A retrospective meta-analysis «Isaacs JD, Cohen SB, Emery P ym. Effect of baselin...»1 of four double-blind, placebo controlled randomised trials (IMAGE, DANCER, SERENE and REFLEX). Funding by Roche Products Ltd.
Inclusion criteria: a diagnosis of RA according to the 1987 ACR criteria for the classification of RA; disease duration ≥ 6 months. 2139 patients (rituximab, n = 1394; placebo, n = 745) had the requisite clinical outcome data at 24 weeks and were included in the meta-analysis. Seropositive was defined RF- and/or ACPA-positive and seronegative was defined that RF- and ACPA-negative.
Patients received rituximab or placebo by intravenous infusion on days 1 and 15 at doses of 2 × 500 mg or 2 × 1000 mg. With the exception of IMAGE, all patients were receiving MTX 10–25 mg/week at a stable dose.
Change from baseline in DAS28-ESR at week 24 was used as the efficacy end point in all analyses presented.
In the rituximab group, seropositive patients experienced an additional mean reduction in DAS28-ESR of 0.35 units (95 % CI 0.12–0.58) at week 24 compared with seronegative patients. This effect was not seen in placebo patients.
The CERERRA is an investigator-led, industry-supported initiative aiming to evaluate clinical aspects of RTX use in patients with RA «Chatzidionysiou K, Lie E, Nasonov E ym. Highest cl...»2. The manuscript was prepared from the authors without any influence by the supporting medical industry.
All 10 participating European registries Czech Republic, Denmark, Finland, The Netherlands, Norway, Russia, Slovenia, Spain, Sweden and Switzerland) submitted fully anonymised datasets with baseline characteristics, including age, gender, disease duration, number of previous synthetic and biological DMARDs, rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibodies (anti-CCP) status of all patients with an established diagnosis of RA who had been treated with RTX.
Clinical response according to reductions in DAS28 and achievement of EULAR response criteria was analysed at 3 and 6 months.
The following predictors of EULAR good response at 6 months were identified in a multivariate analysis: anti-CCP positivity (OR = 2.86, p = 0.003), number of previous DMARDs (OR = 0.84, p = 0.06), ≤ 1 previous biological agents (OR = 1.89, p = 0.04), baseline DAS28 level (OR = 0.74, p = 0.003).