RESUMO
OBJECTIVE: Real-world secukinumab gastrointestinal-related adverse events (GIRAE) data during treatment for AS and PsA are lacking. We aimed to obtain this through baseline evaluation of pre-existing IBD rates and predictors of GIRAE. METHODS: Patient electronic and paper records commencing secukinumab from 10 UK hospitals between 2016 and 2019 were reviewed. GIRAE after initiation were defined as: definite [objective evidence of IBD (biopsy proven), clear temporal association, resolution of symptoms on drug withdrawal, no alternative explanation felt more likely], probable (as per definite, but without biopsy confirmation) or possible (gastrointestinal symptoms not fulfilling definite or probable criteria). RESULTS: Data for all 306 patients started on secukinumab were analysed: 124 (40.5%) AS and 182 (59.5%) PsA. Twenty-four of 306 (7.8%) experienced GIRAE after starting secukinumab. Amongst patients who developed GIRAE, four (1.3%) had definite, seven (2.3%) probable and 13 (4.2%) possible IBD. All definite cases were patients with AS and stopped secukinumab; two had pre-existing IBD and two (0.7%) were de novo cases of which one required surgical intervention. Seven patients (2.3%) had pre-existing diagnoses of IBD prior to initiation, of which five patients experienced GIRAE. CONCLUSION: Absolute rates of new IBD in patients starting secukinumab are low. The majority of patients developing new GIRAE did not develop objective evidence of IBD or stop therapy. For patients with pre-existing IBD and AS the risk of GIRAE is much higher, and prescribing alternatives should be considered.
Assuntos
Anticorpos Monoclonais Humanizados/efeitos adversos , Artrite Psoriásica/tratamento farmacológico , Doenças Inflamatórias Intestinais/induzido quimicamente , Espondilite Anquilosante/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Vigilância de Produtos Comercializados , Estudos Retrospectivos , Adulto JovemRESUMO
BACKGROUND: The association between psychological distress and area of residence has been extensively discussed and debated. However, the focus has been largely on men and area of residence is often dichotomised to urban and rural. The aim of this study is to examine the association between psychological distress and area of residence in young Australian women using a broader geographical measure. METHODS: Data were from 8961 women aged 19-26 in the 1989-95 cohort of the Australian Longitudinal Study on Women's Health in 2015. The association between area of residence (measured by the Modified Monash Model) and psychological distress (measured by the K10), adjusted for demographic factors, indicators of socioeconomic position and health behaviour characteristics, was analysed using logistic regression. RESULTS: Women in regional centres had lower odds of high to very high psychological distress compared with women in metropolitan areas (adjusted odds ratio 0.73 (95% confidence interval 0.60-0.89)). Women living in large rural towns, medium rural towns and small rural towns/remote/very remote communities had similar levels of psychological distress as women living in metropolitan areas. LIMITATIONS: ALSWH uses self-report questionnaires which may introduce potential self-report bias. The small sample size in areas outside of metropolitan areas resulted in the need to collapse small rural towns, remote communities and very remote communities into one category. CONCLUSIONS: The subtle regional differences in levels of psychological distress in young women in Australia highlights the importance of the link between health and where people live and suggests further work is required to understand the regional differences and encourage location specific mental health services.