ObjectivesTo compare the efficacy and safety of innovator infliximab (INX) and CT-P13, an INX biosimilar, in active rheumatoid arthritis patients with inadequate response to methotrexate (MTX) treatment.MethodsPhase III randomised, double-blind, multicentre, multinational, parallel-group study. Patients with active disease despite MTX (12.5–25 mg/week) were randomised to receive 3 mg/kg of CT-P13 (n=302) or INX (n=304) with MTX and folic acid. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 30. Therapeutic equivalence of clinical response according to ACR20 criteria was concluded if the 95% CI for the treatment difference was within ±15%. Secondary endpoints included ACR response criteria, European League Against Rheumatism (EULAR) response criteria, change in Disease Activity Score 28 (DAS28), Medical Outcomes Study Short-Form Health Survey (SF-36), Simplified Disease Activity Index, Clinical Disease Activity Index, as well as pharmacokinetic (PK) and pharmacodynamic (PD) parameters, safety and immunogenicity.ResultsAt week 30, ACR20 responses were 60.9% for CT-P13 and 58.6% for INX (95% CI −6% to 10%) in the intention-to-treat population. The proportions in CT-P13 and INX groups achieving good or moderate EULAR responses (C reactive protein (CRP)) at week 30 were 85.8% and 87.1%, respectively. Low disease activity or remission according to DAS28–CRP, ACR–EULAR remission rates, ACR50/ACR70 responses and all other PK and PD endpoints were highly similar at week 30. Incidence of drug-related adverse events (35.2% vs 35.9%) and detection of antidrug antibodies (48.4% vs 48.2%) were highly similar for CT-P13 and INX, respectively.ConclusionsCT-P13 demonstrated equivalent efficacy to INX at week 30, with a comparable PK profile and immunogenicity. CT-P13 was well tolerated, with a safety profile comparable with that of INX.ClinicalTrials.gov IdentifierNCT01217086

Highlights Students report moderate-to-severe psychological impact of the COVID-19 pandemic. Timely and adequate health information has protective psychological effect. Health care workers are less likely to be psychologically affected. Home quarantine is associated with depression, anxiety and stress symptoms.

The coronavirus disease (COVID-19) pandemic has impacted the economy, livelihood, and physical and mental well-being of people worldwide. This study aimed to compare the mental health status during the pandemic in the general population of seven middle income countries (MICs) in Asia (China, Iran, Malaysia, Pakistan, Philippines, Thailand, and Vietnam). All the countries used the Impact of Event Scale–Revised (IES-R) and Depression, Anxiety and Stress Scale (DASS-21) to measure mental health. There were 4479 Asians completed the questionnaire with demographic characteristics, physical symptoms and health service utilization, contact history, knowledge and concern, precautionary measure, and rated their mental health with the IES-R and DASS-21. Descriptive statistics, One-Way analysis of variance (ANOVA), and linear regression were used to identify protective and risk factors associated with mental health parameters. There were significant differences in IES-R and DASS-21 scores between 7 MICs (p<0.05). Thailand had all the highest scores of IES-R, DASS-21 stress, anxiety, and depression scores whereas Vietnam had all the lowest scores. The risk factors for adverse mental health during the COVID-19 pandemic include age <30 years, high education background, single and separated status, discrimination by other countries and contact with people with COVID-19 (p<0.05). The protective factors for mental health include male gender, staying with children or more than 6 people in the same household, employment, confidence in doctors, high perceived likelihood of survival, and spending less time on health information (p<0.05). This comparative study among 7 MICs enhanced the understanding of metal health in the general population during the COVID-19 pandemic.

The novel Coronavirus-2019 (COVID-19) was declared a pandemic by the World Health Organization (WHO) in March 2020, impacting the lifestyles, economy, physical and mental health of individuals globally. This study aimed to test the model triggered by physical symptoms resembling COVID-19 infection, in which the need for health information and perceived impact of the pandemic mediated the path sequentially, leading to adverse mental health outcomes. A cross-sectional research design with chain mediation model involving 4612 participants from participating 8 countries selected via a respondent-driven sampling strategy was used. Participants completed online questionnaires on physical symptoms, the need for health information, the Impact of Event Scale-Revised (IES-R) questionnaire and Depression, Anxiety and Stress Scale (DASS-21). The results showed that Poland and the Philippines were the two countries with the highest levels of anxiety, depression and stress; conversely, Vietnam had the lowest mean scores in these areas. Chain mediation model showed the need for health information, and the perceived impact of the pandemic were sequential mediators between physical symptoms resembling COVID-19 infection (predictor) and consequent mental health status (outcome). Excessive and contradictory health information might increase the perceived impact of the pandemic. Rapid COVID-19 testing should be implemented to minimize the psychological burden associated with physical symptoms, whilst public mental health interventions could target adverse mental outcomes associated with the pandemic.

Background: Patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) are perceived to be more vulnerable to worse COVID-19 infection outcome. Furthermore, severe shortage in hydroxychloroquine supply was experienced. Objective: We presented the psychological responses of Filipino SLE and RA patients to the COVID-19 pandemic and shortage of hydroxychloroquine supply. Methods: A total of 512 completed online surveys from SLE and RA patients were gathered from May 19 to 26, 2020. The online survey collected data on socio-demographics, health status, contact history, health service utilization, use of hydroxychloroquine, COVID-19 knowledge and concerns, precautionary measures, information needs, the validated Impact of Events Scale-Revised (IES-R) and Depression, Anxiety and Stress Scales (DASS-21) ratings. Results: The psychological impact of COVID-19 outbreak was at least moderate in 20%. The mean IES-R score was higher among SLE (22.34, SD=14.39) than RA (18.85, SD=13.24) patients. Stress, anxiety and depression were moderate to severe in 12.3%, 38.7%, and 27.7% of respondents. The mean stress subscale score was 10.11 (SD=7.95), mean anxiety subscale score was 6.79 (SD=6.57) and mean depression subscale score was 9.03 (SD=8.77). The risk factors for adverse mental health during the COVID-19 pandemic include the presence of comorbidity of hypertension and asthma; being a healthcare worker; and presence of specific symptoms of myalgia, cough, breathing difficulty, dizziness and sore throat. The protective factors for mental health during the pandemic include satisfaction with available health information and wearing of face masks. Conclusion: In the third month of the pandemic in the Philippines, 20% of the respondents with lupus and RA experienced moderate to severe psychological impact. There was moderate to severe anxiety in 38.7% and moderate to severe depression in 27%. Identification of factors that affect mental health in lupus and RA is useful in implementation of effective psychological support strategies.

Objective: The differences between the physical and mental health of people living in a lower-middle-income country (LMIC) and upper-middle-income country (UMIC) during the COVID-19 pandemic was unknown. This study aimed to compare the levels of psychological impact and mental health between people from the Philippines (LMIC) and China (UMIC) and correlate mental health parameters with variables relating to physical symptoms and knowledge about COVID-19.Methods: The survey collected information on demographic data, physical symptoms, contact history, and knowledge about COVID-19. The psychological impact was assessed using the Impact of Event Scale-Revised (IES-R), and mental health status was assessed by the Depression, Anxiety, and Stress Scale (DASS-21).Findings: The study population included 849 participants from 71 cities in the Philippines and 861 participants from 159 cities in China. Filipino (LMIC) respondents reported significantly higher levels of depression, anxiety, and stress than Chinese (UMIC) during the COVID-19 (p &lt; 0.01) while only Chinese respondents' IES-R scores were above the cut-off for PTSD symptoms. Filipino respondents were more likely to report physical symptoms resembling COVID-19 infection (p &lt; 0.05), recent use of but with lower confidence on medical services (p &lt; 0.01), recent direct and indirect contact with COVID (p &lt; 0.01), concerns about family members contracting COVID-19 (p &lt; 0.001), dissatisfaction with health information (p &lt; 0.001). In contrast, Chinese respondents requested more health information about COVID-19. For the Philippines, student status, low confidence in doctors, dissatisfaction with health information, long daily duration spent on health information, worries about family members contracting COVID-19, ostracization, and unnecessary worries about COVID-19 were associated with adverse mental health. Physical symptoms and poor self-rated health were associated with adverse mental health in both countries (p &lt; 0.05).Conclusion: The findings of this study suggest the need for widely available COVID-19 testing in MIC to alleviate the adverse mental health in people who present with symptoms. A health education and literacy campaign is required in the Philippines to enhance the satisfaction of health information.

ObjectiveTo evaluate the efficacy and safety of the immunotherapeutic vaccine interferon-α kinoid (IFN-K) in a 36-week (W) phase IIb, randomised, double-blind, placebo (PBO)-controlled trial in adults with active systemic lupus erythematosus (SLE) despite standard of care.MethodsPatients with SLE (185) with moderate to severe disease activity and positive interferon (IFN) gene signature were randomised to receive IFN-K or PBO intramuscular injections (days 0, 7 and 28 and W12 and W24). Coprimary endpoints at W36 were neutralisation of IFN gene signature and the BILAG-Based Composite Lupus Assessment (BICLA) modified by mandatory corticosteroid (CS) tapering.ResultsIFN-K induced neutralising anti-IFN-α2b serum antibodies in 91% of treated patients and reduced the IFN gene signature (p<0.0001). Modified BICLA responses at W36 did not statistically differ between IFN-K (41%) and PBO (34%). Trends on Systemic Lupus Erythematosus Responder Index-4, including steroid tapering at W36, favoured the IFN-K and became significant (p<0.05) in analyses restricted to patients who developed neutralising anti-IFN-α2b antibodies. Attainment of lupus low disease activity state (LLDAS) at W36 discriminated the two groups in favour of IFN-K (53% vs 30%, p=0.0022). A significant CS sparing effect of IFN-K was observed from W28 onwards, with a 24% prednisone daily dose reduction at W36 in IFN-K compared with PBO (p=0.0097). The safety profile of IFN-K was acceptable.ConclusionsIFN-K induced neutralising anti-IFN-α2b antibodies and significantly reduced the IFN gene signature with an acceptable safety profile. Although the clinical coprimary endpoint was not met, relevant secondary endpoints were achieved in the IFN-K group, including attainment of LLDAS and steroid tapering.Trial registration numberNCT02665364.

As the empirical literature on maladaptive eating patterns has grown, the importance of longitudinal studies in establishing causal risk factors has become apparent. The current study reports longitudinal data gathered from the first 20 months of college for female students (n=117). Eating pathology was assessed using a composite measure from the Eating Disorders Inventory. Variables examined as potential risk factors included depression, reassurance seeking, perfectionism, impulsiveness, body dissatisfaction, and stressful events. Eating symptoms were quite stable across the 20-month interval (r=0.68). Although all of the potential risk variables showed significant correlations with eating symptoms, hierarchical regressions controlling for eating symptoms at Time 1 indicated that perfectionism, impulsiveness, and body dissatisfaction failed to uniquely add to the prediction of eating symptoms at Time 2. Depression, reassurance seeking and stressful events did add to this prediction. Failure to find support for variables in a longitudinal design may be due to the age of participants and relative stability of eating symptoms. Perfectionism, and body dissatisfaction may play a causal role in developing eating symptoms at earlier ages, but do not continue to influence the course of these symptoms in late adolescence. Negative affect (depression), needing reassurance in social relationships, and having to deal with stressful events seem to be risk factors for increased eating symptoms in late adolescence.