Personalised anti-TNF therapy in Crohn’s disease study concludes
You may remember that we announced our £60,000 investment into the personalised anti-TNF therapy in Crohn’s disease study (PANTS), last year.
Although anti-TNF drugs have given new hope for people with Crohn’s Disease and Ulcerative Colitis, and provided an important treatment option, they do not work in some patients. The research looked at the factors involved in why treatment fails many people with Crohn’s disease.
The study aimed to identify clinical and pharmacokinetic factors that predict primary non-response at week 14 after starting treatment, non-remission at week 54, and adverse events leading to drug withdrawal.
1,610 Crohn’s Disease patients were recruited and evaluated for 12 months or until drug withdrawal. Demographic data, smoking status, age at diagnosis, disease duration, location, and behaviour, previous medical and drug history, and previous Crohn’s disease-related surgeries were recorded at baseline. At every visit, disease activity score, weight, therapy, and adverse events were recorded; drug and total anti-drug antibody concentrations were also measured.
The PANTS study showed that about a quarter of patients had no response to the drugs and in one-third of initial responders, the drug stopped working within the first year of treatment. Nearly ten per cent of people experienced harmful side effects that resulted in the treatment being stopped. Overall 37 per cent of patients starting anti-TNF drugs were well and still on treatment at the end of the first year.
Anti-TNF drugs are large, complex molecules and repeated administration causes the immune system to recognise the drug as a potential threat rather than a medicine. This leads to the production of antibodies. These anti-drug antibodies block the action of anti-TNF drugs and increase the rate at which the drugs are removed from the body, reducing drug levels and the effectiveness of treatment.
Dr Tariq Ahmad, of the University of Exeter Medical School, who led the research, said: “The results from the PANTS study suggest there are opportunities to optimise the use of anti-TNF therapies to increase treatment effectiveness. In particular, our data suggests that early personalised dosing, guided by blood level monitoring, together with the use of thiopurine or methotrexate therapy, may help achieve optimal drug levels and minimise the risk of anti-drug antibody formation. We now have cheaper versions of infliximab and adalimumab which means that personalised dose intensification is now more affordable.”
Clinical trials are required to investigate whether personalised induction regimens and treatment-to-target dose intensification improve outcomes.
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