Top-down treatment by way of infliximab Plus, which is an immunomodulator, goes on to substantially enhance the outcomes for patients with newly diagnosed Crohn’s disease as compared to the accelerated step-up therapy, the UK research has found out.
It is well to be noted that the previous trials had gone on to support the earlier usage of anti-tumor necrosis factor therapy, which happens to be usually in combination with an immunomodulator, wrote the researchers in The Lancet Gastroenterology and Hepatology.
But the most common strategy within the UK and also globally was a faster step-up approach, in which the treatment is escalated until the tendency pertaining to relapse gets controlled, said the researchers.
Notably, the multi-center PROFILE trial went on to enroll 386 patients aged between 16 and 80 who had recently been diagnosed with active Crohn’s disease, and who had raised C-reactive protein, calprotectin, of 200 μg/g or even more, apart from an active inflammation on ileo-colonoscopy.
Interestingly, the patients were stratified based on the blood-based biomarker that was previously found so as to correlate with the requirement for future treatment escalation and thereafter randomized to either top-down therapy or went ahead with the accelerated step-up approach.
After more than 48 weeks of follow-up, the biomarker did not show any clinical utility.
But 79% of patients went on to achieve sustained steroid-free as well as surgery-free remission in the top-down group, vis-à-vis to 15% within the conventional therapy group, which was a 64-percentage point difference, they reported.
The fact is that the top-down treatment also went on to show much better efficacy when it came to attaining endoscopic remission, enhanced quality of life as well as reduced number of flares requiring treatment escalation.
Apparently, it was also safer as compared to conventional therapy for Crohn’s disease, with very few adverse and serious adverse events as well as no increased rate when it comes to infection.
