- Van Linschoten RCA, et al. Clinical outcomes of increased verus conventional adalimumab dose inervals in patients with Crohn´s disease in stable remission. OP106, UEG Week 2022, Vienna, Austria, 8–11 October.
An open-label, multicentre, randomised-controlled, non-inferiority trial assessed the clinical outcomes of an increased adalimumab dose interval compared with conventional dosing in MC patients in stable remission1. All 174 patients were in steroid-free clinical remission, while on adalimumab maintenance therapy (40 mg adalimumab, every other week, for at least 9 months). Patients (n=113) were randomised to increase adalimumab dose interval from 2 to 3 and then to 4 weeks, or to continue the conventional dose interval of 2 weeks. The primary study endpoint was the incidence of persistent flares.
The cumulative incidence of persistent flares at week 48 in the intervention group (3/109) was non-inferior compared with the control group (0/609). In addition, the cumulative incidence of transient flares was similar between the groups. “A dose extension was possible in most of the patients in the intervention group, only 10% had to go back to the conventional dose interval,” Dr Reinier van Linschoten (Franciscus Gasthuis en Vlietland, the Netherlands) explained.
At week 48, 91% of the control group and 71% of the intervention group were in clinical remission. Neither disease activity nor quality-of-life differed between the control and the intervention group (all pooled P-values >0.05). However, the intervention group used more rescue mediation. Patients in the intervention group showed an increase in gastrointestinal disorders, mainly mild gastrointestinal side effects. A difference was also noted regarding the infection-associated adverse events: Per 100 person-years 60 infection-related adverse events occurred in the intervention group versus 75 in the control group.
“Increasing the adalimumab dose interval is a possible treatment strategy. However, there are some negative consequences like an increase in escape medication and fewer patients in clinical remission at week 48,” Dr van Linschoten concluded. Therefore, this approach should be discussed individually with the patient.