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September 14th 2023
An analysis of the Phoenix cohort provides insight into responder rates and treatment persistence with infliximab biosimilars among those with no previous exposure to biologics, a previous failure to respond to biologics, or those switching from reference infliximab.
In recent years trial designs have evolved to become increasingly complex and sophisticated with new endpoints that could include patient-reported outcomes, biomarkers, mucosal, and histological healing, central endoscopy reading, and trials that examine both induction and maintenance of remission within the same study.
Guselkumab induction treatment resulted in significantly greater proportions of patients achieving symptomatic remission, clinical response, endoscopy improvement, and histo-endoscopic mucosal improvement at week 12 and symptomatic remission at week 4 compared to placebo.
No statistically significant differences in infusion reaction, serious reaction, or immunogenicity rates were identified between patients switching to an infliximab biosimilar and those who continued treatment on the originator.
Patients in long-remission also presented with fecal bacterial composition that was similar to what was found in the healthy control group and there was a positive correlation between Akkermansia muciniphila abundance and time in remission.
Disease activity and treatment with a small-molecule or an investigation drug were independently linked to an exclusion diet, while a history of stenosis and active disease were associated with fasting.
The results show 52.5% of patients achieved clinical remission at week 96, while 59.0% saw endoscopic improvement, 35.9% achieved endoscopic remission, and 70.5% achieved a clinical response.
Using the bidirectional Montreal classification system, which accounts for disease regression, showed that 90% of patients exhibited inflammatory disease behavior at 5 years, compared to 58% if the hierarchical, unidirectional Montreal classification system was implemented.
At the 6 month follow-up visit, all participants had stable folic acid levels without macrocytic anemia and the monthly questionnaires showed no increase in symptoms or adverse events reported.
The results show 83% of patients in the combination group achieved clinical response at week 12, compared to 61% of the golimumab monotherapy group and 75% of the guselkumab group.
Acute severe ulcerative colitis and a greater number of biologics precoloectomy were linked to an increased probability of acute pouchitis, while older age at colectomy was associated with a decreased probability of acute pouchitis.
There was a 0.9% increase in the first dispensation of infliximab, either the biosimilar or originator during the first year of follow-up, as well as a 16.2% increase in infliximab dose escalation, a 2.4% decrease in the dispensation of antibiotics, and a 2.6% decrease in the new use of prednisone.
The patients that did not undergo colectomy in the infliximab group were more often re-hospitalized because to the need for intravenous corticosteroids at the two-year follow-up compared to the cyclosporine group.
Individuals that did not respond had a lower percentage of naïve T cells compared to responders, while responders had a lower percentage of Th2 and CD4 central memory subsets before vaccination.