Pharmacokinetic and clinical monitoring through posologic changes in adalimumab intensification regimen from 40 mg every week to 80 mg every other week

ABSTRACT

Background: adalimumab dose escalation is often recommended for inflammatory bowel disease (IBD) patients incases of loss of response (LOR). The usual adalimumabintensification regimen was 40 mg every week. Recently,the pharmaceutical companies commercialized the 80 mginjection pen. In the biosimilars era, this pen was sold atthe same price as the 40 mg pen. Due to this and for patientcomfort, we proposed that our stable intensified adalimumab patients on a 40 mg every-week (ew) regimen change toa dose of 80 mg every-other-week (eow).Aim and methods: an observational study was performedto monitor outcome through this posologic change. Clinical,analytic parameters and adalimumab trough levels wereprospectively obtained at baseline, four and 12 monthsafter posologic change. The evolution of this cohort andcalculates savings were described.Results: thirteen patients were included in the study and themedian time of adalimumab intensification prior to posologic change to 80 mg eow was 32 months (IQR 29-63). Atfour months, all patients maintained adalimumab 80 mgeow. After month 4, two patients returned to the previousregimen after mild worsening, without significant changes in C-reactive protein (CRP), calprotectin or adalimumab-trough-levels. At one year, adalimumab was stoppedin one patient in remission with undetectable levels andpositive adalimumab-antibodies. No significant differencesin adalimumab-trough-levels were noted before and afterthe posologic change. Costs fell from 16,276 €/patient/yearof treatment to 8,812.15 €/patient/year of treatment.Conclusion: in IBD patients with stable response to adalimumab intensification regimen of 40 mg ew, changingto 80 mg eow seems to maintain response and similaradalimumab-trough-levels. Furthermore, it is cost-saving,although some patients may perceive mild symptoms. (AU)