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Clinical remission and clinical response odds, in both induction and maintenance periods, have been consistent over time.
A team, led by Fernando Magro, Department of Gastroenterology, São João University Hospital Center, identified time trends in clinical response and clinical remission rates for patients with Crohn’s disease treated with biologics.
In recent years there has been a flux of biologics to garner approval from the US Food and Drug Administration (FDA), for either Crohn’s disease or ulcerative colitis.
“Over the last decade, the number of biological agents with alternative mechanisms of action has gradually increased, resulting in considerable number of therapeutic options for patients with IBD,” the authors wrote.
In the study, the investigators culled randomized placebo-controlled trials involving biological agents in patients with moderate-to-severe Crohn’s disease.
They conducted sub-group and meta-regression analyses to compare treatment and placebo by calculating the pooled odds ratios (OR) of clinical remission and clinical response, across time categories, and publication year.
Finally, they estimated the proportion of patients who achieved clinical remission and clinical response by comparing both groups by publication year.
Overall, the investigators identified 25 studies involving 8879 patients between 1997-2022. The results show clinical remission and clinical response odds, in both induction and maintenance periods, have been consistent over time.
In fact, there was no statistically significant differences found between time categories (clinical remission induction, P = 0.19; maintenance, P = 0.24; clinical response Induction, P = 0.43; maintenance, P = 0.59).
The meta-regression analyses showed that publication year ultimately did not influence the clinical outcomes (clinical remission induction: OR, 1.01; 95% CI, 0.97–1.05; P = 0.72; clinical response induction: OR, 1.01; 95% CI, 0.97–1.04; P = 0.63; maintenance: OR, 1.03 95% CI, 0.98–1.07; P = 0.21).
However, there was 1 exception in that publication year resulted in a decreased effect of clinical remission in maintenance studies (OR, 0.97; 95% CI, 0.94-1.00; P = 0.03).
“No differences in terms of clinical outcomes (response or remission) were identified across temporal categories in both induction and maintenance phases,” the authors wrote. “Moreover, the comparison between the intervention and the placebo groups does not appear to be affected by the publication year. However, a progressive narrowing of the difference between active treatment and placebo can be observed, especially in clinical remission in maintenance studies, which aligns with our meta-regression results.”
Overall, no true patterns emerged.
“The present systematic review highlighted that the achievement of clinical outcomes in CD patients receiving biological treatment has not shown any clear pattern of change over the years,” the authors wrote. “Moreover, specific characteristics, such as disease duration, may not have any noticeable effect.”
Magro, F., Moreira, P. L., Catalano, G., Alves, C., Roseira, J., Estevinho, M. M., Silva, I., Dignass, A., Peyrin‐Biroulet, L., Danese, S., Jairath, V., Dias, C. C., & Santiago, M. (2023). Has the therapeutical ceiling been reached in crohn's disease randomized controlled trials? A systematic review and meta‐analysis. United European Gastroenterology Journal. https://doi.org/10.1002/ueg2.12366