These findings were derived from a study that gathered medical records from 151 patients suffering from RA, who were treated with rituximab. Follow up was conducted for a minimum of 12 months after start of treatment. Majority of the patients were also taking a drug called a disease-modifying anti-rheumatic (DMARD). The duration of the disease was 15 years on average.
Most of the participants were treated with a 1,000-mg IV infusion of rituximab on Days 1 and 15, with an as-needed retreatment option in the event of a disease flare. A smaller cohort, comprised of 17 RA patients, was given 500 mg of the drug 2 weeks apart. Most of the patients in the latter group received retreatment with the 1,000 mg dose.
The clinical response was measured using the 28-joint Disease Activity Score (DAS28), European League Against Rheumatism response criteria and the number of participants who achieved disease remission or low disease activity – defined as having a DAS28 under 2.6 and 3.2, respectively.
128 patients received 2 treatment courses, 76 received 3 treatment courses and 42 received 4 treatment courses (the mean time for the first 4 courses varied from 11 and 13 months).
The researchers noted the average DAS28 to be 5.4 at baseline, which was reduced to 3.3 after initial treatment. The score decreased to 3.1 following 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,” as in the press release.
After the first and second treatment courses, the DAS28 significantly decreases. The trend was observed to be similar in patients that previously received 0 or 1 tumor necrosis factor-alpha inhibitor, and in those who received 2 or more. DAS28 improvements were better in seropositive patients as compared to seronegative.
82 serious adverse events (SAEs) were observed, with 12 related to the use of rituximab; 64 adverse events (AEs) out of a total of 196 were connected to the treatment.
