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- Delcoigne, B, et al.
(författare)
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PSYCHIATRIC DISORDERS IN JUVENILE IDIOPATHIC ARTHRITIS - A POPULATION-BASED COHORT STUDY
- 2021
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Ingår i: ANNALS OF THE RHEUMATIC DISEASES. - : BMJ. - 0003-4967 .- 1468-2060. ; 80, s. 939-939
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Juvenile idiopathic arthritis (JIA) may have substantial consequences for quality of life, for instance due to chronic pain, restriction of activities, concern about physical appearance, and treatment protocols that may limit interactions with peers. However, it remains unclear whether children and adolescents with JIA sow a higher incidence of psychiatric disorders compared with the general population.Objectives:To examine the incidence of psychiatric disorders during childhood in JIA patients in Sweden relative to general population controls.Methods:We performed a register- and population-based cohort study including new-onset JIA patients aged 0 to 17 years 1st January 2012 through 31st December 2017. Incident JIA patients were followed-up from the date of their 2nd JIA diagnosis. At this date, five sex-age-region matched individuals were sampled from the general population. Nine psychiatric disorders were defined with ICD-10 codes and associated drugs (ATC codes): psychotic disorders (ICD-10: F20-29; ATC: N05A), mood and anxiety disorders (F30-F43; N05B, N06A, R06AD01, R06AD02, N03AX16), sleeping disorders (F51; N05C, N03AE01), eating and personality disorders (F50, F60-61, F69), neuropsychiatric disorders (F70-F79, F84, F90; N06BA, C02AC02), substance misuse (F10-F19; N07B), suicide attempts (X60-X84, Y10-34) and death by suicide or substance abuse, and all these combined. The follow-up stopped at date of first outcome, migration, death, 18th birthday or end of the study period, whichever occurred first. Incidence rates were calculated and compared by Cox regression analyses, adjusted for age, sex, calendar year, patient’s and family’s history of psychiatric disorder, country of birth, parents’ education level, and comorbidities (IBD, obesity and celiac disease). In sensitivity analyses, we (1.) excluded children with a history of a psychiatric diagnosis at start of follow-up, and (2.) defined the psychiatric disorders based on ICD-10 codes only.Results:We identified 2224 JIA patients (64% girls, mean age: 9.8 years) and 10,264 matched controls. In the JIA cohort, 309 patients developed a psychiatric disorder (all outcomes combined) during 4998 person-years (pyrs), which corresponded to a crude incidence rate (IR) of 6.2 per 100 pyrs (95% confidence interval (CI): 5.5-6.9). The corresponding crude IR for the general population matched controls was 3.6 (3.4-3.9). Comparing these incidence rates resulted in a sex-age adjusted hazard ratio (HR) of 1.66 (95% CI: 1.46-1.89) and a fully adjusted HR of 1.68 (1.47-1.91). Considering specific outcomes, the IRs per 100 pyrs in the JIA population ranged from 0.1 (suicide attempt) to 3.7 (mood and anxiety disorders) (Table 1). No death from suicide was recorded. There was an overlap across the seven outcomes: among all individuals diagnosed with at least one of the psychiatric outcomes during follow-up, 58% were diagnosed with one outcome only, 25% with two and 19% with three or more outcome conditions. The Cox analyses of the 7 outcome groups demonstrated four statistically significant increased risks for psychotic, mood and anxiety, sleeping and neuropsychiatric disorders (Figure 1). The three latter outcomes were correlated to each other (with Cramer’s V coefficient between 0.3 and 0.5). The sensitivity analyses did not substantially modify these findings.Conclusion:The burden of psychiatric illness in individuals with JIA is increased compared to the general population.Table 1.Risk of psychiatric disorders in JIA patients and general population controls.DisordersN events JIAN events controlsIR JIA (95% CI)IR controls (95% CI)All combined3099186.2 (5.5-6.9)3.6 (3.4-3.9)Psychotic25440.5 (0.3-0.7)0.2 (0.1-0.2)Mood1945343.7 (3.2-4.3)2.0 (1.9-2.2)Sleeping1483482.8 (2.4-3.3)1.3 (1.2-1.5)Neuropsychiatric1264422.4 (2.0-2.8)1.7 (1.5-1.9)Eating13550.2 (0.1-0.4)0.2 (0.2-0.3)Substance misuse14490.3 (0.2-0.4)0.2 (0.1-0.2)Suicide attempt7550.1 (0.1-0.3)0.2 (0.2-0.3)IR: crude incidence rate per 100 person-years; CI: confidence interval1 adjustment: see text.Figure 1.Disclosure of Interests:Bénédicte Delcoigne: None declared, AnnaCarin Horne Consultant of: SOBI and Novartis, Soley Omarsdottir: None declared, Johan Reutfors: None declared, Johan Askling Consultant of: Abbvie, Astra-Zeneca, BMS, Eli Lilly, MSD, Pfizer, Roche, Samsung Bioepis, Sanofi, and UCB. These entities have entered into agreements with Karolinska Institutet with JA as principal investigator, mainly in the context of safety monitoring of biologics via the ARTIS national safety monitoring system
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- Reilev, M, et al.
(författare)
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Methodology of the brodalumab assessment of hazards: a multicentre observational safety (BRAHMS) study
- 2023
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Ingår i: BMJ open. - : BMJ. - 2044-6055. ; 13:2, s. e066057-
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Tidskriftsartikel (refereegranskat)abstract
- Safe and effective pharmacological treatment is of paramount importance for treating severe psoriasis. Brodalumab, a monoclonal antibody against interleukin (IL) 17 receptor A, was granted marketing authorisation in the EU in 2017. The European Medicines Agency requested a postauthorisation safety study of brodalumab to address potential safety issues raised during drug development regarding major adverse cardiovascular events, suicidal conduct, cancer and serious infections.Methods and analysisBRodalumab Assessment of Hazards: A Multinational Safety is a multicentre observational safety study of brodalumab running from 2017 to 2029 using population-based healthcare databases from Denmark, Sweden, Norway, Netherlands, Germany and three different centres in Italy. A distributed database network approach is used, such that only aggregate data are exchanged between sites.Two types of designs are used: a case-time-control design to study acute effects of transient treatment and a variation of the new user active comparator design to study the effects of transient or chronic treatment. As comparators, inhibitors of TNF-α, inhibitors of IL-12 and IL-23, and other inhibitors of cytokine IL-17A are included.In the self-controlled case-time-control design, the risk of developing the outcome of interest during periods of brodalumab use is compared within individuals to the risk in periods without use.In the active comparator cohort design, new users of brodalumab are identified and matched to new users of active comparators. Potential baseline confounders are adjusted for by using propensity score modelling. For outcomes that potentially require large cumulative exposure, an adapted active comparator design has been developed.Ethics and disseminationThe study is approved by relevant authorities in Denmark, Norway, Sweden, the Netherlands, Germany and Italy in line with the relevant legislation at each site. Data confidentiality is secured by the distributed network approach. Results will be published in peer-reviewed journals.Trial registration numberEUPAS30280.
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| 21. |
- Reilev, M, et al.
(författare)
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Methodology of the brodalumab assessment of hazards: a multicentre observational safety (BRAHMS) study
- 2023
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Ingår i: BMJ open. - : BMJ. - 2044-6055. ; 13:2, s. e066057-
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Tidskriftsartikel (refereegranskat)abstract
- Safe and effective pharmacological treatment is of paramount importance for treating severe psoriasis. Brodalumab, a monoclonal antibody against interleukin (IL) 17 receptor A, was granted marketing authorisation in the EU in 2017. The European Medicines Agency requested a postauthorisation safety study of brodalumab to address potential safety issues raised during drug development regarding major adverse cardiovascular events, suicidal conduct, cancer and serious infections.Methods and analysisBRodalumab Assessment of Hazards: A Multinational Safety is a multicentre observational safety study of brodalumab running from 2017 to 2029 using population-based healthcare databases from Denmark, Sweden, Norway, Netherlands, Germany and three different centres in Italy. A distributed database network approach is used, such that only aggregate data are exchanged between sites.Two types of designs are used: a case-time-control design to study acute effects of transient treatment and a variation of the new user active comparator design to study the effects of transient or chronic treatment. As comparators, inhibitors of TNF-α, inhibitors of IL-12 and IL-23, and other inhibitors of cytokine IL-17A are included.In the self-controlled case-time-control design, the risk of developing the outcome of interest during periods of brodalumab use is compared within individuals to the risk in periods without use.In the active comparator cohort design, new users of brodalumab are identified and matched to new users of active comparators. Potential baseline confounders are adjusted for by using propensity score modelling. For outcomes that potentially require large cumulative exposure, an adapted active comparator design has been developed.Ethics and disseminationThe study is approved by relevant authorities in Denmark, Norway, Sweden, the Netherlands, Germany and Italy in line with the relevant legislation at each site. Data confidentiality is secured by the distributed network approach. Results will be published in peer-reviewed journals.Trial registration numberEUPAS30280.
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