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In patients with RA and a high adalimumab concentration, dosing interval can be extended
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The dosing interval can be safely extended to every 3 weeks in patients with rheumatoid arthritis on a regimen of adalimumab and with serum trough concentrations of greater than 8 μg/mL, according to findings.
In the 28-week, open-label noninferiority trial, researchers obtained adalimumab serum trough concentrations from 54 patients with RA who had received treatment with adalimumab 40 mg every other week for a minimum of 28 weeks. Patients had no indication for adalimumab adjustment or discontinuation and were not scheduled for surgery within the next 6 months.
Researchers randomized 55 patients with serum trough concentrations of greater than 8 μg/mL at a to one of two regimens: extension of the dosing interval to 40 mg once a day, every 3 weeks (prolongation group) or to continuing with the established interval of every other week (continuation group). The researchers followed both groups for 28 weeks to be certain that new state states of adalimumab were achieved.
Researchers found minimal improvement in mean DAS28 in the prolongation group (change in DAS28 of -0.14) and slight deterioration in the continuation group (change in DAS28 of 0.3). At 28 weeks, the groups had a difference in change of DAS28 of 0.44, favoring the prolongation group.
At week 28, the prolongation group showed a decrease in mean adalimumab concentration from 10.6±2.5 μg/mL to 6.6±2 μg/mL. The concentration was reduced to less than 5 μg/mL in seven patients during the follow-up. Of these patients, one returned to standard dose after having an increase in DAS28 of at least 0.6.
The continuation group showed a slight reduction in concentration at week 28, dropping from 10.4 ±2.4 μg/mL to 9.3±3 μg/mL. At week 28, there was a mean discrepancy between the groups of 2.6 μg/mL.
Adverse events were reported by 14 patients in the continuation group and by two patients in the prolongation group. There were no reports of serious adverse events.
“This study shows that adalimumab-treated RA patients with trough serum concentrations above 8 μg/mL can prolong their dosing interval to once every 3 weeks without an increase in disease activity,” the researchers wrote. “Considering mean change in disease activity, the prolongation group did well. Correspondingly, in most patients, the adalimumab concentration remained above 5 μg/mL, previously shown to be the concentration needed to block [tumor necrosis factor] TNF. In the few patients where adalimumab concentrations decreased slightly below this level, it had no clinical consequences in the 28 weeks thereafter.”
Disclosures: Please see the study for all other authors’ relevant financial disclosures.
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