenia syndrome: A multicenter Chinese study.

BACKGROUND: There are a few models for predicting the outcomes of patients with severe fever with thrombocytopenia syndrome (SFTS) based on single-center data, but clinicians need more reliable models based on multicenter data to predict the clinical outcomes and effectiveness of drug therapy. METHODOLOGY/PRINCIPAL FINDINGS: This retrospective multicenter study analyzed data from 377 patients with SFTS, including a modeling group and a validation group. In the modeling group, the presence of neurologic symptoms was a strong predictor of mortality (odds ratio: 168). Based on neurologic symptoms and the joint indices score, which included age, gastrointestinal bleeding, and the SFTS virus viral load, patients were divided into double-positive, single-positive, and double-negative groups, which had mortality rates of 79.3%, 6.8%, and 0%, respectively. Validation using data on 216 cases from two other hospitals yielded similar results. A subgroup analysis revealed that ribavirin had a significant effect on mortality in the single-positive group (P = 0.006), but not in the double-positive or double-negative group. In the single-positive group, prompt antibiotic use was associated with reduced mortality (7.2% vs 47.4%, P < 0.001), even in individuals without significant granulocytopenia and infection, and early prophylaxis was associated with reduced mortality (9.0% vs. 22.8%, P = 0.008). The infected group included SFTS patients with pneumonia or sepsis, while the noninfected group included patients with no signs of infection. The white blood cell count and levels of C-reactive protein and procalcitonin differed significantly between the infection and non-infection groups (P = 0.020, P = 0.011, and P = 0.003, respectively), although the absolute difference in the medians were small. CONCLUSIONS/SIGNIFICANCE: We developed a simple model to predict mortality in patients with SFTS. Our model may help to evaluate the effectiveness of drugs in these patients. In patients with severe SFTS, ribavirin and antibiotics may reduce mortality.

Inconsistency analysis between metagenomic next-generation sequencing results of cerebrospinal fluid and clinical diagnosis with suspected central nervous system infection.

BACKGROUND: Recently, with the rapid progress of metagenomic next-generation sequencing (mNGS), inconsistency between mNGS results and clinical diagnoses has become more common. There is currently no reasonable explanation for this, and the interpretation of mNGS reports still needs to be standardised. METHODS: A retrospective analysis was conducted on 47 inpatients with suspected central nervous system (CNS) infections, and clinical data were recorded. The final diagnosis was determined by an expert group based on the patient's clinical manifestation, laboratory examination, and response to treatment. mNGS results were compared with the final diagnosis, and any inconsistencies that occurred were investigated. Finally, the credibility of mNGS results was evaluated using the integral approach, which consists of three parts: typical clinical features, positive results with the traditional method, and cerebrospinal fluid cells ≥ 100 (× 106/L) or protein ≥ 500 mg/L, with one point for each item. RESULTS: Forty-one patients with suspected CNS infection were assigned to infected (ID, 31/41, 75.61%) and non-infected groups (NID, 10/41, 24.39%) after assessment by a panel of experts according to the composite diagnostic criteria. For mNGS-positive results, 20 of the 24 pathogens were regarded as contaminants when the final score was ≤ 1. The remaining 11 pathogens detected by mNGS were all true positives, which was consistent with the clinical diagnosis when the score was ≥ 2. For mNGS negative results, when the score was ≥ 2, the likelihood of infection may be greater than when the score is ≤ 1. CONCLUSION: The integral method is effective for evaluating mNGS results. Regardless of whether the mNGS result was positive or negative, the possibility of infection was greater when the score was ≥ 2. A negative mNGS result does not necessarily indicate that the patient was not clinically infected, and, therefore, clinical features are more important.

Causes and Consequences of Drug Abuse: A Comparison Between Synthetic Drug and Heroin Users in Urban China.

This article examined the differences in causes and health consequences between synthetic drug and heroin abuse in urban China. Two-group comparisons were conducted to quantify differences in individual characteristics, causes of drug use, and HIV/STI risky sexual behavior between synthetic drug and heroin users; logistic regressions were employed to assess the net effect of synthetic drug use on risky sexual behavior. Results revealed that causes of synthetic drug use differed from those of heroin use; a combination of the knowledge gap concerning the harmful impact of synthetic drugs and the lesser punishment for their use appeared a main reason behind the shift from heroin to synthetic drugs; and synthetic drug use was a significant and powerful risk factor for HIV/STI risky sexual behavior. Educational and behavioral interventions are urgently needed to prevent the initiation of synthetic drug use among users to reduce their HIV/STI risky sexual behavior.

Effectiveness of a Peer-Assisted Multicomponent Behavioral Intervention in HIV Risk Reduction Among Female Entertainment Workers in China.

This study examined the effectiveness of a behavioral intervention that combined cognitive and social influence approaches. The intervention consisted of small group sessions targeting HIV knowledge, protection motivation, behavioral skills, and social influences of risk reduction. The control was an attention-controlled HIV/STI health education and counseling. Two-group comparisons were conducted to assess the effectiveness of the intervention; risk reduction over time was analyzed to determine the sustainability of the effectiveness. The analyses revealed that the intervention was effective in reducing/increasing HIV risk/protective behaviors and the effect was sustainable. While participants in the control reported a greater reduction/increase in risk/protective behaviors 3-month post-intervention, the initial strong effect quickly faded and completely disappeared 12-month post-intervention. By contrast, the moderate initial effect of the intervention was not only sustained but actually strengthened over time. The intervention was well received by participants and holds promise for HIV risk reduction behavior change among female entertainment workers in China.

Delineating interpersonal communication networks: a study of the diffusion of an intervention among female entertainment workers in Shanghai, China.

Diffusion of innovation (DOI) is widely cited in the HIV behavior change literature; however there is a dearth of research on the application of DOI in interventions for sex workers. Following a randomized-controlled trial of HIV risk reduction among female entertainment workers (FEWs) in Shanghai, China, we used qualitative approaches to delineate potential interpersonal communication networks and contributing factors that promote diffusion of information in entertainment venues. Results showed that top-down communication networks from the venue owners to the FEWs were efficient for diffusion of information. Mammies/madams, who act as intermediaries between FEWs and clients form an essential part of FEWs' social networks but do not function as information disseminators due to a conflict of interest between safer sex and maximizing profits. Diffusion of information in large venues tended to rely more on aspects of the physical environment to create intimacy and on pressure from managers to stimulate communication. In small venues, communication and conversations occurred more spontaneously among FEWs. Information about safer sex appeared to be more easily disseminated when the message and the approach used to convey information could be tailored to people working at different levels in the venues. Results suggest that safer sex messages should be provided consistently following an intervention to further promote intervention diffusion, and health-related employer liability systems in entertainment venues should be established, in which employers are responsible for the health of their employees. Our study suggests that existing personal networks can be used to disseminate information in entertainment venues and one should be mindful about the context-specific interactions between FEWs and others in their social networks to better achieve diffusion of interventions.

The efficacy of a peer-assisted multi-component behavioral intervention among female entertainment workers in China: an initial assessment.

Women working in China's entertainment industry are at increased risk of acquiring or transmitting HIV/sexually transmitted infections (STIs). Efforts to develop effective risk-reduction interventions for female entertainment workers (FEWs) remain limited. We conducted a randomized controlled trial of a theory-based risk-reduction intervention among FEWs in Shanghai. The intervention condition consisted of small group, peer-assisted sessions integrating information-motivation-behavioral skills training with social influences of behavior change. The control condition was an attention-matched HIV, health education, and counseling. At three-month post-intervention, participants in the intervention condition reported greater reductions in unprotected sex with a stable partner than participants in the control condition. However, participants in the control condition reported greater reductions in unprotected sex with a non-stable partner than participants in the intervention condition. Some aspects of the study design may have diluted the effects of the intervention. Future intervention studies need to pay more attention to social influences of behavior change and the particular challenges of risk-reduction with stable partner(s).

[Association between IgG antibody against the C-terminal region of the preS1 protein of hepatitis B virus and the early response to interferon therapy in chronic hepatitis B].

OBJECTIVE: To determine the relationship between IgG antibody against the C-terminal region of the preS1 protein of hepatitis B virus and the early response to interferon therapy in chronic hepatitis B. METHODS: 69 patients with chronic hepatitis B virus (genotype B) infection were recruited in this study. 42 patients were treated with interferon-a-1b or a-2b, and 27 patients were treated with PEG interferon (a-2a). Peptide mimicking the C-terminal region of the preS1 protein (94-117aa) of genotype B HBV were synthesised, and the IgG antibody against this peptide was measured by ELISA, and the early response to IFN-alpha therapy was judged by the effect on the viral kinetics, transaminase and the status of HBeAg at 12th week after the treatment. RESULTS: 21 patients were positive for anti-preS1 antibody, and 48 patients were negative for anti-preS1 antibody. After 12 weeks of the treatment, the average decrease in viral levels was 3.37log10 copies/ml and 0.33log10 copies/ml in anti-PreS1 positive patients and anti-preS1 negative patients, respectively, the difference between the two groups was significant (Z = -3.658, P = 0.000); the average decrease in ALT levels was 92 U/L and 30.5 U/L in these two groups, respectively (Z = -2.132, P = 0.033). The rate of hepatitis B e antigen (HBeAg) loss was 41.2% (7/17) and the rate of anti-HBe seroconversion was 5.9% (1/17) in anti-PreS1 positive group, however, the rate of hepatitis B e antigen loss was only 12.8% (5/39), and none of the patients in anti-PreS1 negative group showed anti-HBe seroconversion, the difference between the two groups was significant (Z = -5.110, P = 0.000). The rates of response were 71.4% (15/21) and 16.7% (8/48), respectively, in anti-PreS1 positive group and anti-PreS1 negative group. The rates of complete response were 23.8% (5/21) and 6.25% (3/48), respectively, in these two groups. The positive predictive value (PPV) of anti-C-terminal region of preS1 (94-117aa) antibody in predicting early response was 71.6% and the negative predictive value (NPV) was 83.3%. CONCLUCIONS: Detection of anti-C-terminal region of preS1 (94-117aa) antibody may help to improve the efficacy of INF-alpha therapy for chronic hepatitis B (CHB).

Social influence and individual risk factors of HIV unsafe sex among female entertainment workers in China.

Female entertainment workers in China are at increased sexual risk of HIV, but causes of their unprotected sex remain poorly understood. We develop a model that integrates information-motivation-behavioral skills (IMB) with social influences and test the model in a venue-based sample of 732 female entertainment workers in Shanghai. Most IMB and social influence measures are statistically significant in bivariate relationships to condom use; only HIV prevention motivation and behavioral self-efficacy remain significant in the multiple regressions. Self-efficacy in condom use is the most proximate correlate, mediating the relationship between information and motivation and condom use. Both peer and venue supports are important, but their influences over condom use are indirect and mediated through prevention motivation and/or self-efficacy. Behavioral intervention is urgently needed and should take a multilevel approach, emphasizing behavioral skills training and promoting a supportive social/working environment.

Causes and consequences of increasing club drug use in China: a descriptive assessment.

Club drugs have quickly become the most widespread "drugs of abuse" in China. Using data from a convenience sample of 730 club drug users in Shanghai in 2006 , we explored the causes and consequences of club drug use. Descriptive analyses suggest that club drug use is typically polydrug use. Polydrug use is strongly associated with weakened social control, drug use social influences, and a sensation-seeking personality; in addition, it is associated with more negative health and social consequences. Both polydrug and single-club-drug users are at high risk of sexually acquiring and/or transmitting HIV. The study's limitations are noted, and future research is suggested.

Gender, work, and HIV risk: determinants of risky sexual behavior among female entertainment workers in China.

We proposed to integrate cognitive and social factors in the study of unprotected commercial sex. Data from 159 female entertainment workers from 15 establishments in Shanghai who reported commercial sex in the month prior to interview were used to test the approach. Two-sample t tests and multivariate logistic regression were conducted to examine if and how individual cognitive and social influence factors affect the odds of consistent condom use. About 21% of participants reported consistent condom use. Both individual cognitive and social influence factors were important correlates of condom use; models containing either alone suffered significantly in explanatory power. Perceived easiness in condom use was the most proximate determinant of condom use. It helped to translate HIV knowledge and prevention motivation into behavior and to mediate the impact of sexual relationship power. Prevention intervention is urgently needed and should focus on self-efficacy training and promoting supportive social and working environments.

Gender, migration, risky sex, and HIV infection in China.

Gender differences in sexual behavior as a consequence of migration have been ignored in both the migration and the HIV literature in China. This study examines differences among temporary migrants in terms of sexual behavior and factors that make female migrants more vulnerable to the risk of acquiring HIV infection. Results suggest that the interplay of migration and gender renders female temporary migrants particularly vulnerable to engaging in casual and commercial sex. Although male temporary migrants do not differ from male nonmigrants in prevalence of casual and commercial sex, the prevalence rates of casual and commercial sex for female temporary migrants are found to be 14 and 80 times those for female nonmigrants, respectively. Female temporary migrants' higher unemployment rate and concentration in the service and entertainment sectors are keys to understanding differences in the prevalence of casual and commercial sex among temporary migrants according to sex. Policy measures to promote female temporary migrants' equal access to employment are urgently needed to improve their economic well-being and to reduce their risky sexual behavior.

Risky sexual behavior among female entertainment workers in China: implications for HIV/STD prevention intervention.

Using qualitative information from in-depth interviews of 40 female entertainment workers (FEWs) in Shanghai, this article explores factors associated with unprotected sex and barriers to consistent condom use among FEWs. Results suggest that not all FEWs were at high risk, nor did they all engage in unprotected sex for the same reasons. Prevalence of unprotected sex varied by individual characteristics, across different settings where commercial sex took place, and by the FEWs' relationship to pimps or establishment owners. Factors contributing to unprotected sex included lack of HIV transmission knowledge, economic hardship, client refusal/coercion, and control by pimps/establishment owners. Incorrect beliefs also contributed to use of methods that offered no protection. Study participants endorsed the need for HIV/sexually transmitted disease prevention, but were suspicious about government programs. Prevention interventions need to target simultaneously clients of commercial sex and pimps/business owners and to promote a social environment supportive of 100% condom use in commercial sex.