A single 1,000-mg infusion of rituximab significantly slows the development of arthritis among patients at risk for rheumatoid arthritis, according to data published in the Annals of the Rheumatic Diseases.
“According to the current treatment paradigm, treatment of RA is initiated after the clinical onset of the disease,” Paul P. Tak, MD, PhD, of the Amsterdam University Medical Center, told Healio Rheumatology. “With this approach only a small minority of patients achieve disease remission, which is the treatment goal, and many patients need chronic treatment with biopharmaceuticals or targeted small molecules.”
To evaluate the effects of B-cell directed therapy in patients who are at risk for autoantibody-positive RA who never experienced inflammatory arthritis before, as well as to analyze biomarkers that predict the development of arthritis, Tak and colleagues conducted a phase 2b, randomized, double-blind, placebo-controlled study of 82 participants recruited from seven centers across the Netherlands. All participants had arthralgia without any evidence of clinical arthritis in 66 examined joints.
A single 1,000-mg infusion of rituximab significantly slows the development of arthritis among patients at risk for RA, according to data.
The 82 enrolled participants were randomized to receive either a single 1,000-mg infusion of rituximab or placebo, with 41 patients in each group. One member of the placebo group withdrew consent following randomization; thus, 81 participants were included in the primary analysis after a mean followed up of 29 months. The primary outcome was time to the development of clinical arthritis among patients in both groups.
According to the researchers, 37% of the 81 included participants developed arthritis during follow-up. The observed risk for arthritis in the placebo group was 40%, which was decreased by 55% (HR = 0.45; 95% CI, 0.154-1.322) in the rituximab cohort at 12 months. In addition, at the point when 25% of the participants had developed arthritis, treatment with rituximab delayed arthritis by 12 months compared to placebo (P < .0001). The researchers also found that erythrocyte sedimentation rate and the presence of anti-citrullinated -enolase peptide 1 at baseline were significant predictors of arthritis development.
“The results of this study support the view that it may be easier to control the disease process by targeted intervention before signs and symptoms of arthritis have developed, which suggests the existence of a ‘preventive window of opportunity,” Tak said. “With a targeted intervention aimed at eliminating a cell key to the underlying pathogenetic process, the B cell, and influencing their function and products, the results of this study support the concept of a preventive window of opportunity” – by Jason Laday
Disclosure: Tak reports employment with GlaxoSmithKline. Please see the study for all other authors’ relevant financial disclosures.