A retrospective meta-analysis «Isaacs JD, Cohen SB, Emery P, ym. Effect of baseli...»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.
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).
General comment: The pooled analysis was conducted using data from 16 patient registries from Europe and Asia «Courvoisier DS, Chatzidionysiou K, Mongin D, ym. T...»3.
Among patients treated with rituximab, a clear difference was observed between those with seropositive and seronegative disease: the difference in LUNDEX remission was +5.9%, and in low disease activity +11.6%. The LUNDEX index takes both treatment persistence and treatment response into account. In addition, there is at least one large meta-analysis «Maneiro RJ, Salgado E, Carmona L, ym. Rheumatoid f...»4 and one systematic review «de Lemos LL, Costa Jde O, Machado MA, ym. Rituxima...»5 in which the same finding is confirmed. The studies are considered reliable and generalizable to the Finnish population.
Parts of the text were translated from Finnish into English using artificial intelligence. The translation was reviewed by an expert.