Outcomes in Adult Inflammatory Bowel Disease Clinical Trials: Assessment of Similarity Among Participants with Adolescent-onset and Adult-onset Disease.

BACKGROUND AND AIMS: Most paediatric inflammatory bowel disease [IBD] studies are performed after medications are approved in adults, and the majority of participants in these studies are adolescents. We hypothesised that adolescent-onset IBD is not fundamentally different from adult-onset IBD. If this is correct, the value of delaying access to novel drugs in adolescents becomes questioned. METHODS: Data from 11 randomised, double-blind, placebo-controlled, adult Phases 2 and 3 trials of four biologics were analysed. Participants were categorised as having adolescent- or adult-onset disease [diagnosed 12 to <18, or ≥18 years]. Multivariable modelling explored the association between age at diagnosis and response to treatment, after adjustment for disease duration, extent, and severity at baseline. Data from dose arms were pooled to evaluate similarity of therapeutic response between adolescent- and adult-onset IBD within the same trial [not between doses or across trials]. Ratios of odds ratios [ORs] between the two groups were evaluated. RESULTS: Data from 6283 study participants (2575 with Crohn's disease [CD], 3708 with ulcerative colitis [UC]) were evaluated. Of 2575 study participants with CD, 325 were 12-<18 years old at diagnosis; 836 participants [32.4%] received placebo. Of 3708 participants with UC, 221 were 12-<18 years old at diagnosis; 1212 [33%] were receiving placebo. The majority of the ratios of ORs were within 2-fold, suggesting that responses in adolescent- and adult-onset participants are generally similar. CONCLUSION: Data presented lend support for extrapolating efficacy of biologics from adults to adolescents with IBD, which would facilitate earlier labelling and patient access.

Estimation of aboveground biomass of senescence grassland in China's arid region using multi-source data.

Aboveground Biomass (AGB) in the grassland senescence period is a key indicator for assessing grassland fire risk and autumnal pasture carrying capacity. Despite the advancement of remote sensing in rapid monitoring of AGB on a regional scale, accurately monitoring AGB during the senescence period in vast arid areas remains a major challenge. Using remote sensing, environmental data, and 356 samples of grassland senescence period AGB data, this study utilizes the Gram-Schmidt Pan Sharpening (GS) method, multivariate selection methods, and machine learning algorithms (RF, SVM, and BP_ANN) to construct a model for AGB during senescence grassland, and applies the optimal model to analyze spatio-temporal pattern changes in AGB from 2000 to 2021 in arid regions. The results indicate that the GS method effectively enhances the correlation between measured AGB and vegetation indices, reducing model error to some extent; The accuracy of grassland AGB inversion models based on a single vegetation index is low (0.03 ≤ |R| ≤ 0.63), while the RF model constructed with multiple variables selected by the Boruta algorithm is the optimal model for estimating AGB in arid regions during the senescence period (R2 = 0.71, RMSE = 519.74 kg/ha); In the span of 22 years, the annual average AGB in the senescence period of arid regions was 1413.85 kg/ha, with regions of higher AGB primarily located in the northeast and southwest of the study area. The area experiencing an increase in AGB during the senescence period (79.97 %) was significantly larger than that with decreased AGB (20.03 %).