medwireNews: A randomized trial has failed to demonstrate noninferiority of ultra-low dose rituximab to a standard low dose of the drug in patients with rheumatoid arthritis (RA).
The investigators demonstrated that the average decrease in adjusted DAS28-CRP score from baseline to month 3 was noninferior in the 58 patients treated with one dose of the 500 mg ultra-low dose of rituximab compared with the 28 given one standard low dose of 1000 mg. However, this noninferiority was not observed at the 6-month follow-up, and the ultra-low dose of 200 mg, given to 55 patients, could not be tested due to the hierarchical analysis procedure.
Therefore, noninferiority of the 500 or 200 mg doses of rituximab versus the 1000 mg dose “could not formally be established,” reported Lise Verhoef (Sint Maartenskliniek, Nijmegen, the Netherlands) at the EULAR 2019 congress in Madrid, Spain.
However, she said that “ultra-low doses appear effective in the majority of RA patients, judged by [the] DAS28-CRP course over time and B-cell results.” Average DAS28-CRP scores rose from around 2.3 to 2.4 points in the 500 mg group, and fell from approximately 2.4 to 2.1 points in the 1000 mg group. B-cell counts decreased both groups.
Verhoef noted that relative to participants in the 1000 mg group, those in the 500 mg group had a lower incidence of infections (0.52 vs 1.24 per patient–year) but were more likely to experience disease flares (24 vs 10%).
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Ann Rheum Dis 2019; 78: 264–265 (abstract)
European Congress of Rheumatology 2019; Madrid, Spain: 12–15 June