December 31, 2014
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As-needed rituximab delayed need for retreatment, disease flares in patients with RA

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Among patients with rheumatoid arthritis, a significant proportion of those who underwent a treatment-as-needed regimen with rituximab were found to have delayed need for retreatment and disease flare, according to study findings.

The observational study included medical records data for 151 patients with rheumatoid arthritis (RA) who were treated with rituximab and followed up for at least 12 months after the onset of treatment. Most patients were concurrently taking a disease-modifying anti-rheumatic drug (DMARD). Median disease duration was 15 years.

Most patients received 1,000-mg intravenous infusions of rituximab on days 1 and 15, with retreatment given upon disease flare. A small subgroup of 17 patients received 500 mg of rituximab 2 weeks apart, with the majority of these patients receiving retreatment with the 1,000-mg dose.

The researchers measured clinical response through the assessment of change in the 28-joint Disease Activity Score (DAS28), European League Against Rheumatism response criteria and the proportion of patients who achieved disease remission or low disease activity, which was defined as DAS28 of less than 2.6 and less than 3.2, respectively.

One hundred twenty-eight patients received two treatment courses, 76 received three courses, and 42 received four courses, with a mean time to retreatment for the first four courses varying between 11 months and 13 months.

Median DAS28 was 5.4 at baseline, which decreased to 3.3 after initial treatment and again to 3.1 after the second infusion. The researchers reported a median precourse baseline DAS28 of 4.6 prior to the second treatment course and 4.24 prior to the third treatment course.

DAS28 decreases were statistically significant after the first and second treatment courses, with similar responses among patients who had received zero or one prior tumor necrosis factor-alpha inhibitor compared with those who had received two or more, according to the researchers. Additionally, DAS28 improvements were significantly better among seropositive patients compared with seronegative patients.

A total of 82 serious adverse events (SAEs) were reported, with 12 deemed related to the use of rituximab. Of 196 adverse events (AEs) reported, 64 were related to the treatment. Two fatalities included one case of small-cell lung carcinoma and one case of acute leukemia.

Disclosure: See the study for a full list of all authors’ relevant financial disclosures.